Use of prescription contraceptive methods in the UK general population: a primary care study.

OBJECTIVE: To determine prescription contraceptive use in the UK. DESIGN: Observational study using a primary care database. SETTING: The Health Improvement Network (THIN). POPULATION: Women in THIN aged 12-49 years in 2008, registered with their primary care doctor for at least 5 years, and with a prescription history of at least 1 year were included. METHODS: THIN was searched using the Read and MULTILEX codes for the following methods: combined oral contraceptives (COCs), progestogen-only pills (POPs), copper intrauterine devices (Cu-IUDs), the levonorgestrel-releasing intrauterine system (LNG-IUS), progestogen-only implants, progestogen-only injections, and contraceptive patches. MAIN OUTCOME MEASURES: Prevalence, switching, and duration of prescriptions. RESULTS: A cohort of 194 054 women was identified. The prevalence of contraceptive use was: COCs, 16.2% (95% confidence interval, 95% CI 16.1-16.3%); POPs, 5.6% (95% CI 5.5-5.6%); Cu-IUD, 4.5% (95% CI 4.4-4.5%); LNG-IUS, 4.2% (95% CI 4.1-4.2%); progestogen-only implants, 1.5% (95% CI 1.5-1.6%); progestogen-only injections, 2.4% (95% CI 2.3-2.4%); and contraceptive patches, 0.1% (95% CI 0.1-0.2%). Within 1 year, 9.8% of new COC users switched to alternative COCs, and 9.0% changed to a different method. Among new COC users who did not switch method, 34.8% did not continue use beyond 3 months, and were no longer using a prescription contraceptive. CONCLUSIONS: Among users of oral contraceptives who did not switch method, over one-third did not continue use beyond 3 months. This supports current UK guidelines recommending a follow-up consultation with a healthcare professional 3 months after the first prescription of COCs.

Characteristics and drug utilization patterns of new users of rosuvastatin and other statins in four countries.

AIM: This study was undertaken to increase understanding of the utilization of a newly introduced statin through evaluation of characteristics of 'real-life' patients in a pharmacoepidemiology program in the USA, the Netherlands, the UK and Canada. METHODS: This was an observational analysis of prospectively collected data from primary care patients classified as new users of rosuvastatin or any other statin. New users (naïve or switched initiators) of rosuvastatin were compared with initiators of other statins, as identified from automated healthcare databases in the first 1 to 2 years of rosuvastatin availability. Demographics, statin doses, previous statin use and other lipid-lowering therapies, and relevant comorbidities were recorded. The main outcome measure was proportion of naïve and non-naïve statin users in patients prescribed rosuvastatin or 'other statins'. RESULTS: Among 346.547 new statin users identified in the cohorts, 46.838 (13.5%) were new users of rosuvastatin and most (84.1%) were statin-naïve. Patients receiving rosuvastatin were more likely to have been previously treated with another statin or non-statin lipid-lowering therapy and tended to be younger, compared with first users of other statins. CONCLUSION: These findings suggest that rosuvastatin is preferentially prescribed to patients who have not responded satisfactorily to established treatment.

Rheumatoid arthritis in UK primary care: incidence and prior morbidity.

OBJECTIVES: To estimate the incidence of rheumatoid arthritis (RA) in primary care and to investigate associations with consultation behaviour, risk factors, and comorbidities, using the UK General Practice Research Database (GPRD). METHODS: Subjects with a first-ever diagnosis of RA between 1 January 1996 and 31 December 1997 (n = 579) were identified from a cohort of 1 206 918 subjects aged 20-79 years without cancer. Controls from the same cohort were frequency-matched to the RA group by age, sex, and calendar year (n = 4234). Odds ratios (ORs) and 95% confidence intervals (CIs) of being diagnosed with RA in association with a range of factors were estimated using logistic regression analysis. RESULTS: RA incidence was 0.15 per 1000 person-years, was higher in women than in men, and increased with age in both sexes. Consultations and use of non-steroidal anti-inflammatory drugs (NSAIDs) prior to diagnosis were increased in subjects with RA. An increased risk of RA was observed in association with anaemia in the previous year (OR 2.63, 95% CI 1.54-4.48) and with smoking (1.33, 1.07-1.67). A decreased risk of RA was observed in association with infectious diseases (0.68, 0.50-0.94) and pregnancy in the previous year (0.22, 0.06-0.77), diabetes (0.45, 0.26-0.78), and hypertension (0.74, 0.57-0.94). We found no association with alcohol intake, obesity, or use of low-dose aspirin, oral contraceptives, or hormone replacement therapy (HRT). CONCLUSIONS: Smoking was identified as the only significant lifestyle-related risk factor for RA. Infection in the previous year was associated with a reduced likelihood of RA.

