FDA Approves ZOCOR 40 mg as Starting Dose for People at High Risk of Coronary Events because of Coronary Heart Disease or Diabetes

Business Wire, April 17, 2003

ZOCOR 40 mg helped save lives by reducing fatal heart attacks in high-risk patients

The overall primary objective of the Heart Protection Study was to determine whether ZOCOR 40 mg reduced the risk of death in a broad patient population at high risk for cardiovascular events. Treatment with ZOCOR 40 mg as compared to placebo reduced the risk of death from any cause by 13 percent (ZOCOR 1328/10269 vs. placebo 1507/10267, p=0.0003). The risk of death from heart attack, and related coronary events was reduced by 18 percent in the group treated with ZOCOR 40 mg as compared to placebo (ZOCOR 587/10269 vs. placebo 707/10267, p=0.0005).

The safety profile of ZOCOR 40 mg was comparable to placebo in the Heart Protection Study

During the five-year Heart Protection Study, the safety profiles were comparable between patients treated with ZOCOR 40 mg and patients treated with placebo. The number of patients who discontinued the study due to adverse reactions was also comparable (4.8 percent for people on ZOCOR and 5.1 percent for people on placebo). In this trial, only serious adverse effects and discontinuations due to any adverse effects were recorded. The incidence of myopathy/rhabdomyolysis was <0.1 percent in people on ZOCOR 40 mg.

Additional information about ZOCOR

ZOCOR, a cholesterol-lowering prescription medicine from Merck & Co., Inc., is used along with diet to improve cholesterol levels in people with high-cholesterol, when diet alone is not enough. The medication has been proven to significantly improve LDL and HDL cholesterol levels, as well as triglyceride levels. ZOCOR is one of the most studied statins on the market today and the efficacy of ZOCOR has been well documented in numerous clinical trials. In the past 10 years, more than 140 million prescriptions have been written for ZOCOR.

Selected cautionary information for ZOCOR

ZOCOR should not be used by anyone allergic to any of its components, with liver disease, or by women who are pregnant, breast-feeding or likely to become pregnant. Muscle pain or weakness in people taking ZOCOR should be reported to a doctor because these could be signs of a serious side effect. Doctors may perform blood tests before and periodically during treatment with ZOCOR to check for liver problems. People taking 80 mg of ZOCOR should receive an additional liver function test at three months. To help avoid serious side effects, discuss with your doctor medicine or food you should avoid while taking ZOCOR. In clinical trials, adverse reactions usually have been mild and transient. Most common side effects included headache (3.5 percent), abdominal pain (3.2 percent) and constipation (2.3 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.

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. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect the company's businesses, particularly those mentioned in the cautionary statements in Item 1 of our Form 10-K for the year ended Dec. 31, 2002, and in our periodic reports on Form 10-Q and Form 8-K (if any) which we incorporate by reference.