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Fen Phen and Primary Arterial Hypertension News for July
Company Completes Enrollment in STRIDE-4;
Conference Call Scheduled for 4:30 p.m. ET Today
HOUSTON, July 28 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals (Nasdaq: ENCY) today announced financial results for the second quarter ended June 30. The Company also announced that it has closed enrollment in
STRIDE-4, a placebo controlled trial evaluating two dosages of Thelin(TM) versus placebo in patients with pulmonary arterial hypertension (PAH). "We have made significant progress in the second quarter towards the completion of our comprehensive Thelin clinical program," said Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals.
"With STRIDE-4 and STRIDE-6 fully enrolled and our pivotal study STRIDE-2 on track to complete enrollment in the third quarter, the Company is successfully advancing its commercialization strategy of marketing the first selective
endothelin antagonist in PAH."
Second Quarter Financial Overview
For the second quarter, the Company reported a net loss of approximately $12.3 million, or $0.23 per basic and diluted share, compared to a net loss of approximately $14.1 million, or $0.32 per basic and diluted share, for the same period last year. The loss in 2003 included a one-time charge of $8.4 million related to acquiring full rights to Thelin(TM). After
removing the $8.4 million charge in 2003, the increased loss in 2004 over 2003 in the second quarter is primarily the result of increased research and development costs associated with our late-stage clinical trial program supporting Thelin(TM).
Revenue for the second quarter of 2004 was approximately $3.4 million compared to $2.2 million for same period in 2003. In the second quarter, the Company's royalties on net sales of Argatroban by GlaxoSmithKline (GSK) increased to $2.0 million from $1.1 million earned in the same period in 2003,
an increase of 76%. Cash, cash equivalents and investments at June 30, 2004, were approximately $60.6 million compared to approximately $85.5 million on December 31, 2003. Updated Guidance
Previously, the Company had announced plans to license rights for marketing Thelin(TM) outside North America. In June 2004, the Company announced its intention to reserve all marketing rights for Thelin(TM). As a result of this change in strategy, the Company expects to incur additional development costs, including costs associated with regulatory filings in countries outside North America. Additionally, during the first six months of
2004, the Company elected to accept patients beyond its original expectations in certain of the clinical trials and added additional human pharmacology studies. The revised outlook for expenses in 2004, detailed below, reflects these additional Thelin(TM) development costs. Royalty revenues during the first six months of 2004 have exceeded original estimates due to higher-than-expected sales of Argatroban by GSK. Encysive has, therefore, revised royalties guidance, also detailed below. Original Outlook Revised Outlook
Royalties $6.7 to $7.6 million $7.5 to $8.5 million Revenues (including royalties) $9.0 to $10.0 million $10.0 to $11.0 million
Expenses (net of Revotar minority interest) $55.0 to $58.0 million $64.0 to $67.0 million Investment income $0.8 to $1.0 million $0.8 to $1.0 million Net loss $(46.0) to $(48.0) million $(54.0) to $(57.0) million Cash and investments at year end $32.0 to $34.0 million $25.0 to $27.0 million Second Quarter Highlights
* GlaxoSmithKline's dedicated hospital sales force continues to make sales inroads for Argatroban, increasing net sales by 76% for the quarter. Encysive is increasing its full-year guidance for Argatroban royalties from $6.7 - $7.6 million to $7.5 - $8.5 million.
* The Company presented new data on Thelin(TM) at the American Thoracic Society Meeting in May, including results from long-term exposure to Thelin(TM) and data demonstrating that 100 mg of Thelin(TM) was as effective as 300 mg.
* Enrollment was closed in STRIDE-6 (bosentan failure study) in June with top line clinical data expected in the fourth quarter of 2004.
* The Company announced its intention to reserve all marketing rights to Thelin(TM). It had previously planned to license rights for marketing the product outside of North America, while preserving for itself U.S. and Canadian rights. The Company intends to allow the market to continue to grow globally before making a final decision on any marketing plans outside North America.
* J. Kevin Buchi, Chief Financial Officer of Cephalon, Inc., joined
Encysive's Board of Directors. STRIDE-4 Closes Enrollment
The Company today also announced that STRIDE-4, a phase III, randomized double-blind, placebo controlled, 18-week safety and efficacy study in patients with PAH, has exceeded its target of enrolling 90 patients. In this trial, patients were randomized to receive one of three treatments:
Thelin(TM) 50 mg once daily; Thelin(TM) 100 mg once daily; or placebo. Upcoming Events
* Adams, Harkness and Hill Inc. investor presentation on August 5, 2004
* Thelin(TM) data to be presented at European Society of Cardiology meeting from August 28 - September 1 in Germany and the European Respiratory Society meeting from September 4-8, 2004, in Scotland.
* Closure of STRIDE-2 enrollment expected in the third quarter 2004
* Participation in UBS investor conference September 27-30, 2004
* Corporate presence at The American College of Chest Physicians, American Heart Association, American College of Rheumatology
* STRIDE-6 (bosentan failure study) top line clinical data Conference Call Information
You may access the conference call scheduled for Wednesday, July 28, 2004, at 4:30 p.m. (ET) either through the call-in number or an audio webcast. The access number for the call is (612) 332-0720. Or, you may participate live online via Encysive's web site at http://www.encysive.com .
The webcast replay will be available, in addition to a call replay,
beginning July 28, 2004, at 8 p.m. ET through August 2, 2004. The telephone replay can be accessed by calling (320) 365-3844 and entering passcode 738874. About Thelin(TM) and PAH
Thelin(TM) is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular
constriction is important. Thelin(TM) is 6,500 fold selective in the targeting of the endothelin A receptor.
Pulmonary arterial hypertension is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries, which are the blood vessels that connect the right side of the heart to the lungs. PAH causes shortness of breath, limits activity, and is eventually fatal unless treated successfully with heart and lung transplant. Primary and secondary PAH are estimated to afflict approximately 80,000 to 100,000 people worldwide, many of whom are children and young women. Side effects of Thelin(TM) seen in the program to date, and which occurred more frequently than in placebo, include liver dysfunction (increased ALT and AST), headache, edema, constipation, nasal congestion and flushing. Because
Thelin(TM) inhibits the metabolism of warfarin, the dose of warfarin should be adjusted downward when co-administered with Thelin(TM). About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs, is recognized for our expertise in small molecule drug development and vascular biology. Argatroban, our first FDA-approved product, is being marketed by GlaxoSmithKline for heparin-induced thrombocytopenia. Encysive Pharmaceuticals is in Phase III development of the endothelin antagonist, Thelin(TM), for pulmonary arterial hypertension. Our majority-owned affiliate, Revotar Biopharmaceuticals AG, is in Phase II development with the selectin antagonist, bimosiamose, in asthma, psoriasis and atopic dermatitis. Encysive Pharmaceuticals has several other research and development programs ongoing for a range of cardiovascular and inflammatory diseases. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com .