Aspirin in cardiology--benefits and risks.

AIMS: To review the current knowledge of the benefits and risks of long-term aspirin therapy for the prevention of cardiovascular disease. METHODS: Relevant articles published in English between 1996 and 2006 were obtained from the Current Contents Science Edition, EMBASE and MEDLINE databases. RESULTS: Secondary aspirin prophylaxis is effective in reducing the risk of ischaemic events in patients with cardiovascular disease. However, its utility in reducing primary ischaemic events is more controversial; it appears to reduce the incidence of ischaemic stroke, but increase the incidence of haemorrhagic stroke. Aspirin therapy can also lead to an increased risk of gastrointestinal ulcers, upper gastrointestinal bleeding and other haemorrhagic complications. Lower doses of aspirin are associated with a reduced risk of gastrointestinal side effects and are equally effective in reducing cardiovascular risk. Co-therapy with non-steroidal anti-inflammatory drugs, clopidogrel or warfarin increases the risk of gastrointestinal side effects, while co-therapy with proton pump inhibitors reduces it. CONCLUSIONS: Both the benefits and risks need to be considered carefully when prescribing aspirin, particularly in primary prevention. Patients should be prescribed lower doses rather than higher doses of aspirin in line with prescribing guidelines. Co-prescription of a proton pump inhibitors may be necessary in patients at high risk for upper gastrointestinal complications.

Prevalence of, and factors associated with, gastroesophageal reflux disease: a population-based study in Shanghai, China.

The prevalence of gastroesophageal reflux disease (GERD) in China is lower than that in the Western countries, but appears to be increasing. The aim of this pilot study was to evaluate the prevalence of GERD in Shanghai, China, and to explore which population characteristics where associated with GERD. A sample of 1200 adult inhabitants of Shanghai, selected using randomized, stratified, multi-stage sampling, completed Mandarin translations of the Reflux Disease Questionnaire and GERD Impact Scale. Potential risk factors for GERD were examined by nested case-control analysis, using Cochran-Armitage trend testing and logistic regression analysis. The response rate was 86.2%; 919 responses were suitable for analysis. The prevalence of GERD, defined as heartburn and/or regurgitation of any frequency during the previous week, was 6.2% in Shanghai. Obesity and urban dwelling were associated with GERD (odds ratio 3.4, 95% confidence interval 1.3-9.3; and odds ratio 3.6, 95% confidence interval 1.2-10.4, respectively). The prevalence of GERD in Shanghai agreed with previous Chinese studies. GERD in Shanghai was associated with obesity and residency in an urban environment.

Gastro-oesophageal reflux symptoms, oesophagitis and Barrett's oesophagus in the general population: the Loiano-Monghidoro study.

OBJECTIVE: Existing endoscopy-based data on gastro-oesophageal reflux disease (GORD) in the general population are scarce. This study aimed to evaluate typical symptoms and complications of GORD, and their associated risk factors, in a representative sample of the Italian population. METHODS: 1533 adults from two Italian villages were approached to undergo symptom assessment using a validated questionnaire and upper gastrointestinal endoscopy. Data were obtained from 1033 individuals (67.4% response rate). RESULTS: The prevalence of reflux symptoms was 44.3%; 23.7% of the population experienced such symptoms on at least 2 days per week (frequent symptoms). The prevalence rates of oesophagitis and Barrett's oesophagus in the population were 11.8% and 1.3%, respectively. Both frequent (relative risk (RR) 2.6; 95% confidence interval (CI) 1.7 to 3.9) and infrequent (RR 1.9; 95% CI 1.2 to 3.0) reflux symptoms were associated with the presence of oesophagitis. No reflux symptoms were reported by 32.8% of individuals with oesophagitis and 46.2% of those with Barrett's oesophagus. Hiatus hernia was associated with frequent reflux symptoms and oesophagitis, and was present in 76.9% of those with Barrett's oesophagus. We found no association between body mass index and reflux symptoms or oesophagitis. CONCLUSIONS: GORD is common in Italy, but the prevalence of Barrett's oesophagus in the community is lower than has been reported in selected populations. Both frequent and infrequent reflux symptoms are associated with an increased risk of oesophagitis. Individuals with oesophagitis and Barrett's oesophagus often have no reflux symptoms.

