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Post-marketing Surveillance of the Safety of Cimetidine: Twelve-month Morbidity Report
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1985
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Outpatient ClinicsGastroenterologyPharmacotherapyLogistic AnalysisAdverse Drug ReactionDrug ResistanceClinical EpidemiologyAdverse EffectsToxicologyDrug MonitoringDrug ToxicityHealth SciencesDrug SafetyDrug InteractionsPoisoningPharmacologyPharmacological IssueCimetidine TakersDigestive System DiseasesSide EffectPost-marketing SurveillancePatient SafetyForensic ToxicologyPharmacovigilanceMedicinePharmacoepidemiology
Previous reports have described the methods for identifying subjects and 12‑month mortality outcomes in this surveillance study. This study presents a general analysis of morbidity experienced by cimetidine users during the follow‑up year. The study followed 9,928 cimetidine users and 9,351 controls across four UK cities for at least one year, recording hospital visits and deaths. Patients on cimetidine had higher outpatient (39 % vs 21 %) and inpatient (18 % vs 8 %) rates, with 15,325 diagnoses versus 5,002 in controls, mainly reflecting gastrointestinal associations and confounding factors; no new adverse effects were identified, confirming the method’s feasibility and lack of major unrecognized risks.
A total of 9928 patients taking cimetidine and 9351 controls were included in a post-marketing drug surveillance study in Glasgow, Nottingham, Oxford and Portsmouth; 98.8 per cent of the takers and 97.7 per cent of the controls were successfully followed up for at least one year during which hospital visits and deaths were recorded. Methods of identification of subjects and 12-month mortality results have been reported previously. A general analysis of the morbidity experienced by these patients during the study year is presented here. Thirty-nine per cent of takers and 21 per cent of controls were seen at outpatient clinics, and 18 per cent of takers and 8 per cent of controls were admitted to hospital; 15 325 individual diagnoses in takers and 5002 diagnoses in controls were reviewed. An association with cimetidine treatment was found, as expected, for gastrointestinal diseases. Weaker associations were found for haematological disorders, some tumours, infections, disorders of the locomotor system and respiratory diseases. Detailed examination revealed that these were mainly due to confounding from several sources, for example, from the underlying cause of the dyspepsia which resulted in cimetidine use, from the higher level of physician contact in cimetidine takers, and smoking. The scheme successfully detected and quantified some already known adverse effects of cimetidine and did not detect any new effects. It is concluded that this method of collecting information is feasible and useful, but several interpretive pitfalls arise, some of which can be avoided by careful analysis. No evidence of any major unrecognised risk of cimetidine treatment emerged from the study.