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.     

Bone involvement in young patients with non-Hodgkin's lymphoma: efficacy of chemotherapy without local radiotherapy

Of 95 young non-Hodgkin's lymphoma patients entered consecutively on the National Cancer Institute (NCI) Protocol 7704, 26 (27.4%) had involvement of one or more bones. The mean age of these 26 patients was 16.6 years, and the male to female ratio was 3.3:1. Tumor histology included undifferentiated Burkitt's lymphoma in 12, undifferentiated non-Burkitt's lymphoma in two, undifferentiated, unspecified lymphoma in one, diffuse large cell lymphoma in three, and lymphoblastic lymphoma in eight patients. Most had extensive disease; two patients had isolated bone lesions, one had lesions of two bones without involvement of other tissues, and 23 had either multiple bone lesions or single bone lesions with involvement of other tissues. Eight of the 26 patients had bone marrow involvement. Of a subgroup of 12 patients with jaw disease, 11 had undifferentiated lymphoma and one had diffuse large cell lymphoma. Only one had primary a jaw tumor, with two quadrants of the jaw involved. All 26 patients were treated with chemotherapy; only two received radiotherapy initially for bone lesions. Predicted survival of the 26 patients at 5 years is 53.2%. The 12 patients who remain disease free have a mean survival of 62.1 months (range, 22 to 100 months). Our results call into question the role of radiotherapy in the treatment of bone lesions in non-Hodgkin's lymphoma.     

A measurement technique for cell adhesiveness

Determination of the percentage of cells in clumps on a stained smear of human peripheral blood porvided a useful, accurate technique for measuring cell adhesiveness. Smears of human peripheral blood drawn with EDTA were prepared on a blood slide centrifuge, stained, and examined under a light microscope. Statistical analysis showed that the method resulted in a Poisson distribution of particles on the slide, where a particle was considered to be a simple cell, or two or more cells which appeared to be touching, Analysis of the distributions of erythrocytes and leukocytes showed that clumps were formed before the cells were deposited on the slide. When adhesiveness of erythrocytes or leukocytes was increased by incubation with antiserum to the corresponding cell type, the percentage of that cell type in clumps increased proportionately, Preliminary results using the method showed that normal human donors had similar to 1% of their erythrocytes and 1- 5% of their leukocytes in clumps. In chronic myelocytic leukemia, as many as 60% of the leukocytes were in clumps.     

Aflatoxin: Is it a neglected threat for formula-fed infants?

In the present study, the risk of exposure to aflatoxin in infants fed breast milk and formula was investigated. For this purpose, aflatoxin B₁ (AFB₁) was determined in the serum of both breast-fed and formula-fed infants. Serum AFB₁ positivity was significantly higher in the formula-feeding (F) group than the breast-feeding (B) group (42.8 vs 8.5%, P <0.01). The AFB, concentration in different commercial formulas was also determined. Aflatoxin B₁ was found in seven of the eight newly opened packages of different brands of formula. The concentrations showed a statistically significant increase at the 30th day after opening the packages (P <0.01). Although AFB₁ concentrations in the formulas were found to be within acceptable limits for most countries, still, its existence must be carefully evaluated because future influences of very small amounts of aflatoxin on the growing organism have not been fully elucidated. Therefore, it was again concluded that for infants, human milk is safer than commercial formulas because of the lower contamination risk of aflatoxin. Also, commercial formulas must be regularly examined by authorities for the possible risk of aflatoxin contamination.     

Should sperm donors be paid? A survey of the attitudes of the general public

Gamete donation in assisted reproduction is an accepted treatment option for certain infertile couples. Traditionally, men donating spermatozoa have been paid a nominal fee, whilst women donating oocytes have not. The issue of payment for sperm donors has recently attracted attention following the Human Fertilisation and Embryology Authority's (HFEA) suggestion that such payment may be withdrawn. Prior to the final meeting of the HFEA working party which is examining this issue, here we report the results of a survey designed to solicit opinion on whether sperm donors should be paid, to identify social or other factors which influence this opinion, and to examine the influence of financial incentive on potential donors. We surveyed 717 individuals in three distinct groups: the general public, students (potential donors), and infertility patients (potential recipients). The majority of the potential donor group (students) was in favour of paying sperm donors, as were infertility patients. In contrast the general public was not. The opinion of the general public on this issue was influenced by their prior knowledge of whether donors were paid: those of the general public favouring the payment of sperm donors had a prior awareness that such payments were made. Although not in favour of paying sperm donors, the general public overwhelmingly approved of the use of donated spermatozoa for the treatment of infertile couples, and thought that ways should be sought to increase the availability of donor spermatozoa for the treatment of infertility and for research purposes. Within the potential donor group (students), the majority indicated that financial reward was an important factor which would influence their decision to donate spermatozoa. As the majority of both the potential recipients and potential donors feels that sperm donors should be paid, perhaps the views of these groups should carry significant weight when the decision whether or not to withdraw payment is taken. This is especially the case in view of the fact that the majority of the general public is in favour of the use of donated spermatozoa for the treatment of infertile couples.