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  • 1
    Electronic Resource
    Electronic Resource
    Troglitazone has no effect on red cell mass or other erythropoietic parameters (1999)
    Springer
    European journal of clinical pharmacology 55 (1999), S. 101-104 
    Details
    ISSN: 1432-1041
    Keywords: Key words Troglitazone ; Erythropoietic ; parameters ; Plasma volume
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: Troglitazone is a new anti-diabetic agent for the treatment of type 2 diabetes. In placebo-controlled trials troglitazone improves glycaemic control, reduces hyperinsulinaemia and has beneficial effects on blood lipids. However, minor, reversible reductions in erythrocyte count, haemoglobin and haematocrit with no associated clinical symptoms have been observed in some troglitazone-treated patients. The primary objective of the present study was to determine if these changes could be explained by a decrease in red cell mass or change in plasma volume. Methods: Twenty-four healthy males were randomized in a double-blind manner to troglitazone (200 or 600 mg per day) or placebo for 6 weeks. Blood samples for the measurement of red cell mass and plasma volume were obtained in the 2 weeks prior to treatment and after 6 weeks of treatment. Reticulocyte and erythrocyte counts, haemoglobin and haematocrit were also measured. Results: At the end of the treatment period there were no statistically significant changes in red cell mass. Similarly there were no changes in reticulocyte count, erythropoietin or soluble transferrin receptors. These data indicate that troglitazone does not affect erythropoiesis. In addition, troglitazone was not associated with increased red blood cell destruction or haemolysis. There was a trend towards increased plasma volume in the troglitazone groups: increases of 2.5 ml · kg−1 (5.7% increase) in the troglitazone 200 mg group and 3.4 ml · kg−1 (7.8% increase) in the troglitazone 600 mg group were observed compared with placebo. Conclusion: These data suggest that dilutional effects related to a modest increase in plasma volume may explain the haematological changes seen in other clinical trials with high doses of troglitazone, although this study has shown that the changes in plasma volume are not statistically significant.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050602
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Evaluation of personality as a component of the healthy condition of volunteers participating in phase I studies (1996)
    Springer
    European journal of clinical pharmacology 51 (1996), S. 209-213 
    Details
    ISSN: 1432-1041
    Keywords: Key words Phase I clinical trials ; Minnesota Multiphasic Personality Inventory; volunteers ; psychological assessment
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective The present study was conceived in order to recommend use of the Minnesota Multiphasic Personality Inventory for the evaluation of the personality of volunteers participating in Phase I clinical trials. The study was intended to describe personality profiles as objectively as possible, attempting to identify any common traits or tendencies, and to evaluate whether age or cultural background can be associated with significant differences in volunteer personality profiles. Subjects: 358 subjects were evaluated (290 males and 68 females; mean age 30 y, range 18–78 y). Mean values of scales and indices were compared and analysed, both for the sample as a whole and on the basis of its breakdown according to sex, age and education. Results: No psychopathological values were found in terms of sex and education. The mean profile showed common traits of a substantially balanced, self-assured, reliable person, motivated by extremely realistic objectives. Conclusions: The Minnesota Multiphasic Personality Inventory seems to be a useful tool for screening healthy volunteers.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050185
    Library Location Call Number Volume/Issue/Year Availability
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    Paper (German National Licenses)
    Fulltext
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