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Biomedical subjects

R Bruppacher

Publications and source records attributed to R Bruppacher.

At least 19 recordsLinked to original sources
PubMed2006

[Application aids in pharmacotherapy].

The actual administration of pharmacotherapy is in most cases entirely up to the patient. Correct application can often be only achieved with application aids. They are already part of many preparations: printed blister packages, measures for dosing liquids, applicators for topical use, dosage sprays, and supports for eye drop containers. Special needs can be covered by additional application aids like dosage syringes for child medication, spacers for asthma sprays, devices for splitting or crunching tablets. Filling the medicines in containers better manageable by the patient, in week dispensers or week blisters, may also be crucial to guarantee correct dosing and regimen. Application aids often play a significant part in the success of a therapy. Needed are evidence based criteria for the selection of devices and instructions. Such criteria need to be developed because they are still largely lacking.

Drug Administration Schedule↗
PubMed2001

Ethical and legal considerations in a Swiss study on the quality of pharmacotherapy in the city of Basel.

We describe a study on the quality of pharmacotherapy that included downloading electronic records in pharmacies and obtaining other information from the Public Sickness Fund in Basel, Switzerland. Legal and ethical considerations were discussed with and approved by the Internal Review Board of the university clinics through which the project was organized. Technical procedures were used to assure anonymity of the records during data collection and for the analysis. Completion of the records through links with personal data could be performed using a legally required process for quality assurance of the Public Sickness Fund.

Drug Therapy↗
PubMed1999

The differential risk of oral contraceptives: the impact of full exposure history.

Previous discussions have indicated that the small increases of risk of venous thromboembolism (VTE) associated with newer combined oral contraceptives (third generation, containing desogestrel and gestodene) may be attributed to bias due to cohort effects. In a case-control analysis, this may produce an overestimate of risk of newer preparations. In 10 centres in Germany and the UK, the Transnational Study analysed data from 502 women aged 16-44 years with VTE, and from 1864 controls matched for 5-year age group and region. Information on lifetime exposure history from all subjects was added to the dataset used in previous analyses and entered into a Cox regression model with time-dependent covariates. Based on 17 622 continuous exposure episodes comprising 47 914 person-years of observation, the adjusted hazard ratio (equivalent to odds ratio, OR) of VTE for the comparison of current users of third-generation versus current users of second-generation (primarily levonorgestrel compounds) combined oral contraceptives was 0.8 (0.5 to 1.3). The OR obtained in standard case-control analysis had been 1.5 (1.1 to 2.1). Adjustment for past exposures includes more information and appears more valid than the standard cross-sectional analysis. Using this approach, the Transnational Study data show no evidence for an increased risk of VTE with third- compared with second-generation combined oral contraceptives.

Adolescent↗
PubMed1998

Evaluation of the safety of a coumarin-troxerutin combination.

Concerns about liver reactions reported for coumarin preparations prompted a re-evaluation of the combination of coumarin with troxerutin, widely used since 1971 in Germany. No evidence of liver toxicity could be found in available clinical research data. We estimated the number of coincidental cases of unexplained clinically apparent liver disease expected to arise during the patient treatment time on the basis of sales and the maximal recommended daily dosage. A comparison to the number of spontaneous reports yielded reassuring results.

Journal Article↗
PubMed1998

Thromboembolic stroke in young women. A European case-control study on oral contraceptives. Transnational Research Group on Oral Contraceptives and the Health of Young Women.

A matched case-control study was performed between 1993 and 1996 in 16 centers in the United Kingdom, Germany, France, Switzerland, and Austria. The objective was to determine the influence of oral contraceptives (OC), particularly those containing modern progestins, on the risk for ischemic stroke in women aged 16-44 years. A total of 220 women who had had an incident ischemic stroke and were compared with 775 control subjects who were unaffected by stroke. At least one hospital and one community control subject per patient was matched and interviewed with the corresponding patient for 5-year age band and for area of residence. Crude odds ratios (95% confidence intervals [CI]) for ischemic stroke were as follows. For current use of any OC versus no use 2.3 (1.7-3.2), the adjusted odds ratio (OR) 3.6 (2.4-5.4). The OC associated risk was higher for first generation than for second or third generation OC. The risk estimates for patients versus community control subjects were always lower than for hospital control subjects. No major regional difference of the risk estimates was found. Compared with nonusers of OC without hypertension, women with hypertension who used OC had an almost 10-fold increased risk. However, OC users who had had a blood pressure check before OC prescription had a lower risk than did those without such a check. Smoking > 10 cigarettes/day is associated with higher risk of stroke, particularly for OC users. No significant effect was found for duration of OC use. We conclude that although there is a small relative risk of occlusive stroke for healthy women currently using OC, the attributable risk is very small because the incidence in this age group is very low. The small increase in risk of OC use may be further reduced by preventive efforts for cardiovascular risk factors, particularly hypertension and smoking.

