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A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial.

ABSTRACT: To determine the cost-effectiveness of a worksite-based naturopathic (individualized lifestyle counseling and nutritional medicine) approach to primary prevention of cardiovascular disease (CVD).Economic evaluation alongside a pragmatic, multi-worksite, randomized controlled trial comparing enhanced usual care (EUC; usual care plus biometric screening) to the addition of a naturopathic approach to CVD prevention (NC+EUC).After 1 year, NC+EUC resulted in a net decrease of 3.3 (confidence interval: 1.7 to 4.8) percentage points in 10-year CVD event risk (number needed to treat = 30). These risk reductions came with average net study-year savings of $1138 in societal costs and $1187 in employer costs. There was no change in quality-adjusted life years across the study year.A naturopathic approach to CVD primary prevention significantly reduced CVD risk over usual care plus biometric screening and reduced costs to society and employers in this multi-worksite-based study. Trial Registration clinicaltrials.gov Identifier: NCT00718796.

SUBMITTER: Herman PM

PROVIDER: S-EPMC3921268 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial.

Herman Patricia M PM Szczurko Orest O Cooley Kieran K Seely Dugald D

Journal of occupational and environmental medicine 20140201 2

<h4>Objective</h4>To determine the cost-effectiveness of a worksite-based naturopathic (individualized lifestyle counseling and nutritional medicine) approach to primary prevention of cardiovascular disease (CVD).<h4>Methods</h4>Economic evaluation alongside a pragmatic, multi-worksite, randomized controlled trial comparing enhanced usual care (EUC; usual care plus biometric screening) to the addition of a naturopathic approach to CVD prevention (NC+EUC).<h4>Results</h4>After 1 year, NC+EUC resu ...[more]

PMID: 24451612

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Project description:Although cardiovascular disease may be partially preventable through dietary and lifestyle-based interventions, few individuals at risk receive intensive dietary and lifestyle counselling. We performed a randomized controlled trial to evaluate the effectiveness of naturopathic care in reducing the risk of cardiovascular disease.We performed a multisite randomized controlled trial of enhanced usual care (usual care plus biometric measurement; control) compared with enhanced usual care plus naturopathic care (hereafter called naturopathic care). Postal workers aged 25-65 years in Toronto, Vancouver and Edmonton, Canada, with an increased risk of cardiovascular disease were invited to participate. Participants in both groups received care by their family physicians. Those in the naturopathic group also received individualized care (health promotion counselling, nutritional medicine or dietary supplementation) at 7 preset times in work-site clinics by licensed naturopathic doctors. The body weight, waist circumference, lipid profile, fasting glucose levels and blood pressure of participants in both groups were measured 3 times during a 1-year period. Our primary outcomes were the 10-year risk of having a cardiovascular event (based on the Framingham risk algorithm) and the prevalence of metabolic syndrome (based on the Adult Treatment Panel III diagnostic criteria).Of 246 participants randomly assigned to a study group, 207 completed the study. The characteristics of participants in both groups were similar at baseline. Compared with participants in the control group, at 52 weeks those in the naturopathic group had a reduced adjusted 10-year cardiovascular risk (control: 10.81%; naturopathic group: 7.74%; risk reduction -3.07% [95% confidence interval (CI) -4.35% to -1.78%], p < 0.001) and a lower adjusted frequency of metabolic syndrome (control group: 48.48%; naturopathic care: 31.58%; risk reduction -16.90% [95% CI -29.55% to -4.25%], p = 0.002).Our findings support the hypothesis that the addition of naturopathic care to enhanced usual care may reduce the risk of cardiovascular disease among those at high risk.ClinicalTrials.gov, no. NCT0071879.

