Cost-effectiveness of screening for albuminuria with subsequent fosinopril treatment to prevent cardiovascular events: A pharmacoeconomic analysis linked to the prevention of renal and vascular endstage disease (PREVEND) study and the prevention of renal and vascular endstage disease intervention trial (PREVEND IT).

OBJECTIVE: This study estimated the cost-effectiveness,from the Dutch health care perspective, of screening for albuminuria in the general Dutch population to prevent cardiovascular events (CVEs) with subsequent angiotensin-converting enzyme inhibitor treatment, using data from the Prevention of REnal and Vascular ENdstage Disease Intervention Trial (PREVEND IT). METHODS: PREVEND IT was a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design within the larger observational Prevention of REnal and Vascular ENdstage Disease (PREVEND) study. The PREVEND IT study was conducted to assess the effects of fosinopril 20 mg and pravastatin 40 mg on CVEs in subjects with specific inclusion criteria: urinary albumin excretion (UAE) rate in the range from 15 to 300 mg/d, blood pressure <160/100 mm Hg, and plasma cholesterol level <8.0 mmol/L. Cost-effectiveness estimates for the Dutch population were expressed in euros (2002; 1 euro = US 1.01 dollars) as net costs per life-year gained (LYG) in the baseline and sensitivity (stochastic) analyses. RESULTS: Data were assessed for 864 subjects, with a mean (SD) follow-up of 46 (7) months. CVEs occurred in 45 (5.2%) subjects. Subjects who received fosinopril had a 40% lower incidence of CVEs than subjects in the placebo group (3.9% vs 6.5%, respectively; P = NS). The cost-effectiveness of screening for albumnuria was determined to be euro 16,700/LYG for the study population. Stochastic analysis indicated that the probability of the cost-effectiveness being below the suggested Dutch threshold of euro 20,000/LYG was 59% in the baseline analysis. The probability of cost-effectiveness below euro 20,000/LYG would increase to 91% if only subjects with UAE >50 mg/d were treated with fosinopril. Limiting the screening to subjects aged >50 years and >60 years also improved cost-effectiveness. CONCLUSIONS: The results of our study suggest that screening the general Dutch population for albuminuria and subsequently treating those found positive with fosinopril may be cost-effective compared with no screening and adopting the Dutch health care perspective. However, confirmation from larger multicenter trials is needed.

Pharmacoeconomics of angiotensin converting enzyme inhibitors in heart failure.

As a result of the increasing cost of health care and the limited resources available, it has become more difficult to allocate resources efficiently and effectively in the health care system. This environment has led to the development of pharmacoeconomic studies, which have been designed in response to the need for assessment of the economic benefits of a product prior to its acceptance in the market. The field of pharmacoeconomics has grown rapidly, especially in relation to the development of new pharmacological products. Economic analysis is now routinely incorporated into many clinical trials, and this type of information, in conjunction with the usual safety and efficacy data, is becoming more important to pharmaceutical companies, regulatory authorities, third party payers, and end-users. The cost-effectiveness of angiotensin converting enzyme (ACE) inhibitors for the treatment of heart failure has been evaluated on the basis of a number of large-scale studies, including the Survival and Ventricular Enlargement (SAVE) study and the Veterans Administration Cooperative Vasodilator Heart Failure Trials (V-HeFT I and II). The cost-effectiveness of the ACE inhibitor captopril compares favorably with other cardiac interventions, reducing both mortality and the incidence of congestive heart failure (CHF). Captopril also appears to be cost-effective in the treatment of patients with left ventricular dysfunction after acute myocardial infarction. In addition, analysis of more recent studies of the treatment of fosinopril in patients with mild to moderate CHF have been performed and have proved this newer ACE inhibitor to be cost-saving in these patients.