Evaluation of the cost-effectiveness of evolocumab in the FOURIER study: a Canadian analysis.

Background: Evolocumab, a proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor, has been shown to reduce low-density lipoprotein levels by up to 60%. Despite the absence of a reduction in overall or cardiovascular mortality in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, some believe that, with longer treatment, such a benefit might eventually be realized. Our aim was to estimate the potential mortality benefit over a patient's lifetime and the cost per year of life saved (YOLS) for an average Canadian with established coronary artery disease.

Estimating the benefits of patient and physician adherence to cardiovascular prevention guidelines: the MyHealthCheckup Survey.

Background: The management of cardiovascular risk factors such as hypertension and dyslipidemia is poorly described in many communities, and the benefits associated with tighter control remain unknown. We used data from the 2007 MyHealthCheckup survey to document the treatment gaps and estimated the potential benefits of better adherence to recommended guidelines.

Methods: Cardiovascular risk factors, lifestyle habits, and prescribed medications were evaluated among Canadian adults recruited primarily in pharmacies.

Preventing cardiovascular disease among Canadians: is the treatment of hypertension or dyslipidemia cost-effective?

Background And Objectives: The direct health care costs associated with treating hypertension and dyslipidemia continue to grow in most western countries, including Canada. Despite the proven effectiveness of hypertension and lipid therapies to prevent cardiovascular disease, the cost-effectiveness of long-term primary prevention, as currently advocated by Canadian treatment guidelines, remains to be determined.

Methods: Therapeutic efficiency, defined as person-years of treatment per year of life saved (YOLS) and the cost-effectiveness of treatment were estimated for groups of Canadian adults, 40 to 74 years of age.

Determining the cost-effectiveness of preventing cardiovascular disease: are estimates calculated over the duration of a clinical trial adequate?

Background: Economic analyses of randomized clinical trials often focus only on the results that are observed during the study. However, for many preventive interventions, associated costs and benefits will accrue over a patient's remaining lifetime. To determine the importance of the chosen time horizon, the cost-effectiveness (C/E) of ramipril therapy was calculated and compared in the Heart Outcomes Prevention Evaluation (HOPE), the Microalbuminuria, Cardiovascular, and Renal Outcomes in HOPE (MICRO-HOPE) and the Acute Infarction Ramipril Efficacy (AIRE) study versus the entire life expectancy (L/E) of potential patients.

Preventing cardiovascular disease among Canadians: what are the potential benefits of treating hypertension or dyslipidemia?

Background: Treatments for hypertension and dyslipidemia to prevent the development of cardiovascular disease compete for the same finite number of health care dollars. Therefore, the potential benefits of treating Canadians without cardiovascular disease or diabetes who would currently be targeted by the national treatment guidelines were estimated and compared.

Study Design: Canadian Heart Health Surveys data were used to estimate the number of Canadians requiring intervention.

The role of global risk assessment in hypertension therapy.

To maximize the benefits of preventive therapy, lipid and hypertension guidelines increasingly recommend that high-risk individuals be targeted for treatment. An individual's risk of developing cardiovascular disease depends on many risk factors, such as age, sex, blood pressure, blood lipid levels, body weight, physical fitness, smoking habits and familial predisposition. Multivariable statistical models have therefore been developed to better estimate the global risk of future coronary events and stroke.

PROVE-IT proves that lower is better: a contrary view.

Epidemiological studies have demonstrated that low density lipoprotein (LDL) cholesterol and C-reactive protein (CRP) are both independent risk factors for future cardiovascular events. Statin therapy, initially developed to modify blood lipid concentrations, has also been shown to have potentially important pleiotropic effects, including a reduction in CRP concentrations. Recent clinical trials have demonstrated conflicting results regarding the benefits associated with intensively lowering LDL cholesterol.

Do the benefits of finasteride outweigh the risks in the prostate cancer prevention trial?

Purpose: The Prostate Cancer Prevention Trial demonstrated that finasteride could reduce the incidence of prostate cancer by 25%. However, its use was also associated with an increased risk of high grade cancer resulting in uncertainty surrounding the net benefits of therapy.

Materials And Methods: We used the Montreal Prostate Cancer Model, a validated Markov model of prostate cancer progression, to compare the forecasted survival in treated and untreated men.

The prevalence of erectile dysfunction in the primary care setting: importance of risk factors for diabetes and vascular disease.

