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  • 1
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 49 (1995), S. 73-79 
    ISSN: 1432-1041
    Keywords: Postmarketing surveillance ; Ramipril ; Hypertension
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract A prospective observational cohort study of the angiotensin inhibitor, ramipril, was undertaken in four countries within the European Community-Netherlands, United Kingdom, Germany and Belgium. A total of 10,377 consecutive patients with essential hypertension were recruited to the study with the aim of follow-up for one year. Overall 37% of doctors who agreed to participate in the study actually enrolled at least one patient. One third of the doctors who enrolled patients in the study entered two thirds of patients studied. Some 15% of participating males and 27% of females were aged over 70 years. Newly diagnosed hypertensives comprised 22% of the study cohort, the proportion being highest in UK and Netherlands, whereas 53% were established hypertensives of two or more years' duration, the proportion being highest in Germany and Belgium. There were substantial differences among the participating countries in the concurrent treatment these patients were receiving for hypertension, with two or more co-therapies being most frequent in Germany and Belgium. There were also substantial differences in co-therapies for concurrent diseases among the participating countries, reflecting both standard therapeutic practices in local areas and differences in marketing of drugs in the different countries. This report describes the initial findings of this multinational study and emphasises the need to consider several major potentially confounding variables in the analysis of the outcome events both in this study and in other collaborative observational international monitoring schemes for adverse drug reactions.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1573-739X
    Keywords: Family practice ; Nabumetone ; Osteoarthritis ; Piroxicam ; Randomized controlled trials ; Side effects
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract To study nabumetone (1,000 mg once daily) by comparison with piroxicam (20 mg once daily) in patients with osteoarthritis, a randomized, double-blind trial was set up in 40 general practices. Evaluation was based on clinical outcome in 198 patients. There was some evidence that nabumetone is associated with a lower and less severe occurrence of gastric pain, and with more withdrawals due to lack of efficacy. Although the differences between nabumetone and piroxicam were small in this study, these were clinically relevant. The general practitioner should balance the respective benefits of greater safety and tolerance against greater efficacy in meeting the requirements of an individual patient with osteoarthritis.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1573-739X
    Keywords: Nabumetone ; Piroxicam ; osteoarthritis ; Randomized controlled trials ; Sickness Impact Profile ; Activities of daily living
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract There is some evidence that nabumetone (1000 mg once daily) in comparison with piroxicam (20 mg once daily) in patients with OA in general practice is associated with a lower incidence and less severe occurrence of stomach pain but with more withdrawals due to lack of efficacy. The aim of this analysis was to investigate whether these differences are reflected in health-related quality of life assessments. Patients (n=198) included in this study were selected in general practice according to a protocol. The patients were randomized and treated for a period of six weeks. Clinical assessments were performed by the general practitioner (GP) during treatment. The Sickness Impact Profile (SIP), the Activities of Daily Living (ADL), and a pain questionnaire were filled out by the patients before and after treatment. As measured with the SIP, the ADL and the pain questionnaire, there were no significant differences between nabumetone and piroxicam. The comelations between (changes in) patient assessments and (changes in) clinical assessments were low. The differences between the two drugs regarding withdrawals and adverse events were not reflected by patient health-related quality of life assessments. There was a low correlation between patient health-related quality of life assessment and clinical assessments. To get a complete picture of the efficacy and safety of a drug, patient health-related quality of life assessments should be a part of a clinical trial.
    Type of Medium: Electronic Resource
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