“Clinical
trials are designed to assess efficacy, not safety and so post marketing data
is needed to evaluate safety. Jakob et al report the results
of an observational cohort study to assess safety and treatment persistence
with SR during 3 years follow-up in 12,702 postmenopausal women from 7
countries (29).
Mean age was 69.0 years with 16.5% of patients being over 80 years. Mean
follow-up duration was 32 months and mean treatment duration was 25.2 months
(24,956 patient-years of treatment). VTE was reported in 55 patients, an
incidence of 2.1/1000 patient-years (95% CI 1.6, 2.8), lower than that observed
in patients treated with SR in the phase III studies (7.9/1000 patient-years;
95% CI 6.3, 9.7). No DRESS syndrome or Stevens-Johnson syndrome was reported.
Persistence of SR treatment was 80%, 68% and 64% after 12, 24 and 32 months
treatment, respectively.”
29.
Jakob FJ, Palacios S, Audran M, et al. Final results of a 3 years prospective
observational cohort study of patients treated with strontium ranelate.
Osteoporos Int 2012;23(Suppl 2):S73.
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