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APHA Scientific Session and Event Listing

Gregory P. Geba, MD, MPH, USCDMA, Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936, 862-778-6222, gregory.geba@novartis.com, Barbara Ziehmer, MD, Clinical Research and Development, Novartis Pharmaceuticals Corp., One Health Plaza, E Hanover, NJ 07936, Heribert Staudinger, MD, Schering-Plough Corp., 556 Morris Ave., Summit, NJ 07901, and Denise Till, PhD, Clinical Research and Development, Novartis Horsham Research Centre, Wimblehurst Road, Horsham, United Kingdom.

LABAs (long-acting beta-agonists) such as ForadilŪ (FOR) represent a guideline-established treatment option for moderate and severe persistent asthma. FOR efficacy has been demonstrated by: 12 hr bronchodilation, improved symptom scores, and in reducing need for short-acting beta-agonists, in asthma trials of 1 day to 1 year. A recent study in asthmatics comparing a different LABA to placebo showed a small increase in rates of serious adverse events (SAEs) and deaths. We analyzed the FOR asthma clinical trial database to assess differences among FOR 12 mcg bid (US approved dose), FOR 24 mcg (high dose), albuterol (ALB; 180 mcg qid) and placebo (PBO), in terms of significant asthma exacerbations and deaths. Placebo-controlled trials of > 4 weeks in duration were examined to compare rates of significant asthma exacerbations defined as asthma-related SAEs, or those asthma-related AEs leading to treatment discontinuation. Controlled trials, irrespective of duration, were assessed for deaths. Asthma-related SAEs appeared to occur randomly over time. Discontinuations due to asthma-related AEs tended to occur earlier in PBO- compared to FOR-treated groups. Rates of significant asthma exacerbations in FOR-treated subjects were similar to rates observed in those assigned ALB or PBO. There were 3 deaths overall in FOR combined (1 in 1600 pt-yrs exposure), ALB (1 in 242 pts-yrs) and PBO (1 in 572 pt-yrs) groups, only one of which was asthma-related (see Table). Concluding, in conjunction with efficacy shown in these trials, this analysis supports the favorable benefit-risk profile of ForadilŪ in the treatment of asthma.

Learning Objectives:

• Review the safety data from pooled randomized clinical trials of the long-acting beta-agonist, ForadilŪ in the treatment of asthma.

Keywords: Asthma, Clinical Trials

Presenting author's disclosure statement:

Any relevant financial relationships? No