Photo Credit: Mr. Suphachai Praserdumrongchai
Patients with type 2 diabetes and mixed dyslipidemia who were treated with pemafibrate had a mean 37% reduction in ischemic ulcerations or gangrene.
Patients with type 2 diabetes (T2D) and mixed dyslipidemia who participated in the PROMINENT trial and were treated with pemafibrate had a mean 37% reduction in ischemic ulcerations or gangrene related to peripheral artery disease (PAD). According to Aruna Pradhan, MD, MPH, MSc, and colleagues, these findings align with prior studies indicating that PPAR-α agonists positively affect distal small vessel complications in T2D and PAD.
In the double-blind, randomized-controlled PROMINENT trial (NCT03071692), the PPAR-α agonist pemafibrate did not outperform placebo in reducing cardiovascular events, compared with placebo, in a population of patients with T2D and mixed hyperlipidemia.1 “We did see an interesting, but non-significant, trend with respect to new or worsening PAD,” added Dr. Pradhan. The current posthoc analysis hypothesized that pemafibrate reduced clinical ischemic ulceration and gangrene, which are considered microvascular and organ complications of PAD.2
In the subpopulation of patients with ulcers or gangrene (n=91), pemafibrate showed a significant reduction in the cumulative incidence of these events (HR 0.63; 95% CI 0.41–0.96; P=0.03) after a median follow-up of 3.4 years. Both ulcers (HR 0.65; 95% CI 0.38–1.11) and gangrene (HR 0.49; 95% CI 0.27–0.87) were positively influenced by pemafibrate treatment, whereas non-ulcer/gangrene PAD was not (HR 0.89; 95% CI 0.70–1.13).
Medical writing support was provided by Robert van den Heuvel.
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