Registries as a tool in evidence‐based medicine: example of KIMS (Pfizer International Metabolic Database)

Self Cite

Objective: GH deficiency (GHD) in adults is characterized by a tendency toward obesity and an adverse body composition with visceral fat deposit and may thus predispose to the development of type 2 diabetes mellitus. The aim of this study was to assess the observed prevalence proportion (PP) and observed PP over expected PP ratio (standardized prevalence proportion ratio, SPR) of diabetes according to International Diabetes Federation criteria in a large cohort of GH-untreated adult-onset GHD patients. Design and methods: Associations between baseline variables and diabetes prevalence in 6050 GHD patients from KIMS (Pfizer International Metabolic Database) were studied and robust Poisson-regression analyses were performed. Comparisons between baseline status and HbA1c categories in the nondiabetic patients were done with covariance analysis. P values !0.05 were considered statistically significant. Results: PP was 9.3% compared with the expected 8.2%. SPR was 1.13 (95% confidence intervals (95% CIs), 1.04-1.23), which was significantly increased in females (1.23; 95% CI, 1.09-1.38%) but not in males (SPR 1.04; 95% CI, 0.92-1.17%). PP increased significantly by age, familial diabetes, country selection, BMI, waist circumference, number of pituitary deficiencies, and GHD etiology. SPR decreased significantly by age and increased significantly by BMI, waist circumference, and IGF1 SDS. Multiple regression model showed that the most important impact on SPR was from age and BMI. HbA1c values of 6.0-6.5% were found in 9.5% of nondiabetic patients and were associated with higher BMI and waist circumference. Conclusions: GHD is associated with an increased prevalence of diabetes, largely to be explained by the adverse body composition. These data urge toward early initiation of lifestyle modification measures.

Section: Discussionmentioning

confidence: 95%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Prevalence of diabetes mellitus in 6050 hypopituitary patients with adult-onset GH deficiency before GH replacement: a KIMS analysis

Abs¹,

Mattsson²,

Thunander³

et al. 2013

Self Cite

“…KIMS, an international pharmacoepidemiological survey (29), was launched in 1994 at the request of endocrinologists and healthcare decision makers to monitor the outcomes and safety of long-term GH replacement therapy (Genotropin) in hypopituitary adults with GHD being treated in a conventional clinical setting. The study to date contains data on more than 14 000 patients from 31 countries followed for w60 000 patient-years.…”

Section: Kims Databasementioning

confidence: 99%

Assessment of quality of life in adult patients with GH deficiency: KIMS contribution to clinical practice and pharmacoeconomic evaluations

Kołtowska-Häggström¹,

Mattsson²,

Shalet³

2009

Quality of life (QoL) has emerged as an important construct that has found numerous applications across healthcare-related fields, ranging from research and clinical evaluation of treatment effects to pharmacoeconomic evaluations and global healthcare policy. Impairment of QoL is one of the key clinical characteristics in adult GHD and has been extensively studied in the Pfizer International Metabolic Database (KIMS). We provide summarized evidence on GH treatment effects for both clinical and health economic applications based on the KIMS data. The primary focus is on those aspects of QoL research that cannot be investigated in the traditional clinical trial setting, such as specific patient subgroups, cross-country comparisons and long-term follow-up. First, the impact of age, gender, disease onset, primary aetiology, extent of hypopituitarism, previous radiotherapy and obesity on QoL before and during long-term GH replacement is discussed. Secondly, the studies on QoL in relation to country-specific normative values are reviewed. Finally, health economic data derived from KIMS including both burden of disease and utility assessment are evaluated. We conclude that the wide spectrum of analyses performed on the KIMS data allows for practical application of the results not only to research and clinical practice but also to health policy and global medical decision making.

“…Furthermore, the large numbers of patients enrolled permit subgroup analysis that would not be feasible on a local level. This has allowed for the characterisation of GH deficiency (GHD) in different phases of adult life and for the assessment of the effect of GH replacement across the entire adult age range (2). Such databases allow for the documentation of adverse events and safety monitoring, a prerequisite at all stages of life.…”

Section: Introductionmentioning

confidence: 99%

Adult GH deficiency throughout lifetime

Thomas

Monson

2009

It is now accepted that adults with severe GH deficiency (GHD) demonstrate impaired physical and psychological well-being and may benefit from replacement with recombinant human GH. Postmarketing surveillance surveys, such as the Pfizer International Metabolic Database (KIMS), were initially set-up to provide safety data on long-term treatment but have the added benefit of providing ongoing observational data on the effect of GH replacement on body composition, lipid and glucose status, hypertension, bone density and quality of life. These data demonstrate that although GHD has clinical impact at all ages, the individual consequences of this condition may take on greater significance at different stages in life. At all ages, accurate, safe diagnosis and appropriate GH dosing are necessary to provide the individual with the best possible outcome.