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OBJECTIVES: To estimate the risk of a first hospital admission for heart failure (HF) associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: Cohort study with a nested case-control analysis based on the UK General Practice Research Database. Overall, 1396 cases of first hospital admission for non-fatal HF were identified (January 1997 to December 2000) and compared with a random sample of 5000 controls. RESULTS: The incidence rate was 2.7/1000 person years. Prior clinical diagnosis of HF was the main independent risk factor triggering a first HF hospitalisation (relative risk 7.3, 95% confidence interval (CI) 6.1 to 8.8). The risk of a first hospital admission for HF associated with current use of NSAIDs was 1.3 (95% CI 1.1 to 1.6) after controlling for major confounding factors. No effects of dose and duration were found. The relative risk in current users of NSAIDs with prior HF was 8.6 (95% CI 5.3 to 13.8) compared with patients who did not use NSAIDs and without prior clinical diagnosis of HF. CONCLUSION: Use of NSAIDs was associated with a small increase in risk of a first hospitalisation for HF. In patients with prior clinical diagnosis of HF, the use of NSAIDs may lead to worsening of pre-existing HF that triggers their hospital admission. This increased risk, although small, may result in considerable public health impact, particularly among the elderly.

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OBJECTIVE: To study the incidence and mortality of coronary heart disease (CHD) and all-cause mortality in a cohort of men followed during 28 years, and their association with serum cholesterol, systolic blood pressure, glycemia, cigarette smoking and body mass index measured at baseline. RESEARCH DESIGN AND METHODS: A cohort of 1,059 men aged 30 to 59 years and free of cardiovascular diseases at baseline in 1968, was examined every five years until 1988. The last examination was performed in 1996. Information was collected in 96.4% of the participants. RESULTS: Incidence and mortality rates from CHD and from all-causes of death per 105 person-years of observation were 499.80, 235.80 and 925.33, respectively. At the end of follow-up, high levels of serum cholesterol and smoking were independently associated with the incidence and mortality from CHD adjusted for age, blood pressure, glycemia and BMI. Serum cholesterol, hyperglycemia and smoking were independently associated with all-cause mortality. CONCLUSIONS: In this industrial cohort of men, with a relatively low incidence of CHD, smoking and serum cholesterol at baseline were independently associated with the incidence of CHD over 28 years of observation.

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BACKGROUND: Epidemiological studies suggest a decreased risk of coronary heart disease (CHD) in healthy women taking hormonal replacement therapy (HRT). Whether this effect is shared by oral and transdermal preparations is unknown. METHODS AND RESULTS: We conducted a population-based case-control study nested in a cohort of women 50 to 74 years of age without cardiovascular disease history in the United Kingdom. Among 164 769 women from the General Practice Research Database (January 1, 1991, to December 31, 1995), we identified 1242 first acute myocardial infarctions (AMI) and confirmed 1013 after medical record review. We randomly selected 5000 age-frequency-matched control subjects. AMI incidence was 1.6 per 1000 person-years; 13% and 17% of cases and control subjects used HRT within 6 months before the index date. Risk factor and comorbidity-adjusted OR of AMI for current-recent HRT users compared with nonusers was 0.72 (95% CI 0.59 to 0.89). The OR was similar within 30 days before the index date. The beneficial effect was present after 1 year of use (OR 0. 68; 95% CI 0.53 to 0.86), with no increase in risk within the first year. ORs for unopposed and opposed therapy were 0.52 (95% CI 0.35 to 0.78) and 0.79 (95% CI 0. 59 to 1.08); 79% and 21% used oral and transdermal therapy. The protective effect was present at medium-high doses of estrogens with ORs for oral and transdermal therapy of 0.63 (95% CI 0.46 to 0.86) and 0.62 (95% CI 0.37 to 1.06) and ceased after 2 to 3 years since stopping HRT. CONCLUSIONS: Results are consistent with those previously reported in women without CHD who were taking oral HRT and, although based on few users, suggest that transdermal therapy might have similar cardioprotective effects.

