title: The once-daily dose regimen of carvedilol: a meta-analysis approach.
abstract: Establishing the overall efficacy or safety of a drug requires a unified methodological approach and analysis of all clinical trials that are intended to be summarized. As an example, this article presents the aggregated dose-response relationship and a subgroup analysis (by age) over all studies of the antihypertensive drug carvedilol. The clinical end points were change from baseline of blood pressure and pulse after 2-4 weeks of treatment with a once-daily dose regimen. All antihypertensive trials were reanalyzed using an intent-to-treat principle. Aggregated data (mean, standard deviation, sample size) for each random group within each study were then combined by means of meta-analysis. The results show that the main patient population can be treated adequately with 25 mg of carvedilol q.d. The dose-response curve shows a typical sigmoid shape: a steeper increase from 12.5 to 25 mg of carvedilol and a following flat part (25, 50, and 100 mg of carvedilol q.d.). There is a considerable variation of the results between studies, which is much bigger than the dose-response effect. Most of this variation is due to monocentric trials.
authors.affiliation: Department of Biometrics, Medical Development, Boehringer Mannheim GmbH, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Stienen
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects*; D002227:Carbazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D000077261:Carvedilol; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D011412:Propanolamines / Q000008:administration & dosage* / Q000627:therapeutic use; D011897:Random Allocation
chemical_list: D000959:Antihypertensive Agents; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol