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  • 1
    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.
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  • 2
    ISSN: 1432-1041
    Keywords: Key words Sumatriptan ; Postmarketing surveillance ; Migraine; overuse ; pharmacoepidemiology
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: To investigate the frequency of use and misuse of sumatriptan, and to explore the characteristics of patients reporting overuse. Setting: A postmarketing cohort study on adverse reactions to sumatriptan, performed with the assistance of drug-dispensing general practitioners in the Netherlands. Methods: Questionnaires were sent to patients on sumatriptan of drug-dispensing general practitioners in the Netherlands. Use of sumatriptan was classified into five groups: 〈 1, 1–10, 11–20 and 21–30 times per month and a group of patients who reported daily use of sumatriptan more than 10 times per week. Patients in the latter group were regarded as “overusers”. Results: The request to the 1720 patients yielded a response rate of 1202 (70%). Of 952 (79%) of these patients, details of their sumatriptan intake were available. Most patients (718, 75%) took sumatriptan 1–10 times each month. However, 36 patients (4%, 95% CI 2.8–5.2%) took sumatriptan daily or more than 10 times each week. The group with the highest intake consisted mainly of males, and many patients who reported a poor efficacy of sumatriptan. Age was not related to use of sumatriptan. Conclusions: A small group of patients (4%) used sumatriptan too often. A high intake was associated with both male gender and a reported poor efficacy of sumatriptan, but not with age, reported adverse reactions, or headache attributed to sumatriptan. It is important to explain to patients that sumatriptan is only for the treatment of acute attacks, and not for prophylactic use. Drug consumption patterns have to be evaluated, in particular in patients who report low efficacy of sumatriptan.
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  • 3
    ISSN: 1432-1041
    Keywords: Sumatriptan ; Migraine ; pharmacoepidemiology ; adverse reaction ; angina pectoris ; postmarketing surveillance ; general practitioner
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract There are several reports on cardiac adverse reactions attributed to the antimigraine drug sumatriptan in the recent literature. In order to assess the frequency and the character of adverse reactions to sumatriptan, a postmarketing cohort study was performed one year after registration of the drug in The Netherlands. With assistance of 86% of the drug dispensing general practitioners in The Netherlands, 1727 patients who had received sumatriptan were traced in July, 1992. Via their general practitioners, a questionnaire about use of sumatriptan, adverse reactions and other medication was sent to the patients in December 1992. During the study period, seven patients were lost to follow-up. Of the 1720 remaining patients, 1202 (70%) responded to the questionnaire, of whom 1187 had actually used sumatriptan. The most frequently reported suspected adverse reactions were paraesthesiae (139 patients, 95% CI 9.9%–13.5%) and dizziness (96 patients, 95% CI 6.5%–9.7%). Chest pain after use of sumatriptan was reported by 94 patients (7.9%, 95% CI 6.4%–9.4%), and according to the close temporal relationship with the intake of sumatriptan and a positive rechallenge, a causal relationship was probable in most of those patients. The frequency of chest pain attributed to sumatriptan was higher in females (9.0% vs 4.6%; relative risk 1.9, 95% CI 1.1–3.4). Age and hypertension were not associated with chest pain attributed to sumatriptan. Dyspnoea attributed to sumatriptan was reported by 26 patients (2.2%), and was associated with obstructive lung disease (relative risk 5.4 95% CI 1.7–16.9). Thus, in view of the high frequency of chest pain after use of sumatriptan and reports in the literature of cardiac disturbances, including myocardial infarction, cautious use of the drug is advised.
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  • 4
    ISSN: 1432-0428
    Keywords: Keywords Type II diabetes ; diabetes ; genetics ; sulphonylurea receptor ; prevalence.
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Aims/hypothesis. We have analysed to what extent two previously reported single nucleotide polymorphisms in the sulphonylurea receptor gene (SUR1) are associated with Type II (non-insulin-dependent) diabetes mellitus in The Netherlands. Furthermore, we estimated haplotype frequencies in control and diabetic populations, including data extracted from three other studies. Methods. Subjects with Type II diabetes (n = 388) and normoglycaemic subjects (n = 336) were randomly selected from two population-based studies, the Hoorn and Rotterdam studies. DNA was typed for variants in exon 16 (-3c→t variant in the splice acceptor site) and exon 18 (Thr759Thr, ACC→ACT). Results. The genotype frequencies in both populations were similar. We observed an association of the exon 16–3t variant with Type II diabetes (allele frequencies 0.41 % vs 0.48 % in NGT and Type II diabetes, respectively, p = 0.01). There was no association between Type II diabetes and the variant in exon 18 or the combination of both variants (p 〉 0.5). A strong linkage disequilibrium between the exon 16 and exon 18 variants was observed in the diabetic groups but not, or less pronounced, in the control groups from the different studies. Haplotype estimation shows that several different risk haplotypes exist in different Caucasian populations. Conclusion/interpretation. The exon 16–3t allele of the SUR1 gene is associated with Type II diabetes in the Netherlands. Based on estimated haplotype frequencies in different Caucasian populations we conclude that multiple haplotypes on the SUR1 gene seem to confer a risk for developing Type II diabetes in Caucasians. [Diabetologia (1999) 42: 617–620]
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  • 5
    ISSN: 1432-0428
    Keywords: Keywords Insulin resistance ; arterial stiffness ; healthy subjects ; women ; population.
