Merck Study Finds Similarities with COX-2 inhibitor & NSAID drugs

Christine Miller Health Guide
  • Merck, the manufacturer of Vioxx recently announced that preliminary analyses of its MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term Program), show that patients with osteoarthritis and rheumatoid arthritis have similar cardiovascular outcomes between its experimental COX-2 inhibitor drug, Arcoxia, and diclofenac, a traditional nonsteroidal anti-inflammatory drug (NSAID). Merck is developing Arcoxia as the successor to Vioxx.
    The MEDAL program is a group of three studies that began in 2002 and enrolled over 34,000 patients. The research studied the effects of Arcoxia 60 mg or 90 mg on osteoarthritis and rheumatoid arthritis. The preliminary analysis of the study revealed that the incidence of patients withdrawing from the trial due to hypertension-related adverse events was significantly higher for Arcoxia than for diclofenac. Also, the incidence of discontinuations due to edema-related adverse events and congestive heart failure was significantly higher only for Arcoxia 90 mg compared to diclofenac. However, the incidence of discontinuations due to clinical gastrointestinal adverse events and hepatic adverse events was significantly higher for diclofenac compared to Arcoxia. These findings from the MEDAL study are consistent with the previously disclosed findings from the EDGE study, which are described in European labeling for Arcoxia.
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    Merck plans to publish the full results of the program in a scientific peer-reviewed journal and will present findings at scientific meetings. Merck also intends to include the results of the MEDAL Program as part of its response to the "approvable" letter issued by the FDA in October 2004. The DFA withheld Arcoxia in the U.S. pending more information on the drug. The drug is approved outside the U.S., is currently available in 62 countries in Europe, Latin America, the Asia-Pacific region, Middle East and Northern Africa.
    According to Merck’s website, the MEDAL study was conducted in 38 countries, and it is the first arthritis study program designed with cardiovascular safety as its primary endpoint. It is also claimed to be the largest and longest controlled clinical assessment of a selective COX-2 inhibitor vs. a traditional NSAID in an arthritis patient population.

    The MEDAL Program was designed to perform a “non-inferiority analysis of confirmed thrombotic (blood-clotting) CV events following daily treatment of ARCOXIA (60 or 90 mg daily) or diclofenac (150 mg daily) in osteoarthritis (OA) and rheumatoid arthritis (RA) patient populations.” Diclofenac is the most widely prescribed traditional NSAID in the world.
    In September 2004, Merck voluntarily recalled its widely prescribed drug, Vioxx, a COX-2 inhibitor, which was used to treat arthritis and acute pain because a three-year study revealed that the drug increases the risk of heart attack and stroke in patients who have taken the medication for more than 18 months. There are currently over 14,000 lawsuits related to Vioxx involving over 27,000 plaintiffs, in various federal and state courts. Merck faces potentially billions of dollars in liability and because of the resulting backlash toward Vioxx, Merck, the drug industry and the FDA approval process, the research of both Merck and the industry as a whole has come under increased regulatory scrutiny.
Published On: September 06, 2006