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Albiglutide for the...
Albiglutide for the treatment of type 2 diabetes mellitus : An integrated safety analysis of the HARMONY phase 3 trials
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- Ahrén, Bo (author)
- Lund University,Lunds universitet,Diabetes,Forskargrupper vid Lunds universitet,Lund University Research Groups
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- Carr, Molly C. (author)
- GlaxoSmithKline
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- Murphy, Karen (author)
- GlaxoSmithKline
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- Perkins, Christopher (author)
- Pharmaceutical Product Development, LLC (PPD)
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- Rendell, Marc (author)
- Creighton University
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- Mallory, Jason (author)
- GlaxoSmithKline
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- Wilson, Timothy (author)
- PCPS Qsci Clinical Statistics
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- Johnson, Susan L (author)
- GlaxoSmithKline
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(creator_code:org_t)
- Elsevier BV, 2017
- 2017
- English 10 s.
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In: Diabetes Research and Clinical Practice. - : Elsevier BV. - 0168-8227. ; 126, s. 230-239
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http://dx.doi.org/10...
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Abstract
Subject headings
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- Aims Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) stimulate the incretin system and lower glycaemic parameters in type 2 diabetes mellitus (T2DM). This analysis of clinical studies of up to 3 years evaluated the safety of albiglutide, a GLP-1 RA, in people with T2DM. Methods Integrated safety analysis included seven phase-3 T2DM studies of albiglutide compared with placebo and/or active comparators (a dipeptidyl peptidase-4 inhibitor, GLP-1 RA, insulin, sulphonylurea, and thiazolidinedione). Results Studies of 32 months (HARMONY 7), 1 year (HARMONY 6), and 3 years (HARMONY 1–5), reported similar rates of adverse events (AEs) (84.8%, 82.3%), and serious AEs (13.1%, 12.9%) between albiglutide and all comparators, respectively. AEs that did not differ between the groups included symptomatic or severe hypoglycaemia as well as nausea (12.0%, 11.3%) and vomiting (5.3%, 4.7%) for albiglutide and all comparators, respectively. According to the Medical Dictionary for Regulatory Activities preferred terms, only diarrhoea (13.7%, 9.9%), injection-site reaction (9.0%, 2.0%), and peripheral oedema (4.5%, 6.8%) had at least 2% difference between the albiglutide and all-comparator groups. In a similar integrated analysis, pancreatitis occurred more often with albiglutide (0.3%, 0.1%). Renal and cardiac function did not differ between the two groups. Conclusions In an integrated analysis of seven phase 3 clinical trials, albiglutide-treated patients experienced frequencies of AEs (including cardiovascular and renal) similar to the all-comparators group treated with other T2DM medications or placebo. Albiglutide treatment was associated with higher rates of diarrhoea and injection-site reactions, but not increased nausea and vomiting, versus all comparators.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Keyword
- Diabetes mellitus
- Glucagon-like peptide-1
- Incretins
- Long-term safety
Publication and Content Type
- art (subject category)
- ref (subject category)
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