Chief Medical Officer Dr. James Aw and Year-Round Care Nurse Roshni Gandhi were site investigators in the HOPE-3 trial, a widely reported preventive cardiovascular health study involving over 12,700 participants from 21 countries over a six-year period.
The Heart Outcomes Prevention Evaluation (HOPE-3) study focused on individuals with intermediate cardiac risk who had normal to high blood pressure. The researchers observed how dual medication statins and antihypertensives impacted risk to heart disease.
“In particular for patients with hypertension, our study suggests you can essentially double the benefit of lowering blood pressure in hypertensives if you also lower cholesterol simultaneously,” said Salim Yusuf, MD, DPhil, the study’s principal investigator.
While studies in preventive health can be difficult to assess since it’s tough to prove a negative, there were valuable lessons.
Benefits for mid-risk cardiac patients with high blood pressure
Unlike previous studies that focused on high-risk populations, this study focused on mid-risk patients who may be on the fence about taking a statin or other medication for potential heart problems.
The results suggest that patients at intermediate risk could be eligible and benefit for statins, while antihypertensive therapy could only be offered to those with higher blood pressure levels.
“If you are at a low risk, the preventive medicine will likely not help. If you are at high risk, the pills may be for you. This study suggests that if someone is in the grey zone for statins or blood pressure medication, it may be something to discuss with your physician,” says Dr. Aw.
According to a brief from the American Heart Association, the results “may bolster the case for primary prevention with statins and blood pressure drugs. But the trial also makes clear that the benefits, though real, are also modest, and are not evenly distributed between statins and antihypertensives.”
Researchers found that the daily intake of of the polypill was associated with a 30 or at times 40 per cent relative risk reduction in cardiovascular events. The evidence was clearest in the cholesterol-lowering arm of the trial, while results in terms of blood pressure medication prescription were less clear. This research presented in the April issue of The New England Journal of Medicine.
Study focused on primary preventive health
The cardiac polypill concept, which Dr. Aw wrote about when the clinical study started in 2011, is along the same lines of putting flouride in the water for prevention of tooth decay.
The study’s design (double-blind, randomized, placebo-controlled trial) is considered the most objective type of model for clinical trials.
“The HOPE-3 Trial is set to shape the practice of primary prevention with further cardiology research coming from this data base,” says Dr. Aw.
Wider use of statins encouraged by lead researcher
“The implications for practice are huge. I think we certainly should consider using statins much more widely than we have used them thus far,” said Yusuf.
Yusuf reported grant support from the Canadian Institutes of Health Research and AstraZeneca during the conduct of the study; grant support from AstraZeneca, Novartis, Bristol-Myers Squibb, and Cadila Pharma, and grant support, personal fees, and non-financial support from Bayer outside the submitted work.