Background: The prevalence of erectile dysfunction (ED) and associated risk factors has been described in many clinical settings, but there is little information regarding men seen by primary care physicians. We sought to identify independent factors associated with ED in a primary care setting.

Methods: We surveyed a cross-sectional sample of 3921 Canadian men, aged 40 to 88 years, seen by primary care physicians.

Impact of dyslipidemia associated with Highly Active Antiretroviral Therapy (HAART) on cardiovascular risk and life expectancy.

We investigated the effect of dyslipidemia associated with highly active antiretroviral therapy on cardiovascular risk and life expectancy among patients who had the human immunodeficiency virus. Dyslipidemia estimates were based on results from a phase 2 randomized trial that compared lipid changes after 32 weeks of therapy with atazanavir with those with nelfinavir (each in combination with stavudine and lamivudine). The resultant increased coronary risk was estimated using Framingham risk equations, and change in life expectancy (after adjustment for mortality due to human immunodeficiency virus) was based on the cardiovascular life expectancy model, which is based on a published Markov's model.

Treating osteoarthritis with cyclooxygenase-2-specific inhibitors: what are the benefits of avoiding blood pressure destabilization?

Osteoarthritis and hypertension are highly prevalent among older Americans. Anti-inflammatory medications can destabilize blood pressure control. We estimated the decreased cardiovascular risk, premature mortality, and direct health care costs that could be avoided if blood pressure control is not destabilized among hypertensive Americans taking cyclooxygenase-2 (COX-2)-specific inhibitors for osteoarthritis.

Evaluating the benefits of treating dyslipidemia: the importance of diabetes as a risk factor.

Purpose: Diabetes mellitus is associated with an increased risk of cardiovascular disease. We compared the clinical effects of treating dyslipidemia in patients who had diabetes mellitus but no diagnosed cardiovascular disease with the effects of similar treatment in patients who had cardiovascular disease but no diabetes mellitus.

Methods: We estimated the number of adults (ages 30 to 74 years) requiring lipid therapy using data from the third National Health and Nutrition Examination Survey and current lipid treatment guidelines.

Improving the prediction of cardiovascular risk: interaction between LDL and HDL cholesterol.

Background: The ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol (or the ratio of low-density lipoprotein [LDL] to HDL) is currently advocated to estimate the coronary risk associated with LDL and HDL cholesterol levels.

Methods: We analyzed the relation between LDL and HDL cholesterol levels to predict the risk of future coronary events. Using data from the Lipid Research Clinics Follow-up Cohort, we developed multivariate equations to predict coronary deaths among 4684 men and women followed for approximately 12 years.

Costs of dyslipidemia.

Dyslipidemia has been recognized as an important risk-factor for the development of cardiovascular disease. The current, available therapies of dyslipidemia, their effectiveness, costs, cost-effectiveness and healthcare implications are discussed. At the present time, the lipid-lowering therapies are dominated by statins.

How cost-effective is the treatment of dyslipidemia in patients with diabetes but without cardiovascular disease?

Objective: Epidemiological studies have shown that the risk of myocardial infarction (MI) in diabetic patients without cardiovascular disease (CVD) is comparable to the risk of MI in patients with CVD. We used a validated Markov model to compare the long-term costs and benefits of treating dyslipidemia in diabetic patients without CVD versus treating CVD patients without diabetes in the U.S.

Lipid screening to prevent coronary artery disease: a quantitative evaluation of evolving guidelines.

Background: There is strong evidence to support the treatment of abnormal blood lipid levels among people with cardiovascular disease. Primary prevention is problematic because many individuals with lipid abnormalities may never actually develop cardiovascular disease. We evaluated the 1998 Canadian lipid guidelines to determine whether they accurately identify high-risk adults for primary prevention.

Cost-effectiveness of treating hyperlipidemia in the presence of diabetes : who should be treated?

Background: The objective of this study was to estimate the long-term costs and benefits of treating hyperlipidemia among diabetic patients with and without known cardiovascular disease after validating the Cardiovascular Life Expectancy Model.

Methods And Results: The model estimates were compared with the Scandinavian Simvastatin Survival Study (4S) and used to estimate the long-term costs and benefits of treatment with simvastatin. Simulations were performed for men and women, 40 to 70 years of age, having pretreatment LDL cholesterol values of 5.