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The risk of a newly diagnosed episode of upper gastrointestinal bleeding, acute liver and renal failure, agranulocytosis, aplastic anemia, severe skin disorders, and anaphylaxis was examined within 30 days after the first prescription for a low dose of diclofenac, naproxen, or ibuprofen in a cohort in the United Kingdom. We identified 22,146 persons using diclofenac (< or = 75 mg), 46,919 using naproxen (< or = 750 mg), and 54,830 using ibuprofen (< or = 1200 mg). Age, gender, and comorbidity were similar in the three cohorts. Overall 64 potential cases were identified, and 20 were confirmed by medical record review. Incidence rates (95% CI) of upper gastrointestinal bleeding/10,000 people using diclofenac, naproxen, and ibuprofen were 1.8 (0.5-4.6), 2.3 (1.2-4.2), and 0.4 (0.04-1.3), respectively. There were three cases of hepatic injury, one with naproxen and two with ibuprofen. Although low, the incidence of gastrointestinal toxicity remains the main serious adverse event for all study drugs.

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Sequential angiographic follow-up is needed for interpreting coronary events that occur after successful percutaneous translumial coronary angioplasty (PTCA). One hundred eight consecutive patients who had undergone successful dilatation were followed for 10 years, and quantitative sequential angiograms were recorded at 6 months (n = 101) and 10 years (n = 68). The 10-year event rate was: 5.8 +/- 2.4% for cardiac death, 9.7 +/- 3.3% for Q-wave acute myocardial infarction, 18.3 +/- 4.5% for additional surgery, and 22.4 +/- 4.9% for repeated angioplasty. Using Cox's proportional-hazards regression, multivessel coronary artery disease (CAD) (RR 5.6; 95% confidence intervals [CI] 1.2 to 24.7; p = 0.02), restenosis within 6 months (RR 7.8; 95% CI 3.1 to 20.0; p = 0.0001), and CAD progression over 10 years (RR 10.6; 95% CI 1.3 to 87.1; p = 0.004) were the strongest predictors of all-cause death, repeated PTCA, and additional surgery, respectively, after controlling for age and coronary risk factors. The minimal luminal diameter of 48 narrowings with complete sequential angiographic follow-up and without restenosis remained stable from 6 months (2.13 +/- 0.60 mm) to 10 years (2.18 +/- 0.61 mm). Disease progression was similar in nondilated arteries and dilated arteries (32% vs 30%). The 10-year risk of coronary events was higher in patients with baseline multivessel CAD than in those with 1-vessel CAD because of more frequent progression of CAD (RR 3.8; 95% CI 1.6 to 6.8; p = 0.001). Thus, early cardiac events after successful PTCA were related to restenosis, and late events to CAD progression. Nevertheless, after the restenosis period, the target lesion remained stable for the next 10 years. Coronary disease progression was not related to the angioplasty procedure.

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The authors evaluated the risk of venous thromboembolism associated with hormone replacement therapy in a cohort of 265,431 women aged 45-79 years who did not have major risk factors for venous thromboembolism. Through review of hospital charts, 171 cases were confirmed (pulmonary embolism = 77; deep venous thrombosis = 94). Ten thousand controls were randomly sampled. The risk of venous thromboembolism among nonusers of hormone replacement therapy was 1.3 per 10,000 women per year. Current users of hormone replacement therapy had 2.3 times higher risk of venous thromboembolism (95 percent confidence interval 1.0-5.3) compared with nonusers. The increased risk was restricted to the first year of treatment.

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Epidemiology has been defined as "the study of the distribution and determinants of disease frequency in human populations". Therefore, epidemiology has developed study design strategies to provide different approaches to research etiology and causal inference. Among the analytic observational studies, prospective cohort designs are mainly used to test epidemiologic hypotheses. This paper describes the basic concepts of the design, conduct, analysis, and interpretation of these studies, we have emphasized the unique strengths and limitations of the cohort study design that must be taken into account.

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The association between coronary risk factors measured at entry and 20-year coronary heart disease (CHD) incidence and mortality was studied in an industrial cohort of 1059 men aged 30 to 59 years and free of CHD in 1968, in Spain. Myocardial infarction and fatal CHD cases were diagnosed according to recognized criteria. Mean serum cholesterol was 223.3 mg.dl-1 and 67% of men were current smokers. Rates of CHD incidence, CHD mortality and all-causes mortality, per 10(5) persons-year of observation, were 476, 194 and 617, respectively. Age, serum cholesterol, plasma glucose, cigarettes smoked and systolic blood pressure (SBP) contributed to the risk of CHD incidence. The first four variables predicted CHD death risk. All-causes death risk was positively associated with age, plasma glucose and SBP levels. Results are consistent with prior reported low CHD mortality and morbidity rates in the Mediterranean area, and confirm the importance of coronary risk factors in this low-risk population.

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