increased use of cardiovascular drugs and limitations in pre-marketing
trials for drug safety evaluation, post marketing evaluation of
adverse drug reactions (ADRs) induced by this class of medicinal
products seems necessary.
Objectives: To determine the rate and seriousness of adverse reactions
induced by cardiovascular drugs in outpatients. To compare sex
and different age groups in developing ADRs with cardiovascular
agents. To assess the relationship between frequencies of ADRs
and the number of drugs used.
Methods: This cross-sectional study was done in cardiovascular
clinic at a teaching hospital. All patients during an eight months
period were evaluated for cardiovascular drugs induced ADRs. Patient
and reaction factors were analyzed in detected ADRs. Patients
with or without ADRs were compared in sex and age by using chi-square
test. Assessing the relationship between frequencies of ADRs and
the number of drugs used was done by using Pearson analysis.
Results: The total number of 518 patients was visited at the clinic.
ADRs were detected in 105 (20.3%) patients. The most frequent
ADRs were occurred in the age group of 51-60. The highest rate
of ADRs was recorded to be induced by Diltiazem (23.5%) and the
lowest rate with Atenolol (3%). Headache was the most frequent
detected ADR (23%). Assessing the severity and preventability
of ADRs revealed that 1.1% of ADRs were detected as severe and
1.9% as preventable reactions. Women significantly developed more
ADRs in this study (chi square = 3.978, P<0.05). ADRs more
frequently occurred with increasing age in this study (chi square
= 15.871, P<0.05). With increasing the number of drugs used,
the frequency of ADRs increased (Pearson=0.259, P<0.05).
Conclusion: Monitoring ADRs in patients using cardiovascular drugs
is a matter of importance since this class of medicines is usually
used by elderly patients with critical conditions and underlying