A drug recommended for treating alcohol-dependent patients has insufficient evidence to prove its effectiveness, say researchers.
In an analysis of published studies of nalmefene – a drug recommended by NICE as an option for reducing alcohol consumption in alcohol-dependent patients – UK investigators found that the efficacy of nalmefene ‘appears uncertain’ and said its relevance to primary care was ‘doubtful’.
But the company that manufacturers the drug, Lundbeck, said they ‘strongly disagreed’ with the conclusions.
The researchers from the University of Stirling found that nalmefene had not been tested in an NHS setting, concluding that its relevance to UK primary care ‘is unknown’, with other weaknesses in the evidence arising from primary outcomes not being specified fully prior to the start of trials and a lack of trials comparing nalmefene to existing treatments such as naltrexone.
In the analysed trials, the team also found that more participants taking nalmefene dropped out of trials than those taking a placebo due to experiencing more common adverse reactions including nausea, insomnia, fatigue and vomiting.
Writing in the paper, the team state: ‘Proponents for nalmefene argue that it should be used widely and proactively for public health benefit; however, uncertainties about efficacy, effectiveness and cost-effectiveness of nalmefene inhibit appraisal of the possibility of such benefits.’
The study, published in Addiction, searched for all published research papers relating to using nalmefene for alcohol consumption problems and found six published studies to analyse, three of which had been sponsored by Lundbeck, the pharmaceutical company who produce nalmefene under the brand name Selincro.
These three papers were used by the NICE appraisal committee to assess whether nalmefene could be recommended for treatment of alcohol-dependent patients. Two of the trials assessed taking nalmefene with psychosocial therapy for 24 weeks against participants taking a placebo and psychosocial therapy. The other trial assessed taking nalmefene with psychosocial therapy for a year.
NICE currently recommends that nalmefene can be given as an option for reducing alcohol consumption for alcohol-dependent patients who have a high-drinking risk level without physical withdrawal symptoms or in alcohol-dependent patients who do not require immediate detoxification.
Under current marketing authorisation, nalmefene should only be given in conjunction with psychosocial therapy.
Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE says: ‘Our appraisal process for nalmefene thoroughly interrogated the evidence base and, as is the standard with all our appraisals, we engaged with and took into account submissions from a multitude of stakeholders.
‘When presented with the evidence, including the analysis of the clinical studies, the independent committee concluded that there was sufficient evidence to recommend nalmefene in specific circumstances.’
Dr Andrew Jones, medical director for Lundbeck, refuted the claims made by the research. He said: ‘We are surprised by the conclusions of [the study] and strongly disagree. Robust scientific data is the reason for nalmefene being the first and only drug approved for the indication “reduction in alcohol consumption for alcohol dependent patients” and nalmefene has demonstrated a positive efficacy/safety profile for dependent drinkers.
‘Moreover, nalmefene was assessed by NICE and the SMC, who both concluded that nalmefene is a cost-effective treatment for alcohol-dependent patients and should be available for prescription in the NHS in England, Wales and Scotland.’