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Aims/hypothesis. The insulin resistance syndrome is related to arterial stiffness in diabetic subjects. Whether the insulin resistance syndrome is also related to arterial stiffness in non-diabetic subjects is less clear. We studied the association between variables of the insulin resistance syndrome in relation to arterial distensibility in healthy middle-aged non-diabetic women. Methods. This study was done in 180 non-diabetic women, aged 43–55, selected from the general population. Arterial distensibility was assessed in the carotid artery. The associations were evaluated using linear regression analyses. Results. Strong associations were found between arterial distensibility and the variables of the insulin resistance syndrome: body mass index, waist-to-hip ratio, high-density-lipoprotein-cholesterol, triglycerides, glucose, insulin, apolipoprotein A1, plasminogen activator inhibitor-1-antigen and tissue-type plasminogen activator-antigen. After additional adjustment for mean arterial pressure, common carotid arterial distensibility remained associated with body mass index: β-coefficient (95 % confidence interval) per kg/m2: –0.24 (–0.42; –0.06); waist-to-hip ratio: –26.62 (–40.59; –12.65) per m/m; triglycerides: –1.42(–2.77; –0.08) per mmol/l; plasminogen activator inhibitor–1-antigen: –0.01 (–0.02; –0.00) per ng/ml and borderline significant associated with high-density-lipoprotein-cholesterol: 1.93 (–0.01; 3.87; p = 0.07) per mmol/l. Clustering of variables of the insulin resistance syndrome was strongly related to decreased arterial distensibility which remained after adjustment for mean arterial pressure. No association was found between arterial distensibility and variables that are not part of the insulin resistance syndrome: total cholesterol, LDL-cholesterol and apolipoprotein B. Conclusion/interpretation. The results of this study show that variables of the insulin resistance syndrome are associated with decreased arterial distensibility of the common carotid artery in healthy non-diabetic subjects. [Diabetologia (2000) 43: 665–672]
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  • 6
    ISSN: 1432-0428
    Keywords: Keywords Diabetes mellitus ; insulin treatment ; dementia ; Alzheimer's disease ; vascular dementia ; aged ; epidemiology.
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Dementia and non-insulin-dependent diabetes mellitus (NIDDM) are highly prevalent disorders in the elderly. Diabetes has repeatedly been reported to affect cognition, but its relation with dementia is uncertain. We therefore studied the association between diabetes and dementia in the Rotterdam Study, a large population-based study in the elderly. Of 6330 participants, aged 55 to 99 years old, complete information on diabetes and presence of dementia was available. Diabetes was diagnosed as use of anti-diabetes medication or random or post-load serum glucose over 11 mmol/l. Dementia was diagnosed through a stepped approach, including a sensitive screening of all participants and a comprehensive diagnostic work-up. Diabetes was present in 724 (11.4 %) subjects. Of the 265 dementia patients 59 (22.3 %) had diabetes. Multiple logistic regression analyses, adjusting for age and sex differences, revealed a positive association between diabetes and dementia (odds ratio: 1.3, 95 % confidence interval: 1.0–1.9). In particular, strong associations were found between dementia and diabetes treated with insulin (odds ratio: 3.2, 95 % confidence interval: 1.4–7.5). The relation was strongest with vascular dementia, but was also observed with Alzheimer's disease. These associations were independent of educational attainment, smoking, body mass index, atherosclerosis, blood pressure and antihypertensive drug treatment, and could not be explained by clinical cerebral infarctions. The results suggest that NIDDM is associated with dementia. Alzheimer's disease may be more frequent in elderly diabetic patients treated with insulin. [Diabetologia (1996) 39: 1392–1397]
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  • 7
    ISSN: 1432-0827
    Keywords: Key words: Vitamin K – Gammacarboxyglutamate — Osteocalcin — Calcification — Atherosclerosis — Bone mass.
