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Biomedical subjects

M A Wallander

Publications and source records attributed to M A Wallander.

At least 19 recordsLinked to original sources

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.

Adult↗

Gender and drug treatment as determinants of mortality in a cohort of heart failure patients.

AIM: We assessed gender differences in the risk of mortality in heart failure (HF) patients and evaluated the association between HF drug treatment and mortality. METHODS AND RESULTS: We identified a cohort of 820 patients with newly diagnosed HF in 1996 in UK general practices. The diagnosis of HF was confirmed by the general practitioner. Fifty per cent were females and 27% were less than 70 years old. During a mean follow-up of 2 years, 172 patients died. We used computerized records to assess risk factors and drugs prescribed as treatment. The information on severity was assessed through a questionnaire. We performed a nested case-control analysis, and observed that men had twice the risk of dying than females, however the effect of age on mortality was stronger in females than males. We found a similar interaction between HF severity and sex. Data on use of some cardiovascular drugs such as diuretics, beta-blockers ACE-inhibitors and calcium channel blockers were suggestive of a reduced mortality risk. Current use of nitrates and glycosides carried an increased risk. CONCLUSION: Older age, male sex and severity of HF were the main predictors of mortality among HF patients. Long-term use of beta-blockers was associated with a significantly reduced risk of mortality.

Adult↗

Prescription drug use, diagnoses, and healthcare utilization among the elderly.

BACKGROUND: More elderly patients affected by severe and chronic diseases are treated in primary care. Reports on the use of prescription drugs by the general elderly population are scarce, and more investigations are needed to optimize pharmaceutical care for these patients. OBJECTIVE: To analyze prescription drug use, diagnoses, and healthcare utilization among noninstitutionalized elderly patients. DESIGN: Retrospective cohort study. SETTING AND PATIENTS: All people > or =65 years old (n = 4642) living in the community of Tierp, Sweden, in 1994 were included. Prescription drug use and healthcare utilization have been registered for all inhabitants of the community since 1972. Information about filled prescriptions and diagnoses were obtained from a computerized research register. RESULTS: Prescription drug use was high among the elderly (78%); the most used pharmacologic groups were cardiovascular, nervous system, and gastrointestinal medications. Women used more prescription drugs than men (average 4.8 vs. 3.8) and had more nonfatal diagnoses. Use of five or more different prescription drugs during 1994 was common (39.0%), and multivariate analysis showed that the greatest number of primary care visits occurred with multiple drug use (> or =5 drugs over 1 y). CONCLUSIONS: This study shows an extensive multiple drug use among elderly people living at home. Whether this multiple drug use per se is harmful to the patients or not could not be evaluated in this study. Further focused investigations are needed to assess the effect of multiple drug use in an elderly population.

Age Distribution↗

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.

Adult↗

Detection of colorectal tumor and inflammatory bowel disease during follow-up of patients with initial diagnosis of irritable bowel syndrome.

BACKGROUND: We wanted to estimate the incidence of irritable bowel syndrome (IBS) and functional dyspepsia (FD) in the general population, and the detection of colorectal tumor (CRT) and inflammatory bowel disease (IBD) after the diagnosis of IBS and FD. METHODS: Patients aged 20-79 years newly diagnosed with IBS (N = 2956) or FD (N = 9900), together with a comparison cohort randomly sampled from the general source population, were followed-up during a mean time of 3 years. RESULTS: We found an overall incidence of 10.3 per 1000 person-years for FD and 2.6 per 1000 person-years for IBS. There was a greater prevalence of depression, stress, fatigue, and pain disorders among IBS and FD patients than in the general population. During the 1st year after a diagnosis of IBS the cumulative risk of detecting CRT was close to 1% in IBS patients. After the 1st year the risk of CRT in IBS patients was close to that in the general population. We found a significantly increased risk of detecting IBD among patients initially diagnosed as having IBS (relative risk (RR), 16.3; 95% confidence interval (CI), 6.6-40.7), which was constant during all the follow-up period. No association was found between dyspepsia and CRT, or IBD. CONCLUSION: IBS and FD shared some comorbidity features, yet demographics and incidence rates were different. Unlike the detection of colorectal tumor, the excess risk of IBD after an initial diagnosis of IBS was cumulatively increased during all the follow-up period. The continuously increased risk of IBD detection in IBS patients favors a true association between IBS and IBD.

Adult↗

Overall mortality among patients surviving an episode of peptic ulcer bleeding.

STUDY OBJECTIVE: The authors investigated whether patients who have survived an acute episode of peptic ulcer bleeding (PUB) have an excess long term all cause mortality compared with the general population free of PUB. DESIGN: Follow up study of previously identified cohort of patients with a PUB episode and a general population cohort. SETTING: The source population included all people aged 30 to 89 years, registered with general practitioners in the United Kingdom. PATIENTS: All patients alive one month after the PUB episode constituted the cohort of PUB patients (n = 978). A control group of 5000 people was randomly sampled from the source population. The same eligibility criteria as for patients with PUB were applied to the control series. Also, controls had to be free of PUB before start date. MAIN RESULTS: Relative risk of mortality among PUB patients was 2.1, 95% CI: 1.7, 2.6) compared with the general population. This increased mortality risk occurred mainly in the patients less than 60 years old. No difference was observed between men and women. The excess mortality was not only circumscribed to deaths attributable to recurrent gastrointestinal bleed, but also cardiovascular, cancer and other causes. CONCLUSIONS: People who have survived an acute episode of PUB have a reduced long term survival compared with the general population. This reduction was stronger among middle age patients than in the elderly.

