Prescribing trends for sodium valproate in Ireland

Murphy, Sinéad; Bennett, Kathleen; Doherty, Colin P.

doi:10.1016/j.seizure.2016.01.019

Cited by 44 publications

(42 citation statements)

References 27 publications

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“…The results in this study are consistent with those in other earlier studies; the regional variations observed in the extent of AED prescribing and the AEDs most commonly prescribed have been reported elsewhere, including a high prevalence of valproate prescribing in Italy between 2005 and 2011 . The decline in the incidence of valproate prescribing in the United Kingdom is comparable with that reported by an Irish study between 2008 and 2013 and a study of prescriptions to 12 to 18 year olds in the United Kingdom …”

Section: Discussionsupporting

confidence: 91%

“…31 The results in this study are consistent with those in other earlier studies; the regional variations observed in the extent of AED prescribing and the AEDs most commonly prescribed have been reported elsewhere, 9,10,32 including a high prevalence of valproate prescribing in Italy between 2005 and 2011. 30 The decline in the incidence of valproate prescribing in the United Kingdom is comparable with that reported by an Irish study between 2008 and 2013 33 and a study of prescriptions to 12 to 18 year olds in the United Kingdom. 34 The dramatic decline in the incidence of clonazepam prescribing observed in France is explained by changes in the rules on prescribing that came into effect between September 2011 and January 2012, following the observation of misuse and abuse of the product.…”

Section: Strengths and Weaknessessupporting

confidence: 68%

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Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016

Charlton

Damase‐Michel

Hurault‐Delarue

et al. 2019

Pharmacoepidemiology and Drug

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Objectives In November 2014, the CMDh (a regulatory body representing EU Member States) advised doctors not to prescribe sodium valproate for epilepsy or bipolar disorder in preg nant women, in women who can become pregnant, or in girls unless other treatments are ineffective or not tolerated. This study aimed to determine if this warning led to changes in prescription patterns. Design and setting Cohort of 5.4 million women aged between 10 and 50 years identified in electronic health care data from United Kingdom, France, and Italy (2007–2016). Main outcome measures Anti‐epileptic drug (AED) prescriptions. Results The prevalence of women receiving AED prescriptions in 2016 varied from 12.2 per 1000 to 29 per 1000 in the four regions. The incidence of prescribing any AED (excluding clonazepam, gabapentin, and pregabalin) fell each year on average by 7.5% (95% CI, 7.0%‐8.0%; Emilia Romagna), 9.6% (8.3%‐11.0%; France), 7.1% (6.7%‐7.6%; Tuscany), and 0.4% (0.2%‐1.0%; United Kingdom). The relative odds of prescribing sodium valproate rather than any other AED decreased more after 2014 compared with before the end of 2014 in France (OR = 0.77; 95% CI, 0.60‐0.98), Tuscany (0.81; 0.76‐0.86), Emilia Romagna (0.83; 0.76‐0.90), and the United Kingdom (0.92; 0.80‐1.06; not statistically significant). Conclusions There is evidence that the CMDh warning did lead to changes in prescription patterns of sodium valproate in women of childbearing age. There were considerable differences in prescribing practice amongst regions of Europe.

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Section: Discussionsupporting

confidence: 91%

Section: Strengths and Weaknessessupporting

confidence: 68%

Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016

Charlton

Damase‐Michel

Hurault‐Delarue

et al. 2019

Pharmacoepidemiology and Drug

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“…In all regions, valproate prescriptions were issued to at least 10% of women exposed to an AED during pregnancy and almost 30% in Tuscany, where valproate was the most frequently prescribed AED throughout the entire study period. From 2007 to 2016, all regions, with the exception of Tuscany, observed a slight decreasing prevalence of valproate prescribing during pregnancy as reported in previous general population studies in Ireland and the UK . However, since 2013 for Italy and 2014 for France and the UK, several warnings around valproate have been published each year by National Medicines Agencies (on the AIFA [Italian Medicines Agency] website in Italy, on the ANSM [French Medicines Agency] website in France, and on the MHRA [Medicines and Healthcare products Regulatory Agency] website for the UK), and risks associated with valproate exposure during pregnancy have been described in the scientific literature since the 1980s.…”

Section: Discussionmentioning

confidence: 74%

Prescription of antiepileptic medicines including valproate in pregnant women: A study in three European countries

