Indian journal of dermatology, venereology and leprology · 2017
Atorvastatin as adjunctive therapy for chronic plaque type psoriasis versus betamethasone valerate alone: A randomized, double-blind, placebo-controlled trial.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Xu Kaiming, Bhardwaj Ankita, Koundal Sunil, Ren Qin, You Chenyu, Papademetris Xenophon, Benveniste Helene, Georgiou Tryphon T
Аннотация
BACKGROUND: Psoriasis is a T helper 1 cell-mediated chronic inflammation. Statins have been found to have anti-inflammatory and immunomodulatory effects targeting T helper 1 cells and thus, are being investigated as treatments for psoriasis.
AIMS: To investigate the efficacy and safety of atorvastatin as adjunctive treatment for mild to moderate chronic plaque psoriasis; and the impact of atorvastatin on quality of life. The study also aimed to correlate the beneficial effects of atorvastatin with its lipid-lowering effects.
METHODS: Twenty-eight (19-65 year old) mild-moderate chronic plaque psoriasis patients were randomly assigned to two groups (treatment group: atorvastatin 40 mg OD; control group: placebo OD) and followed up for 6 months. All were allowed to use betamethasone valerate 0.1% ointment twice a day for a maximum of 3 weeks continuous application with 1-week rest periods in between. Primary outcome measures were the mean percentage reduction in Psoriasis Area and Severity Index (PASI) scores and percentage of patients achieving PASI-50.
RESULTS: Fourteen patients (treatment: 6, control: 8) completed the trial. Mean reductions in PASI scores between the treatment (2.15 ± 2.17) and control (1.69 ± 2.36) groups were not statistically significant (P = 0.636). Intention-to-treat analysis of PASI-50 showed increased risk of treatment failure with atorvastatin as adjunct but estimates were not significant. Changes in Dermatology Life Quality Index (DLQI) scores (P = 0.214) and high-sensitivity C-reactive protein (P = 0.884) were likewise not statistically significant. Reductions in PASI scores were not linearly correlated with reductions in total cholesterol (P = 0.924), triglycerides (P = 0.274), low-density lipoprotein-cholesterol (P = 0.636), high-density lipoprotein-cholesterol (P = 0.584), or high-sensitivity C-reactive protein levels (P = 0.906). Adverse effects in the treatment group were transient elevated transaminases (n = 1) and mild myalgia (n = 1).
LIMITATIONS: A 50% dropout rate was experienced. This remarkably high dropout rate decreases the robustness of the study results.
CONCLUSIONS: Although atorvastatin exhibited earlier percentage reduction in PASI scores, it was not able to produce an additional benefit compared to psoriatic patients applying steroid alone.
AIMS: To investigate the efficacy and safety of atorvastatin as adjunctive treatment for mild to moderate chronic plaque psoriasis; and the impact of atorvastatin on quality of life. The study also aimed to correlate the beneficial effects of atorvastatin with its lipid-lowering effects.
METHODS: Twenty-eight (19-65 year old) mild-moderate chronic plaque psoriasis patients were randomly assigned to two groups (treatment group: atorvastatin 40 mg OD; control group: placebo OD) and followed up for 6 months. All were allowed to use betamethasone valerate 0.1% ointment twice a day for a maximum of 3 weeks continuous application with 1-week rest periods in between. Primary outcome measures were the mean percentage reduction in Psoriasis Area and Severity Index (PASI) scores and percentage of patients achieving PASI-50.
RESULTS: Fourteen patients (treatment: 6, control: 8) completed the trial. Mean reductions in PASI scores between the treatment (2.15 ± 2.17) and control (1.69 ± 2.36) groups were not statistically significant (P = 0.636). Intention-to-treat analysis of PASI-50 showed increased risk of treatment failure with atorvastatin as adjunct but estimates were not significant. Changes in Dermatology Life Quality Index (DLQI) scores (P = 0.214) and high-sensitivity C-reactive protein (P = 0.884) were likewise not statistically significant. Reductions in PASI scores were not linearly correlated with reductions in total cholesterol (P = 0.924), triglycerides (P = 0.274), low-density lipoprotein-cholesterol (P = 0.636), high-density lipoprotein-cholesterol (P = 0.584), or high-sensitivity C-reactive protein levels (P = 0.906). Adverse effects in the treatment group were transient elevated transaminases (n = 1) and mild myalgia (n = 1).
LIMITATIONS: A 50% dropout rate was experienced. This remarkably high dropout rate decreases the robustness of the study results.
CONCLUSIONS: Although atorvastatin exhibited earlier percentage reduction in PASI scores, it was not able to produce an additional benefit compared to psoriatic patients applying steroid alone.