Interpretation and Application of World‐Wide Safety Data on Diltiazem
- 1 August 1985
- journal article
- clinical trial
- Published by Wiley in Acta Pharmacologica et Toxicologica
- Vol. 57 (s2) , 61-73
- https://doi.org/10.1111/j.1600-0773.1985.tb03576.x
Abstract
The safety of medicinal agents being introduced into the marketplace is of growing concern to consumers, health care providers, and regulatory agencies. Although there are ever increasing efforts to improve techniques for testing drugs, and for anticipating and confirming possible adverse effects, arrangements for monitoring and detecting adverse drug reactions are far from satisfactory. Some factors which need to be understood in order to appropriately interpret data include: maturation processes; pretesting affects, measuring instruments affects; selection bias; and the affects of differential experimental mortality. A safety profile has been presented for the calcium entry blocker diltiazem hydrochloride. Efforts were made to focus attention upon the source of safety information as it relates to the quality of the report. The data presented suggests that diltiazem hydrochloride has a low incidence of adverse experiences.Keywords
This publication has 34 references indexed in Scilit:
- Atrioventricular Dissociation and Sinus Arrest Induced by Oral DiltiazemNew England Journal of Medicine, 1983
- The effect of diltiazem and propranolol, alone and in combination, on exercise performance and left ventricular function in patients with stable effort angina: a double-blind, randomized, and placebo-controlled study.Circulation, 1983
- Effects of Intravenous Diltiazem on Sinus Node Function and Atrioventricular Conduction in PatientsJournal of Cardiovascular Pharmacology, 1983
- Efficacy of diltiazem in angina on effort: A multicenter trialThe American Journal of Cardiology, 1982
- Safety and efficacy of diltiazem hydrochloride for the treatment of stable angina pectoris: Report of a cooperative clinical trialThe American Journal of Cardiology, 1982
- Conduction Abnormalities Due to DiltiazemNew England Journal of Medicine, 1982
- Intracardiac electrophysiologic study of intravenous diltiazem and combined diltiazem-digoxin in patientsAmerican Heart Journal, 1982
- Comparative effects of three calcium antagonists, diltiazem, verapamil and nifedipine, on the sinoatrial and atrioventricular nodes. Experimental and clinical studies.Circulation, 1981
- Postmarketing Surveillance of New Drugs: I. Review of Objectives and MethodologyThe Journal of Clinical Pharmacology, 1979
- Effect of Diltiazem on Coronary Hemodynamics and Its Clinical SignificanceJapanese Heart Journal, 1979