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Efficacy and safety of linagliptin in type 2 diabetes subjects at high risk for renal and cardiovascular disease: a pooled analysis of six phase III clinical trials.

ABSTRACT: In patients with type 2 diabetes mellitus (T2DM), hypertension and microalbuminuria are predictive markers for increased renal and cardiovascular risk. This post hoc analysis of data from a global development program aimed to evaluate the efficacy and safety of linagliptin in a population with joint prevalence of these two vascular risk factors.Data for patients with baseline microalbuminuria (urine albumin-to-creatinine ratio 30-300?mg/g) and hypertension (systolic blood pressure???140?mm Hg and/or diastolic blood pressure???90?mm Hg and/or a history of hypertension; and/or an antihypertensive treatment at baseline) who participated in any of six randomized, placebo-controlled, phase III trials were analyzed. Participants received linagliptin 5?mg daily (alone or in combination with other oral antidiabetic drugs) or placebo for 18 to 24?weeks.Of 3,119 patients, 512 had both microalbuminuria and hypertension (linagliptin, 366; placebo, 146). Baseline mean (SD) HbA1c was 8.3 (0.9)% and 8.4 (0.9)%; median (range) urine albumin-to-creatinine ratio was 60 (30-292) mg/g and 64 (30-298) mg/g; mean (SD) systolic blood pressure was 138 (15) mm Hg and 135 (16) mm Hg; and mean (SD) diastolic blood pressure was 81 (10) mm Hg and 81 (10) mm Hg, for linagliptin and placebo, respectively. Placebo-corrected mean change in HbA1c from baseline to week 18 and week 24 was -0.57% (95% CI: -0.75, -0.39; P?

SUBMITTER: von Eynatten M

PROVIDER: S-EPMC3626685 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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Efficacy and safety of linagliptin in type 2 diabetes subjects at high risk for renal and cardiovascular disease: a pooled analysis of six phase III clinical trials.

von Eynatten Maximilian M Gong Yan Y Emser Angela A Woerle Hans-Juergen HJ

Cardiovascular diabetology 20130409

<h4>Background</h4>In patients with type 2 diabetes mellitus (T2DM), hypertension and microalbuminuria are predictive markers for increased renal and cardiovascular risk. This post hoc analysis of data from a global development program aimed to evaluate the efficacy and safety of linagliptin in a population with joint prevalence of these two vascular risk factors.<h4>Methods</h4>Data for patients with baseline microalbuminuria (urine albumin-to-creatinine ratio 30-300 mg/g) and hypertension (sys ...[more]

PMID: 23570327

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Project description:IntroductionAsian patients with type 2 diabetes (T2D) are younger, leaner, and more likely to develop renal dysfunction than White populations. In this multiethnic analysis of data from phase 3 trials, we investigated the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in Asians stratified by these subphenotypes.MethodsData from randomized, double-blind, placebo-controlled trials evaluating linagliptin (as monotherapy, add-on therapy to metformin ± sulfonylurea, combined with pioglitazone or added to insulin) were pooled with efficacy data from 11 randomized trials of at least 24 weeks and safety data from 15 trials of various durations.ResultsIn the efficacy set, 1404 Asian patients received linagliptin [mean (standard deviation) age 54.5 (10.1) years; body mass index (BMI) 26.0 (3.9) kg/m2] and 661 received placebo [age 55.0 (9.7) years; BMI 26.1 (3.9) kg/m2] with the same glycated hemoglobin (HbA1c): 8.2 (0.9)% in both groups. At 24 weeks, the placebo-corrected adjusted mean ± standard error change from baseline in HbA1c with linagliptin was -0.73 ± 0.04% (95% confidence interval -0.81, -0.65; P < 0.0001). Reductions in HbA1c were similar upon stratification by age [<65 years, -0.71 ± 0.05% (-0.80, -0.62; P < 0.0001); ≥65 years, -0.81 ± 0.10% (-1.01, -0.60; P < 0.0001)], BMI (<25 kg/m2, -0.82 ± 0.06% [-0.94, -0.70; P < 0.0001]; ≥25 kg/m2, -0.65 ± 0.06% [-0.76, -0.54; P < 0.0001]) and estimated glomerular filtration rate [<90 mL/min/1.73 m2, -0.71 ± 0.06% (-0.82, -0.60; P < 0.0001); ≥90 mL/min/1.73 m2, -0.75 ± 0.06% (-0.87, -0.64; P < 0.0001)]. In the safety set (linagliptin, n = 1842; placebo, n = 839), 52.2% and 54.6% of patients, respectively, experienced adverse events. The rates of drug-related adverse events were 10.9% in the linagliptin group and 10.4% in the placebo group. The respective rates of hypoglycemia were 8.3% and 9.5%, mainly among patients treated with sulfonylurea or insulin. Severe hypoglycemia was rare (<1.0% in either group).ConclusionLinagliptin effectively reduced hyperglycemia in Asian patients with uncontrolled T2D, irrespective of age, BMI, renal function, or ethnic subgroups, and was well tolerated.FundingBoehringer Ingelheim, Eli Lilly and Company, and the Diabetes Alliance.

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Efficacy and safety of linagliptin in type 2 diabetes subjects at high risk for renal and cardiovascular disease: a pooled analysis of six phase III clinical trials.

Publications

Efficacy and safety of linagliptin in type 2 diabetes subjects at high risk for renal and cardiovascular disease: a pooled analysis of six phase III clinical trials.

Similar Datasets

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