The rise and fall of raloxifene use for osteoporosis, 1999-2022

Summary — The relevance of raloxifene in current osteoporosis practice is not clear given concerns about its safety and the introduction of newer therapeutic options. We describe the rise and fall in raloxifene use among older females in Ontario, documenting that it remains an important therapeutic option for osteoporosis in select patients.

Purpose — Raloxifene has been available in Canada for postmenopausal osteoporosis since 1998. However, its benefit-to-risk ratio became questioned after evidence of increased risk of thrombosis and fatal stroke emerged in the early 2000s. We aimed to describe the use of raloxifene over time.

Methods — We identified community-dwelling females aged ≥ 66 years initiating raloxifene between 1999/05 and 2022/12 through the Ontario Drug Benefit program, plotted the number of incident and prevalent users by calendar year, and estimated persistence with therapy using a 60-day permissible gap. Patient characteristics were described using medical and pharmacy claims within the year prior to initiation.

Results — We identified 21,896 eligible females (mean age = 74.2 [SD = 6.2] years, 5% fracture history, 57% oral bisphosphonate history). The number of patients initiating raloxifene increased to an annual high of 3,824 in 2001 followed by a 15% drop in 2002 (n = 3,252) before a gradual decline from 2,113 in 2003 to 90 in 2022. In contrast, the number of prevalent users remained >5,000 annually between 2003 and 2011, with a gradual drop from 4,670 in 2012 to 959 in 2022. Overall, 29% persisted with therapy for ≥ 3 years. Besides known population-level treatment trends (increased statins, decreased estrogen therapy), little differences in patient characteristics were identified over time.

Conclusion — Raloxifene initiation has declined substantially since 2003, and overall utilization has declined rapidly since 2012. While less than 100 initiators were identified annually in recent years, around 1,000 continue to take raloxifene every year. Raloxifene thus remains a relevant option among select patients with osteoporosis.