OBJECTIVES: Pregabalin is widely used in neuropathic pain patients (including diabetic neuropathy) as a first-line agent. However, there are concerns regarding its cardiovascular safety, especially the risk of heart failure (HF). Moreover, diabetes is a risk factor for HF. Therefore, it is critical to assess whether pregabalin increases the risk of HF in diabetic neuropathy patients.

METHODS: We conducted a retrospective cohort study in a commercially insured population using IMS LifeLink PharMetrics Plus™ data. Patients with a diagnosis of diabetic neuropathy and receiving any one of the first-line medications – pregabalin, duloxetine, gabapentin or amitriptyline – between June 01 2006 and April 30 2015 were included in the study. Patients were required to be enrolled 6 months prior to the therapy initiation (index date). Primary comparison was between users of pregabalin and users of duloxetine. The outcome was defined as emergency department visit or inpatient hospitalization for HF within 90 days of index date. All covariates were gathered 6 months prior to index date and included in a cox proportion-hazards regression model.

RESULTS: The final sample consisted of 2950 patients for the primary comparison. We found no difference in the risk of HF with pregabalin compared to duloxetine (hazard ratio of 1.319, 95% CI 0.445-3.912). Secondary analyses yielded similar results that pregabalin has no higher risk of HF compared to either amitriptyline or gabapentin (hazard ratio of 0.532, 95% CI 0.219-1.294; hazard ratio of 0.599, 95% CI 0.336-1.069, respectively)

CONCLUSIONS: Our results showed no increase of HF risk in diabetic neuropathy patients who used pregabalin.