Efficacy of topical atorvastatin for the treatment of pressure ulcers: a randomized clinical trial.
OBJECTIVE
To evaluate the effects of topical atorvastatin on the healing process of pressure ulcers in critically ill patients.


METHODS
Randomized, double-blind, placebo-controlled clinical trial.


METHODS
Medical-surgical intensive care unit of a university-affiliated teaching hospital in Tehran, Iran.


METHODS
One hundred four patients with stage I or II pressure ulcers, graded according to the 2-digit Stirling Pressure Sore Severity Scale.


METHODS
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.


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.


CONCLUSIONS
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.
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.
Shadi
S
Farsaei
Hossein
H
Khalili
Effat Sadat
ES
Farboud
Iman
I
Karimzadeh
Mohammad Taghi
MT
Beigmohammadi
D000287:Administration, Topical; D000368:Aged; D000069059:Atorvastatin; D002626:Chemistry, Pharmaceutical; D004311:Double-Blind Method; D005260:Female; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D007492:Iran / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D003668:Pressure Ulcer / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D011758:Pyrroles / Q000008:administration & dosage*; D016896:Treatment Outcome
D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin
atorvastatin; healing; pressure ulcer