Sitagliptin generally well tolerated in elderly patients with type 2 diabetes

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

Literature - Round EM et al. Drugs Aging. 2014 - Drugs Aging. 2014 Feb 8

Round EM, Engel SS, Golm GT, et al.
Drugs Aging. 2014 Feb 8. [Epub ahead of print]


The prevalence of type 2 diabetes (T2DM) increases with advancing age, and the number of elderly patients with T2DM is expected to continue to rise. Management of T2DM in the elderly can be challenging due to pre-existing or co-morbid conditions such as impaired renal or cardiovascular function and the presence of geriatric syndromes [1-4]. Certain types of antihyperglycaemic treatment smay be limited in this population because of potential side effects or contraindications.
Metformin is associated with gastrointestinal side effects and contraindicated in patients with renal impairment [5]. Sulfonylureas and insulin are associated with an increased risk of hypoglycaemia. This could be worse in elderly patients who may have reduced hypoglycaemia awareness [6]. Thiazolidinediones (TZDs) are associated with fluid retention, peripheral edema and a higher risk of congestive heart failure [7]. Thus, safe and well-tolerated antihyperglycaemic treatments in elderly patients with T2DM are needed.
The newer therapies dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RA) have been shown to be well tolerated in clinical trials, with a low risk of hypoglycaemia [8]. This study re-analysed data from 25 double-blind, randomised clinical trials, now focussing on the data from patients older than 65 years (n=2446), to evaluate the safety and tolerability of the DPP-4 inhibitor sitagliptin 100 mg/day in elderly patients.

Main results

  • The sitagliptin and non-exposed groups were generally similar in terms of summary measures of adverse events, although a higher incidence of death and drug-related adverse events was observed in the non-exposed group (mostly hypoglycaemia).
  • The most commonly reported adverse events (> 5 incident events per 100 patient-years in either group) were hypoglycaemia, diarrhoea, nasopharyngitis, upper respiratory tract infection, and urinary tract infection, most of which were not seen at a different rate in the exposed and non-exposed group.
  • Incidence of hypoglycaemia was 7.0 per 100 patient-years in the sitagliptin group and 14.3 in the control group (rate difference: -7.6, 95%CI: -11.2 to -4.3). This difference was mostly the result of the use of a sulfonylurea as a comparator agent: in an analysis that removed the confounding effect of these agents, the incidence rates of hypoglycaemia were 5.2 per 100 patient-years in the sitagliptin and 3.8 in the non-exposed groups (rate difference: 1.5, 95%CI: -1.3 to 4.4).


This pooled analysis that combined data of elderly patients with T2DM from 25 studies, showed that treatment with the DPP-4 inhibitor sitagliptin 100 mg/day is generally well tolerated in these patients. Hypoglycaemia was less often observed in the sitagliptin group than in the non-exposed group. This difference was mostly accounted for by a higher incidence of hypoglycaemia in patients in comparator groups using sulfonylurea. When excluding patients taking sulfonylurea and insulin, the incidence of hypoglycaemia was similar between groups.

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