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      Patient-reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly

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          Abstract

          Background

          Long-acting somatostatin analogues delivered parenterally are the most widely used medical treatment in acromegaly. This patient-reported outcomes survey was designed to assess the impact of chronic injections on subjects with acromegaly.

          Methods

          The survey was conducted in nine pituitary centres in Germany, UK and The Netherlands. The questionnaire was developed by endocrinologists and covered aspects of acromegaly symptoms, injection-related manifestations, emotional and daily life impact, treatment satisfaction and unmet medical needs.

          Results

          In total, 195 patients participated, of which 112 (57%) were on octreotide (Sandostatin LAR) and 83 (43%) on lanreotide (Somatuline Depot). The majority (>70%) of patients reported acromegaly symptoms despite treatment. A total of 52% of patients reported that their symptoms worsen towards the end of the dosing interval. Administration site pain lasting up to a week following injection was the most frequently reported injection-related symptom (70% of patients). Other injection site reactions included nodules (38%), swelling (28%), bruising (16%), scar tissue (8%) and inflammation (7%). Injection burden was similar between octreotide and lanreotide. Only a minority of patients received injections at home (17%) and 5% were self-injecting. Over a third of patients indicated a feeling of loss of independence due to the injections, and 16% reported repeated work loss days. Despite the physical, emotional and daily life impact of injections, patients were satisfied with their treatment, yet reported that modifications that would offer major improvement over current care would be ‘avoiding injections’ and ‘better symptom control’.

          Conclusion

          Lifelong injections of long-acting somatostatin analogues have significant burden on the functioning, well-being and daily lives of patients with acromegaly.

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          Most cited references17

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          Medical progress: Acromegaly.

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            Reference intervals for insulin-like growth factor-1 (igf-i) from birth to senescence: results from a multicenter study using a new automated chemiluminescence IGF-I immunoassay conforming to recent international recommendations.

            Measurement of IGF-I is a cornerstone in diagnosis and monitoring of GH-related diseases, but considerable discrepancies exist between analytical methods. A recent consensus conference defined criteria for validation of IGF-I assays and for establishment of normative data. Our objectives were development and validation of a novel automated IGF-I immunoassay (iSYS; Immunodiagnostic Systems) according to international guidelines and establishment of method-specific age- and sex-adjusted reference intervals and analysis of their robustness. We conducted a multicenter study with samples from 12 cohorts from the United States, Canada, and Europe including 15 014 subjects (6697 males and 8317 females, 0-94 years of age). We measured concentrations of IGF-I as determined by the IDS iSYS IGF-I assay. A new IGF-I assay calibrated against the recommended standard (02/254) and insensitive to the 6 high-affinity IGF binding proteins was developed and rigorously validated. Age- and sex-adjusted reference intervals derived from a uniquely large cohort reflect the age-related pattern of IGF-I secretion: a decline immediately after birth followed by an increase until a pubertal peak (at 15 years of age). Later in life, values decrease continuously. The impact of gender is small, although across the lifespan, women have lower mean IGF-I concentrations. Geographical region, sampling setting (community or hospital based), and rigor of exclusion criteria in our large cohort did not affect the reference intervals. Using large cohorts of well-characterized subjects from different centers allowed construction of robust reference ranges for a new automated IGF-I assay. The strict adherence to recent consensus criteria for IGF-I assays might facilitate clinical application of the results.
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              Consensus statement on the standardization and evaluation of growth hormone and insulin-like growth factor assays.

              Growth hormone (GH) and insulin-like growth factor I (IGF-I) measurements are widely used in the diagnosis of disorders of GH secretion, evaluation of children with short stature from multiple causes, management of disorders that lead to nutritional insufficiency or catabolism, and monitoring both GH and IGF-I replacement therapy. Therefore, there is an ongoing need for accurate and precise measurements of these 2 peptide hormones. Representatives of the Growth Hormone Research Society, the IGF Society, and the IFCC convened an international workshop to review assay standardization, requirements for improving assay comparability, variables that affect assay interpretation, technical factors affecting assay performance, assay validation criteria, and the development and use of normative data. Special attention was given to preanalytical conditions, the use of international commutable reference standards, antibody specificity, matrix requirements, QC analysis, and interference by binding proteins. Recommendations for each of these variables were made for measurements of each peptide. Additionally, specific criteria for IGF-I were recommended for age ranges of normative data, consideration of Tanner staging, and consideration of the effect of body mass index. The consensus statement concludes that major improvements are necessary in the areas of assay performance and comparability. This group recommends that a commutable standard for each assay be implemented for worldwide use and that its recommendations be applied to accomplish the task of providing reliable and clinically useful results.

                Author and article information

                Journal
                Eur J Endocrinol
                Eur. J. Endocrinol
                EJE
                European Journal of Endocrinology
                Bioscientifica Ltd (Bristol )
                0804-4643
                1479-683X
                March 2016
                17 December 2015
                : 174
                : 3
                : 355-362
                Affiliations
                [1]Department of Medicine for Endocrinology, Diabetes and Nutritional Medicine, Charité Universitätsmedizin , Campus Mitte, Charitéplatz 110117, Berlin, Germany
                [1 ]Oxford Centre for Diabetes, Endocrinology and Metabolism , Oxford, UK
                [2 ]Medizinische Klinik und Poliklinik IV, Klinikum der Universität München , Munich, Germany
                [3 ]Department of Endocrinology, The Christie , Manchester, UK
                [4 ]Department of Neurosurgery, University of Erlangen Nuremberg , Erlangen, Germany
                [5 ]Department of Neurosurgery, University of Duisburg-Essen , Essen, Germany
                [6 ]Practice for Endocrinology , Oldenburg, Germany
                [7 ]Endocrinology, Barts and the London School of Medicine, Queen Mary University , London, UK
                [8 ]Endokrinologie and Diabetologie im Zentrum , Stuttgart, Germany
                [9 ]Phase IV Programs , Basle, Switzerland
                [10 ]Chiasma , Newton, Massachusetts, USA
                [11 ]Endocrine Research Laboratories, Medizinische Klinik und Poliklinik IV, Klinikum der Universität München , Munich, Germany
                [12 ]Leiden University Medical Centre , Leiden, The Netherlands
                Author notes
                Correspondence should be addressed to C J Strasburger christian.strasburger@ 123456charite.de
                Article
                EJE151042
                10.1530/EJE-15-1042
                4722610
                26744896
                4d43027f-2750-49dd-bcf1-de8452c27412
                © 2016 The authors

                This work is licensed under a Creative Commons Attribution 3.0 Unported License

                History
                : 22 October 2015
                : 17 December 2015
                Categories
                Clinical Study

                Endocrinology & Diabetes
                Endocrinology & Diabetes

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