Wyeth Posts 4 Percent Drop in 2Q Profit
07.21.2004, 11:43 AM Drug maker Wyeth reported a 4 percent drop in second-quarter profit Wednesday, citing increased research and development costs as the company works to improve its product offerings in the face of ongoing lawsuits over its former diet drugs. The Madison-based maker of antidepressant Effexor and injected arthritis drug Enbrel said net income was $827.3 million, or 62 cents per share. That compares with $864.4 million in the prior year, or 65 cents per share. Analysts surveyed by Thomson First Call had forecast earnings of 59 cents per share. Worldwide net revenue increased 13 percent to $4.2 billion for the second quarter, although the increase would have been only 11 percent excluding the impact of favorable exchange rates. Wyeth's research and development costs during the second quarter were up 17 percent, president and CEO Robert Essner said. Over the last six months, those costs increased 27 percent over the same period in 2003. More than a dozen projects are in late-stage human testing. "What you're seeing now is the emergence into a lot more visibility of a research effort that has been strengthened over the last several years," Essner said. Profit also was down compared to last year because of a one-time gain of $226 million in the second quarter of 2003, when Wyeth sold the rights to seven of its less-important medicines. The company said Wednesday it continued to expect full-year earnings per share of $2.60 to $2.70, vowing "patience and perseverance" in defending itself against litigation from those who opted out of its national diet drug settlement. Wyeth, formerly known as American Home Products, made Pondimin, the fenfluramine half of fen-phen, and a chemical cousin, Redux. "We think that we have very good positions in a very, very large majority of these cases," chief financial officer Ken Martin told analysts. "That's the focus right now. I would expect that the other side would love us to just kind of roll over and put money on the table but that's not where we're at right now." Wyeth officials said Wednesday that there are currently 13 plaintiffs on trial. A Texas jury on April 27 awarded $1 billion to the family of a woman who died after taking one of the now-banned drugs, but Wyeth and legal experts say that award likely will be reduced.
How not to be a health fad junkie If you think yo-yo dieting is a healthy quick fix, then you need to read this. Anne Hart
912.652.0374 l anne.hart@savannahnow.com Got cellulite-fighting sneakers? Excited about the latest research to develop ultrasound waves that bust up fat tissues? Ever popped a diet pill? Were you among the Americans who helped spend an estimated $9.4 billion nationally last year on cosmetic surgery and treatments like Botox and liposuction? If you answered ''yes'' to any of the above, then chances are you're guilty of being a health fad junkie - someone who is quick to yo-yo diet, try the newest metabolism-boosting drug or shell out big bucks for body-shaping surgery. Better to toss the TrimSpa now. Pam Steimle of Memorial Health University Medical Center takes a blood sample form 15 year old Krystle Lawrence at the corporate feel better challenge office in Savannah Mall. John Carrington Savannah Morning News
Health experts say the more effective, more affordable approach to a healthier body is to focus on much larger lifestyle changes. Make a commitment to exercise regularly, for example, rather than spend $234 on MBT fat-busting sneakers from Swiss Masai, which promise a better-looking butt and thighs. Eat a diet rich in whole grains, fruits and veggies, take a multivitamin and quit eating after 8 p.m., rather than hit an overpriced low-carb store or down any of the multitude of high-protein bars on the market today. As a reformed yo-yo dieter, Yalonda Best of Savannah knows all this. In the past few years, she lost pound after pound on Atkins and by taking diet pills such as Adipex Fastin and even the deadly Fen-Phen, before it was pulled from the market. "It all worked at first, every time, but then the weight came back on every time,'' Best said. "One time it came back double.'' She hopes participating in the ''feel better corporate challenge'' will help her stick to a healthy lifestyle - for good. Five Savannah teams are competing in the three-month corporate contest to be the most healthy business. The contest is different from the 20-month "feel better" campaign launched in February involving individuals rather than groups. The corporate effort involves teams of employees of sponsors for the "feel better" campaign - Clear Channel, the Savannah Morning News, WTOC, Savannah Mall and Memorial Health University Medical Center. No quick fix Exercising and eating right for a short period is easy. But within a year, most people are skipping Pilates class and heading back to the drive-thru. Yo-yo dieting not only doesn't have staying power, but has potential health consequences for people who repeatedly lose and regain pounds. ''It's easy to try to find a quick fix, because there are so many different diets rolling out. You're tempted to jump on the band wagon,'' Best said. "But you will only to be disappointed time and time again. The best way to go is to eat healthy, eat small portions, do not overindulge, exercise regularly and drink plenty of water.'' But despite the drawbacks, yo-yo dieting is still a viable option for people following that all-American pursuit - the quick fix. An estimated 50 percent of American women and 25 percent of American men are either dieting or thinking about dieting, The Associated Press reports. "You can't stay on a diet pill for the rest of your life,'' said Helen Hussey, clinical dietician at Memorial Health "It's for the short term. The problem is the people who get hooked on these fads don't have a good healthy, solid foundation for eating in the first place.'' The real challenge is not necessarily losing the weight, Hussey said. ''It's what you do after you lose the weight,'' she said. "They get this idea, 'I've lost this weight (so) I can afford to have this cake.' And they fall right back into their bad habits.'' Overweight people should instead strive to drop a pound a week. "If it comes off slowly, you are most likely to keep it off,'' Hussey said. Educators at the University of California, Berkeley, report that women who began dieting before age 14 were not only heavier, but were also more than twice as likely to have dieted more than 20 times than women who began restricting calories later, The AP reports. Those who begin this pattern of losing and regaining pounds before puberty could disrupt their physical development. Yo-yo dieting may also weaken the immune system, say researchers at the Fred Hutchinson Cancer Research Center in Seattle. In a study of 114 obese, sedentary women ages 50 to 75, researchers measured the effectiveness of natural killer cells, which attack viruses and cancers, AP said. Each woman was asked how many times she had taken off at least 10 pounds in the previous two decades. Among women who had lost weight at least five times, natural killer cell function dropped 30 percent, the researchers reported. The immune cells are part of the body's complex defense against illness and infection. Yo-yo dieting may also leave some people worse off than they would be carrying excess weight, The AP reports. A 2001 article in the Journal of the American College of Cardiology showed yo-yo dieters had 7 percent lower levels of high-density lipoprotein, the good cholesterol. To help make weight loss a gradual and permanent change, communities are being built to get residents to automatically incorporate activity into their lifestyle. The suburban sprawl of strip malls, convenience stores, fast-food joints and subdivisions without sidewalks cause people to drive everywhere. To counter that trend, communities are being built nationally to force people to walk more by mixing housing and businesses. Just look at the King Farm development outside Washington. It's one of the largest and newest ''walkable'' developments, consisting of a mix of townhouses and single-family homes on streets lined with wide sidewalks, according to an AP report. Common areas and parks are scattered throughout. Homes are constructed around a commercial center that mixes office buildings with a grocery store, restaurants and other businesses. Researchers chose King Farm as part of a four-year, $2 million federally funded study to evaluate the effects such communities have on how active residents are and how much they weigh. Federal health officials are developing a model planning code that communities can adopt, using local zoning, ordinances and tax incentives to require sidewalks and other measures to promote walking. Investigators are studying about 2,400 people in 32 neighborhoods, half in Maryland and half in the Seattle area, conducting surveys about their habits and asking them to wear special meters that measure physical activity. Like the proper approach to weight loss, the study is expected to take a little time.
