Results from the post-marketing surveillance (PMS) study, NCT05262764, for empagliflozin (Jardiance®) in patients with chronic heart failure (CHF) were posted on ClinicalTrials.gov on 2025-08-06. The study, which investigated real-world use, reported 61 participants with adverse drug reactions (ADRs) and specific incidence rates for clinical events.
Background
Empagliflozin, marketed as Jardiance®, was the subject of a post-marketing surveillance study designed to assess its long-term safety and effectiveness in patients with chronic heart failure (CHF) under real-world conditions. This surveillance aimed to gather additional data on the drug's performance outside of controlled clinical trial settings.
Trial design
The post-marketing surveillance study, NCT05262764, was completed with an enrollment of 1200 participants. The study focused on patients diagnosed with Heart Failure and investigated the long-term daily use of Jardiance® Tablets to evaluate their safety and effectiveness in a real-world setting.
Key results
The surveillance study reported on the safety and incidence of key cardiovascular events:
- The number of subjects with Adverse Drug Reactions (ADRs) in the Jardiance® group was 61 Participants.
- The incidence of All-cause Death was 3.01 Deaths per 100 person-years. A 95% Confidence Interval was noted but not provided in the results.
- The incidence of Cardiovascular Death was 0.90 Deaths per 100 person-years. A 95% Confidence Interval was noted but not provided in the results.
- The incidence of Hospitalizations for Heart Failure was 2.53 1st Hospitalization per 100 person-years. A 95% Confidence Interval was noted but not provided in the results.
What this means
The results from this post-marketing surveillance study provide real-world data on the safety and event rates associated with long-term empagliflozin (Jardiance®) use in patients with chronic heart failure. The reported incidence rates for adverse drug reactions, all-cause death, cardiovascular death, and hospitalizations for heart failure offer insights into the drug's profile in a broader patient population than typically seen in controlled clinical trials. These data contribute to the ongoing understanding of empagliflozin's safety and effectiveness in routine clinical practice for CHF management.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05262764, titled "Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)," were posted on 2025-08-06 on clinicaltrials.gov.