Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting : the clopidogrel aspirin stent international cooperative study (CLASSICS).
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BACKGROUND: Combination therapy with the ADP receptor antagonist ticlopidine plus aspirin has emerged as standard care after coronary stenting. Clopidogrel, a new ADP receptor antagonist, has greater molar potency than ticlopidine and better safety/tolerability. METHODS AND RESULTS: Patients (n=1020) were randomized after successful stent placement and initiated on a 28-day regimen of either (1) 300-mg clopidogrel loading dose and 325 mg/d aspirin on day 1, followed by 75 mg/d clopidogrel and 325 mg/d aspirin; (2) 75 mg/d clopidogrel and 325 mg/d aspirin; or (3) 250 mg BID ticlopidine and 325 mg/d aspirin. The primary end point consisted of major peripheral or bleeding complications, neutropenia, thrombocytopenia, or early discontinuation of study drug as the result of a noncardiac adverse event during the study-drug treatment period. The primary end point occurred in 9.1% of patients (n=31) in the ticlopidine group and 4.6% of patients (n=31) in the combined clopidogrel group (relative risk 0.50; 95% CI 0.31 to 0.81; P=0.005). Overall rates of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization) were low and comparable between treatment groups (0.9% with ticlopidine, 1.5% with 75 mg/d clopidogrel, 1.2% with the clopidogrel loading dose; P=NS for all comparisons). CONCLUSIONS: The safety/tolerability of clopidogrel (plus aspirin) is superior to that of ticlopidine (plus aspirin) (P=0.005). The 300-mg loading dose was well tolerated, notably with no increased risk of bleeding. Secondary end point data are consistent with the hypothesis that clopidogrel and ticlopidine have comparable efficacy with regard to cardiac events after successful stenting. (+info)
The National Institutes of Health agenda for international research in micronutrient nutrition and infection interactions.
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Nutrition is a central public health concern in the twenty-first century. Previous international research in nutrition was primarily descriptive epidemiology and included large-scale intervention trials. There has been insufficient attention to the mechanisms by which nutrient supplements appear to reduce mortality and little specificity in application and delineation of the forms of a specific nutrient to maximize benefits and minimize adverse affects and on the effect of nutrient combinations. After the dramatic success of the green revolution, agricultural research support was reduced despite an expanding world population and an increasing need for agricultural products. The potential of molecular genetics to improve food quality, specific nutrient content, and yield and disease resistance has just begun to be explored. In addition, the development of edible vaccines as a way to immunize a greater proportion of the world's children is a highly desirable goal and is achievable with sufficient resources. (+info)
The interaction between research and practice: a pan-European approach to managing H.pylori infection in primary care.
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The transposition of evidence into clinical care presents many challenges. New knowledge may be immediately translatable to the practice setting, with barriers to be overcome before implementation. The early guidelines on Helicobacter pylori management presented an overview but were not able to take into account local factors and health care traditions, such as the non-availability of tests and established primary-secondary care relationships. Primary care is a specific specialty across most of Europe, existing within different health care systems and clinical traditions. The creation of H. pylori management guidelines, aimed at European primary care but adaptable to local national circumstances, presented a challenge in methodology and formulation. The process exposed similarities but also tensions between differing health care systems, as well as variations in the conditions in which GPs practise. Clinical differences, such as varying ulcer prevalence and drug resistance rates, highlighted the importance of guidelines being adaptable. This paper analyses the European Society for Primary Care Gastroenterology process of pan-European primary care agreement towards H.pylori management and how diverse views, traditions and national settings were reconciled through an evidence-based approach. (+info)
Impact of diabetes on long-term prognosis in patients with unstable angina and non-Q-wave myocardial infarction: results of the OASIS (Organization to Assess Strategies for Ischemic Syndromes) Registry.
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BACKGROUND: Although unstable coronary artery disease is the most common reason for admission to a coronary care unit, the long-term prognosis of patients with this diagnosis is unknown. This is particularly true for patients with diabetes mellitus, who are known to have a high morbidity and mortality after an acute myocardial infarction. METHODS AND RESULTS: Prospectively collected data from 6 different countries in the Organization to Assess Strategies for Ischemic Syndromes (OASIS) registry were analyzed to determine the 2-year prognosis of diabetic and nondiabetic patients who were hospitalized with unstable angina or non-Q-wave myocardial infarction. Overall, 1718 of 8013 registry patients (21%) had diabetes. Diabetic patients had a higher rate of coronary bypass surgery than nondiabetic patients (23% versus 20%, P:<0.001) but had similar rates of catheterization and angioplasty. Diabetes independently predicted mortality (relative risk [RR], 1.57; 95% CI, 1.38 to 1.81; P:<0.001), as well as cardiovascular death, new myocardial infarction, stroke, and new congestive heart failure. Moreover, compared with their nondiabetic counterparts, women had a significantly higher risk than men (RR, 1.98; 95% CI, 1.60 to 2.44; and RR, 1.28; 95% CI, 1.06 to 1.56, respectively). Interestingly, diabetic patients without prior cardiovascular disease had the same event rates for all outcomes as nondiabetic patients with previous vascular disease. CONCLUSIONS: Hospitalization for unstable angina or non-Q-wave myocardial infarction predicts a high 2-year morbidity and mortality; this is especially evident for patients with diabetes. Diabetic patients with no previous cardiovascular disease have the same long-term morbidity and mortality as nondiabetic patients with established cardiovascular disease after hospitalization for unstable coronary artery disease. (+info)
Standardization of antituberculosis drug resistance surveillance in Europe. Recommendations of a World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) Working Group.
