I ran across this study tonight about nalmefene. The nalmefene was supplied by Biotie which is the company working in conjunction with Lundbeck to get approval for oral nalmefene for targeted use in alcohol dependence.
Quote:
Alcohol Clin Exp Res. 2007 Jul;31(7):1179-87. Epub 2007 Apr 19.
Targeted nalmefene with simple medical management in the treatment of heavy drinkers: a randomized double-blind placebo-controlled multicenter study.
Karhuvaara S, Simojoki K, Virta A, Rosberg M, Löyttyniemi E, Nurminen T, Kallio A, Mäkelä R.
Biotie Therapies Corp, Turku, Finland.
sakari.karhuvaara@pp.inet.fiAbstract
BACKGROUND: Clinical studies with opioid antagonists for treatment of problem drinking have mainly been conducted in specialized alcohol treatment centers, included structured psychosocial treatment, and have focused on maintaining abstinence after a period of abstinence from alcohol.
METHODS: This multisite, randomized double-blind study investigated targeted nalmefene in reducing heavy drinking. Specialized alcohol treatment centers and private general practices enrolled 403 subjects (328 men, 75 women). Subjects were instructed to take nalmefene 10 to 40 mg (n=242) or placebo (n=161) when they believed drinking to be imminent. After 28 weeks, 57 subjects from the nalmefene group continued into a 24-week randomized withdrawal extension. Concomitant psychosocial intervention was minimal and no treatment goals were imposed. Alcohol consumption was recorded using the time-line follow-back method. Biochemical indicators of alcohol use were also measured.
RESULTS: The mean monthly number of heavy drinking days (HDDs) during the 12-week period before inclusion was 15.5 (SD 6.9) in the nalmefene group and 16.2 (SD 6.9) in the placebo group. During treatment, the mean numbers of HDDs were 8.6 to 9.3 in the nalmefene group and 10.6 to 12.0 in the placebo group (p=0.0065). The levels of serum alanine aminotransferase and gamma-glutamyl transferase decreased in the nalmefene group compared with the placebo group (p=0.0088 and 0.0023). During the randomized withdrawal period, subjects randomized to placebo apparently returned to heavier drinking. Subjects receiving nalmefene reported more nausea, insomnia, fatigue, dizziness, and malaise than subjects on placebo.
CONCLUSIONS: Nalmefene appears to be effective and safe in reducing heavy drinking, even when accompanied by minimal psychosocial support.
I read the full text version of the study. I find it interesting that the researchers seem to only be concerned with reporting the reduction in heavy drinking days, but for me as a alcoholic I am more interested in the reduction in drinks per drinking day and # of drinks/week because this is what is going to have the biggest impact on my quality of life. In this study the nalmefene group went from 43.2 (50.4 US units) drinks per week pre-study to 23.2 (27.1) seven months later (a 46% reduction) versus the placebo group who went from 45.0 (52.5 US units) to 28.5 (33.3 US units) drinks/week (a 37% reduction). At the end of the study they took the responders and randomized them to either continued nalmefene or placebo and in the researcher's words,
Quote:
During the randomized withdrawal, there appeared to be a return to more frequent heavy drinking among the subjects randomized to placebo, while the subjects continuing with nalmefene remained at the level of drinking that they had achieved during the initial 28-week period. Partly due to the small number of subjects, the difference between the treatments was not statistically significant (p=0.07, treatment × time interaction)
What I take from this is when the nalmefene responders went on placebo their drinking increased. If I were drinking 50.4 drinks/week (7.2 drinks/day) and began taking oral nalmefene I would be a much more functional human being 7 months later when I was averaging 27.1 drinks/week (3.9 drinks/day). I know this first hand because I've had a lot of weeks around 27 drinks in the last few months. For me there is a huge difference between a 7 drink night and a 4 drink night in terms of my quality of life, ability to function as a single father and generally be a productive person and not put myself or others in harm's way. Presumably, the 37% reduction in drinks/week that the placebo group saw is due to them recognizing they had a drinking problem and enrolling in the study thereby focusing their attention on the fact that they needed to slow down. The difference between nalmefene and placebo (9% extra reduction in drinks/week) is the effect of targeted nalmefene use. I welcome anyone else's interpretation of the results.
Note: edited to convert to US units
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