Adolescent↗
PubMed1997

Case-control study of oral contraceptives and risk of thromboembolic stroke: results from International Study on Oral Contraceptives and Health of Young Women.

OBJECTIVE: To determine the influence of oral contraceptives (particularly those containing modern progestins) on the risk for ischaemic stroke in women aged 16-44 years. DESIGN: Matched case-control study. SETTING: 16 Centres in the United Kingdom, Germany, France, Switzerland, and Austria. SUBJECTS: Cases were 220 women aged 16-44 who had an incident ischaemic stroke. Controls were 775 women (at least one hospital and one community control per case) unaffected by stroke who were matched with the corresponding case for 5 year age band and for hospital or community setting. Information on exposure and confounding variables were collected in a face to face interview. MAIN OUTCOME MEASURES: Odds ratios derived with stratified analysis and unconditional logistic regression to adjust for potential confounding. RESULTS: Adjusted odds ratios (95% confidence intervals) for ischaemic stroke (unmatched analysis) were 4.4 (2.0 to 9.9), 3.4 (2.1 to 5.5), and 3.9 (2.3 to 6.6) for current use of first, second, and third generation oral contraceptives, respectively. The risk ratio for third versus second generation was 1.1 (0.7 to 2.0) and was similar in the United Kingdom and other European countries. The risk estimates were lower if blood pressure was checked before prescription. CONCLUSION: Although there is a small relative risk of occlusive stroke for women of reproductive age who currently use oral contraceptives, the attributable risk is very small because the incidence in this age range is very low. There is no difference between the risk of oral contraceptives of the third and second generation; only first generation oral contraceptives seem to be associated with a higher risk. This small increase in risk may be further reduced by efforts to control cardiovascular risk factors, particularly high blood pressure.

Adolescent↗
PubMed1997

[Hospitalization of young women after selected cardiovascular and thromboembolic incidents in Austria 1993 and 1994].

The aim of this study is to describe the hospitalization and regional distribution of selected cardiovascular and thrombo-embolic events (cardiac infarction, cerebral strokes, deep vein thromboses, pulmonary embolism) of young women in Austria in the years 1993 and 1994, and to collect basic epidemiologic data for the study of the side effects of oral contraceptives. The calculated hospitalization rates are based on the Austrian hospitals' discharge records of 1993 and 1994. The persons concerned are women aged between 15 and 44 who live in Austria. The results of the study reveal that--in 1993--of the above mentioned group 51 out of 100,000 inhabitants were hospitalized because of the selected cardiovascular and thromboembolic events: 4/100,000 had a cardiac infarction, 5/100,000 had a stroke, 17/100,000 had a pulmonary embolism, and 27/100,000 suffered a deep vein thrombosis. In 1994 the counted cases per 100,000 inhabitants were 48, out of which 4/100,000 where cardiac infarcts, 5/100,000 strokes, 16/100,000 pulmonary embolism, and 25/100,000 deep vein thromboses.

Adolescent↗
PubMed1997

The use of oral contraceptives and the occurrence of acute myocardial infarction in young women. Results from the Transnational Study on Oral Contraceptives and the Health of Young Women.

