PARIS – A cardiovascular risk reduction program based on lifestyle changes and implemented in primary care practices led to substantial risk reductions over 1 year in a pilot study of 560 patients.
People who think "we shouldn’t spend a lot of time or effort on behavioral modification, that it doesn’t get us anywhere" are wrong, said Dr. Jafna L. Cox, a cardiologist and research director of the division of cardiology at Dalhousie University in Halifax, N.S.
Dr. Jafna L. Cox
One caveat, however, is that participation required an initial behavior assessment aimed at identifying people who were willing to make lifestyle changes in the first place.
The behavioral modification interventions included goal setting, stimulus control, and changes in the stress management techniques used by participants, Dr. Cox said at the annual congress of the European Society of Cardiology. For example, people who used smoking or eating as their major stress management strategies underwent training to shift to healthier stress management methods, such as exercise.
The resources and skills that made this pilot program work "are readily imported into any practice type," he stressed.
The study’s primary end point was the percentage of people with an intermediate 10-year risk whose risk fell by at least 10 percentage points, plus the percentage of people with a high Framingham Risk Score (FRS) at baseline whose score fell by at least 25 percentage points. This end point was achieved by 43% of people in the intervention group and by 31% of those in the comparison group, a statistically significant difference.
The study’s secondary end point, the percentage of people whose FRS strata dropped by at least one risk category, occurred in 39% of those in the intervention group and in 25% of those in the comparison group, also a statistically significant difference. For every seven people who participated in the intervention program, one person achieved at least one category reduction in cardiovascular risk level beyond what occurred in a control group that received no special intervention.
Furthermore, the lifestyle changes were associated with an average 6-mm Hg reduction in systolic blood pressure, an average 4-mm Hg drop in diastolic blood pressure, an average 2-kg reduction in weight, and an average 3.5-cm cut in waist circumference.
"This was as good as the best drug in a hypertension or weight-reduction trial," said Dr. Blair J. O’Neill, director and professor of cardiology at the University of Alberta in Edmonton, and a collaborator on the study.
The investigation, known as ANCHOR (A Novel Approach to Cardiovascular Health By Optimizing Risk Management) study, enrolled 1,509 people aged 30 years or older from two primary care practices in Nova Scotia, from a five-physician practice in Halifax, and from a 10-physician practice in Sydney. All participants underwent a baseline cardiovascular risk assessment with the FRS that divided them according to their estimated 10-year risk for a cardiovascular event into low-risk (less than 10% risk), intermediate-risk (10%-20% risk), or high-risk (greater than 20% risk) groups.
The current study excluded people with either diabetes or identified cardiovascular disease at baseline, and focused on the 560 people who fell into the intermediate- or high-risk groups. The study also included 67 people from a third Nova Scotia primary care practice in either the intermediate- or high-risk categories who received no special intervention; they were the comparison group. The average age of those in the intervention group was 55 years, 58% were women, and their average 10-year risk for an event was 18%. In the comparison group, the average age was 60 years, 36% were women, and their average 10-year risk was 20%.
The percentage of participants with metabolic syndrome dropped from baseline by 25 percentage points in the intervention group, and by 14 percentage points in the comparison group.
The favorable changes in the intervention group occurred without any significant changes in the medications they received, compared with baseline. For example, the prevalence of prescriptions for lipid-lowering drugs actually fell, from 8% at baseline to 7% after 1 year. The largest change in the prevalence of antihypertensive medications prescribed was in the category of ACE inhibitors, which rose from 8% of patients at baseline to 11% of patients after 1 year.
Dr. Cox attributed the improvement in the comparator group to their participation in the study, a Hawthorne effect, especially because ANCHOR received a lot of media attention in Nova Scotia. "We suspect that these [comparator] patients had an increase in their medications, especially blood pressure–lowering drugs," he said.
After representatives from local health authorities heard the results, Dr. Cox said that they began encouraging other local primary care physicians to routinely perform baseline cardiovascular risk assessments using the FRS, and to incorporate behavioral modification programs into their practices by training their nursing staffs.