To Prevent Heart Attack, Stroke, Amputation, and Death: A National 'PAD Coalition' Is Formed
Thursday August 5, 3:00 pm ET DENVER, Aug. 5 /PRNewswire/ -- The Vascular Disease Foundation has taken the lead in creating a unique coalition in partnership with 14 other major national public health organizations and professional vascular societies. At its inaugural meeting, the Coalition identified as a top priority the need for a unified, long-term national public awareness campaign about peripheral arterial disease (PAD). Another priority area is to coordinate clinician PAD educational efforts. These activities will be designed to improve the clinical outcomes of individuals with PAD. The inaugural meeting of the PAD Coalition was held on the National Institutes of Health (NIH) campus in Bethesda, MD, on June 17, 2004, in cooperation with the National Heart, Lung, and Blood Institute (NHLBI) of the NIH.
This important day-long meeting brought together vascular healthcare professionals from around the country to create the structure of the Coalition. This structure was first conceived at a strategic planning meeting held in January 2003, at which initial consensus was reached and the rationale underlying the goals of such a national PAD awareness campaign was solidified. The PAD Coalition is co-chaired by Alan T. Hirsch, M.D., past-president of the Vascular Disease Foundation, and Marge Lovell, RN, CCRC, CVN, a current officer of the Foundation. "Individuals with PAD have traditionally not enjoyed the healthcare opportunities afforded individuals with established heart disease. The beneficial impact of the Coalition and its public education campaign is thus expected to be particularly powerful," stated Dr. Hirsch. Members of every major PAD-focused healthcare organization will be working together to design accurate, science-based, PAD-focused educational messages. According to Ms. Lovell, "We should emphasize that the establishment of this unique vascular Coalition is precedent-setting, permitting us to amplify our common mission of serving the public." In addition to the Vascular Disease Foundation, participating organizations included the American Association for Cardiovascular and Pulmonary Rehabilitation; American College of Cardiology; American College of Physicians; American Diabetes Association; American Heart Association; American Podiatric Medical Association; American Radiological Nurses Association; Peripheral Vascular Surgery Society; Society for Clinical Vascular Surgery; Society of Interventional Radiology; Society for Vascular Medicine and Biology; Society for Vascular Nursing; Society for Vascular Surgery; and the Society of Vascular Ultrasound. PAD is a highly prevalent disease characterized by blockages in the arteries of the legs. Individuals with PAD face a markedly increased risk of heart attack, stroke, and death. The build-up of plaque is usually a result of atherosclerosis, or hardening of the arteries -- the same condition that leads to heart artery blockages and heart attack. PAD affects 8-12 million Americans, and one in every five people over the age of 70 has the disease. Advanced age, smoking, diabetes, high blood cholesterol and hypertension are key risk factors. The most common and easily recognized symptom of PAD is discomfort, fatigue, or pain that occurs in the buttock, thigh, or calf muscles when walking, and that is promptly relieved with rest. This symptom is called "claudication." Unfortunately, current data suggest that less than one-half of individuals with PAD know they have the disease and its corresponding increased risk of death. This is believed to be because many individuals with PAD do not experience typical leg symptoms. As well, the use of accurate and safe diagnostic tests for PAD, such as the inexpensive, noninvasive diagnostic examination, called an Ankle-Brachial Index (ABI), remains relatively uncommon in most primary office practices. Early diagnosis of PAD can offer an opportunity to treat risk factors that can slow the progression of the disease and decrease the chance of a heart attack or stroke. Other treatments can decrease leg symptoms, prevent amputation, and improve quality of life. About the Vascular Disease Foundation The Vascular Disease Foundation is a nonprofit, public educational organization dedicated to increasing awareness of the prevention, diagnosis, and management of vascular diseases. Its outstanding board of directors includes physicians, nurses, vascular sonographers, rehabilitation professionals, and clinical researchers who have been on the forefront of fighting vascular diseases for many years. For more information on the Vascular Disease Foundation, or on vascular diseases, call 1-866-723-4636 or visit http://www.vdf.org. CONTACT: Sheryl Benjamin, 303-949-8337
ACCP Issues Evidence-Based Clinical Practice Guidelines for Pulmonary Arterial Hypertension July 16, 2004 — The American College of Chest Physicians (ACCP) issued evidence-based clinical practice guidelines for the diagnosis and management of pulmonary arterial hypertension (PAH). These new, comprehensive guidelines, which replace the past consensus statement on this rare but serious condition, are published in the July issue of Chest, and they have been reviewed and endorsed by the American College of Cardiology Foundation, the Pulmonary Hypertension Association, The American Heart Association, and the American College of Rheumatology. "There are many misconceptions about PAH, since it is relatively uncommon, leading to inappropriate reliance on some tests and treatments," panel chair Lewis J. Rubin, MD, from the University of California San Diego School of Medicine in La Jolla, says in a news release. "In addition, symptoms of PAH are similar to other respiratory diseases, such as asthma, and can remain subtle for months or even years. These issues have made diagnosing and managing PAH more difficult and the need for early and accurate testing crucial." Although the true incidence of PAH is difficult to determine, estimated prevalence in the U.S. is greater than 100,000, with several thousand new cases diagnosed each year. PAH affects all ages and ethnic groups, and both sexes, but incidence is highest in women aged 20 to 40 years. The ACCP first formed a consensus panel on primary pulmonary hypertension (PPH) 10 years ago to review the pathobiology, diagnosis, and treatment of PPH. After review of the current evidence provided by the Duke University Center for Clinical Health Policy Research, an international expert interdisciplinary committee of 19 experts wrote the current guidelines to be broader in scope and more evidence-based than the earlier consensus statement and to be targeted toward cardiologists, pulmonologists, rheumatologists, and primary care providers who treat PAH. "The extensive published research on