Vildagliptin Helpful in Treatment of Elderly Patients With Type 2

Vildagliptin monotherapy is effective and well tolerated in treatment-naive elderly patients with type 2 diabetes, according to an analysis from 5 trials. "Vildagliptin is a potent and selective dipeptidyl peptidase-IV (DPP-4) inhibitor that improves glycemic control in patients with type 2 diabetes through incretin-hormone–mediated increases in both α- and β-cell responsiveness to glucose," write Richard E. Pratley, MD, from the University of Vermont College of Medicine in Burlington, and colleagues. "Because the effects of incretin hormones to increase insulin secretion and of GLP-1 [glucagon-like peptide-1] to suppress glucagon secretion are glucose-dependent, DPP-4 inhibitors such as vildagliptin are associated with a very low risk of hypoglycemia…. Hence, vildagliptin appears to possess many characteristics that could make it a useful therapeutic option for treatment of type 2 diabetes in the elderly."

The investigators analyzed pooled efficacy data from 5 double-blind, randomized, placebo- or active-controlled trials of vildagliptin monotherapy (100 mg daily) lasting at least 24 weeks, and they compared the effects of this treatment in younger (< 65 years; n = 1231) and older (≥ 65 years; n = 238) patients. They also analyzed safety data from 8 controlled clinical trials of a duration of 12 weeks or longer and compared adverse events in younger (n = 1890) and older (n = 374) patients.
Compared with younger patients, older patients had significantly lower mean baseline levels of hemoglobin A1C (HbA1c) and fasting plasma glucose (FPG; 8.3% ± 0.1% and 9.6% ± 0.1% mmol/L, respectively, vs 8.6% ± 0.0% and 10.4% ± 0.1% mmol/L). Nonetheless, the adjusted mean change (AMΔ) from baseline level of HbA1cwas –1.2% ± 0.1% for older patients treated with vildagliptin vs –1.0% ± 0.0% in younger patients (P = .092).

In the older subgroup, weight decreased significantly and in contrast, younger patients had smaller, nonsignificant weight decreases.

Although rates of adverse events were slightly higher in older vs younger subgroups, they were lower among older subjects treated with vildagliptin (63.6%) than in the pooled active comparator group (68.1%). Older patients with mild renal impairment did not have increased adverse events with vildagliptin treatment (62.0%). In the older patients, hypoglycemia was infrequent (0.8%), and no severe events were reported.

"Although much remains to be understood about the mechanisms underlying some unique aspects of DPP-4 inhibitors in the elderly, vildagliptin monotherapy is effective and appears to be well-tolerated in OAD [oral antidiabetic drug]-naive patients aged ≥ 65 years," the study authors write. "Accordingly, the present findings strongly support the continued assessment of vildagliptin to more fully ascertain its safety and efficacy in elderly patients with type 2 diabetes."

Practice Pearl: Vildagliptin given to patients older than 65 years vs younger patients with type 2 diabetes is associated with improved HbA1c level, FPG level, and weight but not lipid profile and BP.
Diabetes Care. Published online September 18, 2007.

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