Heterogeneity of Clinical Trials for Antihypertensive Drugs in Japan: Exploratory Analysis of Confirmatory Phase III Trials Used for Marketing Approval
| Autor: | Kota Sano, RPh Reina Kaneko MSc, Shunsuke Ono |
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| Rok vydání: | 2017 |
| Předmět: |
MEDLINE
Eligibility Determination Blood Pressure 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Pharmacotherapy Randomized controlled trial Japan law Medicine Humans Pharmacology (medical) 030212 general & internal medicine Marketing Drug Approval Antihypertensive Agents Randomized Controlled Trials as Topic Pharmacology business.industry Concomitant drug Clinical trial Blood pressure Drug development Clinical Trials Phase III as Topic Meta-analysis Hypertension business |
| Zdroj: | Clinical pharmacology and therapeutics. 104(1) |
| ISSN: | 1532-6535 |
| Popis: | The results of pivotal trials, which provide a rationale for marketing approval decisions for new drugs, are considered for various comparative purposes in postmarketing analyses. Using meta-regression analysis of 91 randomized controlled trials of 61 approved antihypertensive drugs in Japan, we show that mean baseline blood pressure (BP) of each arm was associated with predetermined entry criteria (EC), age, and trial start year (TSY). BP changes following treatment were associated with EC, subject characteristics (e.g., age, complications, baseline BP), study design (e.g., concomitant drug use), and TSY. Effect sizes were generally larger in trials for the first and second drugs in the same class than in trials for follow-on drugs. Results of pivotal trials may vary depending on many factors, suggesting possible challenges associated with the comparison of these results indirectly. Due to the heterogeneity in pivotal trials, caution should be exercised when comparing approved drugs and conducting meta-analyses retrospectively. |
| Databáze: | OpenAIRE |
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