caa a22 4500 477057950 CHVBK 20180405111352.0 cr unu---uuuuu 170330e19960301xx s 000 0 eng 10.1007/BF00195927 doi (NATIONALLICENCE)springer-10.1007/BF00195927 ACE-inhibitor-induced cough, an adverse drug reaction unrecognised for several years: studies in Prescription-Event Monitoring [Elektronische Daten] [K. Kubota, N. Kubota, G. Pearce, W. Inman] Objective: This study examines cough recorded in Prescription-Event Monitoring (PEM) of four ACE-inhibitors. Particular attention was paid to the study of enalapril because the drug was monitored before the causal relationship between cough and ACE-inhibitors had been widely accepted. Results: Several factors which had obscured the causal relationship in the individual cases were found to be also an obstacle in PEM. For example, cough was a common and non-serious event and was under-reported in the PEM study of enalapril and the rate was not strikingly different from that recorded for other drugs. Cough induced by ACE-inhibitors has several characteristics which reduce the chance of a recognis-able ‘signal'. The original questionnaires returned from doctors in the PEM study of enalapril have been reexamined. The observation that the rate of cough diminished after enalapril had been stopped rather than increased after starting, provided the best evidence of causality, because this was not affected by many biases such as the publicity that had occurred prior to doctors participating in PEM completed later reports. Springer-Verlag, 1996 Cough nationallicence ACE-inhibitor nationallicence drug-induced nationallicence post-marketing surveillance nationallicence prescription-event monitoring nationallicence pharmacoepidemiology nationallicence Kubota K. Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK aut Kubota N. Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK aut Pearce G. Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK aut Inman W. Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK aut European Journal of Clinical Pharmacology Springer-Verlag 49/6(1996-03-01), 431-437 0031-6970 49:6<431 1996 49 228 https://doi.org/10.1007/BF00195927 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF00195927 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kubota K. Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK aut NATIONALLICENCE 700 1- Kubota N. Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK aut NATIONALLICENCE 700 1- Pearce G. Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK aut NATIONALLICENCE 700 1- Inman W. Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK aut NATIONALLICENCE 773 0- European Journal of Clinical Pharmacology Springer-Verlag 49/6(1996-03-01), 431-437 0031-6970 49:6<431 1996 49 228 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer