PEP-0008FDA-approved

ALBIGLUTIDE

Also known as

FDA-approved GLP-1 receptor agonist for type 2 diabetes management. Strong evidence grade — the Harmony Outcomes RCT demonstrated cardiovascular benefit. Approved status, low risk.


Evidence

Strong· 8.4

Strong human RCT or meta-analysis

Risk band

Low

Well-characterized, minor reported AEs

Research goals

Summary

Albiglutide is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist used, in combination with diet and exercise, for the treatment of type 2 diabetes, either alone or with other antidiabetic agents [1,4]. In the large double-blind, randomized, placebo-controlled Harmony Outcomes trial in patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo for major adverse cardiovascular events, supporting consideration of evidence-based GLP-1 receptor agonists in this population [2]. Its gastrointestinal tolerability appears comparable to placebo and it has been studied across stages of renal failure, though concerns include a possible imbalance of pancreatitis cases and injection-site reactions leading to discontinuation in up to ~2% of participants [4]; an isolated case of albiglutide-induced pancreatitis has been reported [3]. No published reports of hepatotoxicity have been attributed to albiglutide [1]. Overall the human clinical evidence is robust, reflecting an approved therapeutic with outcome-trial data.

Sources

  1. 1. Albiglutide , 2012.
  2. 2. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial Lancet (London, England), 2018.
  3. 3. Albiglutide-induced pancreatitis Therapeutic advances in drug safety, 2016.
  4. 4. Albiglutide for the management of type 2 diabetes Expert review of endocrinology & metabolism, 2018.

For educational purposes only.