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Safety of Sitagliptin in Elderly Patients with Type 2 Diabetes: A Pooled Analysis of 25 Clinical Studies

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Abstract

Objective

The aim of this study was to evaluate the safety and tolerability of sitagliptin 100 mg/day in elderly patients with type 2 diabetes.

Design

A post hoc pooled analysis of 25 randomized, double-blind, parallel group clinical studies with results available as of 1 December 2011.

Setting

Multicenter, international clinical trials.

Subjects

Patients with type 2 diabetes aged 65 years or older.

Interventions

Patients were randomized to sitagliptin 100 mg/day (n = 1,261) or a comparator (n = 1,185) for 12 weeks to 2 years.

Main Outcome Measures

In each study, investigators reported serious and non-serious adverse events that occurred during the study, and serious adverse events occurring within 14 days following the last dose of study drug. This analysis used patient-level data from each study to assess the exposure-adjusted incidence rates of specific adverse events that occurred following initiation of study drug.

Results

Summary measures of adverse events overall were similar between the sitagliptin and non-exposed (active comparator or placebo) groups, except for higher incidences of deaths and drug-related adverse events in the non-exposed group. Incidence rates of specific adverse events were generally similar between the two groups, with the exception of hypoglycemia. A lower incidence rate of hypoglycemia was observed in the sitagliptin group compared with the non-exposed group [7.0 vs. 14.3 per 100 patient-years; difference −7.6 (95 % CI −11.2 to −4.3]), primarily due to greater use of sulfonylureas in the non-exposed group.

Conclusions

In this pooled safety analysis of elderly patients with type 2 diabetes, treatment with sitagliptin 100 mg/day was generally well tolerated for up to 2 years.

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Acknowledgments

The studies in this pooled analysis were sponsored by Merck & Co., Inc., Whitehouse Station, NJ, USA.

The authors would like to acknowledge the patients, site investigators and their staffs, and Merck personnel from each study included in this pooled analysis for their participation and efforts. The authors acknowledge the following Merck employees: Helen Wang for her statistical programming efforts, Edward A. O’Neill for editorial assistance, and Jennifer Rotonda for assistance with manuscript submission.

Conflicts of interest

All authors are employed by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., the manufacturer of sitagliptin, and may have company stock or stock options.

Author contributions

Elizabeth M. Round, Samuel S. Engel, Gregory T. Golm, Keith D. Kaufman, and Barry J. Goldstein conceived the design for the analyses. Gregory T. Golm performed the statistical analyses. All authors were involved in the interpretation of the analyses, drafting the manuscript or revising it critically for important intellectual content, and approving the final manuscript.

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Author notes

  1. Michael J. Davies

    Present address: Janssen Scientific Affairs, LLC, Raritan, NJ, USA

  2. Barry J. Goldstein

    Present address: Covance, Inc., Princeton, NJ, USA

Authors and Affiliations

  1. Merck & Co., Inc., Whitehouse Station, NJ, USA

    Elizabeth M. Round, Samuel S. Engel, Gregory T. Golm, Michael J. Davies, Keith D. Kaufman & Barry J. Goldstein

  2. Merck Research Laboratories, RY34-A232, PO Box 2000, Rahway, NJ, 07065, USA

    Elizabeth M. Round

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  1. Elizabeth M. Round
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Corresponding author

Correspondence to Elizabeth M. Round.

Appendix

Appendix

See Table 6.

Table 6 Studies and treatment arms included in the analysis
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Round, E.M., Engel, S.S., Golm, G.T. et al. Safety of Sitagliptin in Elderly Patients with Type 2 Diabetes: A Pooled Analysis of 25 Clinical Studies. Drugs Aging 31, 203–214 (2014). https://doi.org/10.1007/s40266-014-0155-7

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