Long-term safety and effectiveness of linagliptin by baseline body mass index in Japanese patients with type 2 diabetes: a 3-year post-marketing surveillance study

Abstract

ABSTRACT Background A recent 3-year post-marketing surveillance (PMS) study reaffirmed the safety and effectiveness of linagliptin in linagliptin-naïve Japanese patients with type 2 diabetes (T2D). We present further analyses from this study by body mass index (BMI). Research design and methods Safety and effectiveness were assessed across BMI subgroups (<25, 25 to <30, and ≥30 kg/m2). Results Data were available for 876, 566, and 201 patients in the BMI subgroups, respectively. Incidence of adverse drug reactions [ADR] with linagliptin was 11.42%, 11.31%, 10.45%, respectively. The most common ADR of special interest was hepatic disorders (n [%]: 6 [0.68], 7 [1.24], and 3 [1.49], respectively). Additional use of glucose-lowering drugs (GLDs) increased with BMI (15.0%, 19.1%, 24.4% of patients; P < 0.001). In the overall population, HbA1c change (adjusted mean %±SE) until week 156 was –0.71±0.04, –0.68±0.04 and –0.74±0.09. In patients receiving linagliptin with no additional GLDs, HbA1c changes were –0.58%±0.04, –0.62%±0.04, and –0.77%±0.11. Conclusions In this study of linagliptin in Japanese patients with T2D, across BMI subgroups no new safety concerns were observed. The proportion of patients with additional GLD use increased with baseline BMI. Decreases in HbA1c were observed in all subgroups, including in patients with no additional GLD use. ClinicalTrials.gov NCT01650259