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  • 1
    Electronic Resource
    Electronic Resource
    Sick population — treated population: the need for a better definition (1991)
    Springer
    European journal of clinical pharmacology 41 (1991), S. 267-271 
    Details
    ISSN: 1432-1041
    Keywords: Randomized clinical trials ; Pharmacoepidemiology ; sick population ; therapist's targed population ; treatment target population
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary There are many questions concerned with therapy and its application. Depending on the perspective of the study there can be several “populations” which, when considered individually, may give different, or even inconsistent conclusions. These populations are:the sick population, the therapist's target population, the eligible population for a study, the study population, the treatment target population, and the treatment distribution population. Semantic precision, giving a better definition of the populations, is an essential prerequirement in order to tackle scientifically all the facets of assessment of therapy Accurate definition will help in the study of areas as varied as the methodology, the therapeutic studies, the validity of the recommendations made, the impact of these recommendations on prescription, and finally, the consequences of the prescription in terms of public health (clinical and economical). Several examples are given to show the relationship between these populations and the importance of an accurate definition for each. Guidelines for the identification of these populations are provided. In this overall approach to therapy, epidemiology is an essential, complementary tool to clinical trials.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00314951
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Doctors' perception of pertinent information (1992)
    Springer
    European journal of clinical pharmacology 43 (1992), S. 113-116 
    Details
    ISSN: 1432-1041
    Keywords: General practitioners ; questionnaire ; patient information ; drug prescription
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The results of a survey aimed at investigating which tools prescribers have at hand to help them to identify pertinent information from a background of “noise” are reported. A questionnaire was sent to 250 general practitioners randomly selected from a list of those practicing in the Rhône-Alpes region in France, of whom 117 (46.8%) replied. The questionnaire consisted of three sections, the first explored how they dealt with intermediate and clinical outcomes in trials, the second presented a series of statements to identify what would make them prescribe a new drug, and the third looked at their knowledge of therapy assessment methodology. It was found that most general practitioners had not been trained to identify the most salient information for selecting the best treatment. This implies that both medical students and qualified doctors should be taught to recognise pertinent information.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01740654
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    Daycare attendance and risk of first infectious disease (1991)
    Springer
    European journal of pediatrics 150 (1991), S. 214-216 
    Details
    ISSN: 1432-1076
    Keywords: Daycare ; Common cold ; Wheezy bronchitis ; Otitis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The health hazards of daycare attendance for the development of upper and lower respiratory tract infections have been well documented; however the importance and the mechanism of this association have not been well defined. In order to ascertain the risk associated with the beginning of daycare (DC) attendance we conducted a survey on 1263 children aged from 3 months to 3 years; the analysis focused on the risk of developing an initial episode of common cold with fever, a first otitis and a first wheezy bronchitis (WB) within the 2 month period following adminission to DC. For each 2 month period, the risk of a first infectious event was much higher in children who had just begun attending DC than in children who remained at home: the risk ratio varied from 1.7 to 2.4 for common cold, from 1.5 to 1.9 for otitis and from 1.8 to 3.2 for WB. Because age at onset of the first infectious event may be related to a higher risk of repeated events we consider that admission to DC under 12 months of age should be quesioned.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01963570
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    Paper (German National Licenses)
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  • 4
    Electronic Resource
    Electronic Resource
    Drug prescription in young children: results of a survey in France (1991)
    Springer
    European journal of clinical pharmacology 41 (1991), S. 489-491 
    Details
    ISSN: 1432-1041
    Keywords: Drug utilization ; Antibiotics ; Infants ; pediatric prescribing
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary A 8.5-month prospective study was performed in the Rhône area of France to study the incidence of infectious diseases in children in day care, and the qualitative and quantitative aspects of drug prescriptions for young children. The families of 1.359 children agreed to participate (98.5% of those selected). During the follow-up period 3.605 infections episodes were reported and 10.706 medications were used, an average of 3.0 medications per episode. Antibiotics were used in the treatment of 2.333 infectious episodes (65%) amoxycillin (36%), cephalosporin (23%), macrolide (17%) and trimethoprim-sulphamethoxazole (9%). Acetylsalicylic acid and paracetamol were used 865- and 1.568-times, respectively. Drugs with multi-active components represented 11.3% of the total number of systemic medicines reported. Paracetamol was prescribed in 59% of cases in a multi-active component drug, whereas this type of product accounted for 83.5% of the antihistamines (used 932-times). The rationale behind the paediatric prescribing habits of French medical doctors is discussed in relation to results previously obtained in other European countries.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00626376
