Use of Pregabalin and Worsening Heart Failure: A Nationwide Cohort Study.

Concerns regarding the increased risk of worsening heart failure with pregabalin have been raised. We assessed the association between use of pregabalin and risk of worsening heart failure in routine clinical practice. We conducted a population-based cohort study in Denmark using data from nationwide registers, from 1 January 2008 to 31 December 2017. The study population consisted of patients 50 years of age or older with a diagnosis of heart failure who were new users of pregabalin or gabapentin (active comparator). We matched a total of 1395 new users of pregabalin to 1395 new users of gabapentin on a propensity score based on 55 covariates. Using proportional hazards regression, we estimated hazard ratios (HRs) for worsening heart failure (hospitalization with, or death from, heart failure) within 90 days of the start of treatment. We observed 33 patients with worsening heart failure among users of pregabalin [incidence rate (IR) 105.7 per 1000 person-years] versus 43 patients among users of gabapentin (IR 133.8 per 1000 person-years), corresponding to an HR of 0.79 [95% confidence interval (CI) 0.50-1.23]. The corresponding absolute risk difference was - 28.6 (95% CI - 66.8 to 31.3) per 1000 person-years. In sensitivity analysis using duloxetine as an alternative active comparator, including 847 new users of pregabalin and 847 new users of duloxetine, the results were similar (HR 1.08, 95% CI 0.60-1.94). The present study found no evidence to support an association between the use of pregabalin and increased risk of worsening heart failure, compared with gabapentin and duloxetine.