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

Berencsi, Klára; Sami, A; Ali, M Sanni; Marinier, K.; Deltour, Nicolas; Perez‐Gutthann, Susana; Pedersen, Lars; Lei, Johan van der; Lapi, Francesco; Simonetti, Monica; Reyes, Carlen; Sturkenboom, Miriam; Prieto‐Alhambra, Daniel

doi:10.1007/s00198-019-05181-6

Cited by 10 publications

(4 citation statements)

References 14 publications

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“…These data must be interpreted with caution since low population sizes from 2011 was analyzed. Formal studies using big populations sizes after contraindication in 2012 and restrictions in 2014 confirmed a decrease of VTE risk factors after the minimization measures disseminated to reduce the cardiovascular risk in 2014 among patients treated with strontium ranelate (21).…”

Section: Discussionmentioning

confidence: 96%

Risk of venous thromboembolism among users of different anti-osteoporosis drugs: a population-based cohort analysis including over 200,000 participants from Spain and the UK

et al. 2017

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Section: Discussionmentioning

confidence: 96%

Risk of venous thromboembolism among users of different anti-osteoporosis drugs: a population-based cohort analysis including over 200,000 participants from Spain and the UK

et al. 2017

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“…However, other downstream factors may also have influenced this process and therefore we used the quarter when the referral concluded as our intervention time point when information first became public. Nevertheless, we add to the evidence demonstrating geographical variation in the impact of pharmacovigilance decisions can occur despite being subject to the same recommendations 3,20‐25 …”

Section: Discussionmentioning

confidence: 96%

Impact of EMA regulatory label changes on hydroxyzine initiation, discontinuation and switching to other medicines in Denmark, Scotland, England and the Netherlands: An interrupted time series regression analysis

Moralès

Macfarlane

MacDonald

et al. 2021

Pharmacoepidemiology and Drug

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Background Hydroxyzine is indicated for the management of anxiety, skin and sleep disorders. In 2015, the European Medicines Agency (EMA) concluded that hydroxyzine was pro‐arrhythmogenic and changes to the product information were implemented in Europe. This study aimed to evaluate their impact in Denmark, Scotland, England and the Netherlands. Method Quarterly time series analyses measuring hydroxyzine initiation, discontinuation, and switching to other antihistamines, benzodiazepines and antidepressants in Denmark, England, Scotland and the Netherlands from 2009 to 2018. Data were analysed using interrupted time series regression. Results Hydroxyzine initiation in quarter one 2010 in Denmark, Scotland, England and the Netherlands per 100 000 was: 23.5, 91.5, 35.9 and 34.4 respectively. Regulatory action was associated with a significant: immediate fall in hydroxyzine initiation per 100 000 in England (−12.05, 95%CI −18.47 to −5.63) and Scotland (−19.01, 95%CI −26.99 to −11.02); change to a negative trend in hydroxyzine initiation per 100 000/quarter in England (−1.72, 95%CI −2.69 to −0.75) and Scotland (−2.38, 95%CI −3.32 to −1.44). Regulatory action was associated with a significant: immediate rise in hydroxyzine discontinuation per 100 000 in England (3850, 95%CI 440‐7240). No consistent changes were observed in the Netherlands or Denmark. Regulatory action was associated with no switching to other antihistamines, benzodiazepines or antidepressants following hydroxyzine discontinuation in any country. Conclusion The 2015 EMA regulatory action was associated with heterogeneous impact with reductions in hydroxyzine initiation varying by country. There was limited impact on discontinuation with no strong evidence suggesting unintended consequences of major switching to other antihistamines, benzodiazepines or antidepressants.

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“…Second, SR has some severe side effects, such as thromboembolism, but most of them can be avoided if physicians strictly follow the indications of SR [ 51 ]. It was reported that physicians strictly control the indications of SR, such as severe osteoporosis with a high absolute fracture risk, significantly reducing the occurrence of these side effects [ 52 ]. Last, the exact mechanisms of how the NF-κB pathway regulates autophagy and how autophagy affects osteoclastogenesis are still unclear and need to be further elucidated.…”

Section: Discussionmentioning

confidence: 99%

Strontium Ranelate Inhibits Osteoclastogenesis through NF-κB-Pathway-Dependent Autophagy

Sun

Zhao

et al. 2023

Bioengineering

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Strontium ranelate (SR) is a pharmaceutical agent used for the prevention and treatment of osteoporosis and fragility fracture. However, little attention has been paid to the effect of SR on alveolar bone remodeling during orthodontic tooth movement and its underlying mechanism. Here, we investigated the influence of SR on orthodontic tooth movement and tooth resorption in Sprague–Dawley rats and the relationship between the nuclear factor–kappa B (NF-κB) pathway, autophagy, and osteoclastogenesis after the administration of SR in vitro and in vivo. In this study, it was found that SR reduced the expression of autophagy-related proteins at the pressure side of the first molars during orthodontic tooth movement. Similarly, the expression of these autophagy-related proteins and the size and number of autophagosomes were downregulated by SR in vitro. The results also showed that SR reduced the number of osteoclasts and suppressed orthodontic tooth movement and root resorption in rats, which could be partially restored using rapamycin, an autophagy inducer. Autophagy was attenuated after pre-osteoclasts were treated with Bay 11-7082, an NF-κB pathway inhibitor, while SR reduced the expression of the proteins central to the NF-κB pathway. Collectively, this study revealed that SR might suppress osteoclastogenesis through NF-κB-pathway-dependent autophagy, resulting in the inhibition of orthodontic tooth movement and root resorption in rats, which might offer a new insight into the treatment of malocclusion and bone metabolic diseases.

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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

Cited by 10 publications

References 14 publications

Risk of venous thromboembolism among users of different anti-osteoporosis drugs: a population-based cohort analysis including over 200,000 participants from Spain and the UK

Risk of venous thromboembolism among users of different anti-osteoporosis drugs: a population-based cohort analysis including over 200,000 participants from Spain and the UK

Impact of EMA regulatory label changes on hydroxyzine initiation, discontinuation and switching to other medicines in Denmark, Scotland, England and the Netherlands: An interrupted time series regression analysis

Strontium Ranelate Inhibits Osteoclastogenesis through NF-κB-Pathway-Dependent Autophagy

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