The Spirometric Efficacy of Once-Daily Dosing With Tiotropium in ...

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The Spirometric Efficacy of Once-Daily Dosing With Tiotropium in ...

Figure 7. Mean weekly mean number of doses per day ofalbuterol inhalation aerosol during 13 weeks for tiotropium andplacebo. The SEM for differences ranged from 0.16 to 0.20doses.Table 3—Adverse Events With Incidence > 2% inTiotropium GroupAdverse EventTiotropium, %(n 279)Placebo, %(n 191)Body as a wholeHousehold accident 2.5 2.6Back pain 2.5 3.1Chest pain 3.2 1.6Headache 5.4 7.3Central and peripheralnervous systemDizziness 3.2 3.7Hypoesthesia 2.2 0.0GI systemAbdominal pain 2.9 0.5Constipation 2.2 1.0Diarrhea 5.0 3.1Dry mouth 9.3 1.6*Respiratory system (lower)COPD exacerbation 16.1 21.5Respiratory system (upper)Pharyngitis 2.9 1.6Sinusitis 3.6 3.1Upper respiratory tractinfection15.8 15.2*p 0.05.would best be judged by trials comparing tiotropiumdirectly with other bronchodilators. Of relevance, apreliminary report comparing tiotropium with ipratropiumfound tiotropium to have superior trough,peak, and average (6 h after dose) response. 24 Therefore,tiotropium has the potential to provide superiorbronchodilation with once-daily dosing. Additionally,the sustained airflow improvement throughout thedosing interval points to the utility of tiotropium as amaintenance drug.In assessing the therapeutic benefit of tiotropium,it is important to understand how the sustainedbronchodilation translates into other health-outcomemeasures that relate to a given patient’s quality oflife. Further studies are necessary to determinewhether the sustained improvement in airflow withtiotropium might improve sleep quality, exercisetolerance, and other quality-of-life measures in patientswith COPD. Demonstration of such benefitswould support the value of bronchodilation in impactingthis chronic disease. 25In summary, tiotropium was demonstrated to providesuperior efficacy relative to placebo for bothin-clinic spirometry and daily measurements of peakflow. These observations were accompanied by bettersymptom control and subjective global assessmentsas well as by less reliance on rescue albuterol.Other than the reported increase in dry mouth,tiotropium was judged as safe and well toleratedduring the 3 months of study. The results of thisstudy suggest that tiotropium should prove useful asonce-daily bronchodilator therapy for COPD.US Tiotropium Study GroupAppendixDevandra Amin, MD, Palm Harbor, FL; Antonio Anzueto,MD, San Antonio, TX; Robert Baughman, MD, Cincinnati, OH;Horst Blumberg, MD, St. Petersburg, FL; Dick D. Briggs, MD,Birmingham, AL; Jeffrey M. Cary, MD, Seattle, WA; RichardCasaburi, PhD, MD, Torrance, CA; Timothy Craig, DO, Hershey,PA; Arthur C. DeGraff, Jr., MD, Hartford, CT; JamesDonohue, MD, Chapel Hill, NC; Mitchell Friedman, MD, NewOrleans, LA; Donald Auerbach, MD, Cherry Hill, NJ; MichaelD. Goldman, MD, Los Angeles, CA; F. Charles Hiller, MD,Little Rock, AR; Terrence P. Kane, MD, Sarasota, FL; JillKarpel, MD, FCCP, Bronx, NY; David Levin, MD, OklahomaCity, OK; Jing Liu, MD, Salem, VA; Donald Mahler, MD,Lebanon, NH; Michael Mandel, MD, Wilkes Barre, PA; K. ScottMiller, MD, Charleston, SC; Joseph W. Ramsdell, MD, SanDiego, CA; James Skatrud, MD, Madison, WI; Jonathan D.Truwit, MD, Charlottesville, VA; and Laurence A. Weiss, MD,PA, Hallandale, FL.References1 Siafakas NM, Vermeire P, Pride NB, et al. Optimal assessmentand management of chronic obstructive pulmonarydisease (COPD). Eur Respir J 1995; 8:1398–14202 Ferguson GT, Cherniack RM. Management of chronic obstructivepulmonary disease. N Engl J Med 1993; 328:1017–10223 Gross NJ. Ipratropium bromide. N Engl J Med 1988; 319:486–494CHEST / 118 /5/NOVEMBER, 2000 1301

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