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Full CAROLINA outcome trial data reveal long-term CVD safety profile

By Editor
12th June 2019
Pharmaceutical, Research Type 2 diabetes

Linagliptin (Trajenta) did not increase cardiovascular risk compared to glimepiride in adults with type 2 diabetes and cardiovascular risk, according to full data from the CAROLINA trial.

Boehringer Ingelheim and Eli Lilly and Company announced the findings on June 10 at the American Diabetes Association’s 79th Scientific Sessions in San Francisco.

The trial met its primary endpoint, defined as non-inferiority for linagliptin versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE), which occurred in 11.8 percent (356 people) of the linagliptin group compared to 12.0 percent (362 people) of the glimepiride group, according to the results. The overall safety profile of linagliptin in CAROLINA® was consistent with previous data, and no new safety signals were observed, the companies said.

CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) assessed linagliptin safety over the longest period ever studied in a DPP-4 inhibitor cardiovascular outcome trial, with a median follow-up of more than six years. Linagliptin was similar but not superior to glimepiride in the secondary endpoint of 3P-MACE plus hospitalisation for unstable angina (4P-MACE – 13.2% for linagliptin versus 13.3% for glimepiride).

In CAROLINA® a higher proportion of people within the linagliptin group (16.0%) achieved the secondary composite efficacy endpoint of treatment sustainability versus the glimepiride group (10.2%). The secondary composite efficacy outcome was defined as HbA1c at or below 7% at the final visit without rescue medication, moderate or severe hypoglycaemia or a 2% or greater weight gain. Compared with glimepiride, linagliptin demonstrated similar overall effects on HbA1c, but significantly reduced the relative risk for hypoglycaemia (low blood sugar) by 77% (10.6% of patients treated with linagliptin experienced any hypoglycaemic incident versus 37.7% for glimepiride, absolute reduction 27.1%), the companies said. This risk reduction was consistent and significant across all hypoglycaemia categories, including severe hypoglycaemia and those requiring hospitalisation, the study found. Linagliptin was also associated with a modest weight reduction of 1.5 kg versus glimepiride, results indicated.

Dr Waheed Jamal, Corporate Vice President and Head of Cardiovascular & Metabolic Medicine, Boehringer Ingelheim, said: “CAROLINA is unique in that it is the only DPP-4 inhibitor cardiovascular outcome trial with an active comparator.When additional glucose-lowering is needed, DPP-4 inhibitors and sulfonylureas continue to be frequently used as add-on therapies to metformin. These data can further support physicians in choosing the most appropriate glucose-lowering treatment for each individual patient.”

Dr Jeff Emmick, Vice President, Product Development, Lilly Diabetes, added: “The American Diabetes Association and European Association for the Study of Diabetes recommend type 2 diabetes treatments with proven cardiovascular benefits for patients with established cardiovascular disease. But, physicians considering additional therapies to lower blood glucose for their patients need an additional agent with an established long-term safety profile. These new data from CAROLINA, along with data from the placebo-controlled cardiovascular outcome trial CARMELINA, expand the evidence and experience with linagliptin, to provide healthcare professionals with confidence in the long-term safety profile across a broad range of adult patients with type 2 diabetes.”

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