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| |  Revia Effective And Safe For Treating Alcohol Dependence HILTON HEAD, SC -- June 23, 1998 -- A multi-centre, open label observational trial of DuPont Merck's Revia, an opioid antagonist, showed the medication to be safe, generally well tolerated and effective in the treatment of alcohol dependence as part of an overall treatment program. Preliminary results of the observational trial were presented late yesterday at the Research Society on Alcoholism's annual meeting by William Lynch, Jr., clinical programs manager, medical affairs, DuPont Merck. The study evaluated over 3,000 patients for four weeks. In initial preliminary results, 57 drinks per week was the average number at baseline. After only four weeks of treatment with Revia, the average number of drinks/week decreased to four. In this study, 71.3 percent of the patients began drinking to intoxication under the age of 20 and 70 percent of the patients had been drinking to intoxication for 10 to 29 years. Even more significant, with observed data (excluding the 26 percent of total patients lost to follow-up), 79 percent of patients remained abstinent over the four weeks of treatment. Overall, Revia, used as an adjunctive treatment with psychosocial therapy, provided a safe and effective drug treatment advancement for alcohol dependent individuals. Due to the results of this trial, it may be feasible to dose Revia with meals or at bedtime to prevent or control nausea. Other modalities that were employed to reduce the nausea were interrupting the dose and/or reducing the dose for a short period of time or treating with antacids. Some of these modalities were combined to most effectively manage nausea. Dosing in this manner may prevent this unwanted side effect and possibly allow for a more favourable outcome. Starting dose of naltrexone was 50 mg orally once daily after patients achieved a minimum of seven days of abstinence from consuming alcohol. The most frequent adverse clinical events experienced in this study were nausea (13.6 percent), headache (2.2 percent), dizziness (1.6 percent), insomnia (1.4 percent), fatigue (1.2 percent), and vomiting (1.1 percent). The severity of adverse clinical events as defined by the study protocol were mostly mild (43.9 percent) to moderate (42.4 percent). When nausea did occur with naltrexone it was a limited acute event with 77 percent of all bouts of nausea being single occurrences. "Multiple clinical studies have demonstrated the effectiveness of Revia as a treatment tool for alcohol dependence and also have highlighted nausea as the most significant adverse event," Lynch said. "This trial has provided clinicians with suggestions on treatment modalities that can help to manage nausea and allow patients to more comfortably continue with their alcohol dependency therapy." The study population included individuals older than 18 years of age, who achieved one to six weeks of abstinence immediately prior to screening and who were actively participating in an alcohol rehabilitation treatment program that utilised social and/or psychotherapeutic methods. When approved for marketing by the FDA in January 1995, Revia was the first medication specifically approved for treating alcoholism in over 40 years. Adverse reactions that have been associated with Revia in 10 percent of patients or greater include: difficulty sleeping, anxiety, nervousness, abdominal pain/cramps, nausea/vomiting, low energy, joint and muscle pain, and headache. Revia has the capacity to cause liver toxicity when given at doses higher than recommended. Revia should not be used in patients with active hepatitis or liver disease. Revia must not be administered to patients who have abused narcotics within the last seven to 10 days. More information on: Revia
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