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01.12.2012 | Original investigation | Ausgabe 1/2012 Open Access

Cardiovascular Diabetology 1/2012

Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme

Zeitschrift:
Cardiovascular Diabetology > Ausgabe 1/2012
Autoren:
Odd Erik Johansen, Dietmar Neubacher, Maximilian von Eynatten, Sanjay Patel, Hans-Juergen Woerle
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2840-11-3) contains supplementary material, which is available to authorized users.

Competing interests

All authors are employees of Boehringer Ingelheim, the sponsor of the study.

Authors' contributions

All authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. All authors contributed to or participated in the design of the study, the analysis of data, the collection of data, and the writing or revision of the manuscript. All authors reviewed and approved the final version of the manuscript.

Abstract

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.
Zusatzmaterial
Additional file 1: Table S1 Overview of linagliptin Phase 3 clinical trials included in the CV meta-analysis. (PDF 7 KB)
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Additional file 2: Figure S1 Subgroup analyses of incidence rates of primary endpoint for linagliptin versus total comparators. (PDF 27 KB)
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Additional file 3: Table S2 Risk for other CV endpoints with linagliptin versus total comparators based on various statistical methods. (PDF 7 KB)
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Authors’ original file for figure 1
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Authors’ original file for figure 2
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Authors’ original file for figure 3
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