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Fen Phen and Primary Arterial Hypertension News for April 2004
Wyeth: Fen-Phen Reserves Adequate Drugmaker Says $14.6B Has Been Put Aside To Cover Liability From Diet Drugs. New York (Reuters) -- Drugmaker Wyeth said Wednesday the $14.6 billion it has already set aside to cover its liability to former users of its "fen-phen" diet drugs appears to be adequate. Company officials told analysts in a conference call they see no immediate need to set aside additional reserves to compensate patients who allege they were harmed by the prescription diet drugs. In 1997 the Madison, New Jersey-based drugmaker recalled two diet drugs, Pondimin (fenfluramine) and Redux (dexfenfluramine), which had been used in the "fen-phen" diet cocktail. It recalled them after some of the 6 million Americans who took the drugs developed signs of heart damage or a highly fatal condition known as primary pulmonary hypertension. Some industry analysts have predicted Wyeth may need to set aside billions of dollars more in coming years to compensate fen-phen users, many of whom allege the company was so intent on driving up sales of the drugs that it failed to inform consumers of the dangers posed by the products. Excerpted from CNN, Wednesday, 23 April 2003.
Viagra Finds Unsexy but Lifesaving Use
Treats rare, deadly blood-pressure disorder
By Adam Marcus
HealthScout Reporter
THURSDAY, Nov. 2 (HealthScout) -- Patients with a rare and frequently fatal blood-pressure disorder may owe a debt of gratitude to men with impotence.
British researchers say they've used Viagra to successfully treat a young Londoner with primary pulmonary hypertension (PPH), a condition in which blood pressure in the lungs becomes dangerously high. While a normal pulmonary artery pressure might be about 14 millimeters of mercury, the 21-year-old university student reached a whopping 128 millimeters. As a result, his lungs were failing, his heart was overworked, and he became physically incapacitated; he became winded at even the mildest exertion. The usual treatment for PPH is a continuous infusion of a drug called epoprostenol, which can reduce pressure and greatly improves survival. But the therapy is highly disruptive, forcing patients to spend their lives attached to an intravenous tube, with unpleasant side effects. When the student rejected the infusion treatment, doctors at London's Royal Brompton Hospital offered him Viagra, or sildenafil citrate, which they had previously found to work in two children with a similar condition. The man was started on 50 milligrams of Viagra a day, a dose his doctors quickly raised to 500 milligrams. Disabled man becomes a gym rat Three months later, his improvement was impressive. His pulmonary artery pressure, though still high, had dropped markedly, and tests of his heart function showed significant gains. The patient, once unable to walk 100 yards without getting exhausted, is now working out at the gym several days a week. "He has been transformed," says Dr. Michael Gatzoulis, a heart specialist at Royal Brompton. "The only side effect is that he had to get a huge supply of Viagra on a weekly basis" -- purchases that prompted curious looks at the pharmacy at first. Gatzoulis and his colleagues, who describe the case in the Nov. 2 New England Journal of Medicine, have since reduced the patient's daily dose of Viagra to 250 milligrams, which is still about five times more than what men typically take for impotence. Dr. Bruce Brundage, medical director of the Heart Institute of the Cascades, in Bend, Ore., calls the finding "interesting" but says it's too soon to know if it's anything more than a chance occurrence. "It's an anecdote, and we don't get too excited about anecdotes," Brundage says. But he says there's a good scientific basis for why Viagra might act on vessels in the lungs. Its active ingredient targets an enzyme that inhibits nitric oxide, a vessel dilator. For that reason, more research into the potential treatment is warranted, he says. Gatzoulis says he and his colleagues are conducting a small pilot study with Viagra in blood pressure patients and should have results within six months. If the drug helps, they then hope to organize a larger trial. What To Do An estimated one person in a million suffers from PPH, says Rino Aldrighetti, executive director of the Pulmonary Hypertension Association in Silver Spring, Md. While the condition can affect everyone from infants to the elderly, about 60 percent of patients are women of childbearing age, he says. If you suffer from this condition, ask your doctor about Viagra. But remember, the evidence still is just anecdotal. To learn more about pulmonary hypertension, visit the Pulmonary Hypertension Association or the PPH Cure Foundation.
Pulmonary Hypertension: CT of the Chest in
Pulmonary Venoocclusive Disease
Arnaud Resten1, Sophie Maitre1, Marc Humbert2, Anne Rabiller2, Olivier Sitbon2, Frédérique Capron3, Gérald Simonneau2 and Dominique Musset1
1 Service de Radiologie, UPRES EA 2705 (Maladies Vasculaires Pulmonaires), Hôpital Antoine Béclère, Assistance Publique–Hôpitaux de Paris, Université Paris–Sud, 157 rue de la Porte de Trivaux, Clamart 92140, France.
2 Service de Pneumologie et Réanimation Respiratoire, Hôpital Antoine Béclère, Clamart 92140, France.
3 Service d'Anatomie Pathologique, Hôpital Antoine Béclère, Clamart 92140, France. OBJECTIVE. Pulmonary venoocclusive disease is a rare cause of pulmonary hypertension that is often difficult to distinguish from severe primary pulmonary hypertension. Unfortunately, medical treatment of primary pulmonary hypertension with prostacyclin can be fatal in patients with venoocclusive disease, and an early pretreatment diagnosis of this uncommon condition is critical. The aim of our study was to evaluate this disease noninvasively using CT of the chest. MATERIALS AND METHODS. We reviewed cross-referenced records from 1996 to 2001 in our departments of radiology and pathology and identified 15 patients with initial pretreatment CT scans who had pathologically confirmed pulmonary venoocclusive disease. Their CT scans were compared with the CT scans of 15 consecutive patients with pathologically confirmed primary pulmonary hypertension. All patients had undergone a postmortem or posttransplantation examination. RESULTS. Ground-glass opacities were significantly more frequent in pulmonary venoocclusive disease (p = 0.003); the opacities were abundant with random zonal predominance and preferentially centrilobular distribution (p = 0.03). Subpleural septal lines and adenopathy were also significantly more frequent (p < 0.0001). CONCLUSION. On the initial pretreatment chest CT scan, the presence of ground-glass opacities (particularly with a centrilobular distribution), septal lines, and adenopathy are indicative of pulmonary venoocclusive disease in patients displaying pulmonary hypertension. Caution should be exercised before vasodilator therapy is initiated in the patients whose scans show such radiologic abnormalities.
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