Endoscopic findings in a cohort of newly diagnosed gastroesophageal reflux disease patients registered in a UK primary care database.

Gastroesophageal reflux disease (GERD) may be accompanied by erosive complications that are diagnosed by endoscopy. This study aimed to describe the characteristics of patients newly diagnosed with GERD who are referred for endoscopy, and the factors associated with esophageal endoscopic findings. This study included patients aged 2-79 years with a first recorded diagnosis of GERD in 1996, as identified in a previous cohort study in the UK General Practice Research Database. The rate and results of endoscopy were recorded. Unconditional logistic regression analysis was used to estimate the odds ratios and 95% confidence intervals for the relationship between a range of factors and endoscopy and its findings. Of the 7159 patients with a new GERD diagnosis, 805 (11%) underwent endoscopy close to the time of first consultation for GERD. Endoscopic findings indicative of esophageal damage were recorded in 73% of these patients. Esophageal endoscopic findings were significantly more likely in males, older patients, and individuals with a history of peptic ulcer disease or gastrointestinal bleeding. Use of acid-suppressive drugs, particularly proton pump inhibitors, was inversely associated with erosive endoscopic findings. Patients with erosive endoscopic findings were more likely to start a new course of treatment with a proton pump inhibitor. In conclusion, relatively few patients are referred for endoscopy close to the first consultation for GERD, and the majority of these individuals have esophageal findings. Male gender, increasing age and a history of bleeding were risk factors for esophageal complications.

Cost of gastro-oesophageal reflux disease to the employer: a perspective from the United States.

BACKGROUND: Employers pay more than just salary for their employees. Previous studies have largely focused on direct medical and prescription drug costs of gastro-oesophageal reflux disease (GERD), and few have reported on total absenteeism costs. AIMS: To examine the annual cost of illness of GERD in an employed US population by benefit category and by place of service for direct medical costs. METHODS: Retrospective data analysis from 2001 to 2004. International Classification of Diseases (ICD)-9 codes (530.1, 530.10, 530.11, 530.12, 530.19, 530.81, 787.1x, 787.2x or 251.5x) were used to identify employees with and without GERD (the control group). Measures included medical and prescription drug claims, plus indirect costs for sick leave, short- and long-term disability, and workers' compensation. For a subset of the population, the direct medical claims were analysed by place of service. RESULTS: Data were available for 267,269 eligible employees of which 11,653 had gastro-oesophageal reflux disease. GERD was associated with a mean incremental cost of US $3,355 per employee of which direct medical costs accounted for 65%, prescription drug costs 17%, and indirect costs 19%. The place of service 'out-patient hospital or clinic' accounted for the largest part (47%) of the difference in medical costs. CONCLUSIONS: GERD is associated with substantial direct and indirect costs, which highlight the importance of managing the disease effectively.

Severe gastro-oesophageal reflux symptoms in relation to anxiety, depression and coping in a population-based study.

BACKGROUND: The association between psychiatric disorders and gastro-oesophageal reflux symptoms is uncertain, and few population-based studies are available. AIM: To examine the association between psychiatric and psychological factors and reflux symptoms. METHODS: Population-based, cross-sectional, case-control study based on two health surveys conducted in the Norwegian county Nord-Trondelag in 1984-1986 and 1995-1997. Reflux symptoms were assessed in the second survey, including 65,333 participants (70% of the county's adult population). 3153 subjects reporting severe reflux symptoms were defined as cases and 40,210 subjects without symptoms were defined as controls. Data were collected in questionnaires. Odds ratio with 95% confidence intervals were estimated using unconditional logistic regression, in adjusted models. RESULTS: Subjects reporting anxiety without depression had a 3.2-fold (95% CI: 2.7-3.8) increased risk of reflux, subjects with depression without anxiety had a 1.7-fold (95% CI: 1.4-2.1) increased risk and subjects with both anxiety and depression had a 2.8-fold (95% CI: 2.4-3.2) increased risk, compared to subjects without anxiety/depression. We observed a weak inverse association between one measure of covert coping and risk of reflux and a weak positive association between another coping measure and risk of reflux. CONCLUSIONS: This population-based study indicates that anxiety and depression are strongly associated with reflux symptoms, while no consistent association regarding coping and reflux was found.

Patients with irritable bowel syndrome in primary care appear not to be heavy healthcare utilizers.

