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  • 1
    Online Resource
    Online Resource
    Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH
    Oxford University Press (OUP) ; 2009
    In:  European Journal of Endocrinology Vol. 161, No. 4 ( 2009-10), p. 533-540
    Details
    In: European Journal of Endocrinology, Oxford University Press (OUP), Vol. 161, No. 4 ( 2009-10), p. 533-540
    Abstract: Changes observed during adult GH deficiency (GHD) are most often reversed with the administration of recombinant human GH (rhGH). To avoid daily injections, a long-acting GH molecule has been obtained by covalent binding of polyethylene glycol (PEG) with rhGH (PEG–GH), allowing weekly s.c. injections. This study was designed to assess its efficacy and safety, in adult GHD subjects. Design and methods This was a randomized, double-blind, placebo-controlled, multiple-dose, parallel group study. Subjects were recruited from 34 centers. A total of 105 subjects with GHD were assigned a treatment. They received 6 weekly injections of either PEG–GH or placebo. Subjects were randomized into one out of four treatment groups (Groups A–D) or placebo (Group E). Groups A, B, and C received 1, 3, and 4 mg PEG–GH respectively, for the first 3 weeks followed by 2, 6, and 8 mg PEG–GH respectively, for the remaining 3 weeks. Group D received 4 mg PEG–GH for 6 weeks. Group E received placebo. The study was suspended because of the development of lipoatrophy in certain subjects and restarted with an injection rotation plan, before being terminated due to further subjects developing lipoatrophy. Results A total of 13 cases of injection-site lipoatrophy were reported, of which ten were in females and three occurred after the first injection; all cases were independent of PEG–GH dose or IGF1 levels, either basal or under treatment. Conclusion The unpredictable occurrence of injection-site lipoatrophy with weekly long-acting pegylated GH molecules may be a limiting factor for their development.
    Type of Medium: Online Resource
    ISSN: 0804-4643 , 1479-683X
    URL: Article
    DOI: 10.1530/EJE-09-0422
    RVK:
    WA 15000
    Language: Unknown
    Publisher: Oxford University Press (OUP)
    Publication Date: 2009
    detail.hit.zdb_id: 1183856-5
    detail.hit.zdb_id: 1485160-X
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  • 2
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    Online Resource
    A randomized, controlled, multicentre trial comparing pegvisomant alone with combination therapy of pegvisomant and long‐acting octreotide in patients with acromegaly
    Wiley ; 2009
    In:  Clinical Endocrinology Vol. 71, No. 4 ( 2009-10), p. 549-557
    Details
    In: Clinical Endocrinology, Wiley, Vol. 71, No. 4 ( 2009-10), p. 549-557
    Abstract: Objective  For patients with acromegaly who are suboptimally controlled on long‐acting octreotide (LAR), treatment options are to switch to pegvisomant monotherapy (PM) or add pegvisomant to LAR (P‐LAR). Our objective was to evaluate if the safety and efficacy of these regimens differ. Design  This was an open‐label, multicentre, randomized, 40‐week outpatient study. The control arm consisted of patients controlled on LAR ( n  = 28). Patients  A total of 27 patients with suboptimally controlled acromegaly [as indicated by a serum IGF‐I level ≥ 1·3 × upper limit of normal (ULN) of the age‐related reference range] were randomized to PM (10 mg once daily initially, then adjusted in 5‐mg increments every 8 weeks based on IGF‐I levels) and 29 to P‐LAR (LAR dosing remained fixed). Measurements  The primary end‐point was adverse events (AEs). The secondary end‐point was biochemical IGF‐I‐based efficacy. The RIA for IGF‐I was discontinued by the manufacturer during the study and a chemiluminescent assay was subsequently used. Previously obtained IGF‐I levels were re‐analysed. Results  PM and P‐LAR were well tolerated and there were no differences in the number of AEs. Patients receiving P‐LAR tended to be more likely to have clinically significant increases in hepatic transaminase levels, especially those receiving high‐dose LAR. Normalization of IGF‐I was similar with both regimens (56% and 62% of patients for PM and P‐LAR respectively). The change in IGF‐I assay resulted in lower rates of IGF‐I normalization than expected. Reductions in fasting glucose levels were greater with PM than with P‐LAR (−0·8 mmol/l; 95% confidence interval −1·16, −0·53 mmol/l). Conclusions  In patients suboptimally controlled on LAR, PM and P‐LAR were equally well tolerated and effective in normalizing IGF‐I, and overall clinical improvement was observed with both regimens. Thus, pegvisomant monotherapy and adjunctive therapy are equally viable options for the treatment of LAR‐resistant acromegaly.
    Type of Medium: Online Resource
    ISSN: 0300-0664 , 1365-2265
    URL: Issue
    URL: Article
    DOI: 10.1111/cen.2009.71.issue-4
    DOI: 10.1111/j.1365-2265.2009.03620.x
    RVK:
    XA 10000
    Language: English
    Publisher: Wiley
    Publication Date: 2009
    detail.hit.zdb_id: 121745-8
    detail.hit.zdb_id: 2004597-9
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  • 3
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    Online Resource
    Four consecutive yearly point-prevalence studies in Wales indicate lack of improvement in sepsis care on the wards
    Springer Science and Business Media LLC ; 2021
    In:  Scientific Reports Vol. 11, No. 1 ( 2021-08-10)
    Details
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 11, No. 1 ( 2021-08-10)
    Abstract: The ‘Sepsis Six’ bundle was promoted as a deliverable tool outside of the critical care settings, but there is very little data available on the progress and change of sepsis care outside the critical care environment in the UK. Our aim was to compare the yearly prevalence, outcome and the Sepsis Six bundle compliance in patients at risk of mortality from sepsis in non-intensive care environments. Patients with a National Early Warning Score (NEWS) of 3 or above and suspected or proven infection were enrolled into four yearly 24-h point prevalence studies, carried out in fourteen hospitals across Wales from 2016 to 2019. We followed up patients to 30 days between 2016–2019 and to 90 days between 2017 and 2019. Out of the 26,947 patients screened 1651 fulfilled inclusion criteria and were recruited. The full ‘Sepsis Six’ care bundle was completed on 223 (14.0%) occasions, with no significant difference between the years. On 190 (11.5%) occasions none of the bundle elements were completed. There was no significant correlation between bundle element compliance, NEWS or year of study. One hundred and seventy (10.7%) patients were seen by critical care outreach; the ‘Sepsis Six’ bundle was completed significantly more often in this group (54/170, 32.0%) than for patients who were not reviewed by critical care outreach (168/1385, 11.6%; p   〈  0.0001). Overall survival to 30 days was 81.7% (1349/1651), with a mean survival time of 26.5 days (95% CI 26.1–26.9) with no difference between each year of study. 90-day survival for years 2017–2019 was 74.7% (949/1271), with no difference between the years. In multivariate regression we identified older age, heart failure, recent chemotherapy, higher frailty score and do not attempt cardiopulmonary resuscitation orders as significantly associated with increased 30-day mortality. Our data suggests that despite efforts to increase sepsis awareness within the NHS, there is poor compliance with the sepsis care bundles and no change in the high mortality over the study period. Further research is needed to determine which time-sensitive ward-based interventions can reduce mortality in patients with sepsis and how can these results be embedded to routine clinical practice. Trial registration Defining Sepsis on the Wards ISRCTN 86502304 https://doi.org/10.1186/ISRCTN86502304 prospectively registered 09/05/2016.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    URL: Article
    DOI: 10.1038/s41598-021-95648-6
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2615211-3
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