MINNEAPOLIS – The Minneapolis Heart Institute Foundation® (MHIF) today announced the publication of data from the Determining Statin Intolerance For Rosuvastatin (DESIFOR) Pilot Study in the Journal of the American College of Cardiology (JACC): Advances. This trial aimed to demonstrate that patients who were previously not able to tolerate a statin due to side effects could become tolerant of a statin by participating in a “N of 1” randomized trial, where patients alternate between statin therapy and a placebo every month but are unaware which intervention they are receiving.
“We have clear evidence that statin therapy reduces risk for heart attack and stroke, but many patients are understandably concerned about safety and possible side effects of statin therapy,” said Michael Miedema, MD, MPH, director of the Nolan Family Center for Cardiovascular Health at MHIF and principle investigator for the trial. “However, we also have clear evidence that the majority of statin side effects are not necessarily directly related to the statin, so we wanted to come up with a way to demonstrate that to the patient and evaluate if we could help them tolerate a statin.”
Patients participating in the study received a weekly survey via text message to monitor possible side effects and overall quality of life while on 20mg of rosuvastatin and while on a placebo. At the end of the 6-month study, patients were received their results to see if they had more side effects while on the statin compared to placebo. Eighteen patients completed the study with the 17 patients having no clear evidence statin intolerance. Fourteen patients were willing to try going back on a statin, of which 12 tolerated the statin well for 3 months without side effects.
“For patients that were willing to participate in this study, we were able to get 2/3 of them back on a statin without any significant side effects,” said Dr. Miedema. “Considering that other cholesterol medications may not work as well or can be quite costly, this approach holds the potential to be a cost-effective way to improve cholesterol treatment and reduce cardiovascular risk.”
About the MHIF Nolan Family Center for Cardiovascular Health
The Nolan Family Center for Cardiovascular Health, under the leadership of Dr. Miedema, is dedicated to cardiovascular prevention research. MHIF has a long history of groundbreaking research and education across a wide spectrum of prevention-related topics, including cardiovascular risk prediction using coronary artery calcium testing, the impact of blood pressure and cholesterol guidelines, the optimal use of statin therapy, and the impact of nutrition and other healthy lifestyle behaviors.
About the Minneapolis Heart Institute Foundation®
The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.
Scientific Innovation and Research – MHIF is a recognized leader across all specialties of heart and vascular research. Each year, MHIF leads more than 220 research studies with more than 2,200 patients and publishes more than 250 articles to share learnings from research. MHIF research has improved the standard of care for patients around the world, including through the development of protocols like Level One, which continues to significantly improve outcomes and survival for heart attack patients.
Education and Outreach – MHIF provides more than 11,000 hours of education each year putting its research into practice to improve outcomes among health care providers. This commitment extends to patients and caregivers through community health and education events to raise awareness of heart care and research, engaging individuals in their own health.
MHIF’s work is funded by generous donors and sponsors and engages in cutting-edge research initiatives with its physician partners from the Allina Health Minneapolis Heart Institute® at Abbott Northwestern Hospital and at 38 community sites across Minnesota and western Wisconsin. For more information, please visit mplsheart.org.
# # #