PAH over the past few years affords the development of guidelines that are based on data and experience for a very serious disease," Dr. Rubin says. "When implemented, the guidelines can lead to earlier and more accurate diagnosis of PAH and more appropriate application of therapies now available." By adopting the nomenclature developed at the 1998 World Health Organization International Conference and then updated at the Third World International Conference in 2003, the panel focused on PAH as the topic of this guideline, rather than the narrower topic of PPH covered in the earlier consensus statement. However, they excluded other causes of pulmonary hypertension, such as chronic parenchymal or airways disease and left-sided heart disease. PAH was defined as a mean pulmonary artery pressure of 25 mm Hg or more and pulmonary capillary wedge pressure of 15 mm Hg or less, both measured at rest by right-heart catheterization. Although the panel could not provide specific, evidence-based guidelines addressing thresholds for the timing of diagnostic and therapeutic interventions in suspected or proven PAH, they warn that the serious and life-threatening nature of PAH mandate aggressive management. Topics addressed include screening, early detection, and diagnosis; medical and surgical therapies; diagnosis and treatment of sleep-disordered breathing; and prognosis. Patients clinically suspected to have PAH should have Doppler echocardiography as a noninvasive screening test, even though it is less precise than invasive evaluation. Because obstructive sleep apnea may be an independent risk factor for PAH, patients with PAH should be evaluated for sleep-disordered breathing and treated when indicated. Patients with unexplained PAH should have testing for connective tissue disease and HIV infection. The guidelines also recommend genetic testing for patients with a family history of PAH and advance screening for patients with chronic diseases predisposing them to PAH. According to the guidelines, women with PAH should avoid becoming pregnant because of the high maternal and fetal mortality rates associated with this disease. "Patients in specific populations, such as women who are pregnant and patients with respiratory disease, are at greater risk of developing severe complications as a result of PAH," Dr. Rubin says. "Genetic testing can help to identify patients who are most at risk for developing PAH, allowing clinicians to closely monitor patients and begin treatment at the first sign of the disease." Normal ventilation-perfusion scanning effectively excludes a diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH). In patients with suspected pulmonary hypertension, right-heart catheterization is required to confirm the specific diagnosis, determine the severity, and guide therapy. Patients with idiopathic PAH should have acute vasoreactivity testing by a physician experienced in the management of pulmonary vascular disease, using a short-acting agent such as intravenous epoprostenol, adenosine, or inhaled nitric oxide. In the absence of right-heart failure, patients with a favorable acute response to vasodilator, which is defined as a decrease in mean pulmonary artery pressure of at least 10 to 40 mm Hg with an increased or unchanged cardiac output, should be considered candidates for a trial of therapy with an oral calcium-channel antagonist. However, in the absence of demonstrated acute vasoreactivity, calcium-channel blockers should not be used empirically, because of potentially fatal adverse effects in unstable patients. "Calcium channel blockers are regularly used to treat high blood pressure because they limit calcium entry into the cells and dilate the constricted systemic blood vessels, thereby lowering blood pressure," Dr. Rubin says. "This rationale is frequently applied to their use in PAH; however, when they are used in patients with PAH whose narrowed pulmonary arteries are not caused by dynamic vessel constriction, the side effects can be fatal." Patients with PAH in functional class III who are not candidates for or who have failed treatment with calcium-channel blockers may benefit from long-term therapy with endothelin-receptor antagonists (bosentan), intravenous epoprostenol, subcutaneous treprostinil, inhaled iloprost, or beraprost. Surgical therapies covered in the guidelines are transplantation, pulmonary thromboendarterectomy, and atrial septostomy. Patients with suspected CTEPH may require pulmonary thromboendarterectomy and should be referred to centers experienced in this procedure. PAH patients with New York Heart Association functional class III and IV symptoms should be referred to a transplant center for evaluation and listing for lung or heart-lung transplantation. In these patients, the procedure of choice is a bilateral lung transplantation. "Evidence-based medicine provides a systematic way of practicing medicine based on a comprehensive review of clinical research findings," says Richard S. Irwin, MD, President of the American College of Chest Physicians. "The new evidence-based guideline for pulmonary hypertension combines clinical expertise with extensive external evidence that will enable health care professionals to practice more effective patient-focused care." Actelion Pharmaceuticals U.S., Inc., Encysive Pharmaceuticals, and GlaxoSmithKline supported the development of these guidelines. Some of the authors report various financial arrangements with one or more pharmaceutical companies. Chest. 2004;126: 4S-92S Learning Objectives for This Educational Activity
Upon completion of this activity, participants will be able to:
- Identify the various etiologies of PAH.
- Describe the diagnosis and management of PAH.
Clinical Context
PAH is commonly defined as a mean pulmonary artery pressure of 25 mm Hg or more along with a pulmonary capillary or left atrial pressure of 15 mm Hg or less. Although systems for classifying the etiology of PAH have changed over time, PPH can be secondary to collagen vascular diseases, congenital pulmonary shunts, portal hypertension, HIV infection, or drugs such as anorexigens. PAH, but not PPH, may also be secondary to diseases of other organs beyond the pulmonary vasculature itself: the heart (congestive heart failure), the lungs (chronic obstructive pulmonary disease), or the blood (chronic thromboembolic disease). The authors of the current analysis seek to codify the best available evidence in the diagnosis and management of PAH. Study Highlights
-The current recommendations were presented by researchers at the Duke University Center for Clinical Health Policy Research. A multidisciplinary team was assembled to review the best evidence from 1992 to 2002 that covered the issues of screening, diagnosis, medical therapies, surgical therapies, prognosis, and sleep apnea as related to PAH.
