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Drug Safety Evaluation

Linagliptin for the treatment of type 2 diabetes mellitus: a drug safety evaluation

 

Abstract

Introduction: Established treatments for type 2 diabetes mellitus (T2DM) have side effects that limit their use in specific populations. New therapies with improved safety profiles are needed, especially because of the chronic and progressive nature of T2DM.

Areas covered: This review describes the overall safety and tolerability of linagliptin – a dipeptidyl peptidase-4 inhibitor that improves glycemic control without increasing risk for hypoglycemia and without weight gain. Specifically, the safety of linagliptin is evaluated in difficult-to-treat patients with T2DM, in relation to risk of cardiovascular (CV) events and acute pancreatitis, and in comparison with other antihyperglycemic drugs.

Expert opinion: Linagliptin is generally well tolerated in a broad range of patient populations. It can be used in patients with renal impairment without dose titration and may be a rational alternative treatment in this vulnerable population. Ongoing long-term trials are fully evaluating the CV and renal safety profile of linagliptin.

Declaration of interest

AH Barnett was fully responsible for all content and editorial decisions, was involved at all stages of manuscript development and has approved the final version of the review, which reflects his interpretation and conclusions. Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Radha Narayan, PhD, of Envision Scientific Solutions, during the preparation of this Review. Boehringer Ingelheim was given the opportunity to check the data used in the manuscript for factual accuracy only. AH Barnett has received honoraria for lectures and advisory work from Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, Bristol Myers Squibb/AstraZeneca, Takeda, Eli Lilly, Novo Nordisk, Sanofi, Janssen and Roche. The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Notes

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