Two-Year Safety and Efficacy of Inhaled Human Insulin (Exubera) in Adult Patients With Type 1 Diabetes  

Oleh:

Skyler, Jay S. ; Jovanovic, Lois ; Klioze, Sol ; Reis, Joann ; Duggan, William T.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Diabetes Care vol. 30 no. 03 (Mar. 2007), page 579.

Ketersediaan

Perpustakaan FK Nomor Panggil: D05.K.2007.01 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

OBJECTIVE—The purpose of this study was to evaluate the long-term (2-year) safety and efficacy of inhaled human insulin (Exubera [insulin human (rDNA origin)] inhalation powder) (EXU) in adult patients with type 1 diabetes. RESEARCH DESIGN AND METHODS—Patients were randomly assigned to receive EXU (n = 290) or subcutaneous (SC) insulin (n = 290), plus basal (intermediate- or long-acting) insulin. The primary end point was the annual rate of decline in pulmonary function (forced expiratory volume in 1 s [FEV1] and carbon monoxide diffusing capacity [DLCO]). RESULTS—The mean ± SEM annual rates of change between months 0 and 24 were –0.051 ± 0.005 l/year with EXU and –0.034 ± 0.005 l/year with SC insulin (significant mean difference –0.017 ± 0.007 l/year [90% CI –0.028 to –0.005]) for FEV1 and –0.437 ± 0.073 ml · min–1 · mmHg–1 · year–1 with EXU and –0.287 ± 0.065 ml · min–1 · mmHg–1 · year–1with SC insulin (nonsignificant mean difference –0.150 ml · min–1 · mmHg–1 · year–1 [–0.310 to 0.011]) for DLCO. The mean annual rates of change in FEV1 between months 3 and 24 were –0.041 ± 0.005 and –0.031 ± 0.006 l/year in the EXU and SC insulin groups, respectively (nonsignificant mean difference –0.011 l/year [–0.023 to 0.002]), indicating that the significant difference between the treatment groups in FEV1 developed during the first 3 months and was not progressive thereafter. Adverse event profiles were similar except for a higher incidence of cough (usually mild and unproductive) in patients receiving EXU (37.6 vs. 13.1%) that decreased to 1.3% by month 24. Glycemic control was sustained in both groups (adjusted mean treatment difference in change from baseline A1C at month 24 0.25 ± 0.07% [0.13–0.37]). Although the overall hypoglycemic events were comparable between groups (4.0 vs. 3.8 events/subject-month), the incidence of severe hypoglycemic events was lower with EXU than with SC insulin (2.8 vs. 4.1 events/100 subject-months, risk ratio 0.67 [0.57–0.79]). Body weight increased to a significantly lesser extent with EXU (adjusted mean treatment difference –1.25 ± 0.36 kg [–1.85 to –0.66]). CONCLUSIONS—Treatment group differences in lung function between EXU and SC insulin in adult patients with type 1 diabetes are small, develop early, and are nonprogressive for up to 2 years of therapy.

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