Withdrawal due to adverse events higher with nalmefene
Patients receiving nalmefene to treat impulse control disorders or substance use suffer from a threefold greater risk of withdrawal because of adverse safety events, according to a new meta-analysis.
The meta-analysis included eight randomized controlled trials (RCTs), of which only six reported serious adverse events (SAEs). There was no significant difference in SAE between the nalmefene and placebo groups (Peto odds ratio [POR], 0.97; 95 percent CI, 0.64 to 1.44; p=0.86; risk difference [RD], -0.00; -0.02 to -0.01; p=0.84).
Similarly, the odds for overall psychiatric SAEs were not significantly different between the nalmefene and placebo groups (POR, 1.32; 0.62 to 2.38; p=0.47; RD, 0.00; -0.01 to 0.01; p=0.40). There were also no differences in the risk of depression, anxiety or death.
Pooled findings from all eight RCTs showed that withdrawals due to adverse events were significantly higher in the nalmefene group than in the placebo group (POR, 3.22; 2.46 to 4.22; p<0.00; RD, 0.09; 0.08 to 0.11; p=0.00).
RCTs were included in the meta-analysis if they compared nalmefene to placebo or active controls in patients with impulse control and/or substance use disorders. Those with data on harms were included.
The databases of PubMed, Medline, Embase, Clinicaltrials.gov and the Cochrane Central Register of Controlled Trials were accessed.
Fifteen studies fulfilled the eligibility criteria and only eight were included in the final analysis because of missing harms data. Of the 15 studies, two were still ongoing. The remaining 13 studies corresponded to 3,793 participants.