Adult↗

Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes.

Evidence documenting the safety of acid-suppressing drugs in pregnancy is very limited. The authors assessed the prevalence of congenital malformations in first trimester-exposed pregnancies to cimetidine, omeprazole, and ranitidine and compared it with nonexposed pregnancies between 1991 and 1996. Two different sources were used, the United Kingdom General Practice Research Database and the Italian Friuli-Venezia Giulia Health Database. The final study cohort included 1,179 pregnancies from the United Kingdom and 1,057 from Italy. Abortions or ectopic pregnancies were not included. There were 20 stillbirths and 2,261 live-born babies in both cohorts combined, with 100 offspring identified with a malformation. The overall malformation rate was 4.4%. The relative risks for nongenetic congenital malformations associated with the use of cimetidine, omeprazole, and ranitidine were 1.2 (95% confidence interval (CI): 0.6, 2.3), 0.9 (95% CI: 0.3, 2.2), and 1.4 (95% CI: 0.8, 2.4), respectively, compared with the nonexposed. No specific grouping in the distribution of malformations was observed in any of the three exposed groups. Moreover, no relation was found between drug exposure and preterm delivery or growth retardation. These findings suggest that the use of acid-suppressing drugs during the first trimester of pregnancy is not associated with a major teratogenic risk.

Abnormalities, Drug-Induced↗

Health resource utilization and drug treatment pattern in a cohort of patients with a first episode of gastroesophageal reflux disease.

PURPOSE: To describe the demographics, comorbidity, and health care resource utilization, as well as treatment patterns among gastroesophageal reflux disease (GORD) patients. METHODS: We identified a population-based cohort of newly diagnosed GORD patients receiving cimetidine, ranitidine or omeprazole. Our final study population consisted of 1193 patients, who were followed up for 1 year. RESULTS: Mild symptoms were reported in 44% of cases, moderate in 52%, and 4% had a severe episode. Moderate and severe cases were more likely to undergo endoscopy and to be hospitalized for GORD than mild cases. They also had a higher probability of receiving long-term continuous treatment and to start initial treatment with omeprazole rather than with cimetidine or ranitidine. Initial treatment failure was greater among severe cases and in patients started on H(2)-blockers. CONCLUSION: This study has shown that severity of initial GORD episode is significantly associated with an increased use of health resources, and is the major determinant of initial treatment failure. Patients started on H(2)-blockers also had a greater risk of initial treatment failure compared to patients started on omeprazole.

Journal Article↗

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.

Adult↗

Ocular disorders in users of H2 antagonists and of omeprazole.

We have conducted a cohort study of users of omeprazole and H(2) antagonists in Italy to investigate whether the peroral use of these drugs may be associated with an increased incidence of ocular disorders leading to loss of vision. We have used the Sistema Informativo Sanitario Regionale (SISR database) in Friuli-Venezia-Giulia to identify all subjects who received at least one prescription for cimetidine, famotidine, niperotidine, nizatidine, omeprazole, ranitidine or roxatidine between 1 January 1991 and 31 December 1994. We have identified all hospital admissions for serious vascular or inflammatory ocular disorders following any such prescription, reviewed and validated all medical records. There were 71,108 users of any of the study drugs, contributing a total of 101,827 person years of observation. Seven cases of serious eye disorders were identified, giving an annual incidence rate of 7/100,000 persons. By comparison to non-users, the incidence rate ratio for current users of all of the study drugs together was 0, with a 95% confidence interval of 0 to 2.1. By comparison to non-users, the incidence rate ratio for past users was 0.47 (95% CI: 0.06-2.4). Our data are consistent with previous studies and add weight to the general impression of the ocular safety of these drugs.

Journal Article↗

Comparison of mortality from peptic ulcer bleed between patients with or without peptic ulcer antecedents.

We studied mortality related to peptic ulcer bleed in a well defined cohort of patients in the month after the episode of peptic ulcer bleed. Our objective was to assess the contribution of peptic ulcer antecedents and other predictive factors on the risk of dying. The study cohort comprised 1,020 patients hospitalized for an episode of peptic ulcer bleed between January 1991 and March 1994 and identified in the General Practice Research Database in the United Kingdom. Six hundred twenty-three patients had no prior episode of peptic ulcer disease, and 384 had peptic ulcer antecedents; for 13 patients, information was not available. Forty-five patients died (mortality rate = 4.4 per 100 person-months; 95% confidence interval = 3.3-5.9) within 1 month of the peptic ulcer bleed. Patients with no peptic ulcer antecedent faced a greater risk of dying than patients with antecedents (relative risk = 3.0; 95% confidence interval = 1.2-7.1). Elderly patients, those undergoing surgery, and current users of acid-suppressing drugs or nonsteroidal antiinflammatory drugs all had an increased mortality risk. Patients presenting with their first-ever episode of peptic ulcer bleed have a higher case fatality rate than those with previous episodes of peptic ulcer.