BACKGROUND: Irritable bowel syndrome is a frequently diagnosed gastrointestinal condition in general practice. Managing this chronic condition requires a co-ordinated effort between patient and doctor. AIM: To explore the patterns of treatment and healthcare utilization of irritable bowel syndrome cases in a Swedish primary care setting. METHODS: All cases with a registered diagnosis of irritable bowel syndrome were identified retrospectively for a 5-year period through computerized medical records at three primary healthcare centres in Sweden. Documentation of diagnosis, healthcare visits, treatments, investigations, medications, referrals, laboratory tests, mental and demographic data were retrieved from the records. RESULTS: Of all 723 irritable bowel syndrome patients identified, only 37% had a follow-up appointment to their General Practitioner during the study period. For 80%, the General Practitioner initiated some treatment during the initial consultation and 75% were prescribed medication. Fibre and bulking laxatives and acid-suppressive drugs were the most common medication. Almost a quarter was referred for complementary investigations at hospital, only 8.9% of the irritable bowel syndrome patients were referred to a specialist investigation. Laboratory investigations varied and were ordered more frequently (P = 0.05) for men. CONCLUSIONS: Irritable bowel syndrome patients appear not to be heavy utilizers of primary care and, of those who attend, the majority are managed by their General Practitioner.

Risk factors for inflammatory bowel disease in the general population.

BACKGROUND: The aetiology of inflammatory bowel disease remains largely unknown. AIM: We performed a comprehensive assessment of potential risk factors associated with the occurrence of inflammatory bowel disease. METHODS: We identified a cohort of patients 20-84 years old between 1995 and 1997 registered in the General Practitioner Research Database in the UK. A total of 444 incident cases of IBD were ascertained and validated with the general practitioner. We performed a nested case-control analysis using all cases and a random sample of 10 000 frequency-matched controls. RESULTS: Incidence rates for ulcerative colitis, Crohn's disease, and indeterminate colitis were 11, 8, and 2 cases per 100 000 person-years, respectively. Among women, we found that long-term users of oral contraceptives were at increased risk of developing UC (OR: 2.35; 95% CI: 0.89-6.22) and CD (OR: 3.15; 95% CI: 1.24-7.99). Similarly, long-term users of HRT had an increased risk of CD (OR: 2.60; 95% CI: 1.04-6.49) but not UC. Current smokers experienced a reduced risk of UC along with an increased risk of CD. Prior appendectomy was associated with a decreased the risk of UC (OR: 0.37; 95% CI: 0.14-1.00). CONCLUSIONS: Our results support the hypothesis of an increased risk of inflammatory bowel disease associated with oral contraceptives use and suggest a similar effect of hormone replacement therapy on CD. We also confirmed the effects of smoking and appendectomy on inflammatory bowel disease.

Epidemiology of multiple sclerosis: results from a large observational study in the UK.

Multiple sclerosis (MS) progression to mortality may not be solely determined by the underlying autoimmune process. We conducted a study in a large cohort of MS patients with the aim of describing characteristics of MS patients and identification of predictors for all-cause mortality in this patient group. We performed a retrospective analysis of primary care data from the UK Clinical Practice Research Datalink. Incident MS cases diagnosed between 1993 and 2006 were identified and validated using electronic and original medical records. Patients were followed to identify deaths; hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional regression with age as time-scale. In total, 1713 incident MS cases were identified. Following MS diagnosis, frequent comorbidities were infections (80%), and depression (46%). Adjusted HRs (95% CIs) for all-cause mortality were: 2.0 (1.2-3.4) for current smoking; 7.6 (3.2-17.7) for alcohol abuse; 2.7 (1.6-4.5) for pneumonia and influenza; 4.1 (2.7-6.3) for urinary tract infections; 2.2 (1.2-4.2) for heart disease and 4.9 (2.9-8.0) for cancer. Our results suggest that MS survival is influenced not only by the underlying autoimmune process, but also by patient comorbidities and lifestyle factors.

Is there any association between myocardial infarction, gastro-oesophageal reflux disease and acid-suppressing drugs?

