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Clinical Investigations: BRONCHODILATORS |

Long-term Cardiovascular Safety of Salmeterol Powder Pharmacotherapy in Adolescent and Adult Patients With Chronic Persistent Asthma*: A Randomized Clinical Trial

Paul Chervinsky, MD; Pinkus Goldberg, MD; Stanley Galant, MD; Yonghua Wang, PhD; Teresa Arledge, DVM; Mary Beth Welch, RPh; Edmundo Stahl, MD
Author and Funding Information

*From the New England Clinical Studies (Dr. Chervinsky), North Dartmouth, MA; Allergy Asthma and Clinical Immunology Associates (Dr. Goldberg), Indianapolis, IN; Pediatric and Adult Allergy and Clinical Immunology (Dr. Galant), Orange, CA; and Glaxo Wellcome Inc (Drs. Wang, Arledge, Welch, and Stahl), Research Triangle Park, NC.



Chest. 1999;115(3):642-648. doi:10.1378/chest.115.3.642
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Study objectives: This study investigates the long-term cardiovascular safety of salmeterol powder vs placebo in adolescent and adult patients with mild persistent asthma.

Design: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

Setting: Eighteen US clinical centers.

Patients: Three hundred fifty-two patients (≥ 12 years) with mild persistent asthma (duration ≥ 6 months) requiring pharmacotherapy; with FEV1 of 70 to 90% of predicted and without abnormal ECG/continuous ambulatory ECG (Holter).

Interventions: Randomized to twice-daily salmeterol powder (50 μg) or placebo via breath-actuated device for 52 weeks. Backup albuterol was available to control asthma symptoms.

Measurements and results: Cardiovascular safety was regularly assessed by 12-lead ECG with a 15-s lead II rhythm strip, 24-h continuous ambulatory ECG (Holter) monitoring, serial vital sign measurements, and review of adverse cardiovascular events. No deaths occurred during the study. No clinically significant between-group differences were observed in pulse rate, ECG QTc interval, median number of ventricular or supraventricular ectopic events, incidence of ventricular ectopic couplets and runs, or incidence of > 100 ventricular or supraventricular ectopic events in 24 h. No clinically significant between-group differences were observed in arterial BP or incidence of adverse cardiovascular events. Salmeterol was well tolerated throughout the 52-week study period, with a cardiovascular safety profile similar to that of placebo.

Conclusions: Long-term, twice-daily pharmacotherapy with salmeterol powder is safe and is not associated with unfavorable clinically significant changes in cardiac function or increases in cardiovascular adverse effects.

Abbreviations: ANOVA = analysis of variance; SVE = supraventricular ectopic; VE = ventricular ectopic


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