Study Finds No Safety Concerns for Sitagliptin Use in Elderly

By Will Boggs MD

NEW YORK (Reuters Health) - Sitagliptin does not appear to increase the risk of cardiovascular events in patients with type 2 diabetes who are 75 years or older, according to results from the TECOS trial.

"The key finding from our study is that, although elderly patients carried a higher burden of disease (higher rates of major cardiovascular adverse events, more heart failure, and higher mortality rates), treatment with sitagliptin had a neutral effect on cardiovascular risk and raised no other safety concerns," Dr. M. Angelyn Bethel from the University of Oxford, in the U.K., told Reuters Health by email.

The overall TECOS trial demonstrated the cardiovascular safety of sitagliptin treatment in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, Dr. Bethel and colleagues note in their report, online January 5 in Diabetes Care.

In the new analysis, the team investigated the safety and clinical outcomes of sitagliptin in the 2,004 participants in TECOS who were 75 years and older, including 582 who were 80 years and older.

The primary composite outcome of cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, or unstable angina hospitalizations occurred significantly more often in the older patients than in the younger (6.46 vs. 3.67 events per 100 person-years).

Older patients were also more likely than younger ones to experience the secondary cardiovascular composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; hospitalization for heart failure; a composite of heart failure or death; all-cause mortality; malignancy; severe hypoglycemia; and bone fractures, according to the online report.

None of these events, however, occurred at significantly higher frequency in patients assigned to sitagliptin than in patients assigned to placebo.

"Among elderly patients with diabetes and cardiovascular disease, there is now a good evidence base for the use of sitagliptin in this population," Dr. Bethel said. "It can be dose-adjusted in those with declining renal function, as was done in TECOS, and does not increase the risk of hypoglycemia, major adverse cardiovascular events or hospitalization, or, importantly, heart failure."

"The main limitation to our results is that the median duration of follow-up was 2.9 years whereas community-based care of elderly patients is likely to be over a longer time period," she said. "Nonetheless, these data are reassuring for health care providers who wish to use sitagliptin in the management of an aging population with diabetes."

Dr. Darren Toh, a pharmacoepidemiologist at Harvard Medical School in Boston, told Reuters Health by email, "As the results in the older patients were consistent with the overall findings published in 2015 - which concluded that sitagliptin was not associated with a higher risk of cardiovascular events - these findings probably will not have major influence on the use of sitagliptin in the older patients."

"The number of older patients (2,004) and the duration of follow-up (median of 2.9 years) may not be adequate to examine clinical events that are rare or take longer to manifest," said Dr. Toh, who was not involved in the study.

Dr. Kuanxiao Tang from Qilu Hospital of Shandong University in Jinan, China, who recently reported on the effects of sitagliptin as initial therapy in newly diagnosed elderly type 2 diabetics, said, "Sitagliptin is effective and safe for elderly diabetic patients, and can be prescribed for the initial treatment of T2DM in elderly patients even with cardiovascular diseases."

"We still need a large, well-designed, randomized study, especially a head-to-head comparative trial, to assess the impact of sitagliptin in elderly patients," Dr. Tang, who also was not part of the new work, told Reuters Health by email. "Concerning the rapid increase of the aging population in China, Chinese physicians are willing to carry out relevant work in cooperation with international endocrinologists."

Merck Sharp & Dohme, a subsidiary of Merck & Co., Inc., sponsored the TECOS trial, employed three of the report's authors and had various relationships with several others.

SOURCE: https://bit.ly/2ktHD8T

Diabetes Care 2017.

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