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【medical-news】2型糖尿病患者吸入单组分人胰岛素
August 29, 2008 — Therapy with inhaled human insulin (Exubera) caused small changes in forced expiratory volume in 1 second (FEV1), and weight gain was less with inhaled human insulin vs subcutaneous insulin in adult patients with type 2 diabetes, according to the results of a 2-year safety study reported in the September issue of Diabetes Care.
"Inhaled human insulin (Exubera [EXU], insulin human [rDNA origin] inhalation powder) is effective in patients with type 2 diabetes in whom glycemic control is not achieved with diet and exercise and provides better glycemic control in patients whose diabetes remains inadequately controlled with either monoagent or combination oral agent regimens," write Julio Rosenstock, MD, from the Dallas Diabetes and Endocrine Center in Dallas, Texas, and colleagues. "In addition, 6-month EXU therapy is at least comparable in efficacy to subcutaneous insulin therapy in type 2 diabetes. Previous controlled studies of EXU in type 2 diabetic patients have shown slight but consistent treatment group differences in pulmonary function in favor of comparators, using nonstandardized lung function testing."
The goal of this study was to assess the 2-year pulmonary safety of inhaled human insulin in 635 nonsmoking adults with type 2 diabetes. Participants were randomized to treatment with prandial inhaled insulin or subcutaneous insulin (regular or short-acting) plus basal (intermediate- or long-acting) insulin. The main endpoints were annual rate of FEV1 decline and carbon monoxide diffusing capacity (DLCO).
During the first 3 months, small differences in FEV1 developed favoring subcutaneous insulin, but these changes did not progress. Between months 0 and 24, adjusted treatment group difference in FEV1 annual rate of change was ⺷0.007 L/year (90% confidence interval [CI], ⺷0.021 to 0.006). However, this was 0.000 L/year (95% CI, ⺷0.016 to 0.016) during months 3 to 24. DLCO annual rate of change was not significantly different between treatment groups.
By month 24, both groups had similar decreases in hemoglobin A1C (last observation carried forward; inhaled human insulin, 7.7% to 7.3% vs subcutaneous insulin, 7.8% to 7.3%). However, inhaled human insulin was associated with greater reductions in fasting plasma glucose than was subcutaneous insulin (adjusted mean treatment difference, ⺷12.4 mg/dL [90% CI, ⺷19.7 to ⺷5.0]).
Both groups had comparable incidence of hypoglycemia, with slightly less incidence in the inhaled human insulin group. Other adverse events were similar in both groups, except that inhaled human insulin was associated with a higher incidence of mild cough and dyspnea. Weight gain was less pronounced with inhaled human insulin than with subcutaneous insulin (⺷1.3 kg; [⺷1.9 to ⺷0.7]).
Limitations of this study include that treatment targets were not met.
"Two-year prandial EXU therapy showed a small nonprogressive difference in FEV1 and comparable sustained A1C [hemoglobin A1C] improvement but lower FPG [fasting plasma glucose] levels and less weight gain than seen in association with subcutaneous insulin in adults with type 2 diabetes," the study authors write.
Pfizer, Inc, maker of inhaled human insulin, sponsored this study and funded editorial support. Some of the authors have disclosed various financial relationships with Pfizer, sanofi-aventis, Novo Nordisk, GlaxoSmithKline, Takeda, Centocor, Johnson & Johnson, Amylin, Merck, Eli Lilly, GlaxoSmithKline, Takeda, Novartis, AstraZeneca, Sankyo, MannKind, and/or the Canadian National Advisory Board for Exubera.
The costs of publication of this article were defrayed in part by the payment of page charges, mandating that it must therefore be hereby marked "advertisement" solely to indicate this fact.
Diabetes Care. 2008;31:1723-1728. [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-06-27 01:33
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