BACKGROUND: A link between gastro-oesophageal reflux disease and coronary heart disease has been suggested. AIM: To estimate the incidence of myocardial infarction in patients with newly diagnosed gastro-oesophageal reflux disease in comparison with that in the general population. METHODS: A population-based cohort study was performed in the UK. Patients aged 18-79 years with a first diagnosis of gastro-oesophageal reflux disease (n = 7084) were identified and a group of 10,000 patients free of gastro-oesophageal reflux disease were sampled. A nested case-control analysis was performed to assess the risk factors for myocardial infarction. RESULTS: The incidence of myocardial infarction in the general population was 4.0 per 1,000 person-years [95% confidence interval (CI), 3.2-4.9] and 5.1 per 1,000 person-years (95% CI, 4.1-6.4) in patients with gastro-oesophageal reflux disease. The relative risk of myocardial infarction in patients with gastro-oesophageal reflux disease was 1.4 (95% CI, 1.0-1.9). The increased risk of myocardial infarction was limited to the immediate days after the diagnosis of gastro-oesophageal reflux disease. Previous chest pain was an important predictor of myocardial infarction in patients free of gastro-oesophageal reflux disease. No association was found between the use of acid-suppressing drugs and the risk of myocardial infarction. CONCLUSION: Our results suggest that gastro-oesophageal reflux disease is not an independent predictor of myocardial infarction. Rather, the increased risk of myocardial infarction in patients with gastro-oesophageal reflux disease in the immediate days after diagnosis indicates that prodromal ischaemic symptoms were misinterpreted as reflux symptoms.

One-year follow-up of newly diagnosed irritable bowel syndrome patients.

BACKGROUND: Irritable bowel syndrome is the most common functional gastrointestinal disorder seen by general physicians. METHODS: We followed up a population-based cohort of newly diagnosed irritable bowel syndrome patients aged 20-79 years, to examine patterns of treatment, comorbidity and healthcare utilization. We used the UK General Practice Research Database as the source population. Individuals with other gastrointestinal diseases, cancer and pregnant women were not included. There were 2956 patients in our final cohort. RESULTS: Irritable bowel syndrome patients were mainly young and middle-aged; only 12% were 60 years or older. The majority of patients were women (74%). There were no marked differences in terms of use of healthcare services or comorbidity status in the year before irritable bowel syndrome diagnosis as compared to the year after. Fourteen per cent of irritable bowel syndrome patients received no drug treatment at all. Among those treated, the first choice was an antispasmodic. Elderly patients (>60 years old) were more likely to receive drug treatment. Females had a slightly higher probability of being treated than men, except for the category of anti-diarrhoeal drugs. CONCLUSION: This study has shown that irritable bowel syndrome patients are mainly young and female. We also found that treatment pattern varied according to age and gender. Elderly patients and females were at a higher risk of receiving drug treatment.

Extra-intestinal manifestations associated with irritable bowel syndrome: a twin study.

BACKGROUND: Little is known about the role of genetic and environmental factors in irritable bowel syndrome. Various extra-intestinal manifestations are more prevalent in cases than in controls. Genetic effects may be important in the liability to develop functional bowel disorders. AIMS: To evaluate the associations of irritable bowel syndrome with several disorders co-morbid with the condition, using both a case-control design and a co-twin control design. METHODS: A sample of 850 Swedish twin pairs, aged 18-85 years, was contacted for a telephone interview. Through a diagnostic algorithm, 72 unrelated cases of irritable bowel syndrome and 216 age- and gender-matched controls were identified. Fifty-eight twin pairs discordant for irritable bowel syndrome were evaluated in co-twin analyses. RESULTS: Renal problems (odds ratio (OR)=3.3; confidence interval (CI), 1.3-8.2), obesity (OR=2.6; CI, 1.0-6.4), underweight in the past (OR=2.4; CI, 1.1-6.4), gluten intolerance (OR=9.0; CI, 1.4-60.1), rheumatoid arthritis (OR=3.2; CI, 1.1-9.4) and poor self-rated health (OR=1.8; CI, 1.0-3.2) were significantly associated with irritable bowel syndrome. In the co-twin analyses, the only factors maintaining significance were renal and recurrent urinary tract problems. CONCLUSIONS: The association between irritable bowel syndrome and renal and urinary tract problems does not reflect a genetic or familial mediation. Eating disorders in childhood represent a familial-environmental influence on irritable bowel syndrome, whereas the association with rheumatoid arthritis and perhaps gluten intolerance probably reflects genetic mediation.

Natural history of gastro-oesophageal reflux disease diagnosed in general practice.