Project description:ImportanceIn the Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) trial, the anti-inflammatory monoclonal antibody canakinumab significantly reduced the risk of recurrent cardiovascular events in patients with previous myocardial infarction (MI) and high-sensitivity C-reactive protein (hs-CRP) levels of 2 mg/L or greater.ObjectiveTo estimate the cost-effectiveness of adding canakinumab to standard of care for the secondary prevention of major cardiovascular events over a range of potential prices.Design, setting, and participantsA state-transition Markov model was constructed to estimate costs and outcomes over a lifetime horizon by projecting rates of recurrent MI, coronary revascularization, infection, and lung cancer with and without canakinumab treatment. We used a US health care sector perspective, and the base case used the current US market price of canakinumab of $73 000 per year. A hypothetical cohort of patients after MI aged 61 years with an hs-CRP level of 2 mg/L or greater was constructed.InterventionsCanakinumab, 150 mg, administered every 3 months plus standard of care compared with standard of care alone.Main outcomes and measuresLifetime costs and quality-adjusted life-years (QALYs), discounted at 3% annually.ResultsAdding canakinumab to standard of care increased life expectancy from 11.31 to 11.36 years, QALYs from 9.37 to 9.50, and costs from $242 000 to $1 074 000, yielding an incremental cost-effectiveness ratio of $6.4 million per QALY gained. The price would have to be reduced by more than 98% (to $1150 per year or less) to meet the $100 000 per QALY willingness-to-pay threshold. These results were generally robust across alternative assumptions, eg, substantially lower health-related quality of life after recurrent cardiovascular events, lower infection rates while receiving canakinumab, and reduced all-cause mortality while receiving canakinumab. Including a potential beneficial effect of canakinumab on lung cancer incidence improved the incremental cost-effectiveness ratio to $3.5 million per QALY gained. A strategy of continuing canakinumab selectively in patients with reduction in hs-CRP levels to less than 2 mg/L would have a cost-effectiveness ratio of $819 000 per QALY gained.Conclusions and relevanceCanakinumab is not cost-effective at current US prices for prevention of recurrent cardiovascular events in patients with a prior MI. Substantial price reductions would be needed for canakinumab to be considered cost-effective.

Project description:BackgroundCardiovascular disease is the leading cause of death worldwide. Like many countries, Australia is currently changing its guidelines for cardiovascular disease prevention from drug treatment for everyone with 'high blood pressure' or 'high cholesterol', to prevention based on a patient's absolute risk. In this research, we model cost-effectiveness of cardiovascular disease prevention with blood pressure and lipid drugs in Australia under three different scenarios: (1) the true current practice in Australia; (2) prevention as intended under the current guidelines; and (3) prevention according to proposed absolute risk levels. We consider the implications of changing to absolute risk-based cardiovascular disease prevention, for the health of the Australian people and for Government health sector expenditure over the long term.MethodsWe evaluate cost-effectiveness of statins, diuretics, ACE inhibitors, calcium channel blockers and beta-blockers, for Australian men and women, aged 35 to 84 years, who have never experienced a heart disease or stroke event. Epidemiological changes and health care costs are simulated by age and sex in a discrete time Markov model, to determine total impacts on population health and health sector costs over the lifetime, from which we derive cost-effectiveness ratios in 2008 Australian dollars per quality-adjusted life year.ResultsCardiovascular disease prevention based on absolute risk is more cost-effective than prevention under the current guidelines based on single risk factor thresholds, and is more cost-effective than the current practice, which does not follow current clinical guidelines. Recommending blood pressure-lowering drugs to everyone with at least 5% absolute risk and statin drugs to everyone with at least 10% absolute risk, can achieve current levels of population health, while saving $5.4 billion for the Australian Government over the lifetime of the population. But savings could be as high as $7.1 billion if Australia could match the cheaper price of statin drugs in New Zealand.ConclusionsChanging to absolute risk-based cardiovascular disease prevention is highly recommended for reducing health sector spending, but the Australian Government must also consider measures to reduce the cost of statin drugs, over and above the legislated price cuts of November 2010.

Dataset Information

A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial.

Publications

A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial.

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