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E Garbe

Publications and source records attributed to E Garbe.

At least 19 recordsLinked to original sources
PubMed2002

[Trends of OC use 1980-1999 in a German cohort of women].

INTRODUCTION: There is no doubt, oral contraceptives are a safe, reversible and commonly used method of contraception. Ever use is about 80 % in developed countries and current use of OCs about 40 %. Almost all information about prevalence of OC use came from cross-sectional studies and did not distinguish between high- and low-dose OCs. This paper deals with the prevalence of OC use as it was observed during lifetime of a large cohort of German women by calendar year and estrogen content. METHODS: The prevalence of OC use between 1980 to 1999 was analysed on occasion of an interim analysis of the German cohort study on women's health. This analysis is based on more than 10 000 women with about 390 000 women-years of observation. RESULTS: The proportion of women under the age of 50, that ever used OCs, increased steeply from 1980, i. e. from 62 % (1980) to about 90 % from 1996 onward. The proportion of current users in a given calendar year rose from 44 % (1980) to 49 % (1991-95) and dropped after the "pill crisis 1995". The percentage of current users who used high-estrogen-dose OCs dropped from 32 % (1980) to 5 % (1999). In contrast, the percentage of users of low-dose OCs of the 2nd generation steeply increased as was the percentage of users of the 3rd generation pills, however the latter dropped after 1995. CONCLUSION: The high acceptance of oral contraceptives despite many "pill crises" underlines the continuously high appreciation of their efficacy on the one hand, but underscores also the high responsibility of physicians and industry concerning surveillance or reduction of discussed side effects.

Adolescent↗
PubMed2000

Venous thromboembolism and oral contraceptive use: a methodological study of diagnostic suspicion and referral bias.

BACKGROUND: In studies of oral contraceptive oral contraceptive use and risk of venous thromboembolism, bias related to heightened diagnostic suspicion and preferential referral of oral contraceptive users has been an issue. The aim of our study was to determine the presence and potential impact of diagnostic suspicion and referral bias. METHODS: We conducted a case/non-case study in 21 regional study centers in Germany and, in parallel, a conventional case-control study using the same cases but randomly selected population controls from the same areas. Women with symptoms compatible with venous thromboembolism were included in the study between 1994 and 1999, and classified as cases or non-cases (first reference group) according to the diagnostic work-up (case/non-case study). A second reference group consisted ofpopulation controls (conventional case-control study as an internal comparison for the case/non-case study): 606 cases, 462 non-cases and 2942 population controls aged 15-49 years. Adjusted unconditional regression analyses were performed. RESULTS: Adjusted odds ratios for venous thromboembolism in oral contraceptive users were systematically higher in the classical case-control study compared to the case/non-case approach (using the same cases) across all subgroup analyses (e.g. for idiopathic cases, the odds ratio was 67% higher in the case-control study: 4.33 (95% confidence interval (CI) 3.27-5.74) versus 2.60 (95% CI 1.75-3.88)). We found a significantly increasing trend of oral contraceptive use in four categories of increasingly sophisticated diagnostic tests that were applied to 1067 women with a suspicion of venous thromboembolism, irrespective of the outcome. Stratified analysis showed the diagnostic level to be a confounder. CONCLUSION: In our population-based study with the possibility of internal comparison, we found clear evidence that diagnostic suspicion and referral bias does play an important role in case-control studies of venous thromboembolism risk among oral contraceptive users. This underlines the importance of making an effort to avoid this bias when designing a new study.

Adolescent↗
PubMed2000

[German Cohort Study of Women's Health--benefits of oral contraceptives. Study protocol].

This publication is about the study protocol of the German Cohort Study on Women's Health. The main objective is to investigate medical benefits of a long-term oral contraceptive use. The design is an analytical cohort study based on inquiries. Additional cases will be recruited to analyse rare events in separate case-control studies. Voluntary participants who signed to participate in a long-term study are included. An annual drop-out rate of 15% is expected. Study variables encompass personal characteristics, lifetime history of diseases, but also disturbances of the state of health, and quality of life. It is anticipated to achieve 400,000 women-years of observation by 2001 (historic and concurrent follow-up). The study started April 1, 1998 and the current financial phase finishes December 31, 2001. 6000 participants were recruited until December 1998 equivalent to about 190,000 observation-years. Until the end of 1999, an additional 70,000 women-years should be included. There have been many suggestions from participants' to include additional issues of women's health into the study.

