Indagine sui ricoveri per patologie cardiovascolari di pazienti con prescrizioni di Triptani in situazioni di potenziale rischio clinico identificabili come controindicate nella AUSL di Bologna
Walter Gesa, Mirna Magnani, Marco Manzoli, Paola Pagano
Introduction: Triptans are selective serotonin receptors agonists, indicated as effective therapy of migraine but with specific contraindications due to vasoconstrictor effects, that may cause adverse cardiovascular and kidney reactions.
The Pharmacovigilance processes of monitoring at AUSL of Bologna showed an increasing number of treated patients over the years potentially at clinical risk because in their age few data about the safety are available or treated with dosage upper than the maximum dose indicated.
The main objective of the study was to analyze this potential clinical risk, derived from the use of Triptans, