Three-years of growth hormone (GH) replacement therapy in GH-deficient adults: effects on quality of life, patient-reported outcomes and healthcare consumption

Svensson, Johan; Mattsson, Anders; Rosén, Thord; Wirén, Lena; Johannsson, Gudmundur; Bengtsson, Bengt‐Åke; Haggstrom, Maria Koltowska

doi:10.1016/j.ghir.2003.12.001

Cited by 56 publications

(53 citation statements)

References 29 publications

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“…Similar results were consistently reported from subsequent studies in the total KIMS population (43) as well as in different cohorts such as patients aged below and above 65 years (46), originating from a single country (34,36,37,47,48), and those who developed GHD following treatment for acromegaly and Cushing's disease (49), childhoodonset (CO) craniopharyngioma (50), adult-onset (AO) non-functioning pituitary adenoma (NFPA) (51) and CO-brain tumours (52). The only exceptions are patients with AO-craniopharyngioma (50) and with CO-GHD due to causes other than craniopharyngioma and brain tumours (52) in whom a gender difference in QoL was not observed.…”

Section: Impact Of Demographic and Clinical Characteristicssupporting

confidence: 90%

“…In order to eliminate the impact of different healthcare systems, two other studies in a single country environment were conducted. Furthermore, these studies evaluated GH effects after 2 (34) and 3 years (47) and attempted to identify the relation between changes in QoL and healthcare consumption. In the Swedish study, the number of doctor visits and hospitalization days was reduced after 3 years, whereas the number of sick leave days decreased after 2 years and returned towards baseline values after 3 years.…”

Section: Healthcare Utilizationmentioning

confidence: 99%

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

Kołtowska-Häggström¹,

Mattsson²,

Shalet³

2009

European Journal of Endocrinology

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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.

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Section: Impact Of Demographic and Clinical Characteristicssupporting

confidence: 90%

Section: Healthcare Utilizationmentioning

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

European Journal of Endocrinology

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“…Specifically, because it relates to the findings of GHD and hypogonadism in this study, GH replacement is known to improve QoL in patients with adult-onset GHD and helps reduce fat mass and improve exercise capacity. 51,52,54,55,[74][75][76][77][78][79][80] The benefits of testosterone therapy for men are clear and considered standard practice. 50,57,81 In addition, the high prevalence of MetS in retired football players is important because lifestyle changes may reverse some of these findings and improve the cardiovascular and metabolic disease risks that are associated with MetS.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of Pituitary Hormone Dysfunction, Metabolic Syndrome, and Impaired Quality of Life in Retired Professional Football Players: A Prospective Study

Kelly

Chaloner

Evans

et al. 2014

Journal of Neurotrauma

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Hypopituitarism is common after moderate and severe traumatic brain injury (TBI). Herein, we address the association between mild TBI (mTBI) and pituitary and metabolic function in retired football players. Retirees 30-65 years of age, with one or more years of National Football League (NFL) play and poor quality of life (QoL) based on Short Form 36 (SF-36) Mental Component Score (MCS) were prospectively enrolled. Pituitary hormonal and metabolic syndrome (MetS) testing was performed. Using a glucagon stimulation test, growth hormone deficiency (GHD) was defined with a standard cut point of 3 ng/mL and with a more stringent body mass index (BMI)-adjusted cut point. Subjects with and without hormonal deficiency (HD) were compared in terms of QoL, International Index of Erectile Function (IIEF) scores, metabolic parameters, and football career data. Of 74 subjects, 6 were excluded because of significant non-football-related TBIs. Of the remaining 68 subjects (mean age, 47.3 -10.2 years; median NFL years, 5; median NFL concussions, 3; mean BMI, 33.8 -6.0), 28 (41.2%) were GHD using a peak GH cutoff of < 3 ng/mL. However, with a BMI-adjusted definition of GHD, 13 of 68 (19.1%) were GHD. Using this BMI-adjusted definition, overall HD was found in 16 (23.5%) subjects: 10 (14.7%) with isolated GHD; 3 (4.4%) with isolated hypogonadism; and 3 (4.4%) with both GHD and hypogonadism. Subjects with HD had lower mean scores on the IIEF survey ( p = 0.016) and trended toward lower scores on the SF-36 MCS ( p = 0.113). MetS was present in 50% of subjects, including 5 of 6 (83%) with hypogonadism, and 29 of 62 (46.8%) without hypogonadism ( p = 0.087). Age, BMI, median years in NFL, games played, number of concussions, and acknowledged use of performance-enhancing steroids were similar between HD and non-HD groups. In summary, in this cohort of retired NFL players with poor QoL, 23.5% had HD, including 19% with GHD (using a BMI-adjusted definition), 9% with hypogonadism, and 50% had MetS. Although the cause of HD is unclear, these results suggest that GHD and hypogonadism may contribute to poor QoL, erectile dysfunction, and MetS in this population. Further study of pituitary function is warranted in athletes sustaining repetitive mTBI.

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“…Some of the QoL improvements seen with GH replacement may arise from improvements in physical factors, such as increased circulating volume, exercise tolerance and muscle strength. Aetiology-specific differences in QoL are seen: craniopharyngioma (65), female gender (6,39,59), Sheehan's syndrome (66) and cranial irradiation (33) are all associated with worse baseline QoL, although it should be noted that all of these, with the exception of irradiation, are associated with particularly low IGF1 levels. Patients with isolated GHD reported in the KIMS database showed no difference in QoL between childhood and adult-onset disease using QoL-AGHDA questionnaires (59).…”

Section: Quality Of Lifementioning

confidence: 99%

“…Open studies of GH replacement have been associated with normalisation of mortality rates. Svensson et al, in an open prospective study, found that after 3 years GH replacement mortality rates were no different to background population rates and were improved compared with mortality rates in a historical hypopituitary cohort not treated with GH (6). Both the increased mortality in hypopituitary patients and the possible improvement in mortality seen with GH replacement are likely to arise from a host of hormonal and non-hormonal interactions, the complexity of which hinders easy interpretation.…”

Section: Introductionmentioning

confidence: 99%

Adult GH deficiency throughout lifetime

Thomas

Monson

2009

European Journal of Endocrinology

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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.

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Three-years of growth hormone (GH) replacement therapy in GH-deficient adults: effects on quality of life, patient-reported outcomes and healthcare consumption

Cited by 56 publications

References 29 publications

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

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

Prevalence of Pituitary Hormone Dysfunction, Metabolic Syndrome, and Impaired Quality of Life in Retired Professional Football Players: A Prospective Study

Adult GH deficiency throughout lifetime

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