The objective of this study was to assess the risk of myocardial infarction (MI) associated with the use of new and old combination oral contraceptives (OC). A matched case-control study in 16 centers in Germany, the United Kingdom, France, Austria, and Switzerland explored the association of current use of combination OC with the occurrence of MI. Our subjects were 182 women aged 16-44 years with MI; the controls were 635 women without MI (at least one hospital control and one community control per case) matched for 5-year age group and region. The main outcome measures were odds ratios comparing current use of a specific group of OC against current use of other groups or against no current use. The adjusted overall odds ratio (OR; 95% confidence intervals) for MI for second generation OC versus no current use was 2.35 (1.42 to 3.89) and 0.82 (0.29 to 2.31) for third generation OC (low dose ethinyl estradiol, gestodene, and desogestrel). A direct comparison of third generation users with second generation users yielded an OR of 0.28 (0.09 to 0.86). In subgroup analyses, the odds ratio for the UK alone was 1.25 (0.36 to 4.29), while for continental Europe it was 0.10 (0.02 to 0.48). For hospital controls, the risk estimated was 0.98 (0.22 to 4.44), and 0.18 (0.04 to 0.65) for community controls. The independent risk of MI among current smokers adjusted for OC use was 7.21 (4.58 to 11.36). Among users of third generation OC, the OR for current smokers was 3.75 (0.65 to 21.74) and among users of second generation it was 9.50 (2.93 to 30.96). A comparison of OC use in the UK for the time before and after regulatory action was taken in October 1995 shows that the likelihood of a control (last control accrued June 1996) being treated with second generation OC is seven times higher after 1 November 1995 than it was before. Third generation OC are the first to be associated with no excess risk of MI. A significantly lower risk of MI is found when comparing use of third generation OC with use of second generation OC. There seems to be an impressive amelioration of risk among smokers using newer OC. An impact of regulatory action in the UK was found in the OC use spectrum of controls.

Adolescent↗
PubMed1997

Use of topical NSAIDs in patients receiving systemic NSAID treatment: a pharmacy-based study in Germany.

Topical non-steroidal anti-inflammatory drugs NSAID account for two-thirds of the most frequently prescribed NSAIDs in Germany. Nevertheless, the extent of use and the benefit of local NSAIDs are viewed critically. We described the use of topical NSAIDs in people with systemic NSAID therapy. The study population consisted of 526 people with an average age of 57 years; two-thirds of the patients were women. We observed that the elderly (60 years and older) and patients with osteo- and/or rheumatoid arthritis had an increased likelihood of being treated with both topical and systemic NSAIDs. We suggest that the frequent use of topical NSAIDs in these patients is based on their supportive therapeutic effect rather than on their efficacy. Further research is needed in order to investigate the potential beneficial effects of topical NSAIDs in NSAID therapy.

Administration, Topical↗
PubMed1996

Third generation oral contraceptives and risk of myocardial infarction: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women.

OBJECTIVE: To test whether use of combined oral contraceptives containing third generation progestogens is associated with altered risk of myocardial infarction. DESIGN: Matched case-control study. SETTING: 16 centres in Austria, France, Germany, Switzerland, and the United Kingdom. SUBJECTS: Cases were 153 women aged 16-44 with a myocardial infarction event. Controls were 498 women (at least 3 controls per case) unaffected by myocardial infarction who were matched with their corresponding case for age and for hospital or community setting within four months of the index infarction. MAIN OUTCOME MEASURES: Odds ratios derived with stratified analyses and unconditional logistic regression to adjust for potential confounding variables. RESULTS: The estimated odds ratio for myocardial infarction of third compared with second generation oral contraceptives among all 651 study subjects was 0.36 (95% confidence interval 0.1 to 1.2) (P = 0.11). The odds ratio for the United Kingdom and Germany alone was 0.45 (0.1 to 1.8) (P = 0.26). Other odds ratios for the five countries were 3.1 (1.5 to 6.3) (P = 0.003) for use of second generation products v no current use and 1.1 (0.4 to 3.4) (P = 0.9) for use of third generation products v no current use. Among the confounding variables the independent contribution of smoking (for which adjustment was made in the above estimates) proved to be important (10.1 (5.7 to 17.9), P < 0.001). CONCLUSION: An odds ratio of 0.45 with wide confidence intervals shows that third generation oral contraceptives compared with second generation products are associated with a reduced risk of myocardial infarction or with no difference. This finding from an interim analysis should be interpreted with extreme caution. However, the excess risk of venous thromboembolism associated with the use of third generation products may be balanced by the reduced risk of myocardial infarction associated with the same products.

Adolescent↗
PubMed1996

The increased risk of venous thromboembolism and the use of third generation progestagens: role of bias in observational research. The Transnational Research Group on Oral Contraceptives and the Health of Young Women.

