Articles
Merck: EFFECT trial puts Fosamax ahead of Evista
May 23, 2003
May 23, 2003 1:34 PM GMT (Datamonitor) - A head to head trial between osteoporosis drugs Fosamax (Merck) and Evista (Lilly) indicates that Fosamax causes greater bone mineral density increases over 12 months than Evista in postmenopausal women. However, while the results put Merck's drug ahead for now, the utility of such trials is increasingly in question.
In research pertaining to non-US audiences only, new results from the EFFECT International trial between Fosamax and Evista were presented at the 30th European Symposium on Calcified Tissues in Rome. It is the first multinational trial to compare the leading drugs, 70mg weekly Fosamax (alendronate) and 60mg daily Evista (raloxifene), in the postmenopausal osteoporosis market, and was funded by Merck.
The trial lasted for 12 months and showed that postmenopausal osteoporotic women had greater increases in bone mineral density (BMD) at the spine and hip with Fosamax than with Evista.
Results showed Fosamax patients achieved a significant two-fold vertebral BMD increase of 4.8% compared to 2.2% with Evista. An almost three-fold increase was seen at the hip with Fosamax, where BMD increased by 2.9% versus 1.0% with Evista at 12 months. Both drugs were well tolerated, but more women taking Evista experienced hot flushes than those taking Fosamax.
While the trial puts Fosamax ahead of Evista in a controlled setting, the results don't really show anything new about either drug. Previous clinical trials show that BMD increases with Fosamax over time are generally larger than those seen with Evista. What the results do is give Merck a useful tool for leveraging the leading position of Fosamax over its rivals.
However, the trial may not even be measuring the right endpoint. Short-term trials focusing on BMD endpoints are becoming less persuasive as the real evidence needed in osteoporosis is the reduction of bone fractures.
Other research shows that BMD has only a moderate contribution to fracture resistance. But as fracture trials must be longer than BMD trials and must include thousands of subjects, they are an incredibly costly undertaking for pharmaceutical companies.
Merck's continued strategy is on the fast result. The company is funding a similar 12-month head-to-head trial with Fosamax and class rival Actonel (P&G/Aventis), where again, the endpoint is BMD.
