Analysis of Adverse Effects among Patients with Essential Hypertension Receiving an ACE Inhibitor or a Beta-Blocker

Abstract

Evaluation of safety and efficacy of new drugs is based largely on data from clinical trials involving a limited number of patients. This approach does not necessarily detect the rare adverse events that may only be observed when very large numbers of patients are studied. Consequently, we designed a double-blind 12-week trial comparing the new angiotensin-converting enzyme (ACE) inhibitor, quinapril (n = 5,053), with a well-established β-adrenergic receptor blocker, metoprolol (n = 506). Essentially hypertensive patients (diastolic blood pressure 95-114 mm Hg) received either 10 mg quinapril or 50 mg metoprolol once daily, and the doses were doubled at 4-week intervals to a maximum of 40 and 200 mg, respectively, in nonresponders. Responder rates were similar under both regimens. Adverse events were assessed by interview as well as by a standard questionnaire. The overall prevalence of adverse events reported by standard questionnaire was higher than that reported spontaneously during interviews. With respect to typical ACE inhibitor adverse reactions (e.g. cough and taste disturbances), there was no difference between quinapril and metoprolol independent of the mode of reporting. In summary, both drugs showed comparable overall tolerance and safety. The discrepancy between spontaneously reported and questionnaire-reported adverse events was noteworthy, and this finding prevailed in a volunteer group of 327 patients who were treated with quinapril for 52 weeks. Thus, a questionnaire is of great significance in addition to the patient history/interview in a large-scale, double-blind study designed to learn about details of drug safety.

Impact of genotype on adverse effects during treatment with metoprolol: A prospective clinical study

“…The frequencies of the ADRs observed in this study should not be used for estimation of true ADR frequencies because there was no placebo group. Furthermore, all of the studied ADRs represented symptoms that were subjectively measured, and, therefore, their frequencies may have been overestimated 34 . On the other hand, one strength of this study was that the ADRs under study were examined in a systematic manner, by means of standardized rating scales and questionnaires, over the 6‐week study period.…”

“…Furthermore, all of the studied ADRs represented symptoms that were subjectively measured, and, therefore, their frequencies may have been overestimated. 34 On the other hand, one strength of this study was that the ADRs under study were examined in a systematic manner, by means of standardized rating scales and questionnaires, over the 6-week study period. In any event our results support the notion that sexual dysfunction may occur during treatment with metoprolol in both men and women.…”

Patient reporting of potential adverse drug reactions: a methodological study

“…However open questionnaires, while not suggesting possible ADRs, identify fewer symptoms [42, 43]. Spontaneous reporting by patients appears to be more reliable for detecting unexpected ADRs than systematic enquiry or checklists [44], but may also result in a lower reporting rate [45].…”

Lebensqualität und psychosoziale Faktoren unter antihypertensiver Therapie Ein Vergleich von Captopril und Quinapril bei geriatrischen Patienten

“…Nachfolgende Vergleichsstudien zur Lebensqualität unter antihypertensiver Therapie wurden bislang meist mit neu eingeführten Substanzen, nicht jedoch wieder mit Captopril durchgeführt [23,28,29,31,32,35,41,44]. Neuere vergleichende Arbeiten zur Lebensqualität speziell bei geriatrischen Patienten erfolgten mit Betablockern, Calciumantagonisten, AT-1-Rezeptorantagonisten und Enalapril und konnten hier keine signifikante Überlegenheit einer antihypertensiven Einzelsubstanz nachweisen [7,9,21,27].…”