Dutch drugmaker Organon, part of Akzo Nobel, has terminated the LIFT study of its hormone replacement therapy Livial after an interim analysis showed that the agent increased the incidence of stroke.
On the advice of the trial’s independent Data and Safety Monitoring Board, Organon has decided to bring the three-year, placebo-controlled randomised study to an end. LIFT was designed to investigate the effect of tibolone, a hormone replacement therapy, on new vertebral fractures in elderly osteoporosis patients.
The finding on stroke was not unexpected. Last October, a report on the side effect ran in the British Medical Journal, and the risk has already been communicated to investigators, health authorities and patients taking the drug. At the time, Organon decided to continue the trial until the next analysis point in January 2006 to see if the problem persisted.
Organon had hoped that approval in osteoporosis would inject renewed vigour into Livial. The product has seen its sales decline in the face of the general downturn in the HRT market that has occurred since the release of the Women’s Health Initiative study results, which revealed that HRT was associated with an increase in cardiovascular risk. Sales of Livial in 2005 fell 6% to 164 million ($195m).
Investigators and patients in the study have been informed and medication has been stopped and the evaluation itself will end after final assessments are completed over the next several months. Following full analysis of the data Organon says it will "reconsider clinical activities for the treatment of osteoporosis indication."