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ONCE-A-DAY ORAL NITRATE PROVEN SAFE

 ATLANTA, Nov. 7 /PRNewswire/ -- According to results presented at the Fourth International Study of Infarct Survival (ISIS-4) investigators meeting, held here Nov. 6, administration of oral, controlled release isosorbide mononitrate once daily for one month, to patients with acute myocardial infarction (MI), while not providing a statistically significant reduction in mortality , did demonstrate a trend toward survival, with a savings of about two to three lives per thousand patients treated. In addition, the trial committee noted that mononitrate therapy can be used for the treatment of ischaemic pain in these acute heart attack patients, whatever their cardiac status. More importantly, treatment with the oral mononitrate selected for the trial, IMDUR (Key Pharmaceuticals), was reconfirmed to be completely safe and well tolerated.
 These conclusions were reached based on the findings of the mega- trial of 58,000 patients with suspected or confirmed acute MI within 24 hours of pain onset and randomized to oral captopril, oral mononitrate, and intravenous magnesium. The study compared five-week and longer term mortality among all patients allocated to each active therapy versus all those receiving corresponding controls.
 At the Nov. 6 meeting, Dr. Peter Held, Goteberg University, Goteberg, Denmark, speaking on behalf of the ISIS-4 study group, stated the the nitrate formulation Imdur was selected for the ISIS-4 trial because of its once-daily regimen, proven long-term efficacy for agina, avoidance of drug tolerance and rebound, bioavailability unaffected by food, and flexible dosing ability due to its easily divisible tablet form. Imdur is the only nitrate formulation available on the market that meets all of these criteria.
 In the trial, although Imdur could not be proven to reduce mortality, it was held in generally high regard by the committee. Said Dr. Peter Sleight, chairman of the ISIS-4 Steering Committee, "I would certainly use nitrates, especially oral nitrates, for more symptomatic patients. They're a great deal cheaper than IV nitrates.
 "Perhaps they're not right for everyone," he continued, "but when you do use them. they're safe and you get symptomatic relief in acute heart attack and that's happy news. I certainly hope there will be less IV nitrates usage," he said, referring to the intravenous nitrate arm of the study.
 In ISIS-4, captopril showed a small but significant reduction in mortality, with five lives per thousand. Administration of intravenous magnesium showed no clinical benefit, and, in fact, the study found that this therapy showed a negative effect, with 100 more deaths than in the control group.
 Mr. Held supported Dr. Sleight's comment by saying "Nitrates are totally safe and can be used without any worries."
 Imdur is a convenient, safe, well tolerated and effective therapeutic choice for the prevention of angina pectoris. A number of clinical studies, including a 30-center trial with 300 patients -- one of the most rigorous antianginal studies ever conducted in the United States -- have demonstrated that Imdur provides at least 12 hours of antianginal efficacy in a once-daily regimen that avoids tolerance, is not subject to first-pass metabolism, and has favorable hemodynamic effects.
 Imdur is marketed in the U.S. by Key Pharmaceuticals, an operating unit of Schering-Plough Corporation (NYSE: SGP). The drug is licensed from Astra Hassle AB, Sweden, which helped finance the ISIS-4 trial with a grant to the University of Oxford, England, the sponsoring institution.
 -0- 11/7/93
 /CONTACT: Dr. Peter Sleight, 0-865-220257, or Dr. Peter Held, 0-865-58104, both for ISIS-4 Committee, Key Pharmaceuticals/
 (SGP)


CO: Key Pharmaceuticals ST: Georgia IN: MCT SU: PDT

TM -- NY003 -- 1512 11/07/93 19:09 EST
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Publication:PR Newswire
Date:Nov 7, 1993
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