We are analyzing https://link.springer.com/article/10.1186/1475-2840-11-3.

Title:
Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme | Cardiovascular Diabetology
Description:
Background This study investigated the cardiovascular (CV) safety profile of the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin versus comparator treatments. Methods This was a pre-specified meta-analysis of CV events in linagliptin or comparator-treated patients with type 2 diabetes mellitus (T2DM) from eight Phase 3 studies. All suspected CV events were prospectively adjudicated by a blinded independent expert committee. The primary endpoint was a composite of CV death, stroke, myocardial infarction, and hospitalization for unstable angina. Three secondary composite endpoints derived from the adjudicated CV events were also pre-specified. Risk estimates were calculated using several statistical methods including Cox regression analysis. Results Of 5239 treated patients (mean ± SD HbA1c 65 ± 10 mmol/mol [8.0 ± 0.9%], age 58 ± 10 years, BMI 29 ± 5 kg/m2), 3319 received linagliptin once daily (5 mg, 3159; 10 mg, 160) and 1920 received comparators (placebo, 977; glimepiride 1-4 mg, 781; voglibose 0.6 mg, 162). Cumulative exposure (patient-years) was 2060 for linagliptin and 1372 for comparators. Primary CV events occurred in 11 (0.3%) patients receiving linagliptin and 23 (1.2%) receiving comparators. The hazard ratio (HR) for the primary endpoint showed significantly lower risk with linagliptin than comparators (HR 0.34 [95% confidence interval (CI) 0.16-0.70]) as did estimates for all secondary endpoints (HR ranging from 0.34 to 0.55 [all upper 95% CIs < 1.0]). Conclusions These results from a large Phase 3 programme support the hypothesis that linagliptin may have CV benefits in patients with T2DM.
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Keywords {🔍}

linagliptin, risk, diabetes, patients, article, comparators, events, versus, pubmed, study, google, scholar, type, primary, cardiovascular, total, treatment, trials, cas, dpp, endpoint, placebo, table, metaanalysis, analysis, data, endpoints, clinical, based, tdm, safety, incidence, adjudicated, phase, control, glimepiride, drug, full, file, authors, mellitus, prespecified, studies, ratio, effects, included, population, size, figure, med,

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eu/docs/en_gb/document_library/scientific_guideline/2010/02/wc500073570 gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627 glucose-dependent insulinotropic polypeptide α-glucosidase inhibitor commonly odd erik johansen european medicines agency article download pdf full size image maximilian von eynatten end-stage renal disease prolonged terminal half-life stratified cochran-mantel-haenszel cochran-mantel-haenszel cv bmc endocr disord established glucose-lowering treatments related subjects incidence-rate risk ratio united states previous cv meta-analyses placebo-controlled trials confirmed glucose-lowering drug full access table s2 risk privacy choices/manage cookies table s1 overview current meta-analysis included dpp-4 inhibitor versus cochran-mantel-haenszel article johansen randomized controlled trial reduce infarct size european economic area favourable safety/tolerability compared intensive glucose lowering clinical trial database cardiovascular risk factors cox hazard model simple cox model oral diabetes medications dipeptidyl peptidase-4 inhibitor lower cv risk cv risk factors glucose-lowering therapies common statistical methods authors meet criteria glucose-independent manner diabetes obes metab chronic kidney disease anti-inflammatory properties cox regression analysis

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         description:This study investigated the cardiovascular (CV) safety profile of the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin versus comparator treatments. This was a pre-specified meta-analysis of CV events in linagliptin or comparator-treated patients with type 2 diabetes mellitus (T2DM) from eight Phase 3 studies. All suspected CV events were prospectively adjudicated by a blinded independent expert committee. The primary endpoint was a composite of CV death, stroke, myocardial infarction, and hospitalization for unstable angina. Three secondary composite endpoints derived from the adjudicated CV events were also pre-specified. Risk estimates were calculated using several statistical methods including Cox regression analysis. Of 5239 treated patients (mean ± SD HbA1c 65 ± 10 mmol/mol [8.0 ± 0.9%], age 58 ± 10 years, BMI 29 ± 5 kg/m2), 3319 received linagliptin once daily (5 mg, 3159; 10 mg, 160) and 1920 received comparators (placebo, 977; glimepiride 1-4 mg, 781; voglibose 0.6 mg, 162). Cumulative exposure (patient-years) was 2060 for linagliptin and 1372 for comparators. Primary CV events occurred in 11 (0.3%) patients receiving linagliptin and 23 (1.2%) receiving comparators. The hazard ratio (HR) for the primary endpoint showed significantly lower risk with linagliptin than comparators (HR 0.34 [95% confidence interval (CI) 0.16-0.70]) as did estimates for all secondary endpoints (HR ranging from 0.34 to 0.55 [all upper 95% CIs < 1.0]). These results from a large Phase 3 programme support the hypothesis that linagliptin may have CV benefits in patients with T2DM.
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