Drug products: Acamprosate, Acamprosate Biogaran, Aotal, Campral
ATC code: N07BB03
Substances: acamprosate, acamprosate calcium
Studies indicate similar effects of acamprosate in men and women, although women report more adverse effects. Acamprosate is excreted more rapidly in patients with a higher renal function, being more common in men, and therefore women are exposed to higher doses and a higher risk of dose dependent side effects.
The risk of alcohol use according to the Global Burden of Disease Study 2010, was ranked as number three in men and number twelve in women. Disability-adjusted life years were three times higher in men than in women and alcohol related deaths were twice as common in men as in women .
In Sweden, hospital care due to alcohol related diagnoses were twice as common in men compared to women in 2012 and alcohol related deaths were more common in men than in women .In a meta-analysis of 22 randomized controlled trials of patients treated with acamprosate (4794 men, 1317 women), 22% of the participants in the trials were females although one-third of alcohol dependent individuals are women .
Pharmacokinetics and dosing
After a single oral dose of 666 mg acamprosate in healthy volunteers (12 men, 12 women) pharmacokinetic parameters were similar in men and women [4, 5]. Acamprosate is excreted renally with linearity between creatinine clearance and clearance of acamprosate . Despite a higher renal function in men than in women  the clinical studies have shown good effect with similar doses in men and women and no sex differentiation in dosing has therefore been suggested by the manufacturer .
A meta-analysis including 22 randomized controlled trials ( 4794 men, 1317 women) of treatment with acamprosate during 3 to 12 months (mean 6 months) found similar effects in men and women. Outcome was measured in the percentage of abstinent days, rate of complete abstinence, percentage of no heavy drinking days, and rate of no heavy drinking . A pooled analysis of the cumulative abstinence duration of seven of the randomized controlled trials included in the meta-analysis (1175 men, 310 women, in all), found that outcome of 3-6 months treatment was similar in men and women . Similar results were shown in a single-blind, placebo-controlled 12 week study (31 men, 19 women) . Also, in a retrospective study of consecutively acamprosate treated chronic alcoholics (19 men, 22 women), drinking was reduced equally in men and women . A small observational study including very few women showed conflicting results .
A meta-analysis of 22 randomized controlled trials of patients treated with acamprosate (in total 4794 men, 1317 women) during 3-12 months (mean 6 months) showed that women reported moderate to severe adverse events more often than men (28% vs 20%), although there was no difference in the rate of discontinuation due to adverse events .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
In a placebo controlled study of patients with alcohol dependence (955 men, 428 women) randomized to naltrexone, acamprosate or naltrexone + acamprosate, with or without supportive counseling during 16 weeks showed a similar medication adherence in men and women .A US study based on data from Veterans Health Administration (VHA) of treatment of alcohol misuse (270 774 men, 9 319 women) showed that women were more likely than men to receive a prescription of acamprosate (1% vs 0.6%), naltrexone (2.9% vs 1.6%), disulfiram (1.8% vs 1.1%), or any medication (5.2% vs 3%). The odds ratio for receiving any of these medications was 1.58 in women compared to men .
Date of litterature search: 2016-04-19
- Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2224-60. PubMed
- Folkhälsan i Sverige Årsrapport 2014. Folkhalsomyndigheten [www]. [updated 2015-12-28, cited 2016-04-19]. Länk
- Mason BJ, Lehert P. Acamprosate for alcohol dependence: a sex-specific meta-analysis based on individual patient data. Alcohol Clin Exp Res. 2012;36:497-508. PubMed
- Saivin S, Hulot T, Chabac S, Potgieter A, Durbin P, Houin G. Clinical pharmacokinetics of acamprosate. Clin Pharmacokinet 1998 Nov;35(5):331-45 PubMed
- Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - CAMPRAL (acamprosate). US Food and Drug Administration [www]. [updated 2004-07-29, cited 2016-04-01]. länk
- Produktresumé Campral (akamprosat) (SPC) Merck Santé
- Läkemedelsboken 2015. Upplaga 19. Uppsala: Läkemedelsverket; 2015. Länk
- Verheul R, Lehert P, Geerlings PJ, Koeter MW, van den Brink W. Predictors of acamprosate efficacy: results from a pooled analysis of seven European trials including 1485 alcohol-dependent patients. Psychopharmacology (Berl). 2005;178:167-73. PubMed
- Gross CM, Spiegelhalder K, Mercak J, Feige B, Langosch JM. Predictability of alcohol relapse by hippocampal volumetry and psychometric variables. Psychiatry Res. 2013;212:14-8. PubMed
- Icro Maremmani AG, Bacciardi S, Rovai L, Rugani F, Massimetti E, Gazzarrini D et al. Six-month outcome in bipolar spectrum alcoholics treated with acamprosate after detoxification: a retrospective study. Int J Environ Res Public Health. 2014;11:12983-96. PubMed
- Aguiar P, Neto D, Lambaz R, Chick J, Ferrinho P. Prognostic factors during outpatient treatment for alcohol dependence: cohort study with 6 months of treatment follow-up. Alcohol Alcohol. 2012;47:702-10. PubMed
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- Harris AH, Kivlahan DR, Bowe T, Humphreys KN. Pharmacotherapy of alcohol use disorders in the Veterans Health Administration. Psychiatr Serv. 2010;61:392-8. PubMed
- Socialstyrelsens statistikdatabas . Stockholm: Socialstyrelsen. 2014 [cited 2016-02-17.] Socialstyrelsens statistikdatabas
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson