COMPARISON OF ORAL BAMBUTEROL AND TERBUTALINE IN ELDERLY PATIENTS WITH CHRONIC REVERSIBLE AIR-FLOW OBSTRUCTION

Bambuterol, a carbamate prodrug of terbutaline, is the first once-dail y oral beta(2)-agonist. The effect/side effect ratio of bambuterol ora l solution was compared with terbutaline mixture in elderly patients w ith chronic reversible obstructive airways disease. The study was of a double-blind, crossover, randomized design and consisted of a 4-7-day run-in period followed by four consecutive treatment periods each of 2 weeks. The treatments were bambuterol solution 20 mg nocte (B20), 10 mg nocte (B10), terbutaline mixture 3 mg t.i.d., (T), and placebo sol ution (P). Patients measured daily peak expiratory flow rate (PEFR), a sthma symptoms, use of inhaled Pz-agonist, and tremor. Of 84 patients, 66 completed all periods. Mean age was 67 years (60-90), basal FEV(1) 1.49 L, and reversibility of FEV(1) 30%. Ninety-four percent of the pa tients used inhaled/oral steroids in constant dosage. All treatments w ere significantly more effective than placebo. B20 resulted in higher morning PEFR than T (306 +/- 2.9 L/min vs. 297 +/- 2.9 L/min), while B 10 gave equivalent results to T. No differences were seen in the use o f inhaled beta(2)-agonist. Less shortness of breath was experienced du ring the night with B20 and during the day with B10 compared with plac ebo. Both B20 and T produced more tremor than B10 and P. In elderly pa tients with chronic reversible airways obstruction once-daily bambuter ol (10-20 mg) has a better effect/side effect ratio than 3 mg terbutal ine thrice daily.