Randomized placebo control study of insulin sensitizers (Metformin and Pioglitazone) in psoriasis patients with metabolic syndrome (Topical Treatment Cohort).
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引用次数: 46
Abstract
Background: Increased prevalence of metabolic syndrome (MS) is observed in psoriasis. Metformin has shown improvement in cardiovascular risk factors while pioglitazone demonstrated anti proliferative, anti-inflammatory and anti angiogenic effects. Study objective is to evaluate the efficacy and safety of Insulin sensitizers (metformin and pioglitazone) in psoriasis patients with metabolic syndrome (MS).
Methods: Single centre, parallel group, randomized, study of metformin, pioglitazone and placebo in psoriasis patients with MS.
Results: Statistically significant improvement was observed in Psoriasis Area and Severity Index (PASI), Erythema, Scaling and Induration (ESI) and Physician global assessment (PGA) scores in pioglitazone (p values - PASI = 0.001, ESI = 0.002, PGA = 0.008) and metformin groups (p values - PASI = 0.001, ESI = 0.016, PGA = 0.012) as compared to placebo. There was statistically significant difference in percentage of patients achieving 75 % reduction in PASI and ESI scores in metformin (p value - PASI = 0.001, ESI = 0.001) and pioglitazone groups (p vaue - PASI = 0.001, ESI = 0.001). Significant improvement was observed in fasting plasma glucose (FPG) and triglycerides levels in metformin and pioglitazone arms. Significant improvement was noted in weight, BMI, waist circumference, FPG, triglycerides and total cholesterol after 12 weeks of treatment with metformin while pioglitazone showed improvement in FPG, triglyceride levels, systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol and LDL cholesterol levels. There was no difference in pattern of adverse drug reaction in three groups.
Conclusion: Insulin sensitizers have shown improvement in the parameters of MS as well as disease severity in psoriasis patients.
Trial registration: CTRI Registration Number: CTRI/2011/12/002252 . Registered on 19/12/2011.
背景:代谢综合征(MS)在银屑病中的患病率增加。二甲双胍显示改善心血管危险因素，而吡格列酮显示抗增殖、抗炎和抗血管生成作用。研究目的是评价胰岛素增敏剂(二甲双胍和吡格列酮)治疗银屑病伴代谢综合征(MS)患者的疗效和安全性。方法:单中心、平行组、随机对照研究二甲双胍、吡格列酮和安慰剂对ms型银屑病患者的治疗效果。结果:吡格列酮组(p值- PASI = 0.001, ESI = 0.002, PGA = 0.008)和二甲双胍组(p值- PASI = 0.001, ESI = 0.016, PGA = 0.012)与安慰剂组相比，银屑病面积和严重程度指数(PASI)、红斑、结皮和硬结(ESI)和医师总体评估(PGA)评分均有统计学意义的改善。在二甲双胍组(p值- PASI = 0.001, ESI = 0.001)和吡格列酮组(p值- PASI = 0.001, ESI = 0.001)中PASI和ESI评分降低75%的患者百分比有统计学意义。二甲双胍组和吡格列酮组的空腹血糖(FPG)和甘油三酯水平均有显著改善。二甲双胍治疗12周后，体重、BMI、腰围、FPG、甘油三酯和总胆固醇均有显著改善，吡格列酮治疗12周后，FPG、甘油三酯水平、收缩压(SBP)、舒张压(DBP)、总胆固醇和低密度脂蛋白胆固醇水平均有改善。三组患者药物不良反应类型无差异。结论:胰岛素增敏剂可改善银屑病患者的MS参数和病情严重程度。试验注册:CTRI注册号:CTRI/2011/12/002252。于2011年12月19日注册。
期刊介绍：
BMC Dermatology is an open access journal publishing original peer-reviewed research articles in all aspects of the prevention, diagnosis and management of skin disorders, as well as related molecular genetics, pathophysiology, and epidemiology. BMC Dermatology (ISSN 1471-5945) is indexed/tracked/covered by PubMed, MEDLINE, CAS, EMBASE, Scopus and Google Scholar.
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