Safety of injectable semaglutide for type 2 diabetes

May 20, 2020Expert opinion on drug safety

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Abstract

Semaglutide is associated with a modest signal for increased gall bladder adverse events.

Semaglutide is the most powerful injectable GLP-1 receptor agonist available.
The cardiovascular outcome trial (SUSTAIN 6) demonstrated cardiovascular superiority.
Adverse events are primarily gastrointestinal, consistent with the GLP-1 receptor agonist class.
Concerns regarding thyroid and pancreatic safety have not been substantiated.
No evidence indicates renal or liver harm, with data suggesting potential benefits in liver disease.
An increase in diabetic retinopathy events reported in SUSTAIN 6 raises safety concerns.

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INTRODUCTION: Semaglutide is the most recently approved injectable glucagon-like peptide-1 receptor agonist (GLP-1RA) for people with type 2 diabetes (T2DM). It is one of the three currently marketed GLP-1RAs that can be administered once weekly.

AREAS COVERED: This review focusses on the safety of injectable semaglutide. Semaglutide has been assessed in the SUSTAIN phase 3 clinical trial programme, which included patients across the disease spectrum, i.e. treatment-naïve to those receiving insulin. The authors have looked at all published literature on safety considerations of once weekly GLP-1RA with particular reference to semaglutide.

EXPERT OPINION: Semaglutide is the most powerful injectable GLP-1RA. The cardiovascular (CV) outcome trial (SUSTAIN 6) showed CV superiority and its adverse event profile is as expected for the GLP-1RA class with predominantly gastrointestinal side-effects. Concerns about the thyroid and pancreatic safety have not been substantiated. There is no indication of renal or liver harm for semaglutide. Data consistent with reno-protection and benefit in liver disease is presented. There is a modest signal for increased gall bladder adverse events. An increase in diabetic retinopathy (DR) events in the SUSTAIN 6 trial is the most concerning safety signal. Caution regarding DR is needed when initiating semaglutide and recommendations are suggested.

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Safety of injectable semaglutide for type 2 diabetes

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