MedicalResearch.com Interview with:
Professor Harvey White
MB ChB DSc FRACP FACC FESC FAHA FHKCC (Hon) FCSANZ FRSNZ La’auli (matai); Prince Mahidol Laureate; John Neutze Scholar, Director of Coronary Care & Green Lane Cardiovascular Research Unit, Green Lane Cardiovascular Service
Auckland City Hospital NEW ZEALAND
MedicalResearch.com: What are the main findings of the study?
Prof. White: During follow-up (median 3.7 years), the composite primary end point (cardiovascular death, myocardial infarction or stroke) occurred in 9.7% of the 7,924 patients randomly assigned to darapladib and 10.4% of the 7,904 patients in the placebo group (HR 0.94, 95% CI 0.85-1.03 p=0.199).
In the first prespecified secondary endpoint of major coronary events (CHD death, MI or urgent revascularization) compared with placebo, darapladib reduced the rate (9.3% vs. 10.3%; HR=0.9; 95% CI, 0.82-1 p=0.045). Total coronary events (14.6% vs. 16.1%; HR = 0.91; 95% CI, 0.84-0.98,p=0.019). (CHD death, MI, any coronary revascularization, hospitalization for unstable angina) were also reduced. No major safety concerns arose during the trial.
MedicalResearch.com: Were any of the findings unexpected?
Prof. White: Patients enrolled in STABILITY had a high rate of background care. At baseline 93% were taking aspirin, 97% statins, 79% beta-blockers, and 79% ACE inhibitors or angiotensin receptors blockers. These rates were maintained for 3.7 years. “One of the messages from this trial is that you can achieve high rates of evidence-based medicine and this should be the standard for testing new therapies”.
MedicalResearch.com: What should clinicians and patients take away from your report?
Prof. White: The signal on coronary events is potentially important for patient care. This finding “needs to be interpreted cautiously in light of the main results not being significant.”
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Prof. White: The STABILITY trial results indicate that darapladib warrants further evaluation in other clinical settings and will be tested in the SOLID-TIMI 52 Trial in patients within 30 days of ACS. In addition there will be biomarker and genetic studies from STABILITY.