Preparat: Acamprosate, Acamprosate Biogaran, Aotal, Campral
ATC kod: N07BB03
Substanser: akamprosat, akamprosatkalcium
En metaanalys av kliniska studier av akamprosat visar god effekt hos både kvinnor och män även om kvinnor rapporterade mer biverkningar. Akamprosat utsöndras långsammare hos personer med lägre njurfunktion vilket är vanligare hos kvinnor, fler kvinnor exponeras därför för högre doser vilket ökar risken för dosberoende biverkningar.
Vår bedömning är att nuvarande kunskapsunderlag inte motiverar skillnad i dosering eller behandling mellan kvinnor och män.
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 .
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 .
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 .
Fler män än kvinnor hämtade ut tabletter innehållande akamprosat (ATC-kod N07BB03) på recept i Sverige år 2015, totalt 4 791 män och 2 591 kvinnor. Det motsvarar 1,0 respektive 0,5 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 50-64 år hos båda könen. I genomsnitt var tabletter innehållande akamprosat 2,2 gånger vanligare hos män .
Faktagranskat av: Mia von Euler
Godkänt av: Karin Schenck-Gustafsson