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Edeltraut Garbe

Publications and source records attributed to Edeltraut Garbe.

11 recordsLinked to original sources
PubMed2007

Dopamine agonists and the risk of cardiac-valve regurgitation.

BACKGROUND: Case reports and echocardiographic studies suggest that the ergot-derived dopamine agonists pergolide and cabergoline, used in the treatment of Parkinson's disease and the restless legs syndrome, may increase the risk of cardiac-valve regurgitation. METHODS: We used data from the United Kingdom General Practice Research Database to identify a population-based cohort comprising 11,417 subjects 40 to 80 years of age who were prescribed antiparkinsonian drugs between 1988 and 2005. We conducted a nested case-control analysis within this cohort in which each patient with newly diagnosed cardiac-valve regurgitation was matched with up to 25 control subjects from the cohort, according to age, sex, and year of entry into the cohort. Incidence-rate ratios for cardiac-valve regurgitation with the use of different dopamine agonists were estimated by conditional logistic-regression analysis. RESULTS: Of 31 case patients with newly diagnosed cardiac-valve regurgitation, 6 were currently exposed to pergolide, 6 were currently exposed to cabergoline, and 19 had not been exposed to any dopamine agonist within the previous year. The rate of cardiac-valve regurgitation was increased with current use of pergolide (incidence-rate ratio, 7.1; 95% confidence interval [CI], 2.3 to 22.3) and cabergoline (incidence-rate ratio, 4.9; 95% CI, 1.5 to 15.6), but not with current use of other dopamine agonists. CONCLUSIONS: In this study, use of the dopamine agonists pergolide and cabergoline was associated with an increased risk of newly diagnosed cardiac-valve regurgitation.

Adult↗
PubMed2006

Contraindication labelling changes in the United States and Germany.

OBJECTIVE: Communication of a drug's benefits and risks through drug labelling is an important tool in the risk management of prescription drugs. Contraindication labelling provides the strongest safety-based guidance for the health care practitioner. In this study, the labelling of new contraindications between the United States (US) and Germany was compared. METHODS: We assessed whether contraindications that were newly labelled in the US between January 2003 and May 2005 had been incorporated into the German Summary of Product Characteristics (SPC) by October 2005 (end of the study period). We classified the results of our comparison as no difference, a slight difference (more detailed contraindication in one country or the other) or as a relevant difference (new US contraindication not contraindicated in the German SPC). We assessed the time difference between the date of the labelling change in the US and October 2005. RESULTS: During the study period, 66 new contraindications were evaluable for analysis. We found no difference in labelling between the US and Germany with regard to 30 contraindications (45.5%) and slight differences with regard to 14 contraindications (21.2%). In 22 instances (33.3%), the new contraindication in the US had not been incorporated into the German SPC. The median delay between the date of labelling in the US and October 2005 was 14 months and ranged between 5 and 31 months. In 77.3% of the relevant differences in contraindication labelling, the pharmaceutical manufacturer was the same in the US and Germany. CONCLUSION: Our study shows a remarkable discrepancy in the labelling of new contraindications between the US and Germany. The underlying reasons for this discrepancy were discussed, but need to be explored further.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Cyclooxygenase-2 selective nonsteroidal anti-inflammatory drugs and the risk of ischemic stroke: a nested case-control study.

BACKGROUND AND PURPOSE: Several randomized trials and a large number of epidemiological studies have provided evidence of an increased risk of acute myocardial infarction associated with the use of cyclooxygenase (COX)-2 selective nonsteroidal anti-inflammatory drugs (NSAIDs). Few data are available concerning the risk of ischemic stroke associated with COX-2 inhibitors. METHODS: We performed a nested case-control study in a cohort of 469,674 patients registered within the UK General Practice Research Database (GPRD), who had at least 1 prescription of an NSAID between June 1, 2000 and October 31, 2004. A total of 3094 cases with ischemic stroke were identified and 11 859 controls were matched on age, sex, year of cohort entry and general practice. Odds ratios (ORs) of ischemic stroke associated with the use of COX-2 selective NSAIDs were calculated by conditional logistic regression. RESULTS: Current use of rofecoxib (OR=1.71; 95% CI, 1.33 to 2.18), etoricoxib (OR=2.38; 95% CI, 1.10 to 5.13), but not of celecoxib (OR=1.07; 95% CI, 0.79 to 1.44) was associated with a significantly increased risk of ischemic stroke. For rofecoxib and etoricoxib, ORs tended to increase with higher daily dose and longer duration of use and were also elevated in patients without major stroke risk factors. CONCLUSIONS: Our study suggests that COX-2 selective NSAIDs differ in their potential to cause ischemic cerebrovascular events. An increased risk of ischemic stroke may be influenced by additional pharmacological properties of individual COX-2 inhibitors.

Aged↗
PubMed2006

Use of first- and second-generation cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs and risk of acute myocardial infarction.

BACKGROUND: The cardiovascular safety of cyclooxygenase (COX)-2-selective nonsteroidal antiinflammatory drugs (NSAIDs) has come under scrutiny after the withdrawal of rofecoxib and halting of the Adenoma Prevention with Celecoxib trial. Whether the newer second-generation COX-2 inhibitors (etoricoxib, valdecoxib) also increase the cardiovascular risk is unknown. METHODS AND RESULTS: We performed a nested case-control study in a cohort of 486,378 persons registered within the United Kingdom General Practice Research Database with at least 1 prescription of an NSAID between June 1, 2000, and October 31, 2004. A total of 3643 cases with acute myocardial infarction (AMI) were matched to 13,918 controls on age, sex, year of cohort entry, and general practice. Rate ratios (RRs) of AMI associated with use of COX-2-selective and -nonselective NSAIDs were calculated. Current use of etoricoxib was associated with a 2.09-fold (95% confidence interval [CI], 1.10 to 3.97) risk of AMI compared with no use of NSAIDs during the prior year. Current use of rofecoxib (RR=1.29; 95% CI, 1.02 to 1.63), celecoxib (RR=1.56; 95% CI, 1.22 to 2.00), and diclofenac (RR=1.37; 95% CI, 1.17 to 1.59) also significantly increased the AMI risk. For current use of valdecoxib, the RR was 4.60 (95% CI, 0.61 to 34.51). RRs appeared to increase with higher daily doses of COX-2 inhibitors and were also increased in patients without major cardiovascular risk factors. CONCLUSIONS: Our study supports the hypothesis that the elevated risk of AMI is a class effect of COX-2 inhibitors. The increase in risk appears to be dose dependent, but further data are needed to verify this observation.

Adult↗
PubMed2005

Case-control study on analgesics and nephropathy (SAN): protocol.

BACKGROUND: The association between intake of non-phenacetin-containing analgesics and the occurrence of chronic renal failure is still controversially discussed. A new epidemiologic study was planned and conducted in Germany and Austria. METHODS/DESIGN: The objective of the international, multicenter case-control study was to evaluate the association between end-stage renal disease (ESRD) and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations. A targeted sample of 1000 new (incident) dialysis patients, aged less than 50 years, was planned to recruit between January 1, 2001 and December 31, 2004. The age limit was chosen to avoid contamination of the study population with phenacetin-containing analgesics to the extent possible. Four control subjects per ESRD case, matched by age, sex, and region were selected from the population living in the region the case came from. Lifetime exposure to analgesics and potential renal risk factors were recorded in a single face-to-face interview. A set of aids was introduced to reinforce the memory of study participants. A standardized, pre-tested interview questionnaire (participants), a medical documentation sheet (physicians in dialysis centres), a logbook for all activities (dialysis centres) were used to collect the necessary data. Quality management consisted of the standardized procedures, (re-) training and supervision of interviewers, regular checks of all incoming data for completeness and plausibility. The study is scientifically independent and governed by a international Scientific Advisory Committee that bridged the gap between the sponsoring companies and the investigators. Also other advisory groups assisted the managing committee of the study. All relevant German and Austrian nephrological associations supported the study, and the study design was carefully reviewed and approved by the Kidney Foundation of Germany. DISCUSSION: The study is expected to answer the main research question by end 2005. There is however a high potential for various biases that we tried to address with adequate measure. One limitation however cannot be overcome: The methodologically needed age-limitation of the study will make it not easy to generalize the results to age groups over 50 years. It might be suggested to repeat the study for persons over 50 years in 10 years when contamination with phenacetin use early in life is likely to be outgrown.

Analgesics↗
PubMed2005

Female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases.

Differences in pharmacokinetics, pharmacodynamics, and physiology contribute to the phenomenon that women and men frequently respond differently to cardiovascular drugs. Hormonal influences, in addition, can play an important role: for example, the menstrual cycle, menopause, and pregnancy--as a result of fluctuations in concentrations of sexual steroids, and of changes in total body water--can be associated with gender-specific differences in the plasma levels of cardiovascular drugs. Clinical relevance accordingly results, especially for substances with a narrow therapeutic margin. This review treats the most important pharmacodynamic gender-relevant differences in this context, and surveys available evidence on the benefits of therapy of chronic cardiovascular diseases in women. On the whole, the study situation for women is appreciably less favourable than for men: owing to the fact that women are under-represented in most studies, and that few gender-specific analyses have been conducted.

Adrenergic beta-Antagonists↗
PubMed2004

Variability of breast cancer risk in observational studies of hormone replacement therapy: a meta-regression analysis.

OBJECTIVES: A re-analysis of data from 51 epidemiological studies reported a significant 14% increase in the risk of breast cancer associated with the use of hormone replacement therapy (HRT). Unlike randomized trials, these observational studies varied in design and methods. This study was conducted to explore the impact of study design factors on the rate ratio. METHODS: We performed a meta-regression analysis of 39 epidemiological studies of HRT and breast cancer. The rate ratio of breast cancer associated with ever use of HRT was evaluated in relation to study design, study period, country, primary study objective, method of exposure measurement, age control, adjustment factors related to reproduction and menopause, and the presence of breast cancer surveillance. We used stepwise multiple regression analysis, weighted by the inverse of the variance of the logarithm of the rate ratio, to estimate ratios of rate ratios for these factors. RESULTS: Exposure measured by personal interview and/or medical record review was associated with a 14% lower rate ratio estimate as compared with telephone interview or self-administered questionnaire (P = 0.018). Among studies that did not adjust for age at menopause, the rate ratio was 12% lower if the primary objective was HRT effect than not (P = 0.016), while it was 43% higher among studies that adjusted for age at menopause (P = 0.042). An index that included as six desirable design features, breast cancer surveillance, matching of controls, more reliable exposure information, adjustment for age at menopause and reproductive risk factors, and as primary objective the effect of HRT suggests that studies with none of these properties would lead to a rate ratio estimate of 1.14 (95% CI: 1.00-1.29) while studies with all six properties would produce a rate ratio of 0.98 (95% CI: 0.83-1.15). CONCLUSIONS: Design factors of epidemiological studies could be an alternative explanation for the reported 14% increase in the risk of breast cancer associated with the use of HRT.

Breast Neoplasms↗
PubMed2004

Proportion of drug-related serious rare blood dyscrasias: estimates from the Berlin Case-Control Surveillance Study.

Drugs are an important cause of serious rare blood dyscrasias. To estimate the proportion of drug-related cases, we used data from the ongoing Berlin Case-Control Surveillance Study. The analysis included a total of 171 cases. The number of cases in which a drug etiology was assessed as at least "possible" was n = 29 (97%) for acute agranulocytosis, n = 4 (0.21%) for aplastic anemia, n = 8 (26%) for immune hemolytic anemia, n = 20 (25%) for immune thrombocytopenia, and n = 2 (20%) for thrombotic thrombocytopenic purpura/hemolytic uremic syndrome. Our analysis suggests that a substantial fraction of blood dyscrasias may be attributable to drug therapy.

Adverse Drug Reaction Reporting Systems↗