Eli Lilly and Company announced a review of long-term data on Evista (raloxifene HCl tablets) therapy including summaries of previously published information; previously unpublished observations; and new data on Evista use.
Evista is indicated for the treatment of osteoporosis in postmenopausal women and reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.
The majority of available data came from the Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the Continued Outcomes of Raloxifene Evaluation (CORE) trial. In these trials, patients were evaluated for up to eight years. While available information is supportive of Evista use for more than three years, the optimum duration of Evista therapy is not known.
“Because of the chronic nature of postmenopausal osteoporosis and the risk of invasive breast cancer associated with the disease in postmenopausal women with osteoporosis, it is critical to evaluate medications that treat these conditions that require therapy over a prolonged period of time,” says Robert Recker, MD, professor of medicine, chief, division of endocrinology, director, Osteoporosis Research Center, Creighton University School of Medicine.
Use of Evista was evaluated by changes in vertebral fracture risk reduction, bone mineral density (BMD), markers of bone turnover, iliac crest bone biopsies, and invasive breast cancer risk reduction:
Vertebral fracture risk reduction: In the MORE trial, the relative risk reduction during the fourth year of the study was similar to the relative risk reduction during years zero to three.
BMD: Patients who stopped Evista therapy in the one-year period between the end of the MORE trial and the beginning of the CORE trial experienced a significant decrease in BMD. Once treatment resumed in the CORE trial, lumbar spine and femoral neck BMD increased in the Evista group.
Bone turnover: Patients who received Evista for three continuous years had lower bone resorption as measured by c-terminal telopeptide (CTX) values, with the average being similar to that found in premenopausal women.
Iliac crest bone biopsies: Newly reported data from a subset of patients in the CORE trial included results of iliac crest biopsies in three patients treated with EVISTA for eight years. The iliac crest biopsies showed normal bone and bone cells and double label in all specimens.
Invasive breast cancer risk reduction: In a subset of postmenopausal women followed for up to eight years from randomization of the MORE trial to the end CORE, a reduction in the incidence of invasive breast cancer was observed in the EVISTA versus placebo group. The long term effects and the recommended length of therapy are not known.
In clinical trials, patients in the Evista versus placebo group had higher incidence of venous thromboembolic events (blood clots in the legs, lungs or eyes), including deep vein thrombosis and pulmonary embolism, compared with patients who received placebo.
The safety profile of Evista after four years of treatment was similar to that of Evista following three years of therapy.
The research was published online in Current Medical Research & Opinion.
Release Date: August 9, 2011
Source: Eli Lilly and Company
Filed Under: Drug Discovery