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Adverse Events in the Treatment of Hypertensive Patients
Author(s) -
Palumbo Gaetana,
Salani Lorenza,
Longhini Paola,
La Guidara Carmela,
Scarani Valter,
Ronchi Esio
Publication year - 1996
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/(sici)1099-1557(199607)5:4<221::aid-pds212>3.0.co;2-x
Subject(s) - medicine , mcnemar's test , adverse effect , retrospective cohort study , pharmacoepidemiology , pediatrics , pharmacology , statistics , mathematics , medical prescription
We evaluated frequency and type of adverse events (AE) and measures adopted in outpatients attending a hospital hypertension unit in a two‐part study: (1) a retrospective review of the charts of the 412 patients seen in 1991 with at least one follow‐up visit and (2) a prospective study of the 491 patients seen in 1993 with at least one follow‐up visit for whom physicians were asked to fill out an AE form. In 1991 18.6% of patients spontaneously reported an AE; those with an AE were older ( p <0.001) than those without and included a greater proportion of females ( p <0.002). This retrospective analysis of AE is reproducible as demonstrated by a blind review of 30 randomly selected charts undertaken by two independent observers (McNemar's test: p =ns). In 1993 AE were reported by 24.4% of patients who had more follow‐up visits ( p <0.001) and included a higher proportion of females ( p =0.016) than the subgroup without AE. AE were different in the two studies ( p <0.001), more specific and drug‐related in 1993. AE were usually considered as mild or moderate (87.4%), the drugs most often involved were calcium antagonists and ACE‐inhibitors and the measure adopted was switching to another substance (44%). The frequency of AE reporting varied widely between different physicians.