Speakers
Deborah J. Wexler, MD, MSc
Associate Professor of Medicine and Diabetes Unit Chief
Massachusetts General Hospital and Harvard Medical School
Brendan M. Everett, MD, MPH
Associate Professor of Medicine
Divisions of Cardiology and Preventive Medicine
Brigham and Women’s Hospital and Harvard Medical School
Keywords
Cardiovascular Health; Kidney Disease; Patient Engagement
Key Points
- Comparative effectiveness of SGLT2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1 RA) for cardiac and kidney outcomes is a major question in cardiac-kidney-metabolic health.
- More broadly, comparative effectiveness of on-patent medications is crucial, yet not mandated, with little incentive (and some disincentive) for pharmaceutical companies to participate.
- The PRECIDENTD trial will seek to test one approach to evaluating the comparative effectiveness of expensive new therapies. Their primary aim is to conduct a head-to-head evaluation of SGLT2i versus GLP-1 RA for the prevention of major adverse cardiovascular/kidney events and death.
- Partnerships with patients, providers and stakeholders will be crucial to the success of PRECIDENTD. Patient engagement strategies include Community Engagement Studios, a Center for Effective Health Communication, and an interactive text messaging system to assess adherence.
- The research team sees the trial, which involves two expensive, brand-name drugs and requires extensive collaboration, as a true test of a pragmatic trial of branded pharmaceutical medications.
- Obtaining informed consent isn’t going to be pragmatic; it is time-consuming, challenging, and individualized.
- Constrained funding in the feasibility phase may hamper the growth of the trial. In a bureaucratic research environment, the administrative burden can take time and energy from a study.
Discussion Themes
Patients have been more interested in participating given that this trial compares one effective, well-understood active drug to another, so there’s no risk of being assigned to a placebo group.
The pragmatic nature of the trial means that the study team is recruiting participants who can go either way when it comes to the two treatment options. The highest-risk people won’t be enrolled.