Romosozumab efficacy and safety in European patients enrolled in the FRAME trial.

In this post hoc analysis, we assessed romosozumab efficacy and safety in European patients enrolled in FRAME. Romosozumab treatment through 12 months, followed by denosumab for a further 24 months, resulted in early and sustained risk reduction for major fracture categories, associated with large gains in bone mineral density. INTRODUCTION: In the multinational FRAME phase 3 trial of romosozumab in postmenopausal women with osteoporosis, marked differences between clinical and non-vertebral fracture outcomes were observed among patients from Central and Southern America versus rest of world. This post hoc analysis assessed romosozumab efficacy and safety in European patients enrolled in the FRAME trial and extension study. METHODS: In FRAME (NCT01575834), patients were randomised 1:1 to romosozumab 210 mg or placebo monthly (QM) for 12 months, followed by open-label denosumab 60 mg Q6M to month 36, including a 12-month extension study. We report incidence of major fracture outcomes, bone mineral density (BMD) change from baseline and safety for European patients enrolled in FRAME. RESULTS: In FRAME, 3013/7180 (41.96%) patients were European; 1494 received romosozumab and 1519 received placebo. Through 12 months, romosozumab reduced fracture risk versus placebo for non-vertebral fracture (1.4% versus 3.0%; p = 0.004), clinical fracture (1.4% versus 3.6%; p < 0.001), new vertebral fracture (0.4% versus 2.1%; p < 0.001) and major osteoporotic fracture (0.9% versus 2.8%; p < 0.001), with results sustained through 36 months following transition to denosumab. Hip fractures were numerically reduced with romosozumab at month 12 (0.2% versus 0.6%; p = 0.092). Romosozumab increased BMD versus placebo at month 12; all patients in the romosozumab and placebo groups experienced further increases by month 36 after transition to denosumab. Adverse events were balanced between groups. CONCLUSIONS: Among European patients in FRAME, romosozumab resulted in early and sustained risk reduction for all major fracture categories, associated with large BMD gains that continued after transition to denosumab.

Liraglutide in the treatment of Type 2 diabetes: clinical data and practical considerations for its use.

Liraglutide is the first once-daily human glucagon-like peptide-1 analog available for use in clinical practice. It has recently been approved by the EMA and the US FDA for treatment of Type 2 diabetes mellitus (T2DM). Initial approval is for use in combination with either metformin or a sulfonylurea, or in combination with metformin plus a sulfonylurea or thiazolidinedione. Liraglutide monotherapy is approved in the USA. Results from the Liraglutide Effect and Action in Diabetes (LEAD) clinical trials program indicate that liraglutide significantly lowers glycosylated hemoglobin (HbA1c) with a low risk of hypoglycemia. Liraglutide is also associated with significant and sustained weight loss, decreased systolic blood pressure, and improvements in other markers of cardiovascular risk. Liraglutide also shows strong potential to preserve ß-cell function. Maximum benefits may be achieved when liraglutide treatment is initiated early on in the course of T2DM.