Hurault‐Delarue

Morris

Charlton

et al. 2019

Pharmacoepidemiology and Drug

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Purpose To study patterns of antiepileptic drugs (AED) prescribing, particularly valproate, during pregnancy over a 10‐year period in the UK, Italy, and France. Methods Data on pregnancies conceived after 1 January 2007 with outcomes before 31 December 2016 were extracted from four European electronic health care databases (380 499 in the United Kingdom (UK), 66 681 in France, and 649 918 in Italy [355 767 in Emilia Romagna and 294 151 in Tuscany]). Prevalence of AEDs with an ATC code starting N03A and clobazam (N05BA09) were stratified by country and calendar year. Results AED prescribing during pregnancy varied from 3.0 (2.8‐3.1) per 1000 pregnancies in Emilia Romagna to 7.8 (7.5‐8.0) in the UK, 5.9 (5.6‐6.1) in Tuscany, and 6.3 (5.7‐6.9) in France. Lamotrigine was commonly prescribed in all regions with a third of women exposed to an AED during pregnancy taking lamotrigine in the UK and France. Valproate was prescribed to 28.6% of AED exposed pregnant women in Tuscany, 21.6% in France, 16.7% in Emilia Romagna, and 11.9% in the UK. Over the study period, the prevalence of AED prescribing increased in the UK mainly due to increases in pregabalin and gabapentin, declined in France mainly related to decreases in clonazepam, and remained constant in Italy. Valproate prescriptions declined to a prevalence <1 per 1000 pregnancies in 2015 to 2016 in the UK, France, and Emilia Romagna. Conclusions Variations in AED prescribing during pregnancy indicate the potential for further reductions, particularly of valproate. Increases in pregabalin/gabapentin prescribing, for which risks are not well known, are a cause for concern.

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“…The onset of this change in 2003 precedes the more recent regulatory and pharmacovigilance measures, 8,36 and likely reflects the combination of accumulating evidence of adverse outcomes in valproate-associated pregnancies 6 and increasing availability of alternative AEDs. 37 While these observations reflect serious concern over adverse effects, teratogenicity, and risk of neurodevelopmental disorders in exposed offspring, 6 they also suggest that people with JME, especially female, may be deprived of the most effective treatment for their condition, a concern already voiced by others. These findings are in keeping with population-based reports of decline in valproate use in treatment of epilepsy in women.…”

Section: Discussionmentioning

confidence: 99%

Comparative effectiveness of antiepileptic drugs in juvenile myoclonic epilepsy

et al. 2019

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Objective To study the effectiveness and tolerability of antiepileptic drugs (AEDs) commonly used in juvenile myoclonic epilepsy (JME). Methods People with JME were identified from a large database of individuals with epilepsy, which includes detailed retrospective information on AED use. We assessed secular changes in AED use and calculated rates of response (12‐month seizure freedom) and adverse drug reactions (ADRs) for the five most common AEDs. Retention was modeled with a Cox proportional hazards model. We compared valproate use between males and females. Results We included 305 people with 688 AED trials of valproate, lamotrigine, levetiracetam, carbamazepine, and topiramate. Valproate and carbamazepine were most often prescribed as the first AED. The response rate to valproate was highest among the five AEDs (42.7%), and significantly higher than response rates for lamotrigine, carbamazepine, and topiramate; the difference to the response rate to levetiracetam (37.1%) was not significant. The rates of ADRs were highest for topiramate (45.5%) and valproate (37.5%). Commonest ADRs included weight change, lethargy, and tremor. In the Cox proportional hazards model, later start year (1.10 [1.08‐1.13], P < 0.001) and female sex (1.41 [1.07‐1.85], P = 0.02) were associated with shorter trial duration. Valproate was associated with the longest treatment duration; trials with carbamazepine and topiramate were significantly shorter (HR [CI]: 3.29 [2.15‐5.02], P < 0.001 and 1.93 [1.31‐2.86], P < 0.001). The relative frequency of valproate trials shows a decreasing trend since 2003 while there is an increasing trend for levetiracetam. Fewer females than males received valproate (76.2% vs 92.6%, P = 0.001). Significance In people with JME, valproate is an effective AED; levetiracetam emerged as an alternative. Valproate is now contraindicated in women of childbearing potential without special precautions. With appropriate selection and safeguards in place, valproate should remain available as a therapy, including as an alternative for women of childbearing potential whose seizures are resistant to other treatments.

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Prescribing trends for sodium valproate in Ireland

Cited by 44 publications

References 27 publications

Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016

Did advice on the prescription of sodium valproate reduce prescriptions to women? An observational study in three European countries between 2007 and 2016

Prescription of antiepileptic medicines including valproate in pregnant women: A study in three European countries

Comparative effectiveness of antiepileptic drugs in juvenile myoclonic epilepsy

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