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine , Physics
    Notes: Abstract. Gammacarboxyglutamate (Gla) is an uncommon amino acid formed by vitamin K action. Increasing evidence indicates that Gla-proteins are involved in the regulation of calcification processes in both bone tissue and atherosclerotic vessel wall. In a population-based study we have previously shown that in a group of 113 postmenopausal women the presence of abdominal aortic calcifications is associated with a reduced vitamin K status. In the present study we investigated whether this reduced vitamin K status was also associated with differences in bone mass or circulating calciotropic hormone levels. Serum immunoreactive osteocalcin with low affinity for hydroxyapatite (irOCfree) was used as a marker for vitamin K status. After correction for age it was found that women with atherosclerotic calcifications had a 7% lower bone mass as measured by metacarpal radiogrammetry (mean difference: 3.2 mm2, 95% CI: −0.2–6.5, P= 0.06). No differences between both groups of women were observed for serum intact parathyroid hormone (PTH) and serum 25-hydroxyvitamin D levels. In the atherosclerotic women (n = 34), markers for vitamin K status were inversely associated with bone mass (r =−0.47, P= 0.013), whereas no such association was found in the nonatherosclerotic women (n = 79). It is concluded that the atherosclerotic women in this study may be at higher risk for osteoporotic fractures as evidenced by their lower bone mass and higher serum irOCfree levels. The finding that in atherosclerotic women vitamin K status is associated with bone mass supports our hypothesis that vitamin K status affects the mineralization processes in both bone and in atherosclerotic plaques.
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  • 8
    ISSN: 1433-2965
    Keywords: Broadband ultrasound attenuation (BUA) ; Epidemiology ; Longitudinal ; Osteoporosis ; Speed of sound (SOS) ; Stiffness ; Ultrasound
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract We examined with a median follow-up of 1.4 years (range 1.0–2.0 years) the rates of change per year in ultrasound parameters of the calcaneus. Speed of sound (SOS), Broadband ultrasound attenuation (BUA) and Stiffness were measured twice in 543 subjects (224 men) participating in the Rotterdam Study. SOS fell by −2.5 m/s per year in both sexes (95% CI −4.0 to −1.1 m/s per year in men and −3.6 to −1.4 m/s per year in women). Stiffness decreased by −0.62 (−1.33 to 0.09) per year in men and −0.66 (−1.24 to −0.08) per year in women. In men the rate of change in SOS and Stiffness tended to increase with age. BUA did not change significantly during follow-up in either sex. The prospectively assessed rates of loss differed considerably from those observed cross-sectionally, especially for SOS in men (cross-sectional −0.7 m/s per year, longitudinal −2.5 m/s per year). There was substantial variation between individuals both in changes per year in SOS and in changes per year in BUA. With a median follow-up time of 1.4 years, approximately 27% of the variation in the rate of change for SOS could be explained by measurement error while for BUA this was approximately 9% and for Stiffness 11%. Only a small percentage of subjects had changes larger than could be accounted for by measurement error (SOS: men 26.8%, women 21.6%; BUA: men 28.5%, women: 38.8%; Stiffness: men 32.6%, women 35.1%). The latter may limit the use of ultrasound measurements as a follow-up tool in individuals rather than in populations.
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  • 9
    ISSN: 1619-7089
    Keywords: Vascular risk factors ; Atherosclerosis ; Cerebral white matter lesions ; Cerebral blood flow ; Elderly population
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract We studied risk factors for cerebral vascular disease (blood pressure and hypertension, factor VIIc, factor VIIIc, fibrinogen), indicators of atherosclerosis (intima-media thickness and plaques in the carotid artery) and cerebral white matter lesions in relation to regional cerebral blood flow (rCBF) in 60 persons (aged 65–85 years) recruited from a population-based study. rCBF was assessed with single-photon emission tomography using technetium-99md,l-hexamethylpropylene amine oxime (99mTc-HMPAO). Statistical analysis was performed with multiple linear regression with adjustment for age, sex and ventricle-to-brain ratio. A significant positive association was found between systolic and diastolic blood pressure and temporo-parietal rCBF. In analysis with quartiles of the distribution, we found a threshold effect for the relation of low diastolic blood pressure (≤60 mmHg) and low temporo-parietal rCBF. Levels of plasma fibrinogen were inversely related to parietal rCBF, with a threshold effect of high fibrinogen levels (〉3.2 g/1) and low rCBF. Increased atherosclerosis was related to low rCBF in all cortical regions, but these associations were not significant. No consistent relation was observed between severity of cerebral white matter lesions and rCBF. Our results may have implications for blood pressure control in the elderly population.
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  • 10
    ISSN: 1749-6632
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Natural Sciences in General
    Type of Medium: Electronic Resource
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