A matched case-control study was undertaken in 10 centers in Germany and the United Kingdom to explore the association of current use of major combination oral contraceptives with the occurrence of venous thromboembolism. The cases recruited were 505 women aged 16-44 years with venous thromboembolism, controls were 1877 women (at least 3 controls per case) matched for 5-year age group and region without VTE. The main outcome measures were odds ratios derived by comparing current use of a specific oral contraceptive or group of OC against current use of other groups or against no current use of OC. The odds ratios (95% confidence intervals) for venous thromboembolism were: for third generation products (low dose ethinyloestradiol, gestodene and desogestrel) versus second generation products (low dose ethinyloestradiol, no gestodene and desogestrel, 1.5 (1.1 to 2.0), for third versus second generation products with norgestimate included in third generation, 1.6 (1.2 to 2.2). The odds ratios for current use for women aged 16-44 of specific progestagens versus levonorgestrel-containing compounds were 1.7 (1.1 to 2.6) for gestodene, 1.8 (1.2 to 2.6) for desogestrel, 1.9 (1.0 to 3.6) for norgestimate and 1.3 (0.7 to 2.5) for progestagen-only pills. For women aged 25 to 44 likely to be exposed to any of these progestagens, odds ratios for the comparison of progestagens versus levonorgestrel showed a successive increase by market introduction ranging from 1.5 (0.9 to 2.5) for desogestrel with 30 micrograms oestrogen content (introduced 1981) to 2.8 (1.3 to 6.5) for desogestrel with 20 micrograms oestrogen content (introduced 1992) significant in linear trend analysis (p = 0.00012). The influence of norgestimate classification as third or second generation product does not significantly alter the results regarding the association of third generation products and venous thromboembolism. A direct comparison of current use of norgestimate (which is primarily metabolized to levonorgestrel) versus levonorgestrel shows an increased odds ratio. The trend of increasing risk of progestagens by recency of market introduction when compared with levonorgestrel is strongly indicative of the existence of external bias due to attrition of susceptibles.

Adolescent↗
PubMed1996

Epidemiology of erythema exsudativum multiforme majus, Stevens-Johnson syndrome, and toxic epidermal necrolysis in Germany (1990-1992): structure and results of a population-based registry.

The severe skin reactions erythema exsudativum multiforme majus (EEM with mucosal involvement, EEMM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) are difficult to study as they are very rare diseases with an incidence of about two cases per 1 million inhabitants per year. We report on the structure of a registry with the aim of ascertaining all hospitalized cases of EEMM, SJS, and TEN in western Germany and Berlin. The registry is structured as an intensive reporting system, regularly contacting more than 1500 departments including 100% of the burn units (n = 34), departments of pediatrics (n = 241), departments of dermatology (n = 106), and 100% of all internal medicine departments in hospitals with intensive care facilities or with more than 200 beds (n = 1161). With a coverage rate up to 95% based on the number of responding departments between April 1, 1990 and December 31, 1992, from a total of 767 reported cases 353 patients with EEMM, SJS, and TEN were finally included in the registry. Most of these patients were directly reported to the registry; only 2.54% (9 of 353) were primarily registered by the German spontaneous reporting systems. Assuming an average population of 64.5 million for western Germany and Berlin an incidence up to 1.89 per 1 million inhabitants per year could be calculated for SJS and TEN.

Epidemiologic Methods↗
PubMed1991

Identifying, evaluating and quantifying adverse drug reactions in children: opportunities and obstacles for the manufacturer.

The monitoring of the safety of its marketed products is a recognized responsibility of the pharmaceutical manufacturer. He has the advantage to concentrate efforts on a relatively small number of compounds and to include a large number of sources and methods. Drug monitoring is especially crucial for the vulnerable groups of patients (children, pregnant women, mentally incompetent and elderly) for whom adequate controlled clinical trials are often lacking with the notable exception of pediatric oncology and vaccinations. The surveillance of adverse drug reactions (ADR) in children represents a special challenge, because of the limited opportunity for usual post marketing surveillance studies. There is a surprising scarcity of epidemiologic projects on ADRs and even of drug usage data in younger age groups. Spontaneous reports are therefore still of great importance. Because of the development of national ADR reporting systems and concomitant regulations and guidelines direct reports to manufacturers account today in the Western world only about 50 percent of the accessible reports, 40% are addressed to national authorities and with only limited access to the manufacturer, sometime even information on age and sex is not provided. The proportion of these reports is increasing and it is important that a better exchange of information can be developed. Reports in the literature account today for about 10 percent of the ADR case reports. Spontaneous reports provide early signals, they can, however, not quantify a risk and need validation. Traditional investigations are often too onerous and time consuming. A promising approach has developed on the basis of computerized health insurance data that enable record linkage of prescriptions and subsequent health events.(ABSTRACT TRUNCATED AT 250 WORDS)

Adverse Drug Reaction Reporting Systems↗
PubMed1990

Malaria chemoprophylaxis among European tourists in tropical Africa: use, adverse reactions, and efficacy.