-The first step in the diagnosis of suspected PAH should be Doppler echocardiography. Although this modality cannot reliably estimate pulmonary artery pressures, it may save patients from undergoing more invasive investigations.
-If no cause is obvious for PAH, patients should be evaluated for HIV along with collagen vascular diseases such as scleroderma and mixed connective tissue disease.
-Sleep disordered breathing should also be evaluated in patients with PAH, although the prevalence of PAH in this condition is low. Polysomnography is the test of choice if obstructive sleep apnea is considered. If the degree of pulmonary hypertension is mild, continuous positive airway pressure may help reduce pulmonary artery pressure.
-Patients with PAH should undergo a ventilation-perfusion scan to rule out CTEPH. A normal scan effectively excludes the possibility of chronic pulmonary embolus. The authors recommend against using computed tomographic or magnetic resonance image scanning to rule out chronic thromboembolic phenomena.
-Right-heart catheterization can confirm the diagnosis of PAH in idiopathic cases as well as judge the severity of disease. These data provide the best guide for treatment of PAH.
-Patients' symptoms with routine physical activity along with simple measures, such as the 6-minute walk test, can help predict the relatively heterogenous prognosis of PAH.
-Patients with idiopathic PAH should have acute vasoreactivity testing with intravenous epoprostenol or adenosine. Inhaled nitric oxide may also be used. Patients who experience a decrease in pulmonary artery pressure of at least 10 to less than 40 mm Hg while not having a decrease in cardiac output may be candidates for therapy with oral calcium-channel antagonists. Nifedipine, diltiazem, or amlodipine are most commonly used. Verapamil should be avoided because of negative inotropic effects. Only patients with known vasoreactivity of the pulmonary vasculature should receive these drugs.
-Sildenafil may be considered for PAH patients who fail treatment with calcium-channel blockers.
-Patients with PAH resulting in a marked reduction in physical activity and who have failed therapy with calcium-channel antagonists may receive treatment with bosentan, intravenous epoprostenol, subcutaneous treprostinil, inhaled iloprost, or beraprost.
-Surgery may benefit patients with CTEPH. Lung or heart-lung transplantation may be considered for PAH patients with symptoms associated with minimal physical activity. Bilateral lung transplantation is the preferred surgery for PAH.
Pearls for Practice
Patients with suspected PAH should undergo a routine battery of tests to evaluate their condition and search for treatable causes of secondary PAH.
Calcium-channel blockers should be reserved for PAH patients with documented vasoreactivity of the pulmonary vasculature.
Woman keeps faith in face of illness By Shaylyn Cochran
News Journal July 6th, 2004
MANSFIELD -- Diagnosed with three potentially deadly illnesses, Heidi Lowe of Mansfield kept her faith and decided to put up a fight. The married mother of two was stricken with bronchiolitis obliterans with organizing pneumonia (BOOP) and primary pulmonary hypertension (PHT) this year. She had bouts with asthma and other minor respiratory problems during the last 10 years, but Lowe's health took a sharp turn for the worse in January. "I had an open lung biopsy and several tests, but the doctors couldn't find the origin of the BOOP," she said. Lowe's medical team at The Ohio State Medical Center updated her condition to include pulmonary fibrosis as the main diagnosis with PHT as a secondary condition and BOOP as a side effect of the two. No cures are available for any of the illnesses. "There is no cure," the 40-year-old-said. "All I can do is hope for a transplant as soon as possible." That hope soon may be a reality, according to Lowe's lifelong friend, Raina Rengert. "We're right in the middle of evaluation for the national (donor) list," Rengert said. Lowe needs a double-lung and possibly a heart transplant. Placement on the list depends on her performance on tests. Doctors meet weekly to discuss her progress and completion of the transplant criteria. The woman, who at one point was taking 38 medications daily and has gained 48 pounds because of the steroid treatment, has begun to reduce her external treatment in preparation for a transplant. In the meantime, Lowe is holding onto her faith to get her through this period. A motto on her Web site, ran by the nonprofit organization Caringbridge, is "If God brings you to it, He will see you through it." "We believe in the power of prayer and that God ultimately will finish the plan he started with Heidi," Rengert said. Despite the strong support group that Lowe has in her husband, Tony, parents, sisters and friends, she still needs more assistance. The weeks following the transplant will require the most help from outside sources. Lowe is bedridden about three times a month, but that number is so low only because of the strict advice of her doctors. Staying in bed causes her heart to beat faster and severely worsens her condition. In addition to the physical and emotional strain, financial burdens are another source of heartache for the Lowe family. Lowe's husband has had back surgery and several spinal fusions. He was on disability at the time of his wife's diagnosis and the family was dependent solely on Heidi's income. "I was taking care of him, and now he's trying to fight through his pain and take care of me," Lowe said. An energetic 6-year-old, Luke, and a recently graduated teen, Chad, fulfill the Lowe family. People wishing to help can donate money at any Bank One or visit Lowe's Web site at www.caringbridge.org/oh/heidi and sign the guestbook to find out how to help. The family is in need of basic household items, toiletries or meals. Another way people can help is by becoming organ donors. Daily, more than 15 people die for lack of an organ transplant, according to the Web site livingbank.com. "After about three more tests, I hopefully can start planning for my transplant," Lowe said.
Wyeth seeks relief in fen-phen verdict
Texas judge is asked to grant new trial, reduce $1 billion award July 13, 2004 Bloomberg News
Wyeth, which has set aside more than $16 billion to resolve fen-phen litigation, asked a Texas judge Tuesday to reduce a $1 billion verdict awarded to the family of a woman who died after taking the diet drug. Lawyers for the pharmaceutical company asked Judge Donald Floyd in Beaumont to grant a new trial based on errors they claimed took place during the trial. They also asked him to overturn or cut the verdict to $35 million or less. "The law is very clear," said Wyeth lawyer Leslie Benitez. "There is no basis for the court to avoid the state's punitive damages limitation." Judge Floyd is expected to rule by the end of the month. Cynthia Cappel-Coffey of Beaumont died in January 2003 of primary pulmonary hypertension, a rare lung-shredding disease, after taking the diet drug fen-phen. On April 27, a jury awarded her family $1.5 million in economic damages, $112 million in additional actual damages and $900 million in punitive damages. Texas law limits punitive damages in most circumstances to twice the amount of economic loss, plus $750,000. Richard Clarkson, a lawyer representing the Cappel-Coffey family, said, "The court has reviewed this time and time again. The evidence is more than sufficient" to justify the award.
