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(Received for publication on Apr. 5, 1999; accepted on Nov. 11, 1999)  相似文献   

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Background

Improved lung function and fewer pulmonary exacerbations (PEx) were observed with lumacaftor/ivacaftor (LUM/IVA) in patients with cystic fibrosis homozygous for F508del. It is unknown whether PEx reduction extends to patients without early lung function improvement.

Methods

Post hoc analyses of pooled phase 3 data (NCT01807923, NCT01807949) categorized LUM/IVA-treated patients by percent predicted forced expiratory volume in 1?s (ppFEV1) change from baseline to day 15 into threshold categories (absolute change ≤0 vs >0; relative change <5% vs ≥5%) and compared PEx rates vs placebo.

Results

LUM (400?mg q12h)/IVA (250?mg q12h)–treated patients (n?=?369) experienced significantly fewer PEx vs placebo, regardless of threshold category. With LUM/IVA, PEx rate per patient per year was 0.60 for those with absolute change in ppFEV1?>?0 and 0.85 for those with absolute change ≤0 (respective rate ratios vs placebo [95% CI]: 0.53 [0.40–0.69; P?<?.0001], 0.74 [0.55–0.99; P?=?.04]).

Conclusions

LUM/IVA significantly reduced PEx, even in patients without early lung function improvement.  相似文献   

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