PROPIT: A PROspective comparative clinical study evaluating the efficacy and safety of PITavastatin in patients with metabolic syndrome. (17th October 2014)

• Record Type: Journal Article
• Authors: Choi, Sung Hee; Lim, Soo; Hong, Eun Shil; Seo, Ji A; Park, Cheol‐Young; Noh, Jung Hyun; Mok, Ji Oh; Lee, Ki Young; Park, Jong Sook; Kim, Dae Jung; Lee, Chang Beom; Kim, Sung Rae; Jang, Hak Chul
• Is Part Of: Clinical endocrinology. Volume 82:Number 5(2015:May)
• Page Start: 670
• Page End: 677
• Publication Date: 2014-10-17
• Subjects: Endocrinology -- Periodicals; 616.4005
• DOI: 10.1111/cen.12580
• Languages: English
• ISSNs: 0300-0664

Abstract

<abstract abstract-type="main" id="cen12580-abs-0001"> <title>Summary</title> <sec id="cen12580-sec-0001" sec-type="section"> <title>Objective</title> <p>Dyslipidaemia and central obesity are the major factors underlying the dramatic increase in metabolic syndrome (MS). We compared the effects of early combined therapy with pitavastatin and intensive lifestyle modification (LSM) on the amelioration of each component of MS with those of LSM only.</p> </sec> <sec id="cen12580-sec-0002" sec-type="section"> <title>Design/Participants/Measurements</title> <p>PROPIT (a PROspective comparative clinical study to evaluate the efficacy and safety of PITavastatin in patients with metabolic syndrome) was a prospective, randomized, multicenter open‐label 48‐week trial. We enrolled 187 patients with MS (central obesity and prediabetes) and randomized them into two treatment groups: 2 mg pitavastatin daily + intensive LSM or intensive LSM only. The primary outcome was the improvements in the components of MS and in the percentage of non‐MS converters.</p> </sec> <sec id="cen12580-sec-0003" sec-type="section"> <title>Results</title> <p>After 1 year treatment, the improvement of MS score was significantly higher in the pitavastatin + LSM group (<italic>P</italic> = 0·039). However, non‐MS converters (MS score ≤2) did not differ between the groups. The secondary outcomes, namely lipid profiles, the Apo B/A1 ratio, visceral fat/subcutaneous fat ratio and the Framingham risk score, were significantly improved in the pitavastatin group. There was no deterioration in glucose metabolism after treatment with pitavastatin for 1 year.</p> </sec> <sec id="cen12580-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Early statin treatment can be an effective option in obese patients with MS, prediabetes and mild dyslipidaemia with further improvement of cardiovascular risk factors. We could not observe the increase rate of glucose intolerance in statin group. Future longitudinal studies are needed to test the benefits of early statin treatment compared with LSM.</p> </sec> </abstract>