New Twist In Fen Phen Lawsuit Jul 7, 2004 3:29 pm US/Central
A new development in the battle between a drug maker and thousands of Fen Phen users who say their health was harmed by the diet combination. The victims may get their money. But the amount could be dramatically less than expected. We've told you about the ongoing struggle between victims who took the sometimes-deadly diet combination Fen Phen. Thousands who used the drug were told the drug maker would settle their claims, and pay them for suffering. But it's been three years and few have actually seen any money. April Linder has been waiting three years for half a million dollars. Money that would compensate her for heart valve problems her doctors say are a direct result of taking Fen Phen. Now lawyers who represent about 40 thousand Fen Phen users are contemplating a new deal with the drug maker Wyeth. “It’s a payoff to get people to shut up and go away.” The latest hope for Linder and the others is called the 7th amendment. If accepted, Wyeth would put in another 1 point 27 billion dollars. Those in the class action suit would be guaranteed to get their money by 2005, but the amount would be drastically reduced. In Linder’s case, her promised 500 thousand dollar settlement would be closer to 50 thousand. Lawyers have until the end of June to see how many clients are willing to enter this deal... Attorneys admit it's a gamble, but it's safer than holding out for bigger settlements. At the end of this week, the drug maker and attorneys will evaluate how many victims are willing to enter this compromised agreement. If there's not enough interest, the attorneys will continue to fight it out, trying to get money out of the original trust set up 3 years ago.
Safeguarding medical records Law gives Kansas more authority over patient documents Wed, Jul. 07, 2004
As questions persist over the conduct of an Overland Park doctor, a new Kansas law promises to make it easier for patients to gain access to medical records. The law, which took effect last week, enables the Kansas Board of Healing Arts to seek a court-appointed custodian to safeguard patient records when necessary. “The purpose of the legislation is to give another layer of protection to patients,” said Mark Stafford, general counsel for the Kansas Board of Healing Arts. “When patients and their new physicians do not have access to medical records, their care might suffer.” Implementation of the law comes amid reports that some patients of physician Alan E. Organ are having difficulty getting their records. The Kansas Board of Healing Arts last month revoked Organ's license, citing repeated misuse of prescription drugs. The Missouri Board of Registration for the Healing Arts, citing a similar complaint, is scheduled to consider revoking Organ's license at a July 17 hearing in Kansas City. Aimee Reid, a 28-year-old Kansas City resident and a former patient of Organ's, said she has been unable to obtain copies of her medical records from Organ, whom she stopped going to a couple of years ago. Reid said it is critical for her to get the information because she is part of a class action lawsuit involving fen-phen, the banned diet drug. “When I was going to him, I took fen-phen, and now I have damage from that,” Reid said. She feels “distraught and upset” over her inability to obtain her records, she said.. Organ did not return calls seeking comment for this story. Stafford said the Kansas board had heard from about 15 persons who have tried unsuccessfully to gain access to their records from Organ. Stafford said the Kansas board has not been able to contact Organ in recent weeks, despite repeated attempts. “We're attempting to find a solution,” Stafford said. “We hope to work this out so that a civil case is not necessary. But, if necessary, we are prepared to use the new law and go to court.” Last week, a note on the door of Organ's Overland Park office stated that the office would be closed until today. The note stated that patients should fax requests for medical records to (913) 491-9361. The office was locked one afternoon last week, but a woman who identified herself as Organ's assistant came to the door when a visitor knocked. The woman, who declined to give her name, said she had gotten “quite a few” requests for copies of records from patients. She said the copies would be sent out after Organ and the rest of the staff returned. The woman confirmed a report that Organ was on a Caribbean cruise. “It's a vacation that was planned six months ago,” she said. Stafford said patients or former patients of Organ's who don't have access to a fax machine may call the Kansas Board of Healing Arts at (785) 296-2482 and ask a board staffer to fax a records request to Organ. Noting that some of Organ's patients or former patients live outside Kansas, Stafford said the board will also perform this service for out-of-state residents. Under the new law, the Kansas Board of Healing Arts is authorized to ask a district court to appoint a custodian over a health care provider's records if: • The provider has abandoned the records. • The provider has abandoned the practice. • The provider's license has been suspended, revoked or canceled. • The provider has dissolved his or her business entity. • The provider is unable or refuses to allow patients access to their care records. • The provider has died and his or her patients are unable to access their records. “The information contained within those records belongs to the patients,” said Lawrence Buening, executive director of the Kansas Board of Healing Arts. “Our only concern right now is to protect the public by making sure they are able to access their records and maintain the continuity of their care.” Stafford said records such as lab reports are crucial to patients. “Imagine a person who had some laboratory procedure and was waiting for good news or bad news and never received the result,” he said. “The bad news might go untreated.” A records custodian appointed under the new law will take exclusive possession of the patient records in question and furnish copies to patients or the authorized representatives of patients. The custodian also must maintain the confidentiality of patient records. However, the custodian will not be held liable for the accuracy or completeness of patient records. Stafford said that the board has used a similar procedure in the past, but that the new law codifies the procedure and spells out the various circumstances in which it may be used. He noted that until now, the board could not ask a court to appoint a records custodian in cases in which doctors had died or had lost their licenses. “It was a frustration when we'd find these situations and really lacked the authority to do anything about it,” Stafford said. “It did not happen regularly, but when it did, the potential for harm to patients was great.” The new law was created through House Bill 2813, which was sponsored by Kansas Rep. Mike O'Neal, a Hutchinson Republican. O'Neal said that in earlier years the records of a deceased doctor would be handled on a relatively informal basis by someone such as a secretary or the doctor's spouse. But new federal rules on patient privacy impose strict standards in the handling of patient records. “We know these situations are going to happen in the future, and when they do, we want patients to know they are not in never-never land in terms of getting their records,” O'Neal said. Missouri has no such law, said Tina Steinman, executive director of the Missouri Board of Registration for the Healing Arts. “We do get complaints about patients not being able to obtain their records, but those complaints are not usually about doctors abandoning their patients,” she said. “The few we've had when physicians left the state, we've been able to locate them and resolve the issue.” Stafford and Steinman said that generally patients who want access to their records should first contact their doctors. If that is unsuccessful, those needing help may call (785) 296-2482 in Kansas or (573) 751-0098 in Missouri.
