Evans M, et al. - In this exploratory analysis, the patient characteristics and on-treatment effects that could have contributed to the different outcomes in the 2 age groups were identified. As per findings, the researchers hypothesized that in younger patients with type 2 diabetes mellitus (T2DM), the positive effects of vildagliptin on systolic blood pressure (SBP), low-density lipoprotein (LDL) cholesterol, hypoglycemia and weight observed could be associated with the lower risk of major adverse cardiac events (MACEs). This was not true for older patients.

Methods

• The researchers examined on-treatment differences (vildagliptin vs comparators) for the change from baseline in CV risk factors using an analysis of covariance model with the baseline value for each variable of interest, treatment and study as covariates.
• When analyzing changes in blood pressure and lipids, additional adjustments for background antihypertensive and statin use were performed, respectively.
• Using descriptive statistics, baseline characteristics and patient demographics were analyzed.

Results

• At baseline, patients aged < 65 years had shorter diabetes duration (4.4 vs 8.2 years) and slightly higher glycated hemoglobin (HbA1c) (8.3% vs 8.0%) than patients aged ≥ 65 years.
• In the ≥ 65 year age group, more patients had hypertension (73.1% vs 51.3%), dyslipidemia (53.3% vs 43.9%) and a history of CV events (32.2% vs 12.9%).
• The researchers found small, but statistically significant differences in the change in HbA1c and total cholesterol in favor of vildagliptin relative to comparators, which were similar in both age groups.
• They observed significant differences in the reduction in systolic blood pressure (SBP) (- 0.52 mmHg; 95% CI - 0.97, - 0.07; p=0.023), low-density lipoprotein (LDL cholesterol) (- 0.12 mmol/l; 95% CI - 0.19, - 0.04; p=0.002) and weight (- 0.48 kg; 95% CI-0.95, - 0.01; p < 0.047) in patients < 65 years, but not in patients ≥ 65 years.
• In patients treated with vildagliptin, the incidence of hypoglycemic events was lower [2.1 and 3.5 per 100 subject years exposure (SYEs) in < 65 and ≥ 65 years, respectively] than with comparators (5.8 and 7.5 per 100 SYEs, respectively).