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    Paper (German National Licenses)
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  • 5
    Electronic Resource
    Electronic Resource
    Pharmacodynamic model of the haemodynamic effects of pinacidil in normotensive volunteers (1993)
    Springer
    European journal of clinical pharmacology 44 (1993), S. 177-182 
    Details
    ISSN: 1432-1041
    Keywords: Pinacidil ; Pharmacodynamic model ; effect-compartment model ; potassium channel activator
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The concentration-effect relationships of pinacidil, a peripheral vasodilator, have been measured in 12 healthy adults who received placebo or pinacidil 25 mg daily for 1 week in a cross-over experiment. Diastolic blood pressure (DBP) and heart rate (HR) were recorded and blood samples were taken on days 1 and 7. Plasma drug concentration-time data were fitted by a biexponential function with zero-order input. The pharmacokinetic model was incorporated into a combined pharmacokinetic-dynamic model (PK-PD) using the Hill equation, which has three parameters: n, the sigmoidicity parameter, Emax the maximum effect and EC50 the concentration which gives 50% of Emax. For ΔDBP, the parameter medians were estimated as n=5, EC50=44.6 ng · ml−1 and Emax=13.5 mm Hg. A hysteresis loop was found when ΔHR was plotted against concentration, which could be fitted by a linear effect compartment model. Simulations showed that experimental ΔDBP points on Day 7 could be predicted from a simulated curve computed by the model using parameters estimated on Day 1. Using the simulation, it was possible to suggest an optimal dosage regimen for pinacidil tablets.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00315477
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    Paper (German National Licenses)
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  • 6
    Electronic Resource
    Electronic Resource
    Surrogate endpoints: A basis for a rational approach (1992)
    Springer
    European journal of clinical pharmacology 43 (1992), S. 235-244 
    Details
    ISSN: 1432-1041
    Keywords: Surrogate endpoints ; Clinical trials ; risk/benefiratio ; assessment
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary In clinical trials, the clinical endpoint is often replaced by an intermediate endpoint, known in some instances as a “surrogate” endpoint. The reasons for the substitution are often both practical and financial. At present, no theoretical basis or practical guidelines exist to help in the choice of surrogate endpoints. An approach is proposed here, based on three provisos which can be verified using one of a series of equations, if sufficient data on the pathophysiology and epidemiology of the disease are available. It is shown that even a strong statistical correlation is not a sufficient criterion for the definition of a surrogate endpoint. It is apparent that results obtained with the commonly used “surrogate” endpoints should be cautiously considered and that the assessment of treatments should, when possible, be based on clinical rather than intermediate endpoints.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02333016
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  • 7
    Electronic Resource
    Electronic Resource
    Evaluation of the effect of phosphodiesterase inhibitors on mortality in chronic heart failure patients (1994)
    Springer
    European journal of clinical pharmacology 46 (1994), S. 191-196 
    Details
    ISSN: 1432-1041
    Keywords: Phosphodiesterase inhibitors ; Mortality ; meta-analysis ; chronic heart failure ; vasodilator
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract We examined the influence of phosphodiesterase inhibitors (PDIs) on mortality in patients with overt chronic heart failure. A total of 13 randomised, placebocontrolled trials of PDIs involving 2808 patients were selected. Meta-analysis, using data for all patients, showed that there was a non-significant (P=0.16) increase of about 17% in the mortality rate of patients receiving a PDI [odds ratio (OR) 1.17, 95% confidence interval (CI) 0.94–1.46]. However, the observed treatment effects were found to be heterogeneous due to the results from the trials on vesnarinone. The heterogeneity became non-significant (P=0.77) when these trials were removed, and a significant increase in the mortality rate was observed under treatment with the other PDIs (OR 1.41, 95% CI 1.11–1.79). In the subgroups of patients with or without additional vasodilator (VD) treatment, similar results were observed (PDI with VD: OR 1.3, 95% CI 1.03–1.7; PDI without VD: OR 2.04, 95% CI 1.1–3.8). These results indicate that PDIs (with the exception of vesnarinone) should not be prescribed for long-term use in patients with overt chronic heart failure. Additional vasodilator treatment in patients receiving PDIs for chronic heart failure does not explain the increased mortality seen with PDIs. This toxicity must, therefore, arise by other mechanisms. Further experimental and clinical evaluation is needed to confirm the beneficial influence of vesnarinone on survival in chronic heart failure patients and to identify the mechanism(s) differentiating this agent's therapeutic effect from that of other PDIs.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00192547
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    Paper (German National Licenses)
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  • 8
    Electronic Resource
    Electronic Resource
    Abstracts of papers (1994)
    Springer
    Pharmacy world & science 16 (1994), S. 3-12 
    Details
    ISSN: 1573-739X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01876919
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    Paper (German National Licenses)
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