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
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
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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 read more 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 vegas golden knights background 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.