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Roberto, Giuseppe (2013) Pattern di utilizzo e sicurezza cardiovascolare dei triptani nella pratica clinica. [Tesi di dottorato]

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Abstract (inglese)

The topic of this PhD thesis concerns the pattern of use and the post-marketing cardiovascular (CV) safety of 5HT1b/d receptor agonists, a class of specific antimigraine agents commonly called “triptans”.
With the aim to describe the pattern of utilization of triptans in a wide sample of the Italian general population, the Emilia-Romagna Regional Health Authority Database was analyzed. All patients receiving at least one triptan prescription in 2007 (N=34915) were followed for 12 months after the date of first prescription. On the basis of triptan exposure during the 12 months preceding the date of recruitment, prevalent users were divided into two groups, new users (N=18104) and already in treatment (N=16811); the respective frequency of triptan use and percentage of subject receiving CV co-prescription (suggestive of potential vasoconstrictive risk or absolute contraindication to triptan use) were described. Results from the analysis provided an estimation of the incidence and the prevalence of triptan use in the general population (0,4% e 0,8% respectively), also highlighting important differences between new users and already in treatment patients. The latter population, whose patients can be considered more “familiar” to the treatment, showed a markedly higher frequency of use compared to new users and, in particular, also a wider percentage of subjects taking >180 posologic units/year, thus potentially affected by chronic headache related to triptan overuse (0.3% vs 15,3%; p<0,001). Even users that received CV co-prescription were more often present among already in treatment patients (12% vs 27,6%; p<0,001). Therefore, on the basis of these evidence, periodic patient monitoring should be recommended and informative intervention should be implemented in order to promote appropriate prescription and safe use of these antimigraine drugs.
With the aim to highlight rare, unexpected or poorly documented adverse CV events concerning triptan therapy, reports of suspected adverse drug reaction from the Food and Drugs Administration_Adverse Event Reporting System (FDA_AERS) database were analyzed. The data-mining process applied to estract reports of potential interest was based on the following steps: duplicate removal, drugs mapping through the ATC classification, estraction of CV event on the basis of the MedDRA classification, application of the Reporting Odds Ratio (ROR) and subsequent statistical adjustment of its values considering co-reported CV drugs as a row proxy of a pre-existing CV condition). Through this approach, all CV events that were more frequently reported in association to triptans rather than to all other drugs in the database were identified. The analysis was based on over two millions reports entered into the database between 2004 and 2010. Among a total of 7808 reports with triptan exposure, the application of the ROR highligthed three main groups of events that could be considered unexpected/poorly documented concerning triptan treatment: cerebrovascular events, aneurysm and dissection, and pregnancy related vascular events. On the basis of these results, a subsequent study was performed in order to focus on the cerebrovacular events previously highlighted, with the aim to provide more details on the actual relation between the drug and the event. Therefore, the further analysis was performed on the same dataset used for the previous study. It was based on two different approaches: i) a case-by-case analysis concerning reports of a specific cerebrovascular event considered of interest (quantitative approach); ii) the selection of a cluster of cerebrovascular events, on the basis of the MedDRA classification, and the calculation of the stratified and adjusted ROR values for triptan exposure on the basis of potentially confounding/modifying factors (quantitative approach). Results from the qualitative analysis demonstrated a possible role of triptans in the onset/exacerbation of a rare cerebrovascular event such as the dissection of the carotid artery. Moreover, the quantitative analysis allowed for identification of sub-populations of users that could be at risk for cerebrovascular accident related to the triptan treatment (i.e. patients aged 18-44, estrogens/contraceptive users). These findings should be considered as specific hypothesis to be tested through further large scale ad hoc epidemiological studies to better define the safety profile of this class of antimigraine agents.

Abstract (italiano)

