Linagliptin Safe in Diabetes Across Age, Renal Groups

11 Jul, 2019
SAN FRANCISCO — In patients with type 2 diabetes and either cardiovascular disease or impaired kidney function, the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (Tradjenta, Boehringer Ingelheim/Lilly) demonstrated cardiovascular safety, no increased risk of hospitalization for heart failure, and "reassuring" kidney safety including a reduction in albuminuria — across renal function and age groups — over 2.2 years.

These findings, from a closer look at the Cardiovascular and Renal Microvascular Outcome Study With Linagliptin (CARMELINA) outcome trial of linagliptin, showed that safety of the agent can be extended to older patients and those with worse kidney function, researchers report.

They presented these findings during a press briefing and symposium last week at the American Diabetes Association (ADA) 2019 Scientific Sessions.

In a population that included older patients and those with severe chronic kidney disease (CKD), linagliptin "demonstrated a reassuring long-term cardiovascular and safety profile, with a reduction in the progression of albuminuria," no increase in hypoglycemia, and no need to adjust the dose, CARMELINA investigator Julio Rosenstock, MD, University of Texas Southwestern Medical Center, Dallas, summarized to the press.
These data are “particularly important” because they prove “categorically the cardiovascular and kidney safety of linagliptin in those with type 2 diabetes who are at a high cardiovascular risk when some degree of kidney disease is associated,” Rosenstock noted.

"These are patients that every practicing doctor [who treats patients with type 2 diabetes] sees...on a daily basis and are difficult to treat because of the risk of hypoglycemia," he explained.

"The take-home message for the practicing clinician," said press briefing moderator Robert H. Eckel, MD, University of Colorado Anschutz Medical Campus, is that CARMELINA showed linagliptin "looks like a good choice," especially for older patients with type 2 diabetes and more advanced kidney disease.

And there was almost a hint of even greater benefit in individuals who were older than 75 years, he noted to Medscape Medical News.

"It just makes us feel that linagliptin in populations that in the past we weren't certain about look okay," he added. "It would make me modify my prescribing patterns if I had a choice — if I wanted to use a DPP-4 inhibitor in those groups."

Main Findings Showed Cardiac and Renal Safety
The main results from CARMELINA were presented at the European Association for the Study of Diabetes (EASD) 2018 Annual Meeting in October, as reported by Medscape Medical News and published online in JAMA.

Among adults with type 2 diabetes at high risk of cardiovascular events (because of a history of MI or advanced coronary artery disease) and albuminuria, or they had impaired kidney function with or without albuminuria, linagliptin added to standard care did not increase the incidence of these events over a follow-up of 2.2 years.
Specifically, linagliptin was not inferior to placebo for the primary outcome of the 3-point major adverse cardiovascular events (MACE) and for a predefined secondary composite renal outcome.