Adult↗

Renal disease and acid-suppressing drugs.

No comparative epidemiological data can be found in the literature on the renal safety of acid-suppressing drugs. We followed-up a cohort of close to 180,000 persons during periods of treatment and non-treatment with five anti-ulcer drugs to evaluate the risk of idiopathic acute renal failure and/or nephrotic syndrome. After reviewing medical records, five patients were found to be cases. Two presented with acute renal failure and three had nephrotic syndrome. Three cases occurred during periods of non-exposure to anti-ulcer drugs. Two cases occurred during current use of ranitidine: one of acute renal failure and one of nephrotic syndrome. No case was encountered during treatment with cimetidine, famotidine, nizatidine or omeprazole. The incidence of idiopathic renal disease in the general population was 1 per 100,000 person-years. The relative risk associated with use of acid-suppressing drugs was 1.8 (95% CI, 0.3-10.7) compared to non-use. These results do not suggest a major increased risk for acute renal injury and/or nephrotic syndrome associated with use of anti-ulcer drugs.

Journal Article↗

Geographical variation in adverse event reporting rates in clinical trials.

A group of 13,698 patients from 127 gastro-intestinal clinical trials, conducted in 13 countries was included in the analyses. All adverse events reported were included in the evaluation. The general adverse event reporting rate, the mean number of adverse events reported, the serious adverse event reporting rate and the mean number of serious adverse events reported were calculated for each country. In addition, the pattern of adverse events reported in each country was studied. The general adverse event reporting rate varied between 17% and 68% with a mean of 47% and the serious adverse event reporting rate varied between 1% and 20% with a mean of 8%. The mean number of adverse events, reported by patients reporting adverse events, varied between 1.5 and 2.7 with a mean of 2.1 and the mean number of serious adverse events, reported by patients reporting serious adverse events, varied between 1.1 and 1.7 with a mean of 1.4. In addition to these differences, patients/investigators had a tendency to put emphasis on different kinds of adverse events in different countries.

Journal Article↗

The risk of acute liver injury associated with cimetidine and other acid-suppressing anti-ulcer drugs.

AIMS: The objective of this study was to estimate the risk of acute liver injury associated with individual acid-suppressing drugs and assess the role of dose and duration of treatment. METHODS: We used a nested case-control study design within a cohort of over 100,000 users of cimetidine, famotidine, omeprazole and ranitidine. The primary source of information was the General Practitioners Research Database. We identified 108,981 persons aged 20-74 years who received at least one prescription for cimetidine, famotidine, omeprazole, or ranitidine during 1990-93, and we ascertained the first occurrence of clinically acute liver injury referred to a specialist or admitted to a hospital. RESULTS: After review of medical records, 33 patients were considered eligible cases of idiopathic acute liver injury with no fatal cases. The type of liver injury was hepatocellular in almost half of the cases, and 80% of all cases presented with jaundice. Twelve cases occurred among current users of cimetidine, five among ranitidine users and one in an omeprazole user. The absolute risk of acute liver injury associated with cimetidine was estimated to be slightly greater than one per 5000 users of cimetidine. The adjusted relative risk (RRs) and 95% CI of developing acute liver injury associated with current use of cimetidine compared to non-use was 5.5 (1.9-15.9), with omeprazole 2.1 (0.2-19.2) and with ranitidine 1.7 (0.5-5.8). In the absence of concomitant use of other hepatotoxic drugs, the RR with cimetidine was 14.4 (2.9-73.7). Among users of cimetidine, the risk was especially high in the first 2 months of starting therapy (RR: 11.3, 3.7-35.1) and at daily doses of 800 mg or greater (RR: 8.8, 3.0-26.0). CONCLUSIONS: Cimetidine was the individual anti-ulcer drug with the highest risk of developing symptomatic acute liver disease. Further data are required to confirm this finding. Our study indicates that there is a dose relationship and a short latent period between cimetidine treatment and acute liver injury.

Adult↗

A cohort study of the ocular safety of anti-ulcer drugs.

1. Recently, some cases have been reported where intravenous use of omeprazole was followed by loss of vision. We followed up a cohort of close to 140,000 persons during periods of treatment and non-treatment with five anti-ulcer drugs. 2. The relative risk of vascular disorders of the eye during use of omeprazole compared with non-use was 1.8 (95% CI 0.5-6.0). Use of other anti-ulcer drugs was associated with a similar risk of vascular disorders. The relative risk associated with current use of any anti-ulcer drug was 1.9 (95% CI 1.1-3.4). We did not find a single case of optic inflammatory disorder during treatment with any of the five anti-ulcer drugs. 3. These results do not suggest a major increased risk for vascular or inflammatory disorders of the eye associated with use of omeprazole or other anti-ulcer drugs.

Adult↗