Efficacy of topical atorvastatin for the treatment of pressure ulcers: a randomized clinical trial.

Author(s): Farsaei S(1), Khalili H, Farboud ES, Karimzadeh I, Beigmohammadi MT.

Affiliation(s): Author information: (1)Faculty of Pharmacy, Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran; Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.

Publication date & source: 2014, Pharmacotherapy. , 34(1):19-27

STUDY OBJECTIVE: To evaluate the effects of topical atorvastatin on the healing process of pressure ulcers in critically ill patients. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Medical-surgical intensive care unit of a university-affiliated teaching hospital in Tehran, Iran. PATIENTS: One hundred four patients with stage I or II pressure ulcers, graded according to the 2-digit Stirling Pressure Sore Severity Scale. INTERVENTION: Patients were randomized to receive topical atorvastatin 1% ointment (51 patients [atorvastatin group]) or placebo ointment (53 patients [control group]) applied once/day to pressure ulcers for 14 days in addition to standard care for pressure ulcers. MEASUREMENTS AND MAIN RESULTS: The efficacy of each treatment was assessed on days 7 and 14. Efficacy was determined based on the degree of healing of the existing pressure ulcer by using the 2-digit Stirling scale. The baseline stage of the pressure ulcers did not differ significantly between the control and atorvastatin groups. However, the mean ± SD stage of pressure ulcers significantly decreased in the atorvastatin group compared with the control group on day 7 (0.97 ± 0.76 vs 1.74 ± 0.75, p<0.01) and day 14 (0.42 ± 0.67 vs 1.71 ± 0.78, p<0.01) of treatment. In addition, the mean ± SD surface areas of ulcers in the atorvastatin group were significantly declined compared with the control group after 7 days (5.55 ± 4.55 vs 9.41 ± 5.03 cm², p<0.01) and 14 days (3.72 ± 4.45 vs 10.41 ± 6.41 cm², p<0.01) of treatment. CONCLUSION: Topical application of atorvastatin ointment 1% for 14 days in addition to standard care significantly accelerated the healing of stage I or II pressure ulcers in critically ill patients.