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Cardiology Month in Review: September 2021

September's cardiology month in review features FDA news related to empagliflozin and tofacitinib, a study into the potential impact of sacubitril/valsartan's label expansion, and a study from HFSA 2021.

Top Stories of September 2021:

  1. FDA Grants Empagliflozin Breakthrough Therapy Designation for HFpEF
    Announced by Boehringer Ingelheim and Eli Lilly and Company on September 9, the Breakthrough Therapy designation for empagliflozin is based on the results of the EMPEROR-Preserved trial.
  2. ESC Congress 2021 Expert Perspective: Top 5 Studies With Brett Nowlan, MD
    Practical Cardiology editorial advisory board member Brett Nowlan, MD, compiled a top 5 list of studies he thought were noteworthy from ESC Congress 2021 and offers his perspective on why he chose each study.
  3. Digital Apps Could Improve Outcomes, Adherence Among Patients With Heart Failure
    Data from the CONNECT-HF trial from HFSA 2021 suggest use of a digital tool designed to improve adherence could contribute to improving outcomes among patients discharged from the hospital with heart failure with reduced ejection fraction.
  4. Sacubitril/Valsartan Label Expansion Could Increase Patient Base by Nearly 2 Million
    An analysis leveraging data from NHANES, the GWTG-HF registry, and PARAGON-HF is providing insight into the potential impact of the FDA's expanded label for sacubitril/valsartan based on optimal implementation.
  5. FDA Issues Warning Over Potential Cardiovascular Disease Risk with Tofacitinib
    Announced in a statement on September 1, the FDA warning is an update to the FDA Drug Safety Communication issued on February 4, 2021 and the results of a review of a trial that found a serious increased risk of CV-related events with the drug.