Medical Device Dailys

It takes a team to change the high-risk lifestyle habits of a single individual, according to a large-scale study conducted by the European Society of Cardiology (ESC; Sophia Antipolis, France) published in the June 14 issue of The Lancet.

Over three years, some 10,000 patients in eight countries participated in the Euro-Action study, the single largest research project ever to be undertaken by the society.

Six pairs of hospitals in each country worked with six pairs of general practices in a coordinated, multidisciplinary approach and comprehensive approach to cardiovascular disease (CVD) prevention.

The ESC did not want to be disappointed again.

Previous studies conducted by the society showed a high percentage of patients did not achieve weight, blood pressure and lipid targets, only a third of patients attended cardiac rehabilitation programs, and CVD prevention in routine clinical practice was inadequate.

The EuroAspire series of studies covered the actual practice of preventive cardiology in 22 countries in comparison to the goals for cardiovascular disease prevention set out in the Joint European Societies Prevention Guidelines.

Researchers discovered that individuals left to themselves find it hard to adhere to recommended lifestyle changes and prescribed treatments such as smoking cessation, changes in diet, increasing physical activity, controlling central obesity, blood pressure, cholesterol and glucose.

The Euro-Action study organized a coordinated assault to force a reduction in cardiovascular risk with a structured collaborative that included nurses, dieticians, physiotherapists, cardiologists and general practitioners.

"Euro-Action is a landmark study showing that preventive goals can be achieved and are sustainable in everyday clinical practice" said Professor Kim Fox, president of ESC.

The key conclusion is clinical practice needs to be extended through nurse-coordinated family involvement in order to achieve patient commitment to change.

"Changing lifestyle behavior, especially giving up smoking and loss of weight, is very hard to achieve," said Catriona Jennings, research nurse coordinator from the National Heart and Lung Institute in the UK.

"On their own, patients struggle and don't do well," she said. "Providing support and follow-up by dieticians, nurses and physiotherapists, made a big difference in helping patients reach their goals. Our team used behavioral techniques and expert advice to address individuals' particular problems and personal challenges as they tried to follow prescribed treatment."

David Wood, MD, professor at Imperial College London and the ESC Fellow who coordinated the study, said, "Cardiovascular disease is the main cause of death in Europe. Euro-Action shows we can achieve lifestyle and risk factor targets in a large majority of patients," and that the prescribed behavior modification offer a practical way forward for reducing the burden of heart disease and stroke.

Over half of patients participating in the study stopped smoking and remained non-smokers after one year.

Physical activity targets of 30 to 45 minutes of exercise four to five items per week were achieved by twice as many Euro-Action patients as compared to usual care patients.

Euro-Action patients reduced their consumption of saturated fat, with three-quarters of patients and their partners achieving the recommended fruit and vegetable consumption, compared to just over a third of usual care patients. Twice as many patients met the recommended weekly intake of oily fish.

The intensity of involvement in the study by patients' spouses showed in the results, with the partners of Euro-Action patients turning in the same healthy trends for changes in diet, as well as increasing their physical activity.

Denmark, France, Italy, the Netherlands, Poland, Spain, Sweden, and the UK participated in the study, which was funded by an unrestricted educational grant from AstraZeneca Pharmaceuticals (London).

CE mark for Saladax 5-FU assay

Saladax Biomedical (Bethlehem, Pennsylvania), a company specializing in chemotherapy therapeutic drug monitoring, reported CE-mark registration for its 5-FU Personalized Chemotherapy Management (PCM) assay on the Olympus AU400 Clinical Chemistry Analyzer.

For European oncologists who prescribe 5-fluorouracil (5-FU) continuous infusion regimens alone or in combination for colorectal, stomach, breast, and pancreatic cancers, this simple blood test will show patients' actual plasma 5-FU levels for individualized dosing.

"Until now, a simple, rapid, and cost-effective 5-FU measurement tool that can be easily integrated into day-to-day practice has not been readily available," said Saladax CEO Salvatore Salamone. "As a result, colorectal cancer patients receive chemotherapy based on their height and weight, with no monitoring system in place to allow oncologists to correlate dose with clinical patient response on an ongoing basis."

He said that access to the new test "will arm oncologists with the ability to individualize 5-FU dosing to ensure [that] patients receive the optimal benefit from their treatment."

"The availability of the 5-FU PCM assay will give oncologists in the EU a powerful, cost-effective tool in the battle against colorectal cancer," said Erick Gamelin, MD, PhD, director of the Paul Papin Cancer Center (Angers, France) and primary investigator of a Phase III Journal of Clinical Oncology study. "Our study demonstrates that the majority of patients are either over-dosed or in most cases, under-dosed. Personalized 5-FU dosing allows us to substantially reduce severe toxicity while improving patient quality of life and treatment outcomes."

New European patent for AutoGenomics

AutoGenomics (Carlsbad, California), a provider of automated, molecular testing solutions, said it has been issued a key European patent for Human papillomavirus (HPV). Patent No.1 499 749 B1, "Human papillomavirus Detection with DNA Microarray," covers a method for detecting the presence of HPV using a microarray.

"This patent is the result of our collaboration with Dr. Erik Thunnissen, a prominent clinician and opinion leader in the field of HPV," said Fareed Kureshy, president/CEO of AutoGenomics. "With increasing demands for alternative technologies to meet the evolving need for genotyping, we are [pleased] that we can offer an automated solution that can significantly enhance workflow efficiency in the laboratory."