CARMELINA findings confirmed in highest CV risk subgroups
medwireNews: Secondary data from the CARMELINA trial, presented at the 79th ADA Scientific Sessions in San Francisco, California, USA, confirm the positive primary cardiovascular and renal safety findings, this time in particularly high-risk patients.
All of the participants in CARMELINA had type 2 diabetes and were at high risk for cardiovascular (CV) events because of macrovascular disease or albuminuria, or impaired kidney function with or without albuminuria.
The primary analysis, previously reported by medwireNews, showed that, after a median 2.2 years of follow-up, there was no significant difference between patients who received linagliptin 5 mg/day (n=3494) in addition to standard care and those who received placebo (n=3485) for the composite CV endpoint of CV death, nonfatal myocardial infarction, or nonfatal stroke.
There was also no difference between the groups in the composite renal outcome of end-stage renal disease, death due to kidney disease, or a sustained decrease in estimated glomerular filtration rate (eGFR) from baseline of at least 40%.
The secondary analysis showed that the results did not differ by age, including among those aged 75 years and older, or by renal function, even in patients with the lowest eGFR (<30 ml/min per 1.73m2).
They also showed that progression to albuminuria was reduced with linagliptin versus placebo in all but the lowest eGFR subgroup, and that there was no increased risk for hospitalization for heart failure by age or renal function.
Finally, the CARMELINA investigators reported that glycated hemoglobin was reduced with no increased risk for hypoglycemia regardless of kidney function.
Study co-author Mark Cooper, from Monash University in Melbourne, Victoria, Australia, said in a press statement that the findings “will better inform clinicians about the choices of glucose-lowering therapies.”
“The results also expand the evidence-base for individuals with reduced renal function at advanced age. It was particularly reassuring that the effects were consistent in individuals that were older than 75. Typically, elderly patients are not allowed to participate [in clinical trials], yet this is the age group in which the incidence of type 2 diabetes is increasing most rapidly.”
Lead investigator Julio Rosenstock, from the University of Texas Southwestern Medical Center in Dallas, USA, added: “This data is particularly important because it proves 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.”
By Laura Cowen
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