Trajenta safe: JAMA study

The result of a trial to assess both the cardiovascular and renal outcomes of a DPP-4 inhibitor has been published in the Journal of the American Medical Association (JAMA).

The Carmelina study assessed the effect of Trajenta (linagliptin) on cardiovascular and renal outcomes in nearly 7,000 patients with type 2 diabetes and high cardiovascular risk, the majority of whom also had kidney disease.

Trajenta demonstrated a similar long-term cardiovascular safety profile to placebo in adults with type 2 diabetes1.

No increase in the rate of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke – the primary endpoint – was reported with Trajenta (5mg) compared with placebo (12.4 versus 12.2 per cent) when added to the standard of care which included glucose-lowering and cardiovascular medicines.

In the study, the overall safety profile of Trajenta was consistent with previous data and no new safety signals were observed. There was no increase in hospitalisation for heart failure in the patients treated with linagliptin.

Details of the study are available on the trial website at 

Study Global Steering Committee Member and Executive Director of the George Institute in Sydney, Professor Vlado Perkovic said Carmelina was the first study to assess both cardiovascular and renal outcomes for a DPP-4 inhibitor.

“This trial provides important evidence of both the cardiovascular and renal outcomes of Trajenta for type 2 diabetes patients with high cardiovascular risk,” he said.

“While an increase in the risk of hospitalisation for heart failure has been observed in some other DPP-4 inhibitor outcomes trials, Carmelina clearly showed no such concerns with Trajenta.

“Importantly, Carmelina also included patients with impaired kidney function. That’s obviously a major risk factor for cardiovascular disease and is a patient group that has been under-represented in other DPP-4 inhibitor cardiovascular outcome trials.

“Doctors can be reassured that Trajenta is an effective and well-tolerated treatment, with a simple dosing regimen, for a broad range of patients with type 2 diabetes. This includes patients with and without type 2 diabetes comorbidities, patients with cardiovascular disease and those who also have kidney disease, who we see frequently in clinical practice,” he said.

It is estimated that 40 per cent of the 1.7 million Australians with type 2 diabetes will develop chronic kidney disease2,3.


  1. Rosenstock, J. et al. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk. The Carmelina randomised clinical trial. JAMA 2018; doi: 10.1001/jama.2018.18269.
  2. The Royal Australian College of General Practitioners. General practice management of type 2 diabetes: 2016-18. East Melbourne, Vic: RACGP, 2016.
  3. Diabetes Australia. About Diabetes, 2018. Available at:

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