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.
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Details
1 Seoul National University College of Medicine, Division of Cardiology, Seoul, South Korea (GRID:grid.31501.36) (ISNI:0000 0004 0470 5905); Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea (GRID:grid.412484.f) (ISNI:0000 0001 0302 820X)
2 Seoul National University College of Medicine, Division of Cardiology, Seoul, South Korea (GRID:grid.31501.36) (ISNI:0000 0004 0470 5905); Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, South Korea (GRID:grid.412480.b) (ISNI:0000 0004 0647 3378)
3 Seoul National University College of Medicine, Division of Cardiology, Seoul, South Korea (GRID:grid.31501.36) (ISNI:0000 0004 0470 5905); Cardiovascular Center, SNU-SMG Boramae Medical Center, Seoul, South Korea (GRID:grid.412479.d)
4 Seoul National University College of Medicine, Division of Cardiology, Seoul, South Korea (GRID:grid.31501.36) (ISNI:0000 0004 0470 5905); Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea (GRID:grid.412484.f) (ISNI:0000 0001 0302 820X); Seoul National University College of Medicine, Department of Internal Medicine, Seoul, South Korea (GRID:grid.31501.36) (ISNI:0000 0004 0470 5905)