Benefits and harms of roflumilast in moderate to severe COPD

Thorax

Volumn 69, Issue 7, 2014, Pages 616-622

  Yu, Tsung ^a   Fain, Kevin ^a   Boyd, Cynthia M ^b   Singh, Sonal ^b   Weiss, Carlos O ^b,c   Li, Tianjing ^a   Varadhan, Ravi ^b   Puhan, Milo A ^a,d  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c MICHIGAN STATE UNIVERSITY   (United States)

^d UNIVERSITY OF ZURICH   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; ROFLUMILAST;

AGED; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL (TOPIC); DEATH; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG EFFECT; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; NEUROLOGIC DISEASE; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROBABILITY; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SENSITIVITY ANALYSIS; SIMULATION; TREATMENT RESPONSE;

AGED; AMINOPYRIDINES; BENZAMIDES; CYCLOPROPANES; FEMALE; HUMANS; MALE; MIDDLE AGED; PHOSPHODIESTERASE 4 INHIBITORS; PLACEBOS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RISK ASSESSMENT;

EID: 84902207693     PISSN: 00406376     EISSN: 14683296     Source Type: Journal    
DOI: 10.1136/thoraxjnl-2013-204155     Document Type: Article

References (26)

1. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the global burden of disease study 2010. Lancet 2012;380:2095-128.
2. Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990- 2010: a systematic analysis for the global burden of disease study 2010. Lancet 2012;380:2163-96.
3. Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med 2011;155:179-91.
4. Anzueto A, Sethi S, Martinez FJ. Exacerbations of chronic obstructive pulmonary disease. Proc Am Thorac Soc 2007;4:554-64. (Pubitemid 47547851)
5. Decramer M, Janssens W, Miravitlles M. Chronic obstructive pulmonary disease. Lancet 2012;379:1341-51.
6. Hansel TT, Barnes PJ. New drugs for exacerbations of chronic obstructive pulmonary disease. Lancet 2009;374:744-55.
7. Loukides S, Bartziokas K, Vestbo J, et al. Novel anti-inflammatory agents in COPD: targeting lung and systemic inflammation. Curr Drug Targets 2013;14:235-45.
8. European Medicines Agency. European Public Assessment Report (EPAR) for Daliresp. 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/ human/medicines/002398/human-med-001415.jsp&mid=WC0b01ac058001d124 (accessed 29 Mar 2013).
9. US Department of Health and Human Services. Food and Drug Administration. Approval package for: application number: 022522Orig1s000. 2011. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2011/022522Orig1s000Approv. pdf (accessed 29 Mar 2013).
10. Chong J, Poole P, Leung B, et al. Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2011;(5):CD002309.
11. US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Medical reviews. Application number: 022522Orig1s000. 2010. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2011/ 022522Orig1s000MedR.pdf (accessed 29 Mar 2013).
12. Gail MH, Costantino JP, Bryant J, et al. Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. J Natl Cancer Inst 1999;91:1829-46.
13. Calverley PM, Rabe KF, Goehring UM, et al . Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet 2009;374:685-94.
14. Schneider C, Jick SS, Bothner U, et al. COPD and the risk of depression. Chest 2010;137:341-7.
15. Schneider C, Jick SS, Bothner U, et al. Reflux disease, gastrointestinal ulcer or weight loss in patients with COPD. COPD 2010;7:172-8.
16. Levy P, Barthet M, Mollard BR, et al. Estimation of the prevalence and incidence of chronic pancreatitis and its complications. Gastroenterol Clin Biol 2006;30:838-44.
17. Centers for Disease Control and Prevention. National Center for Injury Prevention and Control. National Suicide Statistics at a Glance. http://www.cdc.gov/ViolencePrevention/suicide/statistics/index.html (accessed 29 Mar 2013).
18. Puhan MA, Hansel NN, Sobradillo P, et al. Large-scale international validation of the ADO index in subjects with COPD: an individual subject data analysis of 10 cohorts. BMJ Open 2012;2(6). doi: 10.1136/bmjopen,2012-002152.
19. Hurst JR, Vestbo J, Anzueto A, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010;363:1128-38.
20. Puhan M. Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2011;(8):ED000028.
21. US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Statistical reviews. Application number: 022522Orig1s000. 2010. http://www.accessdata.fda.gov/drugsatfda-docs/ nda/2011/022522Orig1s000StatR.pdf (accessed 29 Mar 2013).
22. US Department of Health and Human Services. Food and Drug Administration. Transcript for the April 7, 2010 Meeting of the Pulmonary-Allergy Drugs Advisory Committee. 2010. http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/ UCM212606.pdf (accessed 29 Mar 2013).
23. Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol 2013;66:726-35.
24. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction: GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011;64:383-94.
25. Yu T, Vollenweider D, Varadhan R, et al. Support of personalized medicine through risk-stratified treatment recommendations-an environmental scan of clinical practice guidelines. BMC Med 2013;11:7.
26. Puhan MA, Singh S, Weiss CO, et al. A framework for organizing and selecting quantitative approaches for benefit-harm assessment. BMC Med Res Methodol 2012;12:173,2288-12-173.