European panel recommends major industry-funded research into body fat changes

Keith Alcorn
Estimated reading time 1 minutes
This article is more than 24 years old.

Pharmaceutical companies are to fund four major studies of metabolic and body fat changes following a series of meetings at the request of the European Agency for the Evaluation of Medicinal Products and its scientific advisory committee.

The studies will look at:

  • 15,000 individuals in the EuroSIDA cohort for signs of increased risk of cardiovascular disease in people on HAART. Follow-up will last for two years.

  • Variations in metabolic and body fat changes according to regimen in four major studies of initial regimens and treatment sequencing (ACTG 364, Initio, First and Atlantic). Follow-up will last for at least four years.

  • Analysis of the Veteran's Administration database for signs of increased risk of cardiovascular disease

  • A controlled study of individuals matched for age and other demographics to try to establish a case definition of lipodystrophy based on longitudinal observation rather than retrospective report. Follow-up is likely to last at least eighteen months.

Glossary

metabolism

The physical and chemical reactions that produce energy for the body. Metabolism also refers to the breakdown of drugs or other substances within the body, which may occur during digestion or elimination.

lipodystrophy

A disruption to the way the body produces, uses and distributes fat. Different forms of lipodystrophy include lipoatrophy (loss of subcutaneous fat from an area) and lipohypertrophy (accumulation of fat in an area), which may occur in the same person.

cardiovascular

Relating to the heart and blood vessels.

longitudinal study

A study in which information is collected on people over several weeks, months or years. People may be followed forward in time (a prospective study), or information may be collected on past events (a retrospective study).

retrospective study

A type of longitudinal study in which information is collected on what has previously happened to people - for example, by reviewing their medical notes or by interviewing them about past events. 

However, there will be no research to investigate the causes or the treatment of lipodystrophy.

The studies came about as a consequence of a request to industry from the CPMP's Pharmacovigilance Working Party for proposals on how to monitor the long-term consequences of metabolic and body fat changes on HAART. Proposals were developed by representatives of all pharmaceutical companies with licensed anti-HIV drugs, together with academics and clinicians from Europe, Australia and the USA. Community representatives, including the European AIDS Treatment Group, were also involved in the process.

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