A placebo-controlled comparison of the efficacy and tolerability of picumast dihydrochloride and terfenadine in patients with seasonal allergic rhinitis.
Of 99 evaluable patients with seasonal allergic rhinitis, 33, 35, and 31 were treated with picumast dihydrochloride (3,4-dimethyl-7-[4-(4-chlorbenzyl)piperazine-1-yl]propoxycoumar in dihydrochloride) 1 mg, terfenadine 60 mg, and placebo, respectively, twice daily for 3 weeks. After 7 days' treatment physicians' assessments of symptomatic improvement showed that the effects of the two active drugs were similar and significantly superior to those of placebo. Some further improvement occurred over the remainder of the study, with no significant differences in efficacy appearing between picumast dihydrochloride and terfenadine. After 2 and 3 weeks of treatment the efficacies of both picumast dihydrochloride and terfenadine were "very good/good" in over 90% of patients. The tolerability of all three treatments was classified as "very good" in 60% to 70% of patients. Physicians were prepared to represcribe the study medication in about 90% of patients given picumast dihydrochloride or terfenadine compared with 52% administered placebo. Similar assessments performed by the patients generally agreed with these results. Withdrawal due to lack of efficacy occurred in 13, 2 and 0 patients treated, respectively, with placebo, terfenadine, or picumast dihydrochloride. Few adverse effects were reported. It is concluded that picumast dihydrochloride offers a comparable alternative to terfenadine in the treatment of seasonal allergic rhinitis.
Boerner
D
D
Department of Product Development, Boehringer Mannheim GmbHa, Fed. Rep. of Germany.
Metz
K
K
Eberhardt
R
R
Schürmann
W
W
D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003374:Coumarins / Q000009:adverse effects / Q000627:therapeutic use*; D004361:Drug Tolerance; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016593:Terfenadine
D001559:Benzhydryl Compounds; D003374:Coumarins; D006634:Histamine H1 Antagonists; C013373:picumast; D016593:Terfenadine