Whether MSD’s ertugliflozin, a new antidiabetic SGLT-2 (sodium-glucose cotransporter-2) inhibitor, will take on the market with an aggressive clinical trial is drawing attention.
MSD unveiled the design of the clinical trial on the agent, called “VERTIS-CV,” in a U.S. journal of cardiology in December. The study is to prove ertugliflozin’s cardiovascular benefits and safety such as reduced heart failure risk.
It has long been necessary to demonstrate cardiovascular safety in the treatment of diabetes.
The U.S. Food and Drug Administration set up a rule that all diabetes treatments must demonstrate cardiovascular safety through a study. Guidelines for antidiabetic therapies are increasingly recommending medicines that proved not only safety but benefits first.
Around the world, most commonly used SGLT-2 inhibitors include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. Ipragliflozin is also used in some Asian countries including Korea.
Empagliflozin and canagliflozin showed cardiovascular and renal benefits in Cardiovascular Outcome Trial (CVOT), and dapagliflozin did so recently.
Ertugliflozin is seeking a niche to compete against similar rival drugs.
The VERTIS-CV study will be on patients almost all suffering from cardiovascular disease, just like the other study on rival agent empagliflozin. The goal is apparently to obtain precise results on cardiovascular benefits, observers said.
The most recent CVOT outcome of the SGLT-2 inhibitor, dapagliflozin, demonstrated cardiovascular safety but failed to prove cardiovascular benefits.
Only 40.6 percent of the patients who participated in the dapagliflozin study had cardiovascular disease, which made it difficult to show the agent’s efficacy to reduce cardiovascular disease, experts said.
However, dapagliflozin produced a meaningful result for patients with heart failure. The drug lowered the risk of hospitalization caused by cardiovascular death and heart failure by 17 percent, compared to the placebo, and showed benefits in heart failure which accompanies high medical costs.
Recently, the FDA issued a recommendation for diabetes drug researchers to evaluate the drugs’ effects on heart failure as well as significant adverse cardiovascular events (MACE).
Park Jung-hwan, a professor at the endocrinology and metabolism department at Hanyang University Medical Center, said a recent study revealed that heart failure occurred not only in patients with coronary artery disease and that diabetes itself was a risk factor for heart failure. “That is why the FDA issued such recommendation to include the effect on heart failure in cardiovascular studies,” he said.
MSD was quick to focus on the heart failure effect. In the VERTIS-CV study, the company filled 23.1 percent of the participating patients with those who have a history of heart failure. The percentage is twice that of other studies of rival drugs that were around 9.9-14.4 percent.
The American Heart Journal published the MSD’s research on ertugliflozin in December, with the full title, “Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV).”