PROPIT

A PROspective comparative clinical study evaluating the efficacy and safety of PITavastatin in patients with metabolic syndrome

Sung Hee Choi, Soo Lim, Eun Shil Hong, Ji A Seo, Cheol Young Park, Jung Hyun Noh, Ji Oh Mok, Ki Young Lee, Jong Sook Park, Dae Jung Kim, Chang Beom Lee, Sung Rae Kim, Hak Chul Jang

Research output: Contribution to journalArticle

7 Citations (Scopus)

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. Design/Participants/Measurements 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.

Original languageEnglish
Pages (from-to)670-677
Number of pages8
JournalClinical Endocrinology
Volume82
Issue number5
DOIs
Publication statusPublished - 2015 May 1

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Safety
Life Style
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Prediabetic State
Abdominal Obesity
Dyslipidemias
Clinical Studies
pitavastatin
Therapeutics
Glucose Intolerance
Intra-Abdominal Fat
Subcutaneous Fat
Apolipoprotein A-I
Apolipoproteins B
Secondary Prevention
Longitudinal Studies
Odds Ratio
Lipids
Glucose

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

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PROPIT : A PROspective comparative clinical study evaluating the efficacy and safety of PITavastatin in patients with metabolic syndrome. / 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.

In: Clinical Endocrinology, Vol. 82, No. 5, 01.05.2015, p. 670-677.

Research output: Contribution to journalArticle

Choi, SH, Lim, S, Hong, ES, Seo, JA, Park, CY, Noh, JH, Mok, JO, Lee, KY, Park, JS, Kim, DJ, Lee, CB, Kim, SR & Jang, HC 2015, 'PROPIT: A PROspective comparative clinical study evaluating the efficacy and safety of PITavastatin in patients with metabolic syndrome', Clinical Endocrinology, vol. 82, no. 5, pp. 670-677. https://doi.org/10.1111/cen.12580
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. / PROPIT : A PROspective comparative clinical study evaluating the efficacy and safety of PITavastatin in patients with metabolic syndrome. In: Clinical Endocrinology. 2015 ; Vol. 82, No. 5. pp. 670-677.
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T2 - A PROspective comparative clinical study evaluating the efficacy and safety of PITavastatin in patients with metabolic syndrome

AU - Choi, Sung Hee

AU - Lim, Soo

AU - Hong, Eun Shil

AU - Seo, Ji A

AU - Park, Cheol Young

AU - Noh, Jung Hyun

AU - Mok, Ji Oh

AU - Lee, Ki Young

AU - Park, Jong Sook

AU - Kim, Dae Jung

AU - Lee, Chang Beom

AU - Kim, Sung Rae

AU - Jang, Hak Chul

PY - 2015/5/1

Y1 - 2015/5/1

N2 - 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. Design/Participants/Measurements 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.

AB - 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. Design/Participants/Measurements 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.

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