Pemafibrate reduced the risk of lower extremity ischaemic ulceration or gangrene in the PROMINENT trial of patients with type 2 diabetes (T2D), mild-to-moderate hypertriglyceridemia, and low HDL-C levels who were on guideline recommended lipid lowering therapy.
In her presentation of the new data, Dr Aruna Pradhan (Brigham and Women’s Hospital, Boston, USA) highlighted the increasing incidence of ischaemic ulceration and gangrene as a complication of T2D, with limb ischaemia a contributing factor in most cases, no significant clinical benefit shown with medical therapy and limited options for revascularisation due to small vessel involvement.
In the PROMINENT trial of 10,497 patients, 15% of whom had a prior history of peripheral artery disease (PAD), median follow up was 3.3 years. Incident lower ischaemic extremity ulceration or gangrene occurred in 35 patients in the pemafibrate group compared to 56 patients in the placebo group (HR, 0.63;95% CI, CI 0.41-0.95; p=0.03) (Figure). Ulcer or gangrene most commonly occurred in the foot or toe (92%).
Event rates were highest among patients with prior diabetic foot disease, followed by history of PAD, established microvascular disease and current smoking. However, there was no heterogeneity of treatment benefit according to these or other known ulceration risk factors, and there was a 20-40% reduction in most risk factor groups.
“In patients with type 2 diabetes, mild-to-moderate hypertriglyceridaemia, and low levels of HDL on guideline directed lipid lowering therapy, pemafibrate significantly reduced the risk of lower extremity ischaemic ulceration or gangrene, a finding with potential to address a major and growing unmet clinical need that merits further prospective investigation among patients at high risk of developing this disease,” concluded Dr Pradhan and co-investigators.
Figure. PROMINENT: Cumulative incidence of lower extremity ischaemic ulceration or gangrene
Reference
Pradhan AD, Marinho L, Everett BM et al. Pemafibrate reduces incidence of lower extremity ischemic ulcer and gangrene: evidence from PROMINENT. Presented at American Heart Association Scientific Sessions 2023 (11-13 November, Philadelphia, USA) Session FS.07 – Featured Science: From Artery to Veins – A Fantastic Journey