Adult↗
PubMed2000

[Non-contraceptive benefits of the pill--an often neglected fact].

While rare cardiovascular risks of oral contraceptives (OCs) caused a lot of concern among OC-using women in the recent past, little attention has been paid in the public to the non-contraceptive benefits of OCs. Short, medium and long term non-contraceptive benefits have to be considered. The early Anglo-American cohort and case-control studies demonstrated a reduction of menstrual complaints, iron-deficiency anaemia, ectopic pregnancies, and a partly drastic reduction of some benign and malignant tumours such as endometrial and ovarian cancer. A risk reduction of rheumatoid arthritis is discussed controversially. The present paper gives an overview of the state of knowledge. For newer OCs with different composition, comparable studies are lacking. Therefore, a cohort study was initiated in Germany in April 1998 to investigate these associations as well for newer OCs, which is presented. The described non-contraceptive benefits should be considered in the benefit-risk assessment when prescribing OCs.

Arthritis, Rheumatoid↗
PubMed1999

Oral progestogen-only contraceptives and cardiovascular risk: results from the Transnational Study on Oral Contraceptives and the Health of Young Women.

BACKGROUND: The risk of cardiovascular disease associated with progestogen-only pills has rarely been studied so far. METHODS: In the Transnational case-control study we were looking for a potential cardiovascular disease risk with oral progestogen-only pills in women aged 16-44 years. A total of 1058 cases of myocardial infarction, thromboembolic cerebrovascular accident or venous thromboembolism, and 3808 controls unaffected by these diseases, were enrolled. The group of women who had either used oral progestogen-only pills or no oral contraceptives included 394 cardiovascular disease cases (123 cases of myocardial infarction, 90 cases of thromboembolic cerebrovascular accident and 181 cases of venous thromboembolism) and 2366 controls. RESULTS: The adjusted (matched) odds ratio (OR) for all cardiovascular diseases combined for women using progestogen-only pills compared with non-users of oral contraceptives was 0.84 (95% confidence interval (CI), 0.45-1.58). The adjusted ORs for myocardial infarction, thromboembolic cerebrovascular accidents and venous thromboembolism for users of progestogen-only pills were 0.94 (95% CI, 0.31-2.91), 1.60 (95% CI, 0.24-0.72) and 0.68 (95% CI, 0.28-1.66), respectively. Hence, there was no significant increase in cardiovascular disease risk associated with progestogen-only pill use. The association between cardiovascular disease and established risk factors (smoking and hypertension) was confirmed. CONCLUSION: Although limited by the small number of exposed cases, our data suggest that there is no convincing evidence for an increased risk of cardiovascular disease associated with progestogen-only pill use.

Adolescent↗
PubMed1998

Association of inhaled corticosteroid use with cataract extraction in elderly patients.

CONTEXT: The use of systemic corticosteroids is a known risk factor for the development of cataracts. OBJECTIVE: To determine whether treatment with inhaled corticosteroids is associated with cataract extraction in the elderly. DESIGN: Case-control study. SETTING: Quebec universal health insurance program for all elderly (provincial health insurance plan database [RAMQ database]). PATIENTS: RAMQ enrollees 70 years and older. The 3677 cases were patients with a cataract extraction between 1992 and 1994. The 21868 controls were randomly selected from patients who did not have a diagnosis of cataract and matched to cases on the index date of the case. MAIN OUTCOME MEASURES: Odds ratio of cataract extraction in patients with prolonged cumulative exposure to inhaled corticosteroids compared with nonusers. RESULTS: Excluding patients with systemic steroid treatment and after adjusting for age, sex, diabetes, systemic hypertension, glaucoma, ophthalmic steroids, and the number of physician claims for services, use of inhaled corticosteroids for more than 3 years was associated with undergoing cataract extraction (odds ratio [OR], 3.06; 95% confidence interval [CI], 1.53-6.13). For high average daily doses of beclomethasone or budesonide (>1 mg), the OR was elevated after more than 2 years of treatment (OR, 3.40; 95% CI, 1.49-7.76), whereas for low to medium doses (< or =1 mg) of these drugs, the OR was 1.63 (95% CI, 0.85-3.13) after 2 years. CONCLUSION: Prolonged administration of high doses of inhaled corticosteroids increases the likelihood of undergoing cataract extraction in elderly patients. Further studies are needed to investigate the risk of developing cataracts for low to medium doses over longer periods.

