Clinical experience with diltiazem in Japan
Pharmacotherapy
|May 1, 1982
Summary
Diltiazem, an oral calcium channel blocker, demonstrated a low frequency of minor adverse effects in a large Japanese patient study. Most side effects were gastrointestinal, with no serious events reported, indicating good safety.
Area of Science:
- Pharmacology
- Clinical Toxicology
- Cardiovascular Medicine
Background:
- Diltiazem is an orally administered calcium channel blocking agent.
- Postmarketing surveillance is crucial for assessing drug safety in real-world patient populations.
Purpose of the Study:
- To evaluate the safety and tolerability of diltiazem in a large cohort of Japanese patients.
- To identify the frequency and nature of adverse experiences associated with oral diltiazem administration.
Main Methods:
- A cooperative postmarketing study involving 3,913 Japanese patients.
- Monthly safety evaluations including subjective symptoms, ECG, adverse experiences, vital signs, and biochemical profiles.
- Data processed and analyzed in the United States.
Main Results:
- Adverse experiences occurred in 1.8% of patients, primarily involving the gastrointestinal system (anorexia, nausea).
- No serious or life-threatening adverse experiences were observed.
- Most adverse effects were extensions of diltiazem's known pharmacologic actions.
Conclusions:
- Diltiazem exhibits a low frequency of clinically minor toxicity.
- The drug appears to be well-tolerated in the studied Japanese patient population.
- Postmarketing data supports the favorable safety profile of oral diltiazem.
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