Anders Mattsson
Pfizer Inc, Medical, Department Member
PurposeTo evaluate the value of a registry, set in ‘real-life practice’, as a contribution to evidence-based medicine and to estimate the impact of information collected in such a registry, on the up to date knowledge in growth hormone... more
PurposeTo evaluate the value of a registry, set in ‘real-life practice’, as a contribution to evidence-based medicine and to estimate the impact of information collected in such a registry, on the up to date knowledge in growth hormone (GH)-related disorders.To evaluate the value of a registry, set in ‘real-life practice’, as a contribution to evidence-based medicine and to estimate the impact of information collected in such a registry, on the up to date knowledge in growth hormone (GH)-related disorders.MethodsAnalysis of data collected prospectively for a pharmacoepidemiological registry—KIMS (Pfizer International Metabolic Database)—in assessing long-term clinical and safety outcomes of GH treatment (Genotropin®) in patients with GH deficiency. The study was based on 11 374 treated (40 000 patient-years of observation) and 263 untreated adult GH deficient patients from 30 countries, in whom background characteristics, clinical values such as lipids and body composition, quality of life (QoL) and GH dosage as well as safety profile were evaluated. Citation analysis for the published papers was also performed.Analysis of data collected prospectively for a pharmacoepidemiological registry—KIMS (Pfizer International Metabolic Database)—in assessing long-term clinical and safety outcomes of GH treatment (Genotropin®) in patients with GH deficiency. The study was based on 11 374 treated (40 000 patient-years of observation) and 263 untreated adult GH deficient patients from 30 countries, in whom background characteristics, clinical values such as lipids and body composition, quality of life (QoL) and GH dosage as well as safety profile were evaluated. Citation analysis for the published papers was also performed.ResultsThe study depicts the clinical picture of adult patients with GH deficiency managed in current clinical settings. It confirms the features previously detected such as increased cardiovascular risk, mostly dyslipidemia and abnormal body composition as well as impaired QoL. There was considerable heterogeneity of conditions resulting in GH deficiency. The large database also enabled study of rare causes of the condition. The 31 out of 36 KIMS papers were cited 544 times, in 125 different journals.The study depicts the clinical picture of adult patients with GH deficiency managed in current clinical settings. It confirms the features previously detected such as increased cardiovascular risk, mostly dyslipidemia and abnormal body composition as well as impaired QoL. There was considerable heterogeneity of conditions resulting in GH deficiency. The large database also enabled study of rare causes of the condition. The 31 out of 36 KIMS papers were cited 544 times, in 125 different journals.ConclusionsThese findings and the further insight into the response to GH replacement therapy show that the registry methodology is valuable for filling the gaps of information in evidence-based medicine that cannot be addressed by clinical trials. Copyright © 2007 John Wiley & Sons, Ltd.These findings and the further insight into the response to GH replacement therapy show that the registry methodology is valuable for filling the gaps of information in evidence-based medicine that cannot be addressed by clinical trials. Copyright © 2007 John Wiley & Sons, Ltd.
Research Interests: Pharmacoepidemiology, Evidence Based Medicine, Quality of life, Treatment Outcome, Safety, and 16 moreProspective studies, Humans, Human Growth Hormone, Pharmaceutical Sciences, Cholesterol, Female, Body Composition, Male, Hypopituitarism, Registries, Adult, Public health systems and services research, Drug Safety, Recombinant Proteins, Hormone Replacement Therapy, and Pharmacoepidemiology and drug safety
Age- and gender-specific reference values for the quality of life (QoL) measures used in assessing the impact of growth hormone deficiency (GHD) are important. The objective of this study was to develop such data for the QoL-AGHDA... more
Age- and gender-specific reference values for the quality of life (QoL) measures used in assessing the impact of growth hormone deficiency (GHD) are important. The objective of this study was to develop such data for the QoL-AGHDA instrument for the population of England and Wales and to demonstrate the QoL deficit in patients with GHD. For the purpose of this study, a questionnaire was developed that contained the EurQoL EQ-5D, QoL-AGHDA, questions recording an individual's general situation and social functioning, and a self-reported five-point rating scale of general health. The questionnaire was mailed out to a sample of 1,190 individuals drawn from the general population of England and Wales. Corresponding data for 836 patients were retrieved from KIMS (Pfizer International Metabolic Database). The postal survey data were weighted to ensure that they were representative of the general population. The mean weighted QoL-AGHDA scores for the general population were 6.2 and 7.1 for men and women, respectively, compared with 13.6 and 15.7 for patients. For both males and females the differences in mean QoL-AGHDA scores between the general population and patients were statistically significant for all age categories (p < 0.01). In the general population the mean QoL-AGHDA score for each category of self-assessed health status increased progressively, indicating a poorer QoL as health status declined. This study reports QoL-AGHDA normative values for the population of England and Wales and confirms the extent of QoL impairment in patients with GHD in comparison with the general population.
Research Interests: Quality of life, England, Humans, England and Wales, Human Growth Hormone, and 22 moreHealth related Quality of Life, Wales, Female, Male, Statistical Significance, Reference Data, Growth hormone deficiency, Hypopituitarism, Health Status, Clinical Sciences, Rating Scale, General Health, Aged, Middle Aged, Survey data, Questionnaires, Social Functioning, Adult, Hormone, Reference Values, Reference Value, and General Population
Analysis of insulin-like growth factor I in serum (S-IGF-I) is an integral component in the diagnosis of GH-related disorders and is going to be of interest in the diagnosis and follow-up of many disorders. The objective of the present... more
Analysis of insulin-like growth factor I in serum (S-IGF-I) is an integral component in the diagnosis of GH-related disorders and is going to be of interest in the diagnosis and follow-up of many disorders. The objective of the present study was to develop cross-sectional reference values for S-IGF-I measured by an automated chemiluminescence immunoassay (Nichols Advantage).