title: PROPIT: A PROspective comparative clinical study evaluating the efficacy and safety of PITavastatin in patients with metabolic syndrome.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  After 1 year treatment, the improvement of MS score was significantly higher in the pitavastatin + LSM group (P = 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Sung Hee
authors.initials: SH
authors.lastname: Choi
authors.forename: Soo
authors.initials: S
authors.lastname: Lim
authors.forename: Eun Shil
authors.initials: ES
authors.lastname: Hong
authors.forename: Ji A
authors.initials: JA
authors.lastname: Seo
authors.forename: Cheol-Young
authors.initials: CY
authors.lastname: Park
authors.forename: Jung Hyun
authors.initials: JH
authors.lastname: Noh
authors.forename: Ji Oh
authors.initials: JO
authors.lastname: Mok
authors.forename: Ki Young
authors.initials: KY
authors.lastname: Lee
authors.forename: Jong Sook
authors.initials: JS
authors.lastname: Park
authors.forename: Dae Jung
authors.initials: DJ
authors.lastname: Kim
authors.forename: Chang Beom
authors.initials: CB
authors.lastname: Lee
authors.forename: Sung Rae
authors.initials: SR
authors.lastname: Kim
authors.forename: Hak Chul
authors.initials: HC
authors.lastname: Jang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight; D002318:Cardiovascular Diseases / Q000150:complications; D050171:Dyslipidemias / Q000097:blood; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D008019:Life Style; D008055:Lipids / Q000097:blood; D008297:Male; D024821:Metabolic Syndrome / Q000188:drug therapy*; D008875:Middle Aged; D011446:Prospective Studies; D011804:Quinolines / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008055:Lipids; D011804:Quinolines; C108475:pitavastatin