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Safety of Long‐Term Propafenone Therapy for Cardiac Arrhythmia ‐ Experience with 774 Patients
Author(s) -
RAVID SHMUEL,
PODRID PHILIP J.,
NOVRIT BEVERLY
Publication year - 1987
Publication title -
journal of electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 0892-1059
DOI - 10.1111/j.1540-8167.1987.tb01451.x
Subject(s) - discontinuation , medicine , propafenone , adverse effect , side effect (computer science) , adverse drug reaction , heart failure , incidence (geometry) , drug , toxicity , pharmacotherapy , anesthesia , pharmacology , atrial fibrillation , physics , computer science , optics , programming language
Long term propafenone therapy was initiated in 774 patients who were evaluated at 27 centers in the United States. The average duration of therapy was 183 days. During the treatment period, at least one toxic side effect occurred in 448 patients (58%). The most common reported adverse reactions were cardiovascular in 209 patients (27%), central nervous system in 160 patients (21%), and gastrointestinal in 159 patients (21%). Of those with cardiovascular side effects, 41 (5.3%) had aggravation of arrhythmia, 26 (3.4%) had the induction or worsening of congestive heart failure, and 65 (8.4%) had new conduction abnormalities. Although side effects were frequent, drug discontinuation due to the adverse reaction was necessary in only 114 patients (14.7%). The majority of side effects were dose related especially when 900 mg/day was administered. Additionally, the incidence of toxicity was directly related to age. We conclude that side effects are frequent during long‐term propafenone therapy, but most are mild, dose related, and do not limit the use of the drug. Drug discontinuation because of an adverse reaction is only infrequently required. It is recommended that drug therapy begin with low doses (150 mg t.i.d) with careful and slow titration up to a maximum of 900 mg/day.