Administration, Inhalation↗
PubMed1998

[Trends in cardiovascular risk factor profiles in East Germany. Three independent population studies as part of the project MONICA East Germany].

OBJECTIVE: To demonstrate trends in cardiovascular risk factors in the population of former East Germany. PATIENTS AND METHODS: As part of the international World Health Organisation's MONICA project ("MONItoring of Trends and Determinants of CArdiovascular Disease"), cross-sectional studies of independent random samples were undertaken, during three periods between 1982 and 1994, among the 24-64 year age groups in the population of East Germany. Those examined were 8470 (1982-1984), 9533 (1987-1989) and 2330 (1991-1994) men and women aged 25-64 years living in 17 regions (until 1989) and three regions (since 1991), respectively. Each person had standardized blood pressure measurements, His/her weight and height were measured, a blood sample was taken, and each was given a standardized interview by trained personnel. RESULTS: The prevalence of hypertension, ca. 30% overall, was relatively high. There was, however, a tendency over time towards a reduced prevalence among the women, from 29% to 25% (P < 0.05). The proportion of effectively treated hypertensives was clearly too low: 12-14% among men, 20-25% among women. There was a slightly downward trend in the frequency of hypercholesterolaemia (> 6.7 mmol/l), but it was statistically significant only for women. The proportion of markedly overweight persons (body mass index > or = 30) was not significantly reduced. The frequency of regular smokers decreased among men from 41% to 35% (P < 0.05), while among women (especially those in the younger age groups) there was a slight increase. CONCLUSIONS: Despite the known importance of risk factors, their prevalence was not significantly changed in East Germany over a period about 10 years. More effort and population-related primary prevention of coronary heart disease will thus be required, particularly in view of the risk factors cigarette smoking and hypertension.

Adult↗
PubMed1998

Exposure to allopurinol and the risk of cataract extraction in elderly patients.

OBJECTIVE: To determine whether exposure to allopurinol is associated with an increased risk of cataract extraction in elderly patients. METHODS: We conducted a case-control study using data from the Quebec universal health insurance program for all elderly patients. The 3677 cases were patients with a cataract extraction between 1992 and 1994. The 21,868 controls were randomly selected among patients not diagnosed with cataract and matched to cases on the date of the extraction. We determined the odds ratio of cataract extraction according to the cumulative dose and duration of allopurinol use relative to nonusers, using conditional logistic regression analysis. The analysis was adjusted for the effects of age, sex, diabetes mellitus, hypertension, glaucoma, and ophthalmic and oral corticosteroid exposure. RESULTS: A cumulative dose of allopurinol of more than 400 g or a duration of use of longer than 3 years were associated with an increased risk of cataract extraction, with odds ratios of 1.82 (95% confidence interval [CI], 1.18-2.80) and 1.53 (95% CI, 1.12-2.08), respectively. No increase in risk was observed for lower cumulative doses or shorter exposure periods. CONCLUSION: Long-term administration of allopurinol increases the risk of cataract extraction in elderly patients.

Aged↗
PubMed1998

[Epidemiologic data of stroke. Data of the WHO-MONICA Project in Germany].

