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FDA Approves COZAAR as the First and Only Hypertension Medicine to Help Prevent Stroke in Patients with Hypertension and Left Ventricular Hypertrophy
Business Wire, March 25, 2003
COZAAR demonstrated excellent tolerability in the LIFE trial
In the LIFE trial, adverse events with COZAAR were similar to those reported previously for patients with hypertension. In other clinical trials for hypertension, the most common adverse events occurring with COZAAR (n=1,075) at a rate of one percent or more than placebo (n=334) included upper respiratory infection (8 percent for COZAAR versus 7 percent for placebo), dizziness (3 percent versus 2 percent for placebo) and leg pain (1 percent versus 0 percent for placebo).
Important information about COZAAR
Related Results
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, COZAAR should be discontinued as soon as possible.
COZAAR is contraindicated in patients who are hypersensitive to any component of this product. In patients who are volume-depleted (e.g., those treated with diuretics), symptomatic hypotension may occur after initiation of therapy with COZAAR. These conditions should be corrected prior to administration of COZAAR, or a lower starting dose should be used.
In addition to this new indication COZAAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. COZAAR is also indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio Greater than/ Equal 300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, COZAAR reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation).
In a clinical study in type 2 diabetic patients with nephropathy, the most common adverse events reported with an incidence of Greater than/Equal 4 percent of patients treated with COZAAR (n=751) and occurring at a rate of Greater than/Equal 4 percent above placebo (n=762) on a background of conventional antihypertensive therapy were: diarrhea (15 percent vs. 10 percent), asthenia/fatigue (14 percent vs. 10 percent), hypoglycemia (14 percent vs. 10 percent), chest pain (12 percent vs. 8 percent), hyperkalemia (7 percent vs. 3 percent), and hypotension (7 percent vs. 3 percent).
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.
MERCK FORWARD LOOKING STATEMENT -- This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and product potential. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Additional detailed information concerning a number of factors that could cause actual results to differ materially is available in Item 1 of Merck's Annual Report on Form 10-K for the year ended Dec. 31, 2002, in its periodic reports on Form 10-Q and in its reports on Form 8-K (if any). Copies of these forms are available on request to Merck's Office of Stockholder Services.
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