| 1. |
- Allen, David B, et al.
(author)
-
GH Safety Workshop Position Paper: a critical appraisal of recombinant human growth hormone therapy in children and adults.
- 2016
-
In: European Journal of Endocrinology. - 1479-683X. ; 174:2, s. 1-9
-
Journal article (peer-reviewed)abstract
- Recombinant human growth hormone (rhGH) has been in use for 30 years, and over that time its safety and efficacy in children and adults has been subject to considerable scrutiny. In 2001, a statement from the GH Research Society (GRS) concluded that 'for approved indications, GH is safe'; however, the statement highlighted a number of areas for on-going surveillance of long-term safety including; cancer risk, impact on glucose homeostasis and use of high dose pharmacological rhGH treatment. Over the intervening years, there have been a number of publications addressing the safety of rhGH with regard to mortality, cancer and cardiovascular risk and the need for longterm surveillance of the increasing number of adults who were treated with rhGH in childhood. Against this backdrop of interest in safety, the European Society of Paediatric Endocrinology (ESPE), the GRS and the Pediatric Endocrine Society (PES) convened a meeting to reappraise the safety of rhGH. The ouput of the meeting is a concise position statement.
|
|
| 2. |
|
|
| 3. |
|
|
| 4. |
- Christiansen, J. S., et al.
(author)
-
Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations
- 2016
-
In: European Journal of Endocrinology. - : Oxford University Press (OUP). - 0804-4643 .- 1479-683X. ; 174:6
-
Journal article (peer-reviewed)abstract
- Objective: The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). Participants: A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry. Evidence: Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues. Consensus process: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors. Conclusions: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.
|
|
| 5. |
|
|
| 6. |
- Sundqvist, Hanna S., et al.
(author)
-
Arctic Holocene proxy climate database - new approaches to assessing geochronological accuracy and encoding climate variables
- 2014
-
In: Climate of the Past. - : Copernicus GmbH. - 1814-9324 .- 1814-9332. ; 10:4, s. 1605-1631
-
Journal article (peer-reviewed)abstract
- We present a systematic compilation of previously published Holocene proxy climate records from the Arctic. We identified 170 sites from north of 58 degrees N latitude where proxy time series extend back at least to 6 cal ka (all ages in this article are in calendar years before present - BP), are resolved at submillennial scale (at least one value every 400 +/- 200 years) and have age models constrained by at least one age every 3000 years. In addition to conventional meta-data for each proxy record (location, proxy type, reference), we include two novel parameters that add functionality to the database. First, climate interpretation is a series of fields that logically describe the specific climate variable(s) represented by the proxy record. It encodes the proxy-climate relation reported by authors of the original studies into a structured format to facilitate comparison with climate model outputs. Second, geochronology accuracy score (chron score) is a numerical rating that reflects the overall accuracy of C-14-based age models from lake and marine sediments. Chron scores were calculated using the original author-reported C-14 ages, which are included in this database. The database contains 320 records (some sites include multiple records) from six regions covering the circumpolar Arctic: Fennoscandia is the most densely sampled region (31% of the records), whereas only five records from the Russian Arctic met the criteria for inclusion. The database contains proxy records from lake sediment (60 %), marine sediment (32 %), glacier ice (5 %), and other sources. Most (61 %) reflect temperature (mainly summer warmth) and are primarily based on pollen, chironomid, or diatom assemblages. Many (15 %) reflect some aspect of hydroclimate as inferred from changes in stable isotopes, pollen and diatom assemblages, humification index in peat, and changes in equilibrium-line altitude of glaciers. This comprehensive database can be used in future studies to investigate the spatio-temporal pattern of Arctic Holocene climate changes and their causes. The Arctic Holocene data set is available from NOAA Paleoclimatology.
|
|