New Guidelines for Evaluation of Angina CME July 6, 2004 — New guidelines for evaluation of chronic stable angina are published in the July 6 issue of the Annals of Internal Medicine. The American College of Physicians (ACP) updated their 1999 guidelines, gearing the American College of Cardiology/American Heart Association (ACC/AHA) 2002 guidelines to the primary care physician. The guidelines address "diagnosis and risk stratification for patients with symptomatic chronic stable angina who have not had an acute myocardial infarction (MI) or revascularization procedure in the previous six months" as well as management of asymptomatic patients with known or suspected coronary artery disease (CAD) based on history or electrocardiographic (ECG) evidence of previous MI, coronary angiography, or abnormal results on noninvasive tests. "This in no way constitutes an endorsement of noninvasive testing in asymptomatic patients for the purpose of 'screening,' but rather acknowledges the clinical reality that patients often present after having such an evaluation," write Vincenza Snow, MD, and colleagues from the Clinical Efficacy Assessment Subcommittee of the ACP. Based on a literature review, the committee recommends first considering age, sex, risk factors, and symptoms to determine the probability of significant CAD. Helpful tests include ECG, exercise stress test, imaging or pharmacologic stress test, and cardiac catheterizaton, which is the most definitive but also the most invasive and risky procedure to diagnose CAD. Risk for CAD, exercise ability, ECG results, and use of medications or pacemakers should help determine optimal testing strategies. For patients at low risk, options for further testing and the corresponding risk-benefit ratios should be discussed, along with preventive strategies. Exercise stress testing is indicated for patients not at low risk who are able to exercise, are not taking digoxin, and have a normal ECG, whereas pharmacologic stress testing is a better alternative in patients unable to exercise and in those with left bundle-branch block or ventricular pacemaker. Stress imaging is indicated for patients with an abnormal ECG or who are taking digoxin. If history or examination findings suggest valvular or pericardial disease or left ventricular dysfunction, echocardiography should be performed. The authors note that these recommendations may change based on new data, and that they do not apply to patients with unstable angina. "In patients presenting with chest pain, the probability of CAD should be estimated on the basis of patient age, sex, cardiovascular risk factors, and pain characteristics (level of evidence, B)," the authors write. "Patients with intermediate or high probability should undergo risk stratification through further testing. For patients with a low probability of CAD, the decision to pursue further testing should be based on a shared discussion between the patient and clinician." The ACP supported this study. Some of the authors report potential financial conflicts of interest with various pharmaceutical and device manufacturing companies. Ann Intern Med. 2004;141:57-64 Learning Objectives
Upon completion of this activity, participants will be able to:
Review the risk factors for CAD and symptoms of angina.
Evaluate the appropriate use of cardiac stress testing in different patient populations.
Clinical Context
Cardiovascular disease remains the number one killer of Americans every year, and there is evidence that our culture contributes to the problem. In an analysis of a homogenous sample of 527 immigrants to the U.S. from southern India, Mooteri and colleagues found that confirmed risk factors, such as hyperlipidemia, hypertension, and diabetes, contributed to an increased risk of CAD. In addition, their study, which was published in the Feb. 1, 2004, issue of the American Journal of Cardiology, also demonstrated that the risk of CAD increased by 6% for each additional year spent in the U.S. This association remained significant in multivariate analysis, although more time in the U.S. was also linked to multiple negative lifestyle choices in terms of diet and exercise. As CAD will continue to be a common and deadly condition in the U.S., appropriate management of patients with angina is critical. The authors of the current guidelines affirm the best practice for these patients. Study Highlights
This article sponsored by the ACP is a summary of the 2002 guidelines for the management of stable angina by the ACC/AHA. The authors defined typical angina as substernal chest discomfort that is provoked by exertion and improved with rest. The current guidelines do not apply to patients with unstable angina.
All patients with suspected stable angina should have a thorough evaluation for traditional CAD risk factors. In addition, physicians should screen for conditions that might increase myocardial oxygen demand, such as hyperthyroidism and cocaine use and decreased oxygen supply, such as anemia and pulmonary disease.
An ECG should be performed on all patients with suspected stable angina, but 50% of patients with angina have a normal ECG. While ECG evidence of left ventricular hypertrophy or ST-T wave changes predict CAD, atrial fibrillation, ventricular tachyarrhythmias, left bundle-branch block, or bifascicular block are less specific. Chest radiography or electron-beam computed tomography (CT) is not recommended in the workup of stable angina. CT has been associated with a sensitivity of 90.5% and specificity of 49.2% in diagnosing CAD in highly selected patients.
Patients with at least a moderate clinical risk of CAD should undergo cardiac stress testing, whereas the decision to pursue further testing should be a decision between physician and patient among patients considered at low risk for CAD.
Evaluation of left ventricular function, either with echocardiography or radionuclide scanning, is not necessary for most patients with symptoms of stable angina. However, this evaluation should be considered for patients with a history of MI, patients with pathologic Q waves, patients with symptoms of congestive heart failure (CHF), or patients with complex ventricular arrhythmias. Even if symptoms of CHF are absent, decreased left ventricular ejection fraction implies a worse prognosis.
Exercise ECG testing using the Bruce protocol is recommended as the initial test to analyze stress ischemia among patients with symptoms of stable angina who can exercise and are not taking digoxin. Patients with stable angina and ECG abnormalities, such as Wolff-Parkinson-White syndrome, ventricular pacing, more than 1 mm of ST depression at rest, and complete left bundle-branch block, should not undergo exercise ECG testing. Stress imaging studies have a greater sensitivity for these patients.
In patients with ventricular pacing or complete left bundle-branch block, myocardial perfusion imaging using dipyridamole or adenosine is recommended as an initial cardiac stress test regardless of the patient's ability to exercise. Nuclear studies using chemical stress are more sensitive in these patients.
Stress imaging instead of exercise should also be considered as an initial test for patients with a history of documented CAD or revascularization.
Cardiac stress testing or CT studies are not recommended to screen asymptomatic patients for CAD. The point of such testing is to find patients with asymptomatic lesions who would gain a survival benefit from revascularization procedures, and such patients are rare.
