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Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial.
Trials 2017; 18(1):501T

Abstract

BACKGROUND

The diabetogenic action of statins remains a concern, particularly in patients at high risk for diabetes receiving intensive statin therapy. Despite the risk of diabetes with statin use being considered a potential class effect, recent studies have suggested that pitavastatin exerts neutral or favorable effects on diabetogenicity. However, no randomized trial has compared the long-term effects of pitavastatin with those of other statins on glycemic control in populations at high risk for diabetes. Hence, we aim to assess the long-term effects of pitavastatin in comparison with atorvastatin on glucose metabolism in patients with metabolic syndrome (MetS).

METHODS/DESIGN

The Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM) trial is a prospective, randomized, open-label, active control clinical trial of patients with MetS. We plan to randomize 500 patients with MetS (1:1) to receive high-dose pitavastatin (4 mg) or atorvastatin (20 mg) daily for 24 months. The primary endpoint will be the change in hemoglobin A1c after statin treatment. Secondary endpoints will include the following: (1) changes in biochemical markers, including insulin, C-peptide, homeostasis model assessment of insulin resistance and insulin secretion, and adiponectin; (2) changes in imaging parameters, including carotid elasticity metrics and indices of cardiac function; and (3) the incidence of clinical events, including new-onset diabetes and cardiovascular disease.

DISCUSSION

In this trial, we will explore whether pitavastatin 4 mg does not disturb glucose metabolism in patients with MetS. It will also provide mechanistic information on statin type-dependent diabetogenic effects and surrogate data regarding vascular and cardiac changes achieved by intensive statin therapy.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02940366 . Registered on 19 October 2016.

Authors+Show Affiliations

Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, South Korea.Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, South Korea.Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, South Korea.Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. Cardiovascular Center, SNU-SMG Boramae Medical Center, Seoul, South Korea.Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, South Korea.Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. hkkim73@snu.ac.kr. Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, South Korea. hkkim73@snu.ac.kr. Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea. hkkim73@snu.ac.kr.Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, South Korea.Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, South Korea.Division of Cardiology, Seoul National University College of Medicine, Seoul, South Korea. Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul, 110-744, South Korea.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

29078817

Citation

Park, Jun-Bean, et al. "Long-term Effects of high-doSe pitavaStatin On Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM): Study Protocol for a Randomized Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 501.
Park JB, Jung JH, Yoon YE, et al. Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial. Trials. 2017;18(1):501.
Park, J. B., Jung, J. H., Yoon, Y. E., Kim, H. L., Lee, S. P., Kim, H. K., ... Sohn, D. W. (2017). Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial. Trials, 18(1), p. 501. doi:10.1186/s13063-017-2229-4.
Park JB, et al. Long-term Effects of high-doSe pitavaStatin On Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM): Study Protocol for a Randomized Controlled Trial. Trials. 2017 Oct 27;18(1):501. PubMed PMID: 29078817.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial. AU - Park,Jun-Bean, AU - Jung,Ji-Hyun, AU - Yoon,Yeonyee E, AU - Kim,Hack-Lyong, AU - Lee,Seung-Pyo, AU - Kim,Hyung-Kwan, AU - Kim,Yong-Jin, AU - Cho,Goo-Yeong, AU - Sohn,Dae-Won, Y1 - 2017/10/27/ PY - 2017/06/09/received PY - 2017/10/03/accepted PY - 2017/10/29/entrez PY - 2017/10/29/pubmed PY - 2018/6/26/medline KW - Adiponectin KW - Cardiac function KW - Carotid elasticity KW - Glucose metabolism KW - Metabolic syndrome KW - Statin SP - 501 EP - 501 JF - Trials JO - Trials VL - 18 IS - 1 N2 - BACKGROUND: The diabetogenic action of statins remains a concern, particularly in patients at high risk for diabetes receiving intensive statin therapy. Despite the risk of diabetes with statin use being considered a potential class effect, recent studies have suggested that pitavastatin exerts neutral or favorable effects on diabetogenicity. However, no randomized trial has compared the long-term effects of pitavastatin with those of other statins on glycemic control in populations at high risk for diabetes. Hence, we aim to assess the long-term effects of pitavastatin in comparison with atorvastatin on glucose metabolism in patients with metabolic syndrome (MetS). METHODS/DESIGN: The Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM) trial is a prospective, randomized, open-label, active control clinical trial of patients with MetS. We plan to randomize 500 patients with MetS (1:1) to receive high-dose pitavastatin (4 mg) or atorvastatin (20 mg) daily for 24 months. The primary endpoint will be the change in hemoglobin A1c after statin treatment. Secondary endpoints will include the following: (1) changes in biochemical markers, including insulin, C-peptide, homeostasis model assessment of insulin resistance and insulin secretion, and adiponectin; (2) changes in imaging parameters, including carotid elasticity metrics and indices of cardiac function; and (3) the incidence of clinical events, including new-onset diabetes and cardiovascular disease. DISCUSSION: In this trial, we will explore whether pitavastatin 4 mg does not disturb glucose metabolism in patients with MetS. It will also provide mechanistic information on statin type-dependent diabetogenic effects and surrogate data regarding vascular and cardiac changes achieved by intensive statin therapy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02940366 . Registered on 19 October 2016. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29078817/Long_term_Effects_of_high_doSe_pitavaStatin_on_Diabetogenicity_in_comparison_with_atorvastatin_in_patients_with_Metabolic_syndrome__LESS_DM_:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2229-4 DB - PRIME DP - Unbound Medicine ER -