Organon ends LIFT trial; Livial future uncertain

Dutch drugmaker Organon has terminated the LIFT study of its osteoporosis drug Livial (tibolone) after an interim analysis showed that the agent increased the incidence of stroke, as well as causing less vertebral fractures.

After considering advice from its independent Data amd Safety Monitoring Board and Steering Committee, Organon has decided to close the three-year placebo-controlled randomized study, which was designed to investigate the effect of tibolone, a hormone replacement therapy, on new vertebral fractures in elderly osteoporotic patients.

The finding on stroke was already reported in October last year in the British Medical Journal and communicated to investigators, health authorities and patients in September 2005. Organon, which is the pharmaceutical unit of the Akzo Nobel group, decided to take action after the DSMB's latest analysis in January demonstrated that the finding had persisted.