Analyses of stroke morbidity or mortality are usually based on official statistics. A reduction in stroke mortality rates has been shown for many countries. It is not clear, however, whether this is due to declining morbidity or case fatality (or both). For this purposes population-based register data are required. Using the standardized methodology of the WHO-MONICA Project, stroke cases were also registered in Germany from 1984 to 1993 (7,435 first-ever and recurrent stroke cases). The data collection was almost restricted to East Germany. The age-specific stroke rates in males/females showed an increase from 9/11 per 100,000 population in the youngest age group (25-34) to 1,005/779 cases per year in the oldest group under study (65-74). If one tries to classify stroke types, which is not always possible in a population-based register, the best estimate for men (women) would be: 63(62%) thromboembolic stroke, 25(22)% intracerebral hemorrhage, and 12(17)% subarachnoid hemorrhage. The 28-day case fatality of the 25-74 year old stroke patients was found to be about 40%. Neither for stroke attacks nor for case fatality was a convincing time trend over the 10-year period found. The very small changes observed over 10 years time should lead to increased attention to strokes, particularly primary and secondary prevention, and this not only in East Germany. This applies also for treatment in the acute phase, because the case fatality before admission in the hospital and during the first few days is still very high. Population-based studies of the long-term prognosis of stroke patients in Germany are also missing, i.e., including the effectiveness of various forms of treatment and rehabilitation. Systematic monitoring of the development in this field is an important part of the assessment of the quality and effectiveness of the health care service.

Adult↗
PubMed1998

Selection of controls in database case-control studies: glucocorticoids and the risk of glaucoma.

In case-control studies conducted using computerized databases, controls are often selected as a random sample from the base population. This representative choice of controls is intended to guard against selection bias. We show, using data from a database case-control study, that such a definition of controls may also lead to selection bias under two conditions: (1) if the target disease has a prolonged asymptomatic clinical course with its detection depending on a specific physical examination and (2) if exposed patients have a higher likelihood of having the disease detected than unexposed patients. The extent of the bias that could result from the use of randomly selected controls was investigated in the context of a case-control study of the risk of ocular hypertension or glaucoma associated with the use of glucocorticoids, conducted using the Quebec universal health insurance computerized databases. This article also illustrates that a computerized database can be useful to empirically explore opportunities for bias.

Aged↗
PubMed1997

Risk of ocular hypertension or open-angle glaucoma in elderly patients on oral glucocorticoids.

BACKGROUND: Ocular hypertension and open-angle glaucoma are well-known side-effects of treatment with topical ophthalmic glucocorticoids. There is uncertainty about the risk of these disorders with oral glucocorticoid therapy. METHODS: Data from the Quebec universal health insurance programme for the elderly were used to identify 9793 patients with a new diagnosis of ocular hypertension or open-angle glaucoma, or on newly prescribed treatment for these disorders (cases). 38,325 controls were randomly selected from ophthalmology patients seen in the same month and year as the case (index date). Current use of oral glucocorticoids was defined as that within 14 days of the index date. All glucocorticoid doses were converted to the equivalent amount of hydrocortisone. The case-control analysis was done by conditional logistic regression and adjusted for age, sex, systemic hypertension, diabetes mellitus, ophthalmic glucocorticoids, glucocorticoid injections, and variables related to general health. FINDINGS: The mean ages of cases and controls were similar (74.9 [SD 6.3] vs 74.7 [6.4]). The adjusted odds ratio of ocular hypertension or open-angle glaucoma for current users of oral glucocorticoids compared with non-users was 1.41 (95% CI 1.22-1.63). There was a dose-related increase in the adjusted odds ratios for current users: 1.26 (1.01-1.56) for less than 40 mg per day of hydrocortisone, 1.37 (1.06-1.76) for patients on 40-79 mg per day, and 1.88 (1.40-2.53) for patients on 80 mg or more per day. The odds ratios also increased with the duration of treatment over the first 11 months of exposure. INTERPRETATION: The use of oral glucocorticoids increases the risk of ocular hypertension or open-angle glaucoma in elderly patients. In patients in this age-group who need long-term treatment with high doses of oral glucocorticoids, monitoring of intraocular pressure may be justified.