BACKGROUND: Cross-sectional studies indicate that gastro-oesophageal reflux disease symptoms have a prevalence of 10-20% in Western countries and are associated with obesity, smoking, oesophagitis, chest pain and respiratory disease. AIM: To determine the natural history of gastro-oesophageal reflux disease presenting in primary care in the UK. METHODS: Patients with a first diagnosis of gastro-oesophageal reflux disease during 1996 were identified in the UK General Practice Research Database and compared with age- and sex-matched controls. We investigated the incidence of gastro-oesophageal reflux disease, potential risk factors and comorbidities, and relative risk for subsequent oesophageal complications and mortality. RESULTS: The incidence of a gastro-oesophageal reflux disease diagnosis was 4.5 per 1000 person-years (95% confidence interval: 4.4-4.7). Prior use of non-steroidal anti-inflammatory drugs, smoking, excess body weight and gastrointestinal and cardiac conditions were associated with an increased risk of gastro-oesophageal reflux disease diagnosis. Subjects with gastro-oesophageal reflux disease had an increased risk of respiratory problems, chest pain and angina in the year after diagnosis, and had a relative risk of 11.5 (95% confidence interval: 5.9-22.3) of being diagnosed with an oesophageal complication. There was an increase in mortality in the gastro-oesophageal reflux disease cohort only in the year following the diagnosis. CONCLUSIONS: Gastro-oesophageal reflux disease is a disease associated with a range of potentially serious oesophageal complications and extra-oesophageal diseases.

Reported current use of prescription drugs and some of its determinants among 35 to 65-year-old women in mid-Sweden: A population-based study.

To investigate prescribed drug utilization in a middle-aged female population and factors possibly related to drug consumption in this population. A random sample of 4200 women aged 35-65 years, drawn from the population register of seven countries in mid-Sweden, received a postal questionnaire. Two thousand nine hundred ninety one (2991) (71.2%) women responded. Forty percent (40%) of the women were currently using drugs and 12% of the users were taking four drugs or more. Polypharmacy increased by age. A large number of factors were correlated with current drug use. In multivariate analyses age, perceived health, body mass index, and educational level remained significantly related to drug use, while factors such as menopausal state, smoking habits, employment status, marital status, and physical activity lost their significance. Current drug use among women increased by age, bad perceived health status, obesity, and college or university education.

Incidence of newly diagnosed heart failure in UK general practice.

AIM: To estimate the incidence rate of heart failure in the general population and to assess risk factors associated with the occurrence of newly diagnosed heart failure. METHODS: From the source population that was derived from the UK General Practice Research Database, we identified patients aged 40--84 years newly diagnosed with heart failure in 1996, and estimated incidence rates. We sent questionnaires to a random sample of heart failure patients (N=1200) and performed a nested case-control analysis to assess risk factors for heart failure. RESULTS: The overall incidence rate for heart failure was 4.4 per 1000 person-years in men and 3.9 per 1000 person-years in women. The incidence increased steeply with age in both sexes. The relative risk of heart failure was 2.1 (95% C.I.: 1.7--2.6) among men compared with women less than 65 years old and 1.3 (95% C.I.: 1.2--1.4) above the age of 65. Slightly more than half of the cases were categorized in NYHA III--IV at the time of the first diagnosis. Within one month of initial diagnosis 62% of the men and 50% of the women were referred to specialists and/or hospitalized for heart failure. Smoking, hypertension, diabetes, obesity were independently associated with heart failure as well as history of distant dyspnoea. Coronary heart disease was the most common cause of heart failure with a greater relative prevalence in men than women. CONCLUSION: Incident heart failure cases mainly comprised elderly men and women frequently burdened with several diseases in general practice. Women had a lower incidence of heart failure than men. However, traditional risk factors such as smoking, hypertension, obesity, diabetes and dyspnoea appeared to confer the same relative increase in heart failure risk among women and men.

The way towards adverse event monitoring in clinical trials.

Different approaches to the monitoring of adverse reactions to drugs have been used over the years, with the aim of preventing catastrophes like the thalidomide episode and to rationalise drug usage. In the 1960s, the use of national and international adverse event monitoring was first suggested by the British statistician, David Finney. According to Finney, the method was well suited for the postmarketing surveillance of drugs. The idea was rejected by the World Health Organization (WHO) but was later taken up by the Prescription Event Monitoring Event System in the UK. Subsequent to problems with practolol in the 1970s it was suggested that adverse event monitoring could also be useful in clinical trials to detect adverse reactions before a drug is launched. The idea of adverse event monitoring has been tested by Astra Hässle in Sweden in clinical trials with felodipine and omeprazole, and is now the standard method within the company. Adverse event monitoring is an expensive and time-consuming method seen from a short term perspective. However, such monitoring offers an opportunity to optimise the use of clinical trials in safety monitoring, and its ability to predict possible adverse drug reactions is superior to other methods.