September 22, 2017
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Anti-osteoporosis prescription prevalence steadily decreasing in Spain

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Utilization of anti-osteoporosis therapies increased by 41% from 2001 to 2006 before steadily declining by 63% during the next 7 years, according to an analysis of Spanish registry data.

“During the study period, the management of osteoporosis has undergone different revisions,” Elisa Martin-Merino, PhD, a senior epidemiologist at the Spanish Agency of Medicines and Medical Devices in Madrid, and colleagues wrote. “Apart from changes in the diagnostic criteria of osteoporosis itself and fracture risk-assessment strategies, modifications in the available pharmacological treatment happened.”

Changes from 2001 to 2013 included new restrictions and new indications for use of existing anti-osteoporosis therapies, as well as the marketing of new therapies, all potentially affecting clinician and patient perspectives and resulting in changes in prescription practices, the researchers noted.

Martin-Merino and colleagues analyzed data from 1,488,211 adults aged at least 50 years between 2001 and 2013, using the Spanish Database for Pharmaco-epidemiological Research in Primary Care, a longitudinal, population-based database of electronic medical records from the Spanish National Health System. Researchers followed patients until a paper-based prescription of dispensation for any anti-osteoporosis medication, death, loss to follow-up or Dec. 31, 2013. Prevalent users were stratified according to the first anti-osteoporosis prescription received, including alendronate, other oral bisphosphonates, selective estrogen receptor modulators, strontium ranelate, teriparatide (Forteo, Eli Lilly) and denosumab (Prolia, Amgen). IV bisphosphonates were not included in the study. Researchers calculated age- and sex-standardized incidence rates to compare incidence rates of different calendar years.

Within the study population, 135,410 (124,642 women) were prescribed an anti-osteoporosis therapy anytime during the 12-year study period, for a prevalence of 6.1% for women and 1.1% for men. Overall prevalence of anti-osteoporosis prescriptions increased sharply from 2001 to 2009, according to researchers, before decreasing thereafter. The most commonly prescribed therapy between 2002 and 2008 to then decrease thereafter was alendronate (40% to 44% of all treatments).

The new users’ cohort included 95,057 patients beginning treatment between 2002 and 2013 (79% of total users). Of this group, 90.7% were women. The overall incidence rate of anti-osteoporosis therapy use was 14.3 per 1,000 person-years, with the rate much higher among women (24.9 per 1,000 person-years) vs. men (2.8 per 1,000 person-years). The overall rate rose from 12.81 per 1,000 person-years in 2001 to 19.66 per 1,000 person-years in 2003, remained stable until 2007 and decreased thereafter until it fell to 7.33 per 1,000 person-years in 2013. After standardizing by age and sex, researchers determined there was a 41% increase in the incidence rate from 2001 to 2006, before falling by 63% from 2006 to 2013.

The treatment incidence rates were highest for bisphosphonates across all years, although numbers declined for both sexes from 2009 to 2013, according to researchers. Selective estrogen receptor modulators were the second most-prescribed therapies until 2005, whereas strontium ranelate was most prescribed between 2006 and 2012. The incidence rate for teriparatide increased from marketing in 2004 onward, as did denosumab from marketing in 2011 onward.

“In our study, a higher proportion of patients with history of fractures and use of drugs acting on calcium homeostasis among those newly treated with [anti-osteoporosis therapies] during the last period and/or with the last approved drugs (teriparatide and denosumab) was observed vs. previous years,” the researchers wrote. “That may suggest that [anti-osteoporosis] treatment has been limited, in some extent, to patients at highest risk of fractures and/or symptomatic osteoporosis.” – by Regina Schaffer

Disclosures: One of the authors reports his research group received unrestricted research grants from Servier Laboratories and Amgen. Martin-Merino reports no relevant financial disclosures.