The cost-effectiveness of exercise training for the primary and secondary prevention of cardiovascular disease.

Background: Although exercise training improves cardiovascular disease (CVD) risk factors, few studies have evaluated its potential long-term cost-effectiveness.

Methods: Using the Cardiovascular Disease Life Expectancy Model, a validated disease simulation model, we calculated the life expectancy of average 35- to 74-year-old Canadians found in the 1992 Canadian Heart Health Survey. The impacts of exercise training on cardiovascular risk factors were estimated as a 4% decrease in low-density lipoprotein (LDL) cholesterol, a 5% increase in high-density lipoprotein (HDL) cholesterol, and a 6 mm Hg decrease in both systolic and diastolic blood pressure.

The economic burden of prostate cancer in Canada: forecasts from the Montreal Prostate Cancer Model.

Background: We developed an economic model of prostate cancer management from diagnosis until death. We have used the Montreal Prostate Cancer Model to estimate the total economic burden of the disease in a cohort of Canadian men.

Methods: Using this Markov state-transition simulation model, we estimated the probability of prostate cancer, annual prostate cancer progression rates and associated direct medical costs according to patient age, tumour stage and grade, and treatment modalities in a 1997 cohort of Canadian men.

The clinical burden of prostate cancer in Canada: forecasts from the Montreal Prostate Cancer Model.

Objectives: The incidence of prostate cancer is increasing, as is the number of diagnostic and therapeutic interventions to manage this disease. We developed a Markov state-transition model--the Montreal Prostate Cancer Model--for improved forecasting of the health care requirements and outcomes associated with prostate cancer. We then validated the model by comparing its forecasted outcomes with published observations for various cohorts of men.

Impact of treating hyperlipidemia or hypertension to reduce the risk of death from coronary artery disease.

Objective: To compare the prevalence of modifiable risk factors for cardiovascular disease among hypertensive and nonhypertensive adults and to estimate the effect of treating hyperlipidemia or hypertension to reduce the risk of death from coronary artery disease.

Methods: The authors evaluated a sample of 7814 subjects aged 35-74 years free of clinical cardiovascular disease from the Canadian Heart Health Surveys to estimate the prevalence of cardiovascular risk factors. They identified hyperlipidemic subjects (ratio of total cholesterol to high-density lipoprotein cholesterol [total-C/HDL-C] 6.

Cost-effectiveness of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the secondary prevention of cardiovascular disease: forecasting the incremental benefits of preventing coronary and cerebrovascular events.

Objective: To forecast the long-term benefits and cost-effectiveness of lipid modification in the secondary prevention of cardiovascular disease.

Methods: A validated model based on data from the Lipid Research Clinics cohort was used to estimate the benefits and cost-effectiveness of lipid modification with 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) based on results from the Scandinavian Simvastatin Survival Study (4S), including a 35% decrease in low-density-lipoprotein (LDL)-cholesterol levels and an 8% increase in high-density-lipoprotein (HDL)-cholesterol levels. After comparing the short-term outcomes predicted for the 4S with the results actually observed, we forecast the long-term risk of recurrent myocardial infarction, congestive heart failure, transient ischemic attacks, arrhythmias, and strokes and the need for surgical procedures such as coronary artery bypass grafting, catheterization, angioplasty, and pacemaker insertions.

Identifying adults at low risk for significant hyperlipidemia: a validated clinical index.

The objective of this study was to develop and validate a simple clinical index to identify individuals at increased risk of an elevated CHL/HDL ratio. Using recursive partitioning, factors associated with an elevated CHL/HDL ratio were identified among 1993 men and 1631 women in the Lipid Research Clinic Prevalence Study. These factors were weighted using logistic regression analyses to develop a clinical index that was validated on 486 men and 484 women reported in the Santé Québec cardiovascular health survey.

Can computerized risk profiles help patients improve their coronary risk? The results of the Coronary Health Assessment Study (CHAS).

Background: The Coronary Health Assessment Study (CHAS) was developed to determine the feasibility of using patient-specific, multifactorial computerized coronary risk profiles as a clinical decision aid to support primary prevention of CHD.

Methods: Study participants included 253 community based physicians, randomized into profile and control groups, and 958 of their patients. The profile group physicians received coronary risk profiles for their patients within 10 working days after the baseline patient assessment providing early feedback.