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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: BMcV who wrote (2500)	4/21/1999 1:27:00 PM
From: Dr. John M. de Castro	Read Replies (1) \| Respond to of 10280

SEPR will present the following paper at the American Thoracic Society - 1999 International Conference, San Diego, California, USA, April 23-2827-Apr-99 8:15A C45] [Poster: A73] Efficacy And Safety Of Levalbuterol In African American Patients With Asthma: A Subset Analysis. M. Lenoir. Few clinical trials have reported safety and efficacy of beta-agonists in African Americans (AA) with asthma. It may be possible to extrapolate from non-AA, but there may be pharmacogenetic differences in metabolism or receptors to warrant separate trials or subset analyses. In an attempt to determine if differences exist, the efficacy and safety following a single dose of levalbuterol [single isomer (R)-albuterol, LEV], racemic albuterol (RAC), or placebo was examined in AA asthmatics enrolled in 2 controlled studies [1 pediatric (age 6-11 yr) and 1 in patients aged 12]. Thirty-nine AA patients were enrolled. The trend in peak change (D) and peak % D FEV_{1} was similar in AA patients compared to non-AA patients (Table). Mean % D FEV_{1} over time indicated that LEV 1.25 mg resulted in the greatest improvements, as seen in the non-AA group. LEV 0.63 and RAC 2.5 mg showed similar but lower responses in AA compared to non-AA. Beta-mediated changes were dose dependent and similar for LEV 0.63 and RAC 2.5 mg. Results obtained from AA patients are comparable to those of all patients and non-AA patients. The rank order of efficacy was LEV 1.25 > LEV 0.63 = RAC 2.5 > placebo. However, these are based on a relatively small sample and should be interpreted with that perspective. Due to the small number of patients in this subset and the prevalence of asthma in African Americans, further study is warranted. Placebo Lev 0.63 Lev 1.25 All AA (n=39) 0.38 (26) 0.52 (26) 0.74 (48) AA > 11 yrs (n=26) 0.41 (23) 0.55 (27) 1.0 (63) AA 6-11 yrs (n=8) 0.35 (29) 0.26 (17) 0.30 (22) Non-AA > 11 yrs (n=251) 0.35 (18) 0.91 (46) 0.98 (48) RAC 2.5 All AA (n=39) 0.53 (31) AA > 11 yrs (n=26) 0.7 (38) AA 6-11 yrs (n=8) 0.27 (20) Non-AA > 11 yrs (n=251) 0.82 (42) Data reported are peak D FEV_{1} in liters and peak % D FEV_{1} (in parentheses) SEPRACOR Session: 8:15 am-4:15 pm, ASTHMA THERAPY Presentation Date: Tuesday, April 27, 1999, Time: 8:15A, Room: Area A - Special Events/Sail Area (Upper Level), San Diego Convention Center