The cardiovascular effects of ertugliflozin, an inhibitor sodium-glucose cotransporter 2, have not been established.In a multicenter, double-blind trial, we randomly assigned patients with type 2 diabetes and atherosclerotic disease to receive 5 mg or 15 ertugliflozin placebo once daily. With the data from two dose groups pooled for analysis, primary objective was show noninferiority respect outcome, major adverse events (a composite death causes, nonfatal myocardial infarction, stroke)....

Decreased high-density lipoprotein (HDL) cholesterol levels constitute a major risk factor for coronary heart disease; however, there are no therapies that substantially raise HDL levels. Inhibition of cholesteryl ester transfer protein (CETP) has been proposed as strategy to

In patients with type 2 diabetes mellitus, sodium-glucose cotransporter inhibitors reduce the risk of hospitalization for heart failure (HHF). We assessed effect ertugliflozin on HHF and related outcomes.VERTIS CV (Evaluation Ertugliflozin Efficacy Safety Cardiovascular Outcomes Trial), a double-blind, placebo-controlled trial, randomly assigned mellitus atherosclerotic cardiovascular (CV) disease to once-daily 5 mg, 15 or placebo. Prespecified secondary analyses compared (pooled doses)...

Ertugliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), approved in the United States and European Union to improve glycemic control adults with type 2 diabetes mellitus (T2DM). The VERTIS cardiovascular (CV) outcomes trial (NCT01986881) has a primary objective demonstrate non-inferiority ertugliflozin versus placebo on major adverse CV events: time first event death, nonfatal myocardial infarction, or stroke. Secondary objectives are superiority to: 1) composite outcome...

Pharmacological inhibition of the cholesteryl ester transfer protein (CETP) in humans increases high-density lipoprotein (HDL) cholesterol (HDL-C) levels; however, its effects on apolipoprotein A-I (apoA-I) containing HDL subspecies, apoA-I turnover, and markers reverse transport are unknown. The present study was designed to address these issues.Nineteen subjects, 9 whom were taking 20 mg atorvastatin for hypercholesterolemia, received placebo 4 weeks, followed by CETP inhibitor torcetrapib...

To evaluate the efficacy and safety of ertugliflozin sitagliptin co-administration vs individual agents in patients with type 2 diabetes who are inadequately controlled metformin.In this study (Clinicaltrials.gov NCT02099110), glycated haemoglobin (HbA1c) ≥7.5% ≤11.0% (≥58 ≤97 mmol/mol) metformin ≥1500 mg/d (n = 1233) were randomized to 5 (E5) or 15 (E15) mg/d, 100 (S100) E5/S100 E15/S100. The primary endpoint was change from baseline HbA1c at Week 26.At 26, least squares mean reductions...

To assess ertugliflozin in patients with type 2 diabetes who are inadequately controlled by metformin and sitagliptin.

Ertugliflozin is a sodium-glucose cotransporter 2 inhibitor in development for type diabetes mellitus (T2DM). The safety and efficacy of ertugliflozin were evaluated over 52 weeks patients with chronic kidney disease (CKD).In this double-blind randomized study (NCT01986855), glycated hemoglobin (A1C) 7.0-10.5% stage 3 CKD [estimated glomerular filtration rate (eGFR) ≥ 30 to < 60 mL/min/1.73 m2] who undergoing treatment standard therapy (or therapies) including insulin and/or sulfonylureas...

Abstract Introduction This study assessed the safety and efficacy of ertugliflozin (an oral sodium-glucose cotransporter 2 inhibitor) vs. glimepiride in patients with type diabetes mellitus (T2DM) inadequately controlled on metformin. Methods phase III, double-blind, non-inferiority (NCT01999218) randomized HbA1c ≥ 7.0% ≤ 9.0% stable metformin 1500 mg/day 1:1:1 to 15 or 5 mg once-daily (QD), (titrated from 1 QD). The primary hypothesis was that non-inferior (non-inferiority criterion: upper...

Atypical antipsychotic medications like olanzapine (OLZ) induce weight gain and increase the risk of diabetes in patients with schizophrenia. The goal this study was to assess potential mechanisms OLZ-induced accompanying metabolic effects. Healthy, lean, male volunteers received OLZ placebo (PBO) a randomized, double-blind, crossover study. In periods 1 2, subjects (5 mg for 3 days then 10 12 days) or matching PBO separated by minimum 12-day washout. Twenty-four hour food intake (FI),...

Ertugliflozin is an oral sodium-glucose cotransporter 2 inhibitor that being developed to treat type diabetes mellitus (T2DM). This study assessed the efficacy and safety of co-initiation ertugliflozin sitagliptin compared with placebo in patients T2DM inadequately controlled on diet exercise. In this phase III, randomized, double-blind, multicenter, placebo-controlled 26-week (NCT02226003), glycated hemoglobin (HbA1c) 8.0–10.5% diet/exercise were randomized 1:1:1 5 mg once daily (QD) 100 QD...

