Comparative effectiveness of vildagliptin in combination with other oral anti-diabetes agents in usual-care conditions: the EDGE–Latin America study

Abstract

Objective:

To assess the proportion of patients on vildagliptin add-on dual therapy who respond to treatment over a 12 month follow-up, relative to comparator oral anti-diabetes dual therapy, in a usual care setting.

Research design and methods:

Participants were patients with type 2 diabetes (T2DM) aged 18 years and older from 311 centers in Argentina, Colombia, Ecuador, Mexico and Venezuela. Patients were taking monotherapy with an oral anti-diabetes drug (OAD), and were prescribed a new add-on OAD based on the judgment of their personal physician. According to this choice, patients were assigned to one of the two cohorts: vildagliptin or comparator OADs.

Main outcome measures:

The primary endpoint was the proportion of patients achieving an A1c drop >0.3% without edema, hypoglycemia, weight gain or discontinuation due to gastrointestinal (GI) events. The secondary endpoint was the proportion of patients with baseline A1c ≥7% who reached the goal of an A1c <7% without hypoglycemia or weight gain.

Results:

The per-protocol population (a subset of the intention-to-treat population that excluded patients with pre-specified protocol deviations) comprised 3773 patients, 3002 in the vildagliptin cohort and 771 in the comparator cohort. The proportion of patients reaching the primary endpoint was higher in the vildagliptin cohort (60.3%) than the comparator cohort (50.7%), OR 1.48 (95% CI: 1.25–1.73). The same was observed for the secondary endpoint (44.8 versus 33.1%) OR 1.64 (95% CI: 1.37–1.98). The incidence of adverse events was low and similar between treatment cohorts.

Conclusion:

In a usual care setting, patients treated with a vildagliptin combination succeeded in lowering A1c to <7%, without weight gain, hypoglycemia or peripheral edema more often than patients treated with comparator combinations, without increased risk of adverse events. Key limitations are the observational nature of the study and its relatively limited 12 month timeframe.

Keywords::

• Anti-diabetics
• Diabetes
• Dipeptidyl peptidase-IV inhibitors
• Vildagliptin

Transparency

Declaration of funding

This study was funded by Novartis Pharma AG. The sponsor and steering committee had equal roles in determining study design, protocol finalization and data interpretation. The funder was involved in study design and data collection but did not have involvement in data analysis, decision to publish or preparation of the manuscript. All authors had final responsibility for the data, content, and decision to submit for publication.

Declaration of financial/other relationships

J.A. has disclosed that he was an employee of Novartis AG at the time of execution of this study. O.S. has disclosed that she is a consultant to Novartis AG. C.O.M., E.M.-R., I.D.Á., G.P. and C.R. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors thank Carlos García and Marcia Kayath from Novartis Latin America, as well as Roberto Altamira from Novartis Mexico for their support and commitment to the execution of this study.