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- W2912679950 abstract "The data collection and analysis of the Salmeterol Multicenter Asthma Research Trial were conducted with rigor, scientific integrity, and without known bias; our article was a transparent, peer-reviewed communication designed to inform health-care practitioners. Dr. Seymour questions why data from the 28-week treatment period plus a 6-month follow-up period were included along with data from the 28-week treatment period. The protocol included a 6-month follow-up because patients received 6 months of therapy and underwent minimal procedures to retrieve unused medication. It is well-recognized that medication therapy compliance is poor; therefore, patients may have had study medication left and continued to take it beyond the 28-week period. Although it is possible that patients receiving placebo may have initiated salmeterol therapy after the study, the only planned analysis included the data from the 28-week treatment period plus the additional 6-month follow-up period, which were provided to an independent Data Safety Monitoring Board and subsequently to the US Food and Drug Administration (FDA). After study termination and the reporting on the interim analysis, further discussions with the US FDA led to an agreement to focus the analysis on the 28-week treatment period, although no substantial differences exist between the analysis of the 28-week treatment period and that of the 28-week treatment period plus the 6-month follow-up period. Dr. Seymour further questions the data reported for the two distinct phases. These data were acknowledged in the article as being exploratory. It is well-recognized that study design and recruitment approaches can lead to confounding in studies. Switching from media-driven recruitment, yielding 13 asthma-related deaths in 15,342 patients (phase I), to investigator-driven recruitment, yielding 3 asthma-related deaths in 11,013 patients (phase II), suggests that the recruitment approach may have affected outcomes. Furthermore, the quality of care and the physician-patient relationship can affect outcomes and were likely different between the phases, providing the scientific basis for this analysis. We agree that interested readers should review the breadth of the data and the proceedings of the US FDA advisory committee that was convened to discuss long-acting β-agonists. Comments on the Salmeterol Multicenter Asthma Research TrialCHESTVol. 130Issue 3PreviewThe Salmeterol Multicenter Asthma Research Trial (SMART)1 was initiated to further explore the signal for asthma-related death seen in the Serevent Nationwide Surveillance Study2 in light of US postmarketing reports3 of asthma fatalities associated with salmeterol. SMART confirms the earlier findings that salmeterol use leads to an increased incidence of asthma-related death. We have two comments on the report by Nelson et al.1 Full-Text PDF" @default.
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- W2912679950 date "2006-09-01" @default.
- W2912679950 modified "2023-10-16" @default.
- W2912679950 title "Comments on the Salmeterol Multicenter Asthma Research Trial" @default.
- W2912679950 doi "https://doi.org/10.1378/chest.130.3.931" @default.
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