The results of a comprehensive clinical trial were presented recently at the American College of Cardiology Scientific Session 2015 in San Diego and published at the same time in the New England Journal of Medicine. Professor Mikael Dellborg at the Institute of Medicine directed the Swedish part of the PEGASUS study.
The study is closely associated with Sahlgrenska Academy and Gothenburg: a number of the leading researchers at AstraZeneca received their scientific and clinical training at Sahlgrenska University Hospital/East, obtained their PhDs and became associate professors at Sahlgrenska Academy.
PEGASUS is a collaborative effort of AstraZeneca and the TIMI Study Group, an academic research organization out of Boston. The study concerned Brillique, a platelet aggregation inhibitor by AstraZeneca, and ticagrelor, its active substance.
“Ticagrelor therapy significantly reduced the risk of cardiovascular death, myocardial infarction or stroke among patients who had suffered a myocardial infarction more than one year previously,” Professor Dellborg says.
The study included 21,162 patients who had suffered myocardial infarctions 1-3 years earlier. The subjects were randomized to a group that received 90 grams and one that received 60 grams of ticagrelor twice daily. The double-blind design ensured that neither patients nor doctors knew which tablet they were taking. Patients were monitored for an average of almost three years. The lower dose turned out to be just as effective as the higher one currently prescribed and caused less major bleeding.
“Fewer than ten patients dropped out of the study worldwide, a unique record,” Professor Dellborg says. “A total of 507 Swedes participated. The data from our centers were widely hailed for their quality. We had no dropouts and all the centers did an excellent job of monitoring the subjects.”
The study illustrates one of Sahlgrenska Academy’s greatest strengths: patient-oriented clinical research. It is also an excellent example of the merits of collaboration between the healthcare system, academia and the pharmaceutical industry.
“Patients are highly appreciative of the care and continuity that both doctors and nurses provide during clinical trials,” Professor Dellborg says. “And there’s little doubt that the opportunity to actively contribute to research and scientific progress is a source of great satisfaction to them as well.”
He notes that clinical trials are good business for the healthcare system. In this case, all Swedish participants received checkups, blood tests, EKGs and lifestyle suggestions without costing the system a penny.
“Our studies have shown that subjects also thrive on the chance to meet and get to know committed doctors and nurses,” Professor Dellborg says. “Clinical trials can teach the healthcare system a thing or two when it comes to the logistics and structure of effective care.”
Article in the New England Journal of Medicine: http://www.nejm.org/doi/full/10.1056/NEJMoa1500857