In order to determine knowledge, attitudes and practices towards malaria prophylaxis, as well as its side-effects and efficacy, a self-administered questionnaire was distributed to European travellers on return flights from tropical Africa to Europe. Between 1985 and 1988 the questionnaire was completed by 44,472 passengers (80.1% of those on board) on 242 flights. A follow-up questionnaire was completed by 42,202 (94.9%) of the same travellers 3 months later. Almost all knew about the risk of malaria, but 10% relied solely on advice from nonmedical sources. While 55.6% had taken at least one measure against mosquito bites, only 4.5% adopted three such measures (used repellents and insecticides and wore long clothing after dusk). Compliance with chemoprophylaxis use was reported by 57.0% of travellers who spent less than 3 months in Africa, compared with 29.2% who stayed 3-12 months. Depending on the antimalaria regimen taken, 11-44% of the travellers experienced adverse effects, while four deaths were attributed to the chemoprophylaxis. The incidence of malaria per month of exposure for travellers who took no chemoprophylaxis was 15.2 per 1000 in East Africa and 24.2 per 1000 in West Africa. In East Africa, the prophylactic efficacy of the currently recommended antimalaria regimens (relative to that of no chemoprophylaxis) was zero for a chloroquine dosage of 300 mg base per week (4 malaria fatalities), 64.1% for a chloroquine dosage of 600 mg base per week (P = 0.03), and 94.0% for mefloquine (P = 0.003).

Adult↗
PubMed1989

Epidemiological criteria for evidence of beneficial or adverse effects of elevated dosages of vitamins.

Criteria for epidemiological evidence of effects of elevated dosages of vitamins are basically the same as those for the evidence of effects of other exposures. Given the unambiguous classifications of both exposure and cases, they comprise strength, significance, specificity, and consistency of the statistical association, plausible time relationship as well as dose-effect relationship and consistency with other evidence. Today, the term epidemiological evidence usually refers to field experience, often to "observational," i.e., non-experimental, evidence. An extreme example for this are the so-called "ecological studies," which are frequently criticized because of their potential for exaggerated interpretations, though they can be very helpful in constructing and supporting hypotheses. For very rare and long-term effects the description and evaluation of individual cases are often combined with attempts of quantification, by relating them to the estimated exposure of the source population. This is subject to numerous sources of errors. If it is difficult to confirm the existence of rare and late effects, as the collection and interpretation of data on the prevention of such effects often present almost insurmountable methodological challenges. However, with correct interpretation and by keeping the quantitative perspective in mind, epidemiological evidence can be extremely helpful in the assessment of the overall importance, i.e., the public health significance, of such effects.

Epidemiologic Methods↗
PubMed1989

[Epidemiologic criteria for the evaluation of positive and negative effects of the administration of high doses of vitamins].

Epidemiological methods can provide evidence, not proof, of cause effect relationships. They can confirm and quantify the existence of statistical relationships. Causality in epidemiological terms means that such relationships are strong and stable enough to enable the change of the suspected effect by changing the suspected cause. Criteria for epidemiological evidence of effects of elevated dosages of vitamins are basically the same as those for the evidence of effects of other exposures. Given the unambiguous classifications of both exposure and cases, they comprise strength, significance, specificity and consistency of the statistical association, plausible time relationships as well as dose effect relationship and consistency with other evidence. Epidemiological evidence for beneficial or detrimental effect of elevated vitamin doses may be derived from experimental or observational studies. It may confirm effects extrapolated from much higher exposure or from animal models. Today the term epidemiological evidence usually refers to field experience often to "observational", i.e. non-experimental evidence. Here comparison groups may not come from the same source populations and many confounding variables can only be controlled by sophisticated statistical procedures. A typical example for this are the so-called "ecological studies". They are frequently criticized because of their potential for exaggerated interpretations but they can be very helpful in constructing and supporting hypotheses. For very rare, and long term effects the description and evaluation of individual cases are often combined with attempts of quantification by relating them to the estimated exposure of the source population. This is subject to numerous sources of errors.(ABSTRACT TRUNCATED AT 250 WORDS)

Dose-Response Relationship, Drug↗