Background/Purpose: Duloxetine is a serotonin-norepinephrine reuptake inhibitor approved by the FDA for the treatment of different forms of chronic pain. Because of its adrenergic activity, duloxetine could increase the risk for cardiovascular events, but conversely, given its antiplatelet activity, duloxetine may decrease cardiovascular risk. Therefore, there is a need to define duloxetine’s comparative safety relative to other non-opioid medications used to treat chronic pain. We aimed to compare rates of a composite cardiovascular outcome among new users of duloxetine with rates among new users of the active comparator gabapentin in US Veterans with non-cancer chronic pain.

Methods: This is a retrospective cohort study among Veterans with chronic pain who received new prescriptions for one of the study drugs: duloxetine or gabapentin. The cohorts were assembled using the VA Informatics and Computing Infrastructure (VINCI). We excluded Veterans with cancer or other life-threatening diagnoses in the year prior to their first prescription of the study drugs. The primary outcome was a composite cardiovascular disease outcome including acute myocardial infarction (AMI), stroke, or out-of-hospital death. We calculated time-dependent propensity scores and used inverse probability weighting analysis to compare the risk of cardiovascular disease between the study drugs and adjust for confounding.

Results: The study included new users of duloxetine and gabapentin. At baseline, the groups had similar rates of cardiovascular comorbidities and medications. However, before inverse probability weighting, the groups differed in some baseline characteristics. In particular, fewer users of duloxetine had a diagnosis of diabetes neuropathy compared to gabapentin users (5.2% vs. 11.2%). During 288,430 person-years, the rate of cardiovascular events among new users of duloxetine was 11.5/1,000 person-years compared to 17.5/1,000 person-years among new users of gabapentin [unadjusted HR=0.66 (95% CI=0.60-0.73)]. However, after inverse probability weighting adjustment, the risk for cardiovascular events in new users of duloxetine was not statistically different than in new users of gabapentin [aHR=1.07 (95%CI: 0.94-1.21)].

Conclusion: In this large-scale retrospective study of VA patients who received treatment for non-cancer pain, new users of duloxetine and gabapentin had similar risks of cardiovascular events.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/duloxetine-and-the-risk-for-cardiovascular-events-in-us-veterans-with-non-cancer-pain/