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Safety of lansoprazole
1Queen Alexandra Hospital, Portsmouth, UK.
Alimentary Pharmacology & Therapeutics
|January 1, 1993
Summary
Lansoprazole, a proton pump inhibitor, was well-tolerated in 4749 subjects during clinical trials. Most adverse events were mild, with diarrhoea and headache being most common, and few patients discontinued treatment due to side effects.
Area of Science:
- Pharmacology
- Clinical Drug Safety
- Gastroenterology
Background:
- Clinical trials meticulously monitor patients, creating valuable databases for drug safety assessment.
- Understanding a drug's properties, metabolism, and pharmacological action is crucial for safety evaluations.
- Comparing with similar drugs can identify specific safety concerns for investigation.
Purpose of the Study:
- To evaluate the safety and tolerability of lansoprazole based on clinical trial data.
- To identify common adverse events associated with lansoprazole use.
- To determine the rate of patient withdrawal due to suspected drug-related events.
Main Methods:
- Analysis of safety data from clinical trials involving 4749 subjects who received lansoprazole.
- Assessment of adverse events, patient withdrawals, and their relationship to drug dosage.
- Leveraging existing knowledge of lansoprazole's pharmacology and its drug class.
Main Results:
- Lansoprazole was administered to 4749 subjects and demonstrated good tolerability.
- Only 1.2% of patients were withdrawn due to suspected drug-related events, with no discernible pattern or dose relationship.
- The most frequently reported adverse events were headache (4.7%) and diarrhoea (3.2%).
Conclusions:
- Lansoprazole exhibits a favorable safety profile in a large patient cohort.
- The incidence of drug-related adverse events leading to withdrawal is low.
- Commonly reported side effects like headache and diarrhoea are generally manageable.