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Disclosure:
Szarek reports receiving grants from Lexicon while conducting the study; CiVi and Esperion personal fees; other scholarships from Baxter, Jannsen, and Resverlogix; Scholarships, personal fees, and non-financial assistance outside of Sanofi’s work submitted; as well as grants and non-financial support outside of Regeneron’s submitted work. Please refer to the study for all relevant financial information from the other authors.
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Sotagliflozin increased the number of days of life and out of hospital compared to placebo in patients with type 2 diabetes who were at high risk of intermittent hospitalization due to worsening heart failure.
The results come from a new pre-specified analysis of participants enrolled in the study, Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes After Worsening Heart Failure (SOLOIST-WHF).
Reference: Szarek M, et al. Anna Intern Med. 2021; doi: 10.7326 / M21-0651.
Previously, the SOLOIST-WHF study showed that sotagliflozin reduced cardiovascular deaths, as well as hospital admissions and urgent visits for heart failure in patients with diabetes recently hospitalized for worsening heart failure. Michael Szarek, PhD, MRS, a visiting professor in the cardiology department at the University of Colorado School of Medicine, said Healio Primary Care.
In the current analysis, Szarek and colleagues examined the days of life and out of the hospital (DAOH) among 1,222 older adults from 32 countries, including about a third women who took 200 mg of sotagliflozin (with the potential to reduce the dose to 400 mg) daily or Placebo.
Michael Szarek
“We knew about the primary endpoint” [of SOLOIST-WHF] that sotagliflozin reduced the overall rate of hospital admissions for heart failure and there was a favorable trend in all-cause mortality, ”Szarek said said Healio Primary Care. “But based on these results, we didn’t know if this would lead to an expansion of DAOH. In addition, few previous studies have shown a beneficial effect of treatment on DAOH as it involves hospitalization for any reason, many of which should not necessarily be influenced by a particular treatment. “
In the new pre-specified analysis, patients were followed for a median of 9 months. The researchers wrote that 38.5% of the sotagliflozin group and 41.4% of the placebo group were hospitalized at least once. In the sotagliflozin group, 16.3% of patients were hospitalized more than once compared with 22.1% in the placebo group. The researchers reported 64 deaths in the sotagliflozin group and 76 deaths in the placebo group.
The DAOH rate was 3% higher in the sotagliflozin group than in the placebo group (rate ratio = 1.03; 95% CI, 1-1.06). That difference was mainly due to a decrease in the death rate (rate ratio = 0.71; 95% CI 0.52-0.99) rather than a decrease in hospital days regardless of the cause, the researchers said. The results showed for each more more days alive and outside the hospital (91.8 vs. 88.9 days), fewer deceased and outside the hospital (6.3 vs. 8.9 days) and fewer days in hospital (1st , 9 vs. 2.2 days). 100 days of follow-up in the sotagliflozin group compared to the placebo group.
“Even given the positive results of the primary endpoint, the results were not necessarily to be expected,” said Szarek in the interview.
The results will help clinicians initiate an SGLT2 inhibitor as soon as possible after hospitalization, said Szarek.
“Not only is reducing hospital stays for any reason a clear benefit for patients, but the COVID-19 pandemic also illustrates the health system benefits of keeping patients out of the hospital in general,” he said.
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