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Surveillance of antituberculosis drug resistance is an essential tool for evaluating the quality of tuberculosis control programmes. Consensus-based recommendations on uniform reporting of antituberculosis drug resistance surveillance data in Europe have been developed by a Working Group of the World Health Organization (WHO) and the International Union Against Tuberculosis and Lung Disease (IUATLD). Laboratories should use standardized methods for testing drug susceptibility with a quality assurance programme including national and international proficiency testing. The proportion of drug resistance, particularly resistance to isoniazid, rifampicin or both (multidrug resistance) among all definite, i.e. culture-positive, tuberculosis cases at the start of treatment is the major indicator of interest. It should be calculated separately among patients treated previously and among those who have never been treated with > or = 1 month of combined antituberculosis drugs. The Working Group recommends that, in countries in which resources allow, laboratories report drug susceptibility test results on all isolates of the Mycobacterium tuberculosis complex. Test results of the specimen at the start of treatment and clinical data from the notification should be linked using a suitable identifier. Results should be presented by calendar year and analysed by age, sex, place of birth, site of disease and sputum smear results. In countries in which a routine system cannot be organized, representative surveys or sentinel systems are possible alternatives. In some countries, the annual prevalence of multidrug-resistant tuberculosis may be estimated through a national laboratory reporting system. (+info)
Eyes on the prize: transnational tobacco companies in China 1976-1997.
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Internal tobacco industry documents relevant to China as published on www.tobaccoarchives.com located between 31 May and 1 August 1999 were searched. Documents describing the ambitions and conduct of transnational tobacco companies (TTCs) in China between 1976 and 1997 were located and reviewed in three sections: part A-early identification of market potential and attempts to enter the market, and improve trade and technology; part B-marketing and promotion efforts; part C-efforts to pre-empt legislation, control the smoking and health debate, and undermine the anti-tobacco lobby. (+info)
International Quit and Win 1996: comparative evaluation study in China and Finland.
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OBJECTIVES: To compare background and process variables, as well as follow up status, of the participants in the International Quit and Win '96 contests of China and Finland, and analyse factors contributing to sustained maintenance. DESIGN: A standardised 12 month follow up was conducted in both countries with random samples of participants. The sample sizes were 3119 in China and 1448 in Finland, with response rates of 91.2% and 65.2%, respectively. INTERVENTIONS: The International Quit and Win '96 contest was the second coordinated, multinational smoking cessation campaign targeted at adult daily smokers. Altogether 25 countries participated, including China with 15 000 and Finland with 6000 smokers registered. MAIN OUTCOME MEASURES: Conservative (considering all non-respondents relapsed) and non-conservative (based on respondents only) estimates were calculated for one month abstinence, 12 month continuous abstinence, and point abstinence at the time point of follow up. RESULTS: Great differences were found in the background and process variables, as well as in the outcome measures. At one year follow up, the conservative continuous abstinence rates show that the Chinese participants maintained their abstinence better (38%) compared to the Finnish ones (12%). In China women reached higher abstinence rate (50%) than men (36%), whereas in Finland men achieved a better result (14%) than women (9%). CONCLUSIONS: The Quit and Win contest is a mass smoking cessation method feasible in countries showing great variance in smoking habits and rates. However, in countries with different stages of anti-smoking development, such as China and Finland, different practical implementation strategies may be needed. (+info)
Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction.
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Definition of MI. Criteria for acute, evolving or recent MI. Either one of the following criteria satisfies the diagnosis for an acute, evolving or recent MI: 1) Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following: a) ischemic symptoms; b) development of pathologic Qwaves on the ECG; c) ECG changes indicative of ischemia (ST segment elevation or depression); or d) coronary artery intervention (e.g., coronary angioplasty). 2) Pathologic findings of an acute MI. Criteria for established MI. Any one of the following criteria satisfies the diagnosis for established MI: 1) Development of new pathologic Q waves on serial ECGs. The patient may or may not remember previous symptoms. Biochemical markers of myocardial necrosis may have normalized, depending on the length of time that has passed since the infarct developed. 2) Pathologic findings of a healed or healing MI. (+info)