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Objective: Esomeprazole, the S-isomer of omeprazole, was launched in the UK in September 2000. The first proton pump inhibitor, omeprazole, has been marketed in the UK for over 10 years. However, the adverse event database of newly marketed drugs is limited, and it is only after widespread clinical use that the adverse effect profile of a drug is ascertained more comprehensively. This study aims to monitor the safety of esomeprazole prescribed in the primary care setting in England using prescription-event monitoring (PEM)., Methods: A postmarketing surveillance study using the observational cohort technique of PEM. Patients were identified from dispensed prescriptions for esomeprazole issued by general practitioners between September 2000 and April 2001. Questionnaires ('green forms') requesting clinical event data on these patients were sent to prescribers approximately 6 months after the date of the first dispensed prescription for each individual patient. Incidence densities (IDs), expressed as the number of first reports of an event/1000 patient-months of exposure (PME), were calculated. Significant differences between IDs for events reported in the first month (ID1) and the following 5 months (ID2-6) of exposure were regarded as potential signals. Other methods for signal detection such as medical evaluation of selected events and evaluation of reasons for stopping were also applied., Results: Green forms containing clinically useful information for 11 595 patients (median age 56 years; 53.2% female) were received. Diarrhoea was the event with the highest ID1 in month 1 (8.0 per 1000 patient months of exposure). Adverse events that occurred significantly more often in the first month of treatment with esomeprazole compared with months 2-6 included diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, headache/migraine, intolerance, malaise/lassitude, pruritus, unspecified adverse effects and abnormal sensation., Conclusions: The safety profile of esomeprazole was consistent with the prescribing information and experience reported in the literature.

Aims: A postmarketing Prescription-Event Monitoring study was undertaken to monitor the safety of rofecoxib, a cyclo-oxygenase (COX)-2 selective inhibitor prescribed in primary care in England., Methods: Questionnaires requesting clinical event data were sent to prescribing physicians between February and November 2000, and the data analysed for all events., Results: There were 15,268 patients identified, mean age 62 years, 67% female. The commonest specified indication was osteoarthritis (24%). Dyspepsia and nausea were the most frequently reported adverse events. A history of dyspeptic or upper gastrointestinal (GI) conditions, recent use of other nonsteroidal anti-inflammatory drugs (NSAIDs), use of selected concomitant gastroirritant drugs (NSAIDs, aspirin, anticoagulants, antiplatelet drugs), or gastroprotective drugs (misoprostol, antacids, proton-pump inhibitors, histamine-2 antagonists), and age (>/= 65 years) modified the risk of having minor GI events. During treatment or within 1 month of stopping, 110 serious GI events were reported (including 76 upper GI bleeds/peptic ulcers, one perforated colon), 101 thromboembolic events, three reports of acute renal failure, one each of Stevens-Johnson syndrome, severe anaphylaxis and angio-oedema., Conclusions: Doctors should continue to prescribe NSAIDs including COX-2 selective inhibitors with caution.

Background: Aspirin and statins are the two drugs most commonly indicated for secondary prevention of atherosclerotic disease in the UK. Statin treatment, which is more expensive, is under-prescribed., Aim: To assess the expenditure in Greater Manchester general practices on aspirin and statins., Design: Survey of general practice records., Methods: Practice registers were searched for patients receiving regular prescriptions for aspirin. For each patient, the next patient of the same sex, aged within +/- 5 years, not on aspirin, acted as a control. Details of all medications were recorded. In a sub-study, records of 100 patients on aspirin were studied to determine indications for aspirin prescription., Results: There were 1003 (511 men, 492 women) in each group; mean age was 70 years in both groups. In the sub-study, 79% of patients received aspirin for established vascular disease, 9% for hypertension, 5% for diabetes mellitus, 5% for unknown reasons and 2% for arthritis. Of the patients on aspirin, 67% received dispersible aspirin 75 mg/day. The rest were on higher doses (10%) or on more expensive preparations (22%), costing up to 22.4 p/day. The mean daily cost of aspirin was 1.7p. Dyspepsia treatment was received by 266 patients and 194 controls (p<0.001). There was a wide range of dyspepsia medications (10-306p/day), averaging in the groups as a whole 15.5p/day in patients and 12.5p/day in controls. Of the patients on aspirin, 28% received statins, compared to 4% of controls. Mean daily expenditure on statins in patients was 23.4p., Conclusion: Assuming the difference in the use of medication for dyspepsia between patients and controls was due to aspirin, the full cost of aspirin treatment was 4.7p/day. Statins were probably under-prescribed in aspirin-takers, many of whom would have been at high CHD risk.

The prevalence of a range of gastrointestinal symptoms was compared in 1014 cases, identified in general practice, receiving chronic non-steroidal anti-inflammatory drug (NSAID) treatment and 975 matched community controls. The NSAIDs being taken included aspirin (33%), ibuprofen (17%), naproxen (11%), piroxicam (9%), indomethacin (8%), and diclofenac (7%). The 12-month prevalence of dyspepsia in cases was 46% and in controls 43%, with no differences in symptoms prevalence between those taking aspirin and other NSAIDs or between individual NSAIDs. About one-third of the cases had consulted a GP about their symptoms and 7% had a co-prescription for an H2-receptor antagonist. Lower-bowel symptoms were more common in the NSAID-taking cases, particularly constipation and straining, and constipation was a more common reason for stopping medication than dyspepsia.

Little is known about how non-steroidal anti-inflammatory drugs (NSAIDs)-related dyspepsia is managed in general practice. A survey was conducted to ascertain the preferred methods of investigation and management of NSAIDs-related dyspepsia by GPs in the Leeds district in the summer of 1992. A total of 261/300 (87%) replied to the questionnaire. Most (87%) GPs discontinued NSAIDs, and 12% changed the drug. Only 42 (16%) suggested endoscopy.