Evidence map›Paper›PMID 31696274›Full record

ArticleOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2020

Impact of risk minimisation measures on the use of strontium ranelate in Europe: a multi-national cohort study in 5 EU countries by the EU-ADR Alliance.

K Berencsi, A Sami, M S Ali, K Marinier, N Deltour, S Perez-Gutthann, L Pedersen, P Rijnbeek, J Van der Lei, F Lapi and 4 more

Erratum issuedAbstract read
PubMed Publisher
In one paragraph

Article in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Comparative cardiovascular safety of strontium ranelate and bisphosphonates: a multi-database study in 5 EU countries by the EU-ADR Alliance.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

K BerencsiDepartment of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.
A SamiPharmaco- and Device Epidemiology, Centre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, UK.
M S AliPharmaco- and Device Epidemiology, Centre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, UK.
K MarinierDepartment of Pharmacoepidemiology, Servier, Suresnes, France.
N DeltourDepartment of Pharmacoepidemiology, Servier, Suresnes, France.
S Perez-GutthannRTI Health Solutions, Barcelona, Spain.
L PedersenDepartment of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.
P RijnbeekDepartment of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.
J Van der LeiDepartment of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.
F LapiHealth Search, Italian College of General Practitioners and Primary Care, Florence, Italy.
M SimonettiHealth Search, Italian College of General Practitioners and Primary Care, Florence, Italy.
C ReyesGREMPAL Research Group, Idiap Jordi Gol Primary Care Research Institute and CIBERFes, Universitat Autonoma de Barcelona and Instituto de Salud Carlos III, Barcelona, Spain.
M C J M SturkenboomJulius Global Health, University Medical Center, Utrecht, The Netherlands.
D Prieto-AlhambraPharmaco- and Device Epidemiology, Centre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, UK. Daniel.prietoalhambra@ndorms.ox.ac.uk.ORCID http://orcid.org/0000-0002-3950-6346

Funding

Servier NA
6 · The paper itself

Abstract

introductionIn May 2013 and March 2014, the European Medicines Agency (EMA) 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. The EMA required an assessment of the impact of RMMs on the use of SR in Europe. Methods design: multi-national, multi-database cohort Setting: electronic medical record databases based on hospital (Denmark) and primary care provenance (Italy, Spain, the Netherlands, UK).

participantsthe database source populations were included for population-based analyses, and SR users for patient-level analyses.

interventionNew RMMs included contraindications (ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, uncontrolled hypertension) and restricted SR indication to severe osteoporosis with initiation by experienced physician and not as first line anti-osteoporosis therapy.

methodsPrevalence and incidence rates of SR use in the population; prevalence of contraindications and restricted indications in SR users, plus 1-year therapy persistence. Drug use measures were calculated in three periods for comparison: reference (2004 to May 2013), transition (June 2013 to March 2014) and assessment (from April 2014 to end 2016).

resultsThe study population included 143 million person-years(PY) of follow-up and 76,141 incident episodes of SR treatment. Average monthly prevalence rates of SR use dropped by 86.4% from 62.6/10,000 PY (95 CI 62.4-62.9) in the reference to 8.5 (8.5-8.6) in the assessment period. Similarly, the incidence rate of SR use fell by 97.3% from 7.4/10,000 PY (7.4-7.4) to 0.2 (0.2-0.2) between the reference and assessment period. The prevalence of any contraindication decreased, whilst the prevalence of restricted indications increased in these periods. One-year persistence decreased in the assessment compared with reference period.

conclusionsOur study demonstrates a substantial impact of the regulatory action to restrict use of SR in Europe: SR utilisation overall decreased strongly. The proportion of patients fulfilling the restricted indications, without contraindications, increased after the proposed RMMs.

Indexed as

Bone Density Conservation AgentsOrganometallic CompoundsCohort StudiesEuropeHealth PolicyHumansItalyNetherlandsSpainThiophenesBone Density Conservation AgentsOrganometallic Compoundsstrontium ranelateThiophenesPharmacoepidemiologyRisk minimisation measuresStrontium ranelate

Identifiers

PMID31696274

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.