Encysive Pharmaceuticals Reiterates Guidance for STRIDE-2 Trial Enrollment
HOUSTON, July 6, 2004 (PRIMEZONE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today confirmed that enrollment in the STRIDE-2 clinical trial is expected to complete in the third quarter of 2004. Enrollment is close to three quarters complete in this 240 patient study. The Company expects to provide its next update when STRIDE-2 has been fully enrolled. STRIDE-2 is a Phase III, randomized, double-blind, placebo-controlled safety and efficacy study of Thelin(tm) treatment with an open-label bosentan arm in patients with pulmonary arterial hypertension (PAH). Patients are randomized to receive one of four treatments: Thelin 50 mg once daily, Thelin 100 mg once daily, placebo once daily, or bosentan twice daily according to the package insert. The duration of the trial is 18 weeks. About Thelin(tm) and PAH Thelin is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. Thelin is 6,500 fold selective in the targeting of the endothelin A receptor. Pulmonary arterial hypertension (PAH) is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries, which are the blood vessels that connect the right side of the heart to the lungs. PAH causes shortness of breath, limits activity, and is eventually fatal unless treated successfully with heart and lung transplant. Primary and secondary PAH are estimated to afflict approximately 80,000 to 100,000 people worldwide, many of whom are children and young women. Side effects of Thelin(tm) seen in the program to date, and which occurred more frequently than in placebo, include liver dysfunction (increased ALT and AST), headache, edema, constipation, nasal congestion and flushing. Because Thelin inhibits the metabolism of warfarin, the dose of warfarin should be adjusted downward when co-administered with Thelin. About Encysive Pharmaceuticals Encysive Pharmaceuticals Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs, is recognized for our expertise in small molecule drug development and vascular biology. Argatroban, our first FDA-approved product, is being marketed by GlaxoSmithKline for heparin-induced thrombocytopenia. Encysive Pharmaceuticals is in Phase III development of the endothelin antagonist, Thelin, for pulmonary arterial hypertension.
Our majority-owned affiliate, Revotar Biopharmaceuticals AG, is in Phase II development with the selectin antagonist bimosiamose in asthma, psoriasis and atopic dermatitis. Encysive Pharmaceuticals has several other research and development programs ongoing for a range of cardiovascular and inflammatory diseases. To learn more about Encysive Pharmaceuticals please visit our web site: www.encysive.com This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected.
Among those risks, trends and uncertainties are timing and cost of our clinical trials, attainment of research and clinical goals and milestones of product candidates, attainment of required government approvals, sales levels of our products and availability of financing and revenues sufficient to fund development of product candidates and operations. In particular, careful consideration should be given to cautionary statements made in the various reports Encysive Pharmaceuticals, including as Texas Biotechnology Corporation, has filed with the Securities and Exchange Commission. The Company undertakes no duty to update or revise these forward-looking statements. The Encysive Pharmaceuticals Inc. company logo can be found at http://media.primezone.com/prs/single/?pkgid=843 CONTACT: Encysive Pharmaceuticals
Investors
Ann Tanabe (713) 796-8822 Media
BMC Communications
Brad Miles (212) 477-9007 ext. 17 The Trout Group
Hershel Berry (415) 392-3385
Woman keeps faith in face of illness By Shaylyn Cochran
News Journal
MANSFIELD, July 6th, 2004 -- Diagnosed with three potentially deadly illnesses, Heidi Lowe of Mansfield kept her faith and decided to put up a fight. The married mother of two was stricken with bronchiolitis obliterans with organizing pneumonia (BOOP) and primary pulmonary hypertension (PHT) this year. She had bouts with asthma and other minor respiratory problems during the last 10 years, but Lowe's health took a sharp turn for the worse in January. "I had an open lung biopsy and several tests, but the doctors couldn't find the origin of the BOOP," she said. Lowe's medical team at The Ohio State Medical Center updated her condition to include pulmonary fibrosis as the main diagnosis with PHT as a secondary condition and BOOP as a side effect of the two. No cures are available for any of the illnesses. "There is no cure," the 40-year-old-said. "All I can do is hope for a transplant as soon as possible." That hope soon may be a reality, according to Lowe's lifelong friend, Raina Rengert. "We're right in the middle of evaluation for the national (donor) list," Rengert said. Lowe needs a double-lung and possibly a heart transplant. Placement on the list depends on her performance on tests. Doctors meet weekly to discuss her progress and completion of the transplant criteria. The woman, who at one point was taking 38 medications daily and has gained 48 pounds because of the steroid treatment, has begun to reduce her external treatment in preparation for a transplant. In the meantime, Lowe is holding onto her faith to get her through this period. A motto on her Web site, ran by the nonprofit organization Caringbridge, is "If God brings you to it, He will see you through it." "We believe in the power of prayer and that God ultimately will finish the plan he started with Heidi," Rengert said. Despite the strong support group that Lowe has in her husband, Tony, parents, sisters and friends, she still needs more assistance. The weeks following the transplant will require the most help from outside sources. Lowe is bedridden about three times a month, but that number is so low only because of the strict advice of her doctors. Staying in bed causes her heart to beat faster and severely worsens her condition. In addition to the physical and emotional strain, financial burdens are another source of heartache for the Lowe family. Lowe's husband has had back surgery and several spinal fusions. He was on disability at the time of his wife's diagnosis and the family was dependent solely on Heidi's income. "I was taking care of him, and now he's trying to fight through his pain and take care of me," Lowe said. An energetic 6-year-old, Luke, and a recently graduated teen, Chad, fulfill the Lowe family. People wishing to help can donate money at any Bank One or visit Lowe's Web site at www.caringbridge.org/oh/heidi and sign the guestbook to find out how to help. The family is in need of basic household items, toiletries or meals. Another way people can help is by becoming organ donors. Daily, more than 15 people die for lack of an organ transplant, according to the Web site livingbank.com. "After about three more tests, I hopefully can start planning for my transplant," Lowe said.
Release Date: July 2004 MATTERS OF THE HEART
One in nine women aged 45 to 64 has heart disease, and this number grows to one in five after age 65. But you can improve your health and lower your risk of heart disease by taking steps now. Send for Matters of the Heart, a free package of information from the Food and Drug Administration (FDA) and the Federal Citizen Information Center, and get the facts on heart disease and strokes Having high blood pressure increases your chances for developing heart disease and having a stroke. To lower your risk, visit your doctor regularly for blood pressure and cholesterol checks. If you find out your blood pressure is too high, reduce the amount of salt and fat in your diet and exercise everyday. Exercise makes the heart stronger and improves your blood flow. And if you smoke, stop or try to cut down. Smoking can thicken your blood and cause dangerous blood clots. Taking aspirin daily may also lower your risk of having a heart attack or stroke. Ask your doctor if taking a daily dose of aspirin is right for you. Take the first steps to better health. Order your free Matters of the Heart package. There are three easy ways to get your free publications: Send your name and address to
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