Acamprosate, in conjunction with psychosocial treatment, has demonstrated efficacy in maintaining abstinence in alcohol-dependent patients in multiple clinical trials. Data from 13 short-term (≤26 weeks) and long-term (≥48 weeks) clinical trials were analyzed to assess the safety and tolerability of acamprosate: 4234 patients were randomized to placebo (N = 1962), acamprosate 1332 mg/d (N = 440), 1998 mg/d (N = 1749), or 3000 mg/d (N = 83). Overall incidence of treatment-emergent adverse events (AEs) was 61% for acamprosate and 56% for placebo (P < 0.01). The majority of AEs in all groups were reported as transient and considered “mild” or “moderate” in severity, and discontinuation rates due to AEs were comparable. Most common AEs were diarrhea (16% acamprosate versus 10% placebo, P < 0.01) and flatulence (3% acamprosate versus 2% placebo, P < 0.01). Patients taking concomitant medications commonly used to treat alcohol dependence reported comparable AEs between placebo- and acamprosate-treated groups.
Acamprosate was shown to be safe in patients with hepatic impairment. A dose reduction is recommended in patients with renal impairment. No clinically meaningful between-group differences were reported for clinical chemistry tests or vital sign parameters. This ad hoc analysis demonstrates that acamprosate can be used safely in alcohol-dependent patients, including those taking concomitant medications, or having renal or hepatic impairment.
From Columbia University College of Physicians & Surgeons and St. Luke's Roosevelt Hospital Center (RNR), New York, NY; Forest Laboratories, Inc. (AG, JLP), New York, NY; Lipha Pharmaceuticals, Inc. (AMG), New York, NY.
Received July 24, 2007; revised November 20, 2007; accepted November 25, 2007.
Dr. Richard Rosenthal is an advisory board member for Forest Laboratories, Inc. and Alkermes, Inc. He has received research funding from Forest Laboratories, Inc. and Titan Pharmaceuticals, Inc. Dr. Allyson Gage is a full-time employee of Forest Laboratories, Inc. Dr. James Perhach is a full-time employee of Forest Laboratories, Inc. Dr. Anita Goodman was a paid employee of Lipha Pharmaceuticals, Inc., a subsidiary of Merck KGaA, Darmstadt, Germand, and its affiliate Merck Santé, Lyon, France, the supplier and developer of acamprosate, at the time that the clinical development of acamprosate occurred.
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This work was supported by Forest Laboratories, Inc.