High Mortality in an Older Japanese Population with Low Forced Vital Capacity and Gender-Dependent Potential Impact of Muscle Strength: Longitudinal Cohort Study

Generally, weak muscle power is associated with high mortality. We aimed to evaluate the unknown association between % predicted value forced vital capacity (FVC% predicted) and mortality in asymptomatic older people, and the impact of muscle power on this association. We analyzed the Tsurugaya cohort that enrolled Japanese people aged ≥70 for 15 years with Cox proportional hazards model. Exposure variables were FVC% predicted and leg power. The outcome was all-cause mortality. The subjects were divided into quartiles by FVC% predicted or leg power, or into two groups by 80% for FVC% predicted or by the strongest 25% for leg power. Across 985 subjects, 262 died. The males with lower FVC% predicted exhibited higher mortality risks. The hazard ratio (HR) was 2.03 (95% CI 1.30–3.18) at the lowest relative to the highest groups. The addition of leg power reduced the HR to 1.78 (95% CI 1.12–2.80). In females, FVC% predicted under 80% was a risk factor and the HR was 1.67 (95% CI 1.05–2.64) without the effect of leg power. In FVC% predicted <80% males HRs were 2.44 (95% CI 1.48–4.02) in weak and 1.38 (95% CI 0.52–3.64) in strong leg power males, relative to ≥80% and strong leg power males. Low FVC% predicted was associated with high mortality with potential unfavorable effects of weak leg power in males

Long-term safety and efficacy of alogliptin, a DPP-4 inhibitor, in patients with type 2 diabetes: a 3-year prospective, controlled, observational study (J-BRAND Registry)

Introduction Given an increasing use of dipeptidyl peptidase-4 (DPP-4) inhibitors to treat patients with type 2 diabetes mellitus in the real-world setting, we conducted a prospective observational study (Japan-based Clinical Research Network for Diabetes Registry: J-BRAND Registry) to elucidate the safety and efficacy profile of long-term usage of alogliptin.Research design and methods We registered 5969 patients from April 2012 through September 2014, who started receiving alogliptin (group A) or other classes of oral hypoglycemic agents (OHAs; group B), and were followed for 3 years at 239 sites nationwide. Safety was the primary outcome. Symptomatic hypoglycemia, pancreatitis, skin disorders of non-extrinsic origin, severe infections, and cancer were collected as major adverse events (AEs). Efficacy assessment was the secondary outcome and included changes in hemoglobin A1c (HbA1c), fasting blood glucose, fasting insulin and urinary albumin.Results Of the registered, 5150 (group A: 3395 and group B: 1755) and 5096 (3358 and 1738) were included for safety and efficacy analysis, respectively. Group A patients mostly (>90%) continued to use alogliptin. In group B, biguanides were the primary agents, while DPP-4 inhibitors were added in up to ~36% of patients. The overall incidence of AEs was similar between the two groups (42.7% vs 42.2%). Kaplan-Meier analysis revealed the incidence of cancer was significantly higher in group A than in group B (7.4% vs 4.8%, p=0.040), while no significant incidence difference was observed in the individual cancer. Multivariate Cox regression analysis revealed that the imbalanced patient distribution (more elderly patients in group A than in group B), but not alogliptin usage per se, contributed to cancer development. The incidence of other major AE categories was with no between-group difference. Between-group difference was not detected, either, in the incidence of microvascular and macrovascular complications. HbA1c and fasting glucose decreased significantly at the 0.5-year visit and nearly plateaued thereafter in both groups.Conclusions Alogliptin as a representative of DPP-4 inhibitors was safe and durably efficacious when used alone or with other OHAs for patients with type 2 diabetes in the real world setting