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Related Experiment Videos

Clinical experience with diltiazem in Japan.

B F McGraw, S D Walker, J A Hemberger

    Pharmacotherapy
    |May 1, 1982
    PubMed
    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.

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    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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