La presente tesi di dottorato ha avuto come oggetto lo studio delle modalità di utilizzo ed il profilo di sicurezza cardiovascolare (CV) post-marketing degli agonisti selettivi dei recettori 5HT1b/d, una classe di specifici agenti antiemicranici, comunemente chiamati “triptani”.
Al fine di descrivere le modalità di prescrizione dei triptani in un ampio campione della popolazione italiana, è stata analizzata la banca dati regionale di Assistenza Farmaceutica Territoriale dell’Emilia-Romagna. Tutti i pazienti che durante il 2007 avevano ricevuto almeno una prescrizione contenente un triptano (N=34915) sono stati osservati per i 12 mesi successivi alla data di prima prescrizione. Sulla base dell’esposizione al farmaco nei 12 mesi precedenti al reclutamento, gli utilizzatori prevalenti sono suddivisi in due distinte popolazioni, new users (N=18104) e already in treatment (N=16811), le quali sono state successivamente confrontate in termini di frequenza di utilizzo del farmaco e percentuale di soggetti che ricevevano co-prescrizioni di farmaci CV, utilizzate come proxy di un potenziale rischio vasocostrittivo o una controindicazione assoluta verso la terapia con triptani. I risultati dell’analisi hanno permesso di stimare l’incidenza e la prevalenza annuale d’utilizzo dei triptani nella popolazione generale (0,4% e 0,8% rispettivamente), mettendo in luce, inoltre, importanti differenze fra new users e i pazienti already in treatment. Questi ultimi, che possono essere considerati come pazienti più “familiari” al trattamento, mostravano una frequenza d’uso marcatamente più elevata rispetto ai new users e, in particolare, una percentuale significativamente più elevata di soggetti che assumevano >180 unità posologiche/anno, quindi potenzialmente affetti da cefalea cronica correlata all’ uso eccessivo di triptani (0.3% vs 15,3%; p<0,001). Anche i pazienti che ricevevano una co-prescrizione CV erano più spesso presenti fra i pazienti already in treatment (12% vs 27,6%; p<0,001). Pertanto, sulla base delle evidenze raccolte, sarebbero auspicabili interventi informativi ad hoc al fine di promuovere l’appropriatezza prescrittiva e l’uso sicuro di questi farmaci antiemicranici, raccomandando ai medici prescrittori un monitoraggio periodico dei pazienti.
Allo scopo di mettere in evidenza eventi di natura CV rari, non noti o poco documentati rispetto alla terapia con triptani, sono state analizzate le segnalazione di sospetta reazione avversa a farmaco presenti nel database internazionale del Food and Drugs Administration_Adverse Event Reporting System (FDA_AERS). Per l’estrazione delle segnalazioni di possibile interesse è stato applicato uno specifico processo di data-mining basato sui seguenti passaggi: rimozione dei duplicati, mappatura dei farmaci tramite la classificazione ATC, estrazione degli eventi CV secondo la classificazione MedDRA, applicazione del Reporting Odds Ratio (ROR) e successivo aggiustamento statistico per la concomitante assunzione di farmaci CV (proxy grezzo di un disturbo CV di base). In tal modo sono stati evidenzati tutti gli eventi CV che venivano segnalati più frequentemente in associazione ad un qualsiasi triptano rispetto a tutti i restanti farmaci presenti nel database. L’analisi si è basata su oltre due milioni di segnalazioni inserite nel database fra il 2004 ed il 2010. Tra i 7808 report riguardanti almeno un triptano, l’applicazione del ROR ha evidenziato una possibile relazione fra l’assunzione di un triptano ed una serie di eventi che potevano essere considerati inattesi rispetto alla terapia con questi farmaci: eventi di natura cerebrovascolare, aneurismi e dissezioni, ed eventi correlati alla gravidanza. Sulla base di questi risultati, nel successivo studio è stato possibile focalizzare l’attenzione sui soli eventi cerebrovascolari messi precedentemente in evidenza, allo scopo di acquisire maggiori informazioni sulla relazione tra farmaco ed evento. L’analisi, effettuata sullo stesso dataset del precedentemente studio, si è basata sull’applicazione di due differenti approcci: i) una case-by-case analysis riguardante le segnalazioni di uno specifico evento giudicato d’interesse (approccio quantitativo); ii) la selezione di un cluster di eventi cerebrovascolari, tramite la classificazione MedDRA, ed il calcolo del ROR riguardo l’esposizione a triptani, stratificato ed aggiustato statisticamente sulla base di variabili potenzialmente confondenti/modificanti (approccio quantitativo). I risultati dell’analisi qualitativa hanno dimostrato un ruolo possibile dei triptani nell’insorgenza/esacerbazione di un evento cerebrovascolare raro quale la dissezione dell’arteria carotide. Inoltre, l’analisi quantitativa ha permesso di mettere in evidenza alcune sottopopolazioni di utilizzatori che potrebbero essere potenzialmente esposte ad un maggior rischio di accidenti cerebrovascolari correlati all’assunzione di triptani (i.e. 18-44 anni ed utilizzatori di estrogeni/contraccettivi). Tali risultati, potranno essere utilizzati come ipotesi da testare attraverso successivi studi epidemiologici su larga scala che saranno utili a meglio definire il profilo di sicurezza di questi farmaci.

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Tipo di EPrint:Tesi di dottorato
Relatore:Poluzzi, Elisabetta
Dottorato (corsi e scuole):Ciclo 25 > Scuole 25 > SCIENZE FARMACOLOGICHE > FARMACOLOGIA, TOSSICOLOGIA E TERAPIA
Data di deposito della tesi:28 Gennaio 2013
Anno di Pubblicazione:28 Gennaio 2013
Parole chiave (italiano / inglese):Triptani, Pattern di utilizzo, Sicurezza cardiovascolare, farmacoutilizzazione, farmacovigilanza, FDA AERS
Settori scientifico-disciplinari MIUR:Area 05 - Scienze biologiche > BIO/14 Farmacologia
Struttura di riferimento:Centri > Centro Interdipartimentale di ricerca sulla Biochimica, la Farmacologia, la Fisiopatologia e la terapia del Dolore
Codice ID:5523
Depositato il:10 Ott 2013 12:46
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