Article Figures & Data
Tables
- Table 1. Large Bronchodilator Trials According to Factors For Interpreting Good Clinical Practice on Design, Results, and Translation
Study (trial registry; funding) Characteristics Medication Protocol Effect Focus* Patients (n) Length of Follow-up Selection Criteria (Part) Population Interventions Rescue Prohibited medication Allowed bias medication Primary outcome Results Significance Calverley, 20076 (registered; funding from GSK) 6112 3 years 40–80 years old, COPD diagnosis FEV1: <60% FER: <0.70 before BD Reversibility: <10% No respiratory disease, use of oxygen 65 years 75% male 43% smoker FEV1 44% predicated value Salmeterol/Fluticason Salmeterol Fluticason Placebo Albuterol Long-acting BD, steroids Short-acting and other BD Mortality 12.6% vs 13.5% vs 16.0% vs 15.2% NS A Calverley et al,4 2003 (not registered; funding from GSK) 1465 1 year FEV1: 25% to 70% before BD FER: <0.70 before BD Reversibility: <10% ≥1 exac/year 3 years No respiratory disease, use of oxygen 63.5 years 72.5% male 51% smoker FEV1 49% predicted value Salmeterol/ Fluticason Salmeterol Fluticason Placebo Albuterol Long-acting β-agonist, steroids Anticholinergics and theophillin FEV1 before BD 10% vs 2% vs 2% vs −3% P < .01 B Tashkin et al,7 2008 (registered; funded by BI and Pfizer) 5993 4 years >40 years FEV1: <70%, FER: <0.70 No respiratory disease, use of oxygen Myocardial infarction during last 6 months, unstable arrhythmia 64.5 years 75% male 30% smoker FEV1 48% predicted value Spiriva Placebo — Short-acting anticholinergics All nonanticholinergics FEV1 decline before and after BD Before BD: 30 vs 30 mL/yr After BD: 40 vs 42 mL/yr NS C Niewoehner et al,5 2005 (not registered; funded by BI and Pfizer) 1829 6 months >40 years COPD diagnosis FEV1: <60% FER: <0.70 No asthma Myocardial infarction during past 6 months, cardiac hospital during past year 67.8 years 99% male 30% smoker FEV1 36% predicted value 29% oxygen Spiriva Placebo — Short-acting anticholinergics All nonanticholinergics %Exacerbation 32.3% vs 27.9% P = .037 D %Exacerbation hospitalization 9.5% vs 7.0% NS Vogelmeier et al,8 2011 (registered; funded by BI and Pfizer) 7376 1 year >40 years FEV1: <70%, FER: <0.70 ≥1 exacerbation during past year No asthma CVD 62.9 years 74.7% male 48% smoker FEV1 49% predicted value Spiriva Salmeterol Albuterol Anticholinergics, long-acting β-agonist Short-acting β-agonist Time to first exacerbation 187 vs 145 days (first fourth of patients) P < .001 E -
↵* A: Acknowledge statistically nonsignificant results for primary outcome, but the focus is on beneficial effect and secondary outcome in main text discussion and conclusion. They claim the study is underpowered. B: Focus is on secondary outcomes in main text discussion. C: Focus is on secondary outcome in result and discussion section of both abstract and main text. Of many nonsignificant post hoc subgroup analyses, they only state the significant one. D: Acknowledge statistically nonsignificant results for the primary outcome (called “borderline significant”), but focus is on beneficial effect in the abstract and main text results. E: Focus is on an exaggerated effect on one fourth of all patients (a third had an exacerbation), which is not stated in the abstract. Focus is on inaccurate description of population in main text discussion and conclusion.
BD, bronchodilator; BI, Boehringer Ingelheim; COPD, chronic obstructive pulmonary disease; CVD, cardiovascular disease; FER, forced expiratory ratio; FEV1, forced expiratory volume in first second; GSK, GlaxoSmithKline; NS, not significant.
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