Abstract Aims/hypothesis This study aimed to evaluate the effect of ertugliflozin, a sodium–glucose cotransporter 2 (SGLT2) inhibitor, on eGFR and albuminuria (urine albumin/creatinine ratio [UACR]) vs glimepiride or placebo/glimepiride (non-ertugliflozin) over 104 weeks treatment in participants with type diabetes mellitus, using pooled data from two randomised controlled, active comparator studies eValuation ERTugliflozin effIcacy Safety (VERTIS) programme ( Clinicaltrials.gov NCT01999218...

Abstract Purpose The sodium-glucose transporter 2 inhibitor (SGLT2i) empagliflozin may reduce the incidence of obstructive sleep apnea (OSA) in patients with type diabetes (T2D) and cardiovascular (CV) disease. This analysis VERTIS CV, CV outcome trial for SGLT2i ertugliflozin conducted a similar group patients, explored effects on reported incident OSA. Methods In ≥ 40 years T2D atherosclerotic disease (ASCVD) were randomized to 5 or 15 mg placebo. primary endpoint was composite major...

Introduction: VERTIS CV was a placebo-controlled cardiovascular (CV) outcome trial evaluating the sodium-glucose cotransporter 2 inhibitor ertugliflozin in patients with type diabetes and established atherosclerotic disease. The aim of current analyses to evaluate cardiorenal outcomes according baseline use renin-angiotensin-aldosterone system (RAAS) inhibitors or diuretics, including mineralocorticoid receptor antagonists (MRAs). Methods: Participants received 5 mg, 15 placebo once daily...

Objective: To assess the safety and efficacy of ertugliflozin over 104 weeks in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin. Methods: In this double-blind, multicenter, randomized, phase III study (VERTIS SU; NCT01999218), adults T2DM glycated hemoglobin (HbA1c) 7.0-9.0% metformin ≥1500 mg/day received 5 mg or 15 mg, glimepiride. The primary time point was Week 52; double-blinded treatment continued until 104. Results: Baseline characteristics treated...

Cholesteryl ester transfer protein (CETP) inhibition with torcetrapib not only increases high-density lipoprotein cholesterol levels but also significantly reduces plasma triglyceride, low-density (LDL) cholesterol, and apolipoprotein B (apoB) levels. The goal of the present study was to define kinetic mechanism(s) by which CETP apoB-containing lipoproteins.Nineteen subjects, 9 whom were pretreated 20 mg atorvastatin, received placebo for 4 weeks, followed 120 once daily weeks. Six subjects...

Introduction Here we report the glycemic efficacy and safety of ertugliflozin in patients VERTIS CV cardiovascular outcome trial with chronic kidney disease (CKD) stage 3. Research design methods Prespecified post-hoc analyses were performed an estimated glomerular filtration rate (eGFR) 30–&lt;60 mL/min/1.73 m 2 at screening. The primary endpoint was week 18. Longer term changes body weight, systolic blood pressure (SBP), eGFR also evaluated. Results Among 8246 CV, 1776 had CKD 3; 1319 3A...

Background: This pooled analysis assessed the efficacy of ertugliflozin versus placebo as monotherapy or with other antihyperglycaemic agents across patient subgroups defined by demographic and disease characteristics. Methods: Data from three phase III randomised, placebo-controlled, double-blind studies (NCT01958671, NCT02033889 NCT02036515) similar designs populations were ( N = 1544). Results: At Week 26, placebo-adjusted least squares mean changes baseline in glycated haemoglobin 5 15...

Inhibition of phosphodiesterase 5 is an attractive candidate mechanism for blood pressure (BP) lowering. In this study, a novel long-acting inhibitor, PF-00489791, was evaluated in 133 patients with mild to moderate hypertension, randomized into 1 4 groups: placebo, mg, 10 and 20 mg titrated after 14 days dosing 40 mg. Study medication administered once daily 28 days. Ambulatory BP monitoring used. There statistically significant decrease (compared placebo) mean daytime systolic on day at...

The sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin is approved for the treatment of adults with type diabetes mellitus (T2DM). This analysis was conducted on safety data pooled from phase 3 studies using 5 mg or 15 versus placebo an active comparator. pool (n = 1544) comprised three similarly designed 26-week placebo-controlled studies. broad 4849) these plus four placebo- active-controlled durations up to 104 weeks. In pool, there were no notable differences across groups in...

To assess selected cardiorenal outcomes with ertugliflozin according to use of baseline glucose-lowering agent.