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- W2091851522 abstract "I disagree with Klaus F Rabe and colleagues (Aug 13, p 563) when they conclude that roflumilast for the treatment of chronic obstructive pulmonary disease “improved lung function and reduced exacerbations”. Lung function results are given as changes from baseline, with a 0·051 L mean improvement in forced expiratory volume in 1 s (FEV1, the primary endpoint) after 24 weeks of the higher dose of roflumilast. In the placebo group, an FEV1 decrease of 0·045 L was seen. But the reader has to go back to the baseline characteristics to note that the mean FEV1 before treatment was 1·57 L (SD 0·48) in the placebo group and 1·50 L (0·48) in the roflumilast group. Therefore, this 3·4% improvement in FEV1 for the patients treated with roflumilast leads to a mean absolute value for FEV1 at the end of the trial of 1·55 L in the roflumilast group and of 1·53 L in the placebo group, with an SD of 0·48. There is no significant difference when the comparison is done, as it has to be done, with absolute numbers. Rabe and colleagues state that the number of patients with exacerbations is significantly different between groups: 157 of 555 patients in the roflumilast group and 97 of 280 patients in the placebo group. But a classic 2 test gives a non-significant p value of 0·48, with a relative risk reduction of 0·076 (–0·143 to 0·252). Health-related quality of life, a coprimary variable, improved with placebo and roflumilast treatment, with no statistical difference. The mean number of moderate or severe exacerbations per patient was 0·30 (SD 0·64) in the placebo group and 0·28 (0·62) in the roflumilast group. In my view, the clinical benefit of this treatment remains doubtful. Evidencebased decisions are made on the basis of randomised controlled trials, but the conclusions of these trials have to be faithful to the observed results. I declare that I have no conflict of interest." @default.
- W2091851522 created "2016-06-24" @default.
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- W2091851522 date "2005-11-01" @default.
- W2091851522 modified "2023-09-23" @default.
- W2091851522 title "Roflumilast for chronic obstructive pulmonary disease" @default.
- W2091851522 cites W2001965102 @default.
- W2091851522 cites W2053702984 @default.
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- W2091851522 doi "https://doi.org/10.1016/s0140-6736(05)67746-x" @default.
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