Administration, Oral↗
PubMed1997

Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma.

OBJECTIVE: To determine whether the use of inhaled and nasal glucocorticoids is associated with an increased risk of ocular hypertension or open-angle glaucoma. DESIGN: Case-control study. SETTING: Québec universal health insurance program for all elderly (registered in the Régie de l'assurance maladie du Québec [RAMQ] database). PATIENTS: Enrollees in the RAMQ database aged 66 years and older. The 9793 case patients were ophthalmology patients with a new diagnosis of borderline glaucoma or open-angle glaucoma or were newly started on treatment for ocular hypertension or glaucoma between 1988 and 1994. The 38,325 control patients were randomly selected among noncases with ophthalmologist visits in the same month and year as the case event (index date). MAIN OUTCOME MEASURES: The odds ratio (OR) of ocular hypertension or open-angle glaucoma was determined in patients using inhaled or nasal glucocorticoids relative to nonusers, using conditional logistic regression analysis. The OR was adjusted for age, sex, diabetes mellitus, systemic hypertension, use of ophthalmic and oral glucocorticoids, and characteristics of health care system use in the year before the index date. RESULTS: Overall, current use of inhaled and nasal glucocorticoids was not associated with an increased risk of ocular hypertension or open-angle glaucoma. Current users of high doses of inhaled steroids prescribed regularly for 3 or more months were at an increased risk with an OR of 1.44 (95% confidence interval, 1.01-2.06). CONCLUSION: Prolonged administration of high doses of inhaled glucocorticoids increases the risk of ocular hypertension or open-angle glaucoma. This finding suggests that in these patients intraocular pressure monitoring may be warranted.

Administration, Inhalation↗
PubMed1993

Clinical and statistical issues in therapeutic equivalence trials.

Absolute proof of efficacy can only be given by placebo controlled trials. It is, however, important to classify a drug within the spectrum of existing therapeutic alternatives and, where effective treatment is available, it may be imperative due to ethical considerations to demonstrate that one drug is as effective as another. The issue of therapeutic equivalence trials is discussed along the lines of the important items which should be defined in the protocol: a) the target parameter, which is the primary endpoint of the trial, b) the reference drug, which should be selected with respect to efficacy (superior to others), and safety (largest amount of data), c) the acceptance range, which depends on the primary endpoint, and its implication for the clinical endpoints of morbidity and mortality (the conventional acceptance range for bioequivalence trials does not apply), and d) the statistical procedures, which must take into consideration the unsuitability of the conventional power approach for confirming equivalence. In an equivalence trial, compared to those that are placebo-controlled, the proof that one drug is as effective as another relies much more upon the quality of conduct of the study according to Good Clinical Practice.

Clinical Trials as Topic↗
PubMed1990

Adrenomedullary hyperplasia and phaeochromocytoma. DNA cytophotometric findings in 47 cases.

Fifty adrenalectomy specimens containing normal (n = 3), hyperplastic (n = 4) or neoplastic (n = 43) medullary tissue were subjected to quantitative cytophotometric measurements of DNA content. Differing evaluation schemes were applied for interpretation of DNA distribution patterns. Of the 43 phaeochromocytomas (PCC), 16 were inherited as part of the syndrome of multiple endocrine neoplasia type 2a (MEN 2a). Five of 27 sporadic PCCs followed a malignant course. Three benign and three malignant PCCs lacked endocrine activity. In normal medulla and in adrenomedullary hyperplasia, diploid or euploid DNA distributions were found. In contrast, 87% (33/38) of the benign and all 5 malignant PCCs exhibited non-diploid or aneuploid DNA histograms. No differences in DNA content existed between functioning and non-functioning PCCs or between sporadic and hereditary tumours. In this study, in contrast to earlier communications, DNA cytophotometry did not discriminate between benign and malignant adrenomedullary tumours. In addition, as opposed to the findings in a variety of other endocrine tumours, DNA measurements did not appear to be a useful tool to assess the prognosis of an individual malignant PCC.

Adrenal Gland Neoplasms↗