The hospital component of the baclofen study publishes mixed results. Compared to placebo, the drug has little effect on alcohol withdrawal.
- In March 2014, the National Medicines Safety Agency authorized the use of baclofen in alcohol dependence.
- A Temporary Recommendation for Use (RTU) allows the drug to be dispensed.
- Only 6% of alcohol-dependent patients benefited from the protocol. The ANSM has therefore relaxed the indications.
Baclofen delivers disappointing results. Much awaited by alcohol-dependent patients, it brings little benefit in weaning. The ALPADIR study, carried out in French hospitals, reveals this in Alcohol and Alcoholism. Six months after the start of treatment, administered in high doses, the drug does not cause a major difference compared to a placebo.
Massive doses
These mixed results emerge from the follow-up of 320 adults dependent on alcohol, recruited in French addiction services. Half received baclofen, the other half received placebo. The molecule shows only low efficiency. 12% of the volunteers remained abstinent for 20 weeks in a row under medication compared with 10.5% in the placebo group.
A question remains, that of the doses administered. They were high, since 180 mg per day were prescribed. In multiple sclerosis, the initial indication for treatment, 20 to 80 mg per day, is recommended. This increase in dosage may cause more serious side effects than in the context of MS.
Defining the benefit in relation to the risks is precisely one of the objects of the temporary recommendation for use (RTU), set up by the National Medicines Safety Agency. For the time being, a study conducted by the Grand Ouest poison control center has reported an increased risk of voluntary and involuntary poisoning. Between 2008 and 2013, 300 overdoses were reported. Nine were fatal.
An effect on craving
If alcohol consumption drops from the first month of treatment, the difference is small between the two arms of the study. Patients on baclofen consume only 10.9 grams less alcohol daily than their peers who received a placebo. The difference is slightly more marked among people whose consumption is at high risk.
“It is not the miracle drug that many describe”, recently conceded Professor Michel Reynaud, coordinator of the study. One element, however, arouses interest: the craving, that is, the overwhelming desire to drink, is significantly reduced thanks to baclofen. A key element, because approximately 10% of French adults have a disorder related to their alcohol consumption.
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