All phase 2 and 3 studies should include a prospective, independent adjudication of CV events.
*Includes data only from trials with prospective independent adjudication of hospitalization for CHF (n = 3314).
AE-reported terms coded to these specific MedDRA preferred terms were used to identify possible heart failure events.> -wrap-foot> *Trials with prospective independent adjudication of hospitalization for CHF.
Although the results of the current meta-analysis suggest that there may be an association between exenatide and improved CV outcomes, data from multi-year, randomized, controlled, adequately-powered clinical trials with prospective blinded adjudication of CV events are needed to evaluate whether exenatide has cardio-protective effects.
However, the robustness of the findings of the present study is supported by its pre-specified design, which incorporated independent prospective, blinded adjudication of CV events, and by the consistency of the results, both across the individual trials and across the different pools of results.
However, the pre-specified design of the present meta-analysis involved prospective and blinded adjudication of CV events, which should strengthen the validity of the current findings.
In summary, this pre-specified CV meta-analysis of a large Phase 3 programme that involved prospective and independent adjudication of CV events provides valuable new insights on the CV safety profile of linagliptin.
Strengths of this analysis include the size and diversity of the cohort, the use of prospective ascertainment and adjudication of outcomes, the large number of clinical events, and the range of covariates available for analysis, including physical activity and depression.
The methods of accrual and adjudication for this prospective cohort have been previously described [36].
