MSD is expected to announce the results of a study, whether Steglatro (ingredient: ertugliflozin), the latecomer sodium-glucose cotransporter 2 (SGLT-2) inhibitor, showed cardiovascular benefits. The company completed the study late last year.

SGLT-2 inhibitors are a class of drugs that inhibit the reabsorption of glucose in the kidney from lowering blood sugar.

Some expect that MSD will obtain the most desirable data from the study because the company designed the trial based on SGLT-2 inhibitors’ therapeutic effects for cardiovascular diseases such as heart failure.

However, others raise concerns that vague results might rekindle the controversy over the effectiveness of SGLT-2 inhibitors.

According to the online site Clinicaltrial.gov, the VERTIS-CV trial on Steglatro ended on Dec. 30, 2019.

The VERTIS-CV study evaluates the cardiovascular safety and benefits of Steglatro in patients with type-2 diabetes who accompany cardiovascular diseases. About 8,000 diabetic patients participated in the trial.

Other SGLT-2 inhibitors such as Forxiga (dapagliflozin), Jardiance (empagliflozin), and Invokana (canagliflozin) proved their safety (non-inferiority to placebo) through cardiovascular trials. However, Forxiga failed to prove cardiovascular benefits (superiority to placebo) in the DECLARE study.

After the DECLARE study results came, diabetes experts raised a question that different SGLT-2 inhibitors might show different efficacy.

As the DAPA-HF trial on Forxiga demonstrated the full therapeutic effect for heart failure, physicians started to recognize SGLT-2 inhibitors’ overall cardiovascular benefits.

Learning lessons from the Forxiga trials, MSD designed the VERTIS-CV study to prove Steglatro’s cardiovascular benefits more clearly.

The company set the participating patients as a high-risk group where 99.9 percent of them had cardiovascular diseases. The company also doubled the proportion of patients with heart failure, compared to that of those who participated in the DECLARE study on Forxiga.

In the DECLARE study, 40.6 percent of patients had cardiovascular diseases, and only 9.9 percent of them had a history of heart failure.

Experts said the upcoming results of the VERTIS-CV study on Steglatro would yield the most favorable outcomes among trials on SGLT-2 inhibitors.

On the other hand, skeptics worried that failing to prove cardiovascular benefits in the VERTIS-CV study, even with the most favorable conditions, would prompt the controversy over the efficacy of SGLT-2 inhibitors.

“If the outcomes fall short of everyone’s anticipation for positive results, people will focus the problem on the drug itself. If the results are positive, they will be regarded as SGLT-2 inhibitors’ overall effect,” said Kim Sung-rae, a professor at the Endocrinology Department of the Catholic University of Korea Bucheon St. Mary’s Hospital.

MSD’s study results will have to be exceptionally good because Steglatro is the latecomer SGLT-2 inhibitor, he added.

kym@docdocdoc.co.kr

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