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| |  Results Published Demonstrate that Irbesartan Provides Greater Blood Pressure Reduction than Valsartan in Patients with Elevated Blood Pressure PARIS, FRANCE and PRINCETON, NJ -- May 24, 2002 -- Results of a recent published study show that patients treated with Irbesartan (Avapro®/Aprovel™/Karvea™) -- a blood pressure lowering agent of the angiotensin II receptor antagonist (AIIRA) class marketed by Bristol-Myers Squibb and Sanofi-Synthelabo -- achieved greater blood pressure reductions (the primary endpoint of the study), greater normalization of blood pressure, and more patients responded to treatment (secondary study endpoints) versus those who received valsartan, another commonly prescribed AIIRA. Both drugs were studied at their recommended starting doses. The results of the study titled, "An Ambulatory Blood Pressure Monitoring Study of the Comparative Antihypertensive Efficacy of Two Angiotensin II Receptor Antagonists, Irbesartan and Valsartan," are published in the current issue of Blood Pressure Monitoring.(1) The study was designed to evaluate the blood pressure reducing effects of the usual recommended starting doses of Irbesartan versus valsartan. In the study, 426 men and women with mild to moderate high blood pressure were randomized to either Irbesartan 150 mg daily or valsartan 80 mg daily for a period of eight weeks. Patients who received Irbesartan experienced a greater reduction in 24-hour ambulatory diastolic blood pressure of 6.73 mm Hg versus 4.84 mm Hg for valsartan (p=0.035) and achieved a greater reduction in ambulatory systolic blood pressure of 11.62 mm Hg for Irbesartan versus 7.5 mm Hg for valsartan (p<0.01). Using three different means of assessing blood pressure (ambulatory blood pressure monitoring, office blood pressure measurement and home blood pressure measurement), it was found that a significantly larger number of patients met pre-determined diastolic blood pressure reduction goals in the Irbesartan group. "High blood pressure is one of the most prevalent and difficult conditions to effectively manage, yet previous studies have shown that its reduction is needed to protect the patient from an increased risk of cardiovascular disease," said Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Medicine, Prevention and Applied Biotechnologies at the University of Milano-Bicocca, S. Gerardo Hospital, Monza, Italy. "The present study provides unequivocal evidence that Irbesartan is particularly effective, among the angiotensin II receptor antagonist class, in lowering an elevated blood pressure. This particular pronounced blood pressure lowering effect can be seen throughout daily life blood pressure values, which are the values more closely related to patient's prognosis and protection." Other important study findings show that a significantly larger number of patients receiving Irbesartan responded to treatment compared to those receiving valsartan (63.9 percent versus 44.3 percent, respectively). Both Irbesartan and valsartan produced significant reductions in blood pressure from baseline, however, overall Irbesartan produced significantly greater duration and magnitude of reductions across all three methods of blood pressure measurement used in the study. The study did not compare Irbesartan and valsartan at their highest recommended doses (300 mg daily and 320 mg daily, respectively). "Several findings indicate that lowering blood pressure more than it has been done in the past, may be more protective for patients with a high cardiovascular risk profile, and perhaps also for hypertensive individuals in general," said Professor Mancia. "In this study, Irbesartan definitely showed its ability to score in this direction, as can be seen by the data which were consistent for blood pressure measured in three different contexts: in the doctor's office, at home, and throughout the day and night." Hypertension or high blood pressure is a serious health problem that affects more than 600 million people worldwide. Uncontrolled high blood pressure is a major risk factor for heart attack, stroke, heart failure and kidney disease. The World Health Organization (WHO) estimates that globally, up to 3 million people die annually as a direct result of high blood pressure and that 75 percent of people with hypertension do not have their blood pressure adequately controlled. The study was conducted by Giuseppe Mancia M.D., Professor of Medicine and Chairman of the Department of Medicine, Prevention and Applied Biotechnologies at the University of Milano-Bicocca, S. Gerardo Hospital, Monza. The University of Milan-Bicocca is the second State university and its medical faculty is based at the S. Gerardo Hospital located in Monza, within the Milan province. Irbesartan is marketed worldwide by Bristol-Myers Squibb and Sanofi-Synthelabo under the brand names of Avapro®, Aprovel™, and Karvea™. Irbesartan is also marketed in combination with hydrochlorothiazide under the brand names Avalide®, CoAprovel™ and Karvezide™. Irbesartan, discovered by Sanofi-Synthelabo research teams, is part of a co-development and marketing agreement initiated in 1993 between Bristol-Myers Squibb and Sanofi-Synthelabo. As soon as pregnancy is detected, discontinue Irbesartan (see boxed WARNING regarding Use in Pregnancy in full prescribing information). In earlier clinical hypertension trials, there were no significant differences in adverse events between Irbesartan and placebo that occurred in at least 1 percent of patients treated with Irbesartan and at a higher rate versus placebo, including: diarrhea (3% vs. 2%), dyspepsia/heartburn (2% vs. 1%), musculoskeletal trauma (2% vs. 1%), fatigue (4% vs. 3%), and upper respiratory infection (9% vs. 6%). For additional information concerning Irbesartan, including full prescribing information, please contact Bristol-Myers Squibb Company or Sanofi-Synthelabo. Visit Bristol-Myers Squibb on the World Wide Web at http://www.bms.com (1) Blood Pressure Monitoring May-June 2002, 7:135-142
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