心衰竭有新藥

FDA同意上市藥物較現有治療安全

  FDA在週一同意近十四年來對急性心衰竭第一新的治療藥物,而它也比現有治療顯現出更高的安全性。一項名為Natrecor,這藥物是人類荷爾蒙-稱為「促尿鈉排泄胺基酸」的人工合成物,能擴張靜脈與動脈。臨床試驗顯示它比三硝甘油酯能更快的改善呼吸困難。Natrecor將在這禮拜底在醫院開始使用。將近五百萬的美國人患有心衰竭,而其中將近一百萬的病人一開始有短暫的急性呼吸困難,需要醫院治療。Natrecor,由Scios Inc.所製造,就是為了上列後述的病人。該藥廠的副總裁Darla Horton, MD,告訴WebMD:「這藥品是在醫院一到三天,以靜脈內注射服用的。」

Heart Failure Gets a New Drug

FDA-Approved Drug Safer Than Current Therapies

By Steve Mitchell, MS
WebMD Washington Correspondent

Reviewed by Gary D. Vogin, MD

Aug. 13, 2001 (Washington) -- The FDA approved the first new treatment for acute heart failure in 14 years on Monday, and it appears to be safer than current therapies for the condition.

Called Natrecor, the drug is a synthetic version of a human hormone called natriuretic peptide, which dilates veins and arteries. Clinical trials show that it works faster than nitroglycerin to improve dyspnea.

Natrecor will be at hospitals by the end of the week.

About 5 million Americans have heart failure and approximately 1 million of these patients experience acute episodes of severe shortness of breath requiring a hospital for treatment.

Natrecor, which is manufactured by Scios Inc., is intended for these latter patients. The drug is given intravenously for one to three days at a hospital, Scios' vice president of medical affairs Darla Horton, MD, tells WebMD.

Previously, the FDA had rejected the drug because of concerns that it may cause hypotension.

So Scios went back to the drawing board and conducted one of the largest-ever heart failure studies and "demonstrated to our satisfaction and the advisory committee's" that the drug was effective with a low risk of hypotension, Douglas Throckmorton, MD, tells WebMD. Throckmorton is a deputy director for the FDA.

Natrecor caused some hypotension, but no more so than nitroglycerin, Throckmorton says. The key was that the new trial used a lower dose and a slower rate of infusion of the drug, he says.

But the agency wanted the risk emphasized on labeling to ensure that doctors carefully monitor blood pressure, because when hypotension occurs with Natrecor it tends to last longer than with nitroglycerin, Throckmorton says.

Uri Elkayam, MD, who is director of the heart failure program at the University of Southern California and was involved in two clinical trials of the drug, doesn't see hypotension as a major concern. As long as the physician is aware of it and monitors for it, "it's not really something that is life-threatening," he tells WebMD.

Natrecor makes patients feel better, but whether it extends their life has yet to be determined, Scios' Horton tells WebMD. But she notes that another class of heart failure treatments called inotropes can actually increase the risk of death. "Natrecor does not do this," she says.

Elkayam agrees. Natrecor is "equally effective" as the inotropes but "substantially safer."

He notes that a head-to-head comparison of the two drug types showed that inotropes caused significant arrhythmias, but Natrecor did not.

Elkayam predicts that this advantage will make Natrecor available "in ERs and anywhere in the hospital" in the future. This is not possible with the inotropes because their risk of arrythmia requires them to be administered in the intensive care unit where the patient can be treated quickly if a problem develops.

Natrecor is also safer than nitroglycerin -- it is "more effective and has fewer side effects," Elkayam says.

Another advantage is that Natrecor is easier for physicians to manage than nitroglycerin. Patients first receive an initial dose of Natrecor followed by a continuous infusion of the drug, and the "effect is quite predictable," Elkayam says. With nitroglycerin, it is difficult to know the correct effective dose and when to stop administering the drug.

 

© 2001 WebMD Corporation. All rights reserved.

    
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