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| |  Diovan Better Than Cozaar To Lower High Blood Pressure DORVAL, QUEBEC -- June 26, 1997 -- A recent study has demonstrated that a greater percentage of patients treated with Diovan(TM) (valsartan) 160 mg responded successfully, or achieved desired levels of blood pressure reduction, than patients treated with Cozaar(R) (losartan) 100 mg. Overall reductions in blood pressure were comparable. The study was presented on May 29 at the American Society of Hypertension Twelfth Scientific Meeting. This large, multicentre, international study is the first placebo-controlled, head-to-head trial comparing the AT1 receptor blockers Diovan and Cozaar. Further investigation would be needed to confirm this initial finding. The newest class of antihypertensive medications, AT1 receptor blockers have an excellent side effect profile with an overall incidence of adverse effects similar to placebo. "If the results of this trial are confirmed, they can have clinical implications for physicians choosing an AT1 receptor blocker for the treatment of their patients with essential hypertension," said Suzanne Oparil, M.D., professor of medicine, division of cardiovascular disease, UAB (University of Alabama at Birmingham), who was the lead investigator of the study. "All other things being equal, physicians will naturally want to choose a drug that is more likely to produce a successful response in their patients." Diovan 160 mg was statistically significantly superior to 100 mg Cozaar when responder rates were compared. "The significant difference in responder rates is compelling and warrants further investigation," said Dr. Oparil. "The findings of this study also suggest that physicians can titrate patients from Diovan 80 mg to the higher available dosage of Diovan 160 mg and achieve success in a far greater percentage of patients than with the recommended 50 mg dosage of Cozaar," Dr. Oparil said. In a clinical trial of antihypertensive drugs, successful responder rates represent the percentage of patients who achieve predetermined levels of blood pressure reductions with each drug. In this trial, successful responses were defined as a mean sitting diastolic blood pressure (MSDBP) less than 90 mm Hg, or a decrease in MSDBP greater than or equal to 10 mm Hg compared to baseline. The multicentre, double-blind, randomized study measured the efficacy and safety of Diovan versus Cozaar in essential hypertension. A total of 1,369 patients in the United States, Italy and Scandinavia were randomized to 80 mg Diovan, 50 mg Cozaar or placebo. After four weeks, patients were force titrated to the higher dosages of Diovan (160 mg) or Cozaar (100 mg) for an additional four weeks. Responder rates with Diovan were statistically significantly superior to Cozaar at the higher of two dosage levels studied for each of the two drugs ( p=0.021). The responder rates were 62 percent for 160 mg Diovan and 55 percent for 100 mg Cozaar. At the lower dosage levels, the difference between responder rates for the two drugs did not reach statistical significance, with responder rates of 46.2 percent for 80 mg Diovan and 44 percent for 50 mg Cozaar. In terms of absolute reduction in blood pressure, both Diovan and Cozaar were found to be statistically significantly superior to placebo at both dosages, with comparable reductions in mean sitting diastolic blood pressure. Specifically, Diovan 80 mg demonstrated a similar reduction in mean sitting diastolic blood pressure when compared to Cozaar 50 mg (-8.3 mm Hg with Diovan 80 mg versus -8.0 mm Hg with Cozaar 50 mg). There was a slight trend in favour of Diovan 160 mg in mean sitting diastolic blood pressure when compared to Cozaar 100 mg (-10.5 mm Hg versus -9.7 mm Hg, respectively). However, the trend observed in this efficacy variable did not reach statistical significance. Diovan and Cozaar also demonstrated similar reductions in mean sitting systolic blood pressure. Of the 1,520 patients who entered into the study, 1,369 were randomized to valsartan, losartan or placebo. The overall incidence of adverse events in the valsartan, losartan and placebo groups was comparable. Thirty-three patients reported serious adverse events and/or discontinued prematurely from the trial due to adverse experiences (13 in the valsartan group, 13 in the losartan group, and seven in the placebo group). Adverse events occurred in 31.6 percent of the valsartan group, 29.3 percent of the losartan group and 32 percent of the placebo group. Headache and dizziness were the most commonly reported adverse events and occurred more frequently in the placebo-treated patients than in the active treatment groups. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Diovan should be discontinued as soon as possible. Diovan is contraindicated in patients who are hypersensitive to any component of this product. In most countries, the recommended starting dose for Diovan is 80 mg once daily. If additional antihypertensive effect is required, the dosage may be increased to 160 mg or a diuretic may be added. No dosage adjustment is required for elderly patients, for patients with mild or moderate kidney impairment, or for patients with mild or moderate liver insufficiency. However, care should be exercised when administering Diovan in patients with liver or severe kidney impairment. Volume- and/or salt depletion should be corrected in patients prior to administering Diovan or symptomatic hypertension may occur. Diovan is a product of the Novartis Group, which was formed by the merger of Ciba and Sandoz and is the largest pharmaceutical business in the world. The medication was introduced to the U.S. market in February, 1997. Diovan is not yet available in Canada. Novartis Pharmaceuticals Canada Inc. is a leading research-based pharmaceutical company with a wide-ranging program for the development, manufacturing, and distribution of medicines for Canadians. The company’s head office and major research facilities are located in Dorval, Quebec. More information on: Diovan, Novartis Pharmaceuticals Canada Inc.
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