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Women's hormone intervention secondary prevention trial


Dates: 2000-2002
Funding: Medical Research Council, Novo Nordisk Pharma
Collaborators: Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London
Information: Alastair Gray

Cardiovascular disease is one of the leading causes of death and disability in women and evidence from large epidemiological studies suggests that hormone replacement therapy (HRT) may reduce cardiovascular mortality in women by up to 40%.

WHISP was a randomised pilot study assessing the feasibility and safety of treatment with hormone replacement therapy (HRT) versus placebo within 28 days of the onset of acute coronary syndromes, including MI and unstable angina. 100 women were enrolled in 17 centres in the UK. Follow up is complete. The data from the study showed that HRT had beneficial effects on CAD risk markers without adverse effects on haemostasis. There was an apparent decrease in cardiovascular events and no evidence of an early increase in risk.

The economic component of the pilot study examined the main cost drivers and mechanisms for collecting resource use and cost information. Data were collected on the costs of the continuous combined HRT regimen and monitoring, and the costs associated with related events and procedures, including diagnostic tests, outpatient and inpatient care and operative procedures.