Bromazepam: acute benefit-risk assessment in general practice
Current Medical Research and Opinion
|January 1, 1984
Summary
This study found bromazepam effective for anxiety relief in 79% of patients. The new anxiolytic drug demonstrated an acceptable benefit-risk profile prior to its market release.
Area of Science:
- Pharmacology
- Clinical Medicine
- Psychiatry
Background:
- Bromazepam is a novel drug evaluated for anxiolytic properties.
- Assessing the benefit-risk ratio is crucial before pharmaceutical marketing.
Purpose of the Study:
- To evaluate the benefit-risk ratio of bromazepam in general practice.
- To determine the efficacy and safety of bromazepam as an anxiolytic.
Main Methods:
- A pre-marketing study involving 393 general practitioners.
- Data collected from 3101 patients treated with bromazepam.
Main Results:
- Bromazepam demonstrated anxiolytic efficacy in 79% of patients.
- The drug was administered at daily doses ranging from 3 mg to 9 mg.
- Acute treatment risks were predictable and low.
Conclusions:
- Bromazepam exhibits an acceptable acute benefit-risk ratio.
- The drug is suitable for its intended class and indication.
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