Safety and effectiveness of insulin aspart in Basal-bolus regimens regardless of age: a1chieve study results

无论年龄大小,门冬胰岛素在基础-餐时胰岛素治疗方案中的安全性和有效性:a1chieve 研究结果

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Abstract

INTRODUCTION: Hypoglycemia is a complication in the management of type 2 diabetes, and elderly people are at greater risk of experiencing hypoglycemia events than younger patients. Insulin analogs achieve glycemic control with minimal risk of hypoglycemia and may therefore be a good treatment option for all patients. METHODS: A1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who started/switched to therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone/in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of insulin aspart as part of a basal-bolus regimen (±oral glucose-lowering drugs) in three age-groups (≤40, >40-65, and >65 years) of insulin-experienced and insulin-naive people with type 2 diabetes. RESULTS: In total, 4,032 patients were included in the sub-analysis. After 24 weeks of insulin aspart treatment, significant improvements versus baseline were observed in all age-groups for: proportion of people with ≥1 hypoglycemia events (18.3-27.1% and 11.0-12.7%, at baseline and 24 weeks, respectively), ≥1 major hypoglycemia events (3.3-6.7% and 0-0.2%), and ≥1 nocturnal hypoglycemia events (9.2-13.7% and 2.9-4.9%); glycated hemoglobin (9.6-9.8% and 7.4%); fasting plasma glucose (change from baseline ranged from -3.6 to -4.4 mmol/l); and post-breakfast post-prandial plasma glucose (change from baseline ranged from -5.5 to -5.9 mmol/l). Fourteen serious adverse drug reactions were reported. Health-related quality of life was significantly improved for all age-groups (all, p < 0.001). CONCLUSION: All age-groups showed improved glycemic control and reduced risk of hypoglycemia when starting/switching to insulin aspart therapy within a basal-bolus regimen; this may be particularly important for elderly patients given their greater risk of hypoglycemia versus younger patients.

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