Low-dose aspirin, taken up to 24 weeks, does not facilitate healing or restoration rate or improve quality of life (QOL) in patients with venous leg ulcers, researchers reported in the BMJ.
Andrew Jull, PhD, from the School of Nursing at the University of Auckland in New Zealand, and colleagues conducted a double-blind, placebo-controlled trial in which 251 patients, aged 18 or older, with venous leg ulcers were randomly administered 168 capsules of 150-mg doses of aspirin (125 patients) or 168 capsules of a placebo (126 patients) in addition to a compression therapy background treatment.
The primary outcome was the overall ulceration healing time, while the secondary outcomes were the number of healed patients and changes in ulcer area, patient QOL, and any associated negative effects.
The authors noted that the aspirin group took a median of 77 days for ulcers to heal, and the placebo group had a median of 69 days for ulcers to heal (hazard ratio, 0.85). Seventy percent of the aspirin group and 80% of the placebo group healed at the close of the 24-week period (risk difference, -9.8%).
With a mean difference of -0.7cm2, the aspirin group (4.1cm2) showed less ulcer change than the placebo group (4.8cm2), which indicated that aspirin did not benefit venous leg ulcer patients. In addition, the investigators reported more adverse effects in patients who were administered aspirin than in those who received placebo (incidence rate ratio, 1.1). Twenty-nine patients in the aspirin group (40 events) were negatively affected, while 27 individuals in the placebo group were affected (37 events).
When administered with compression therapy, an effective treatment for venous leg ulcers, 150 mg aspirin did not aid in patient healing time or healing size. “The direction of effect seems to be the opposite of that in previous trials,” the authors stated.
“Until the evidence base has been expanded by anticipated reports from new trials evaluating 300 mg doses, aspirin should not be used as an adjuvant for the treatment of venous leg ulcers,” the investigators concluded.
- Jull A, Wadham A, Bullen C, et al. Low dose aspirin as adjuvant treatment for venous leg ulceration: pragmatic, randomized, double blind, placebo controlled trial (Aprinin4VLU). BMJ. 2017 Nov 24. doi: 10.1136/bmj.5157