Lilly Announces Tradjenta Cardiovascular Outcome Study Data
Zacks Investment Research | Jun 10, 2019 09:03PM ET
Eli Lilly (NYSE:LLY) and Boehringer Ingelheim announced detailed data from the cardiovascular outcome study – CAROLINA – evaluating their type II diabetes drug, Tradjenta (linagliptin) in patients with type II diabetes.
In February, the companies announced that the study met the primary endpoint of non-inferiority to Sanofi’s (NASDAQ:SNY) Amaryl (glimepiride). Detailed data from the study were presented at the American Diabetes Association's Scientific Sessions.
Shares of Lilly have decreased 1.6% so far this year against the industry ’s increase of 1.7%.
Patients treated with the DPP-4 inhibitor, Tradjenta, did not show increased cardiovascular risk compared to Amaryl.
The time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE) in patients was non-inferior to Amaryl, which was the primary endpoint of the study. It was seen that 11.8% of the patients treated with Tradjenta suffered 3P-MACE compared to 12% for Amaryl.
Moreover, data from the study showed that patients treated with Tradjenta experienced fewer events of hypoglycemia (low blood sugar) and resulted in modest weight reduction versus Amaryl. Tradjenta reduced the relative risk of hypoglycemia by 77% compared to Amaryl. Tradjenta was also associated with modest weight reduction of 1.5 kg versus Amaryl. Treatment with Tradjenta and Amaryl resulted in a similar effect on A1C, a measure of average blood glucose levels over the past 3 months,
The CAROLINA study assessed the safety profile for Tradjenta for a median follow-up of more than six years. The overall safety profile for the drug was consistent with previous data. Study results from CAROLINA, along with previously completed CARMELINA outcomes study, which showed similar long-term cardiovascular safety for Tradjenta compared with placebo, may boost the drug’s prospects as a better therapeutic option for patients with type II diabetes.
Tradjenta is a key drug in Lilly’s Endocrinology segment, which generated sales of $131.9 million. Lilly also markets a combination of Tradjenta and SGLT-2 inhibitor, Jardiance, under the trade name Glyxambi for type II diabetes patients. Earlier this month, a triple combination of Jardiance, Tradjenta and metformin extended release was approved by the FDA as a fixed dose tablet for type II diabetes.
Lilly and Boehringer Ingelheim jointly develop and commercialize Trajenta, Jentadueto, Jardiance, Glyxambi, Synjardy and Basaglar as a part of their diabetes alliance.
Ina separate press release, Lilly announced data from a new post-hoc analysis of the EMPA-REG OUTCOME cardiovascular study evaluating Jardiance in type II diabetes patients. Data from the study showed that treatment with Jardiance reduced cardiovascular and renal risk in patients with chronic kidney disease without overt proteinuria.
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