Efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus and comparison of hypoglycemic action of concomitant medications: a subanalysis of the JAMP study

Abstract

Purpose To determine the efficacy and safety of sitagliptin when used with some therapeutic drugs to treat elderly patients. Methods Sitagliptin (50 mg/day) was added to the preexisting therapy for type 2 diabetes. Changes in the glycated hemoglobin (HbA1c) level after 3 months of treatment were compared with the baseline, and exploratory analysis was performed. These analyses were conducted as subanalyses of the JAMP study, which was an open-label observational study.Results For patients who were C65 years of age, the change in HbA1c level from baseline ranged from -0.50 to -0.87% at 3 months after starting treatment. There was no significant difference in the change in HbA1c level between the patients treated with different concomitant drugs. No significant difference in HbA1c variations at 3 and 12 months from baseline was noted among the three age groups (C75, 65-74, and \65 years). Multiple regression analysis was performed, and it revealed that patients with higher HbA1c levels at baseline were likely to show decreased HbA1c levels, while those with higher triglyceride (TG) levels were unlikely to show decreased HbA1c levels. Conclusion Sitagliptin has the potential to both improve glycemic control and prevent hypoglycemia, and can be considered a potent alternative drug.A complete list of the JAMP (Januvia Multicenter Prospective Trial in Type 2 Diabetes) Study Investigators is provided in the ''Compliance with ethical standards'' section.

Efficacy and Safety of Alogliptin in Elderly Patients With Type 2 Diabetes Mellitus

“…Our previous study of sitagliptin showed that eGFR decreased significantly in elderly subjects aged over 65; however, this parameter did not decrease in the patients with low baseline eGFR, although it decreased in the patients with high baseline eGFR [15]. Ujihara et al reported similar results [16]. Their study showed the eGFR change to be -2.7 ± 8.1 in elderly patients receiving sitagliptin for 3 months, a level similar to ours in the present study; it can be conjectured that there is no major difference in renal effects in the elderly between sitagliptin and alogliptin.…”

Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study

“…Such changes in renal function parameters after sitagliptin treatment are consistent with previous reports, including our own 27 , 33 . In fact, a previous study demonstrated that sitagliptin treatment decreased eGFR in older T2D patients with a high baseline eGFR, but not in those a low baseline eGFR 22 . Renal hemodynamic effects beyond glycemic control have been suggested for GLP-1-based therapies 34 .…”

“…In a randomized controlled study comparing treatment with sitagliptin and placebo, sitagliptin monotherapy did not cause hypoglycemia in 206 older T2D 40 . In an open-label observational study for older adults with T2D, there was no case of hypoglycemia after sitagliptin was added on to other oral anti-diabetic drugs, including sulfonylureas 22 . In the present study, we found that the incidence of hypoglycemia was not increased in sitagliptin group, which reinforces the evidence that sitagliptin is unlikely to cause severe hypoglycemic event in older adults with T2D.…”

“…The magnitude of HbA1c reduction by sitagliptin treatment was similar to that observed in a study on a combination therapy with sitagliptin and insulin 28 . In addition, Ujihara, et al 22 performed a single-arm observational study on the efficacy of sitagliptin add-on to non-insulin/GLP-1 pre-existing therapy in older adults with T2D. In the study, HbA1c levels decreased by 0.56–0.67% at 3 months after sitagliptin add-on to the other oral anti-diabetic drugs.…”

“…In addition, among older adults with T2D, the efficacy and safety of sitagliptin have been suggested for both mono- and combination therapies 20 – 24 . Some single-arm observational studies have analyzed glycemic parameters and the incidence of hypoglycemia under sitagliptin monotherapy and combination therapy in older adults with T2D 20 – 22 . In addition, Terauchi et al 24 performed a randomized study (START-J trial) comparing sitagliptin monotherapy with sulfonylurea monotherapy in drug-naïve T2D patients aged ≥ 60 years.…”