Abstract
Background: In May 2013 and March 2014 the European Commission
issued two decisions restricting the use of strontium ranelate (SR).
These risk minimisation measures (RMM) introduced new contraindications
and limited the indications of SR therapy. At the 32nd and
33rd ICPE we presented the interim findings of our study evaluating
the effectiveness of these measures; we here report the final study
results.
Objectives: To assess the impact of RMMs on SR utilization in three
periods: Reference (01JAN2004‐31MAY2013), Transition
(01JUN2013‐31MAR2014) and Assessment (from 01APR2014).
Methods: Design: Multi‐national, multi‐database cohort studySetting:
Routinely collected electronic health care databases: 1 hospital discharge
registry (Denmark) and 4 primary care registries (Italy, Spain,
the Netherlands, UK).Exposure: In addition to the prior venous thromboembolism
contraindication, RMMs included new contraindications
(ischaemic heart disease, peripheral arterial disease, cerebrovascular
disease, uncontrolled hypertension) and restricted indications (initiation
by experienced physician, not as first line anti‐osteoporosis therapy,
severe osteoporosis).Outcomes and statistical analyses: We
conducted population (average monthly prevalence rates per year
and annual incidence rates of SR use), prescription (prevalence of contra/indications)
and treatment episode level analyses (1‐year cessation
probability).
Results: Follow‐up time comprised more than 143 million person‐
years (PY) including 76 141 incident episodes of SR treatment. Average
monthly prevalence rate of SR use dropped from 62.63/10 000
PY [95% CI: 62.37‐62.89] in the Reference to 8.54 [8.45‐8.62] in the
Assessment period. Similarly, the incidence rate of SR use fell from
7.35/10 000 PY [7.35‐7.35] to 0.22 [0.22‐0.22] in the same two
periods. The prevalence of any contraindication changed from 2.16%
[2.06‐2.27] to 1.75% [1.03‐2.97] in incident SR prescriptions and
decreased from 2.28% [2.24‐2.31] to 1.61% [1.48‐1.76] in prevalent
SR prescriptions; the prevalence of restricted indications increased
for both incident and prevalent SR prescriptions. The probability of
therapy cessation after 1 year changed from 91.3% [91.0‐91.5] to
93.6% [91.4‐95.3].
Conclusions: These findings confirm a substantial impact of RMMs on
SR utilization: SR use decreased overall, and the proportion of patients
fulfilling the limited indications and lacking contraindications
increased.
issued two decisions restricting the use of strontium ranelate (SR).
These risk minimisation measures (RMM) introduced new contraindications
and limited the indications of SR therapy. At the 32nd and
33rd ICPE we presented the interim findings of our study evaluating
the effectiveness of these measures; we here report the final study
results.
Objectives: To assess the impact of RMMs on SR utilization in three
periods: Reference (01JAN2004‐31MAY2013), Transition
(01JUN2013‐31MAR2014) and Assessment (from 01APR2014).
Methods: Design: Multi‐national, multi‐database cohort studySetting:
Routinely collected electronic health care databases: 1 hospital discharge
registry (Denmark) and 4 primary care registries (Italy, Spain,
the Netherlands, UK).Exposure: In addition to the prior venous thromboembolism
contraindication, RMMs included new contraindications
(ischaemic heart disease, peripheral arterial disease, cerebrovascular
disease, uncontrolled hypertension) and restricted indications (initiation
by experienced physician, not as first line anti‐osteoporosis therapy,
severe osteoporosis).Outcomes and statistical analyses: We
conducted population (average monthly prevalence rates per year
and annual incidence rates of SR use), prescription (prevalence of contra/indications)
and treatment episode level analyses (1‐year cessation
probability).
Results: Follow‐up time comprised more than 143 million person‐
years (PY) including 76 141 incident episodes of SR treatment. Average
monthly prevalence rate of SR use dropped from 62.63/10 000
PY [95% CI: 62.37‐62.89] in the Reference to 8.54 [8.45‐8.62] in the
Assessment period. Similarly, the incidence rate of SR use fell from
7.35/10 000 PY [7.35‐7.35] to 0.22 [0.22‐0.22] in the same two
periods. The prevalence of any contraindication changed from 2.16%
[2.06‐2.27] to 1.75% [1.03‐2.97] in incident SR prescriptions and
decreased from 2.28% [2.24‐2.31] to 1.61% [1.48‐1.76] in prevalent
SR prescriptions; the prevalence of restricted indications increased
for both incident and prevalent SR prescriptions. The probability of
therapy cessation after 1 year changed from 91.3% [91.0‐91.5] to
93.6% [91.4‐95.3].
Conclusions: These findings confirm a substantial impact of RMMs on
SR utilization: SR use decreased overall, and the proportion of patients
fulfilling the limited indications and lacking contraindications
increased.
| Original language | English |
|---|---|
| Pages (from-to) | 189 |
| Number of pages | 1 |
| Journal | Pharmacoepidemiology and Drug Safety |
| Volume | 27 |
| Issue number | S2 |
| Publication status | Published - Aug 2018 |