APO-TRANDOLAPRIL

Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Essential Hypertension Trandolapril was evaluated for safety in double-blind, placebo-controlled and open-label studies, which included 2581 patients with mild to moderate essential hypertension.

Of these, 265 patients were ≥65 years of age. A total of 126 patients prematurely discontinued across the various trials due to adverse events (AEs). In long-term open-label trials, 1049 patients received trandolapril therapy, of which 212 continued treatment for 24 months, 689 for ≥12 months, and 911 for ≥6 months.

5%). One serious adverse reaction was judged to be possibly related to trandolapril therapy. This involved a rapid supraventricular arrhythmia with atrial flutter which occurred in a 68 year old male patient with a known history of heart disease.

The adverse reactions (corresponding to possibly, probably or definitely related to treatment) with an incidence ≥ 1% in all double-blind, placebo-controlled trials and open-label Phase 3 hypertension trials (n=2581) are shown in Table 1.

Table 1. 01 Treatment Following Acute Myocardial Infarction In a survival study in patients with left ventricular dysfunction following myocardial infarction, 876 patients randomized to trandolapril, and 873 to placebo, were treated for an average of 2 years.

A total of 209 patients prematurely discontinued across the various trials due to AEs. 5%). The most frequent clinical adverse reactions occurring more frequently with trandolapril than with placebo were cough, dizziness and hypotension.

The adverse reactions (corresponding to possibly, probably or definitely related to treatment) with an incidence ≥ 1%, occurring in a higher percentage of trandolapril-treated patients than in placebo-treated patients, are presented in Table 2.

Table 2. 6 Less Common Clinical Trial Adverse Drug Reactions (<1%) APO-TRANDOLAPRIL Product Monograph Page 14 of 47 Blood and Lymphatic System Disorders: Anemia, leukopenia, platelet disorder, thrombocytopenia and white blood cell disorder.