For adults with diabetic neuropathy, how does pregabalin compare with placebo?

Abstract

More adults with painful diabetic neuropathy have pain relief and also adverse events with pregabalin 300 or 600 mg daily than with placebo, but researchers found no clear benefit or harm with a 150‐mg dose.Moderate‐certainty evidence shows that, compared with placebo, more adults with painful diabetic neuropathy had their pain intensity reduced by at least 30% with daily pregabalin for 5 to 15 weeks (47 and 169 difference per 1000 people with 300 mg and 600 mg pregabalin, respectively; all results on average) and by at least 50% (72 and 143 difference per 1000 people with 300 mg and 600 mg pregabalin, respectively), but low‐certainty evidence suggests no clear benefit with 150 mg.More people showed improvement on the Patient Global Impression of Change (PGIC) with pregabalin than with placebo (236 and 274 difference per 1000 people with 300 mg and 600 mg pregabalin, respectively; moderate‐certainty evidence); results for pregabalin 150 mg did not reach statistical significance.High‐certainty evidence shows that fewer people withdrew because of lack of efficacy with pregabalin 600 mg than with placebo (30 vs 59 per 1000 people), but researchers observed no clear difference between groups for 150 mg or 300 mg. More people withdrew because of adverse events with pregabalin than with placebo (24 and 78 difference per 1000 people with 300 mg and 600 mg pregabalin, respectively), although withdrawal rates were similar for 150 mg. Also, more people experienced adverse events with pregabalin than with placebo (93 and 290 difference per 1000 people with 300 mg and 600 mg pregabalin, respectively), although adverse events with the 150‐mg dose did not reach statistical significance.The rate of serious adverse events was low for any pregabalin dose, and there were no clear differences between groups. More people experienced somnolence and dizziness with pregabalin than with placebo.