Safety and Tolerability of Sitagliptin in Type 2 Diabetes
Author Information
Author(s): Williams-Herman Debora, Engel Samuel S, Round Elizabeth, Johnson Jeremy, Golm Gregory T, Guo Hua, Musser Bret J, Davies Michael J, Kaufman Keith D, Goldstein Barry J
Primary Institution: Merck Research Laboratories, Rahway, NJ USA
Hypothesis
The safety and tolerability of sitagliptin 100 mg/day is comparable to non-sitagliptin treatments in patients with type 2 diabetes.
Conclusion
Sitagliptin 100 mg/day was generally well tolerated in clinical trials of up to 2 years in duration.
Supporting Evidence
- Sitagliptin was well tolerated in clinical trials lasting up to 2 years.
- The incidence of hypoglycemia was lower in sitagliptin-treated patients compared to those not treated with sitagliptin.
- Overall adverse events were similar between sitagliptin and non-exposed groups.
- Patients treated with sitagliptin had a similar incidence rate of bone fractures compared to those not exposed to sitagliptin.
- No increase in cardiovascular risk was observed with sitagliptin treatment.
- Adverse events related to infections were similar between treatment groups.
- Constipation was reported more frequently in the sitagliptin group.
- Overall, the findings support the safety profile of sitagliptin in type 2 diabetes management.
Takeaway
This study looked at how well sitagliptin works for people with type 2 diabetes and found that it is safe and doesn't cause more problems than other treatments.
Methodology
The analysis pooled data from 19 double-blind clinical studies involving 10,246 patients who received either sitagliptin or a comparator agent.
Limitations
The results may not fully reflect use in the general population and multiple comparisons were made without adjustment for multiplicity.
Participant Demographics
The cohort had an average age of 55 years, with 54% men, and included 64% White, 15% Asian, and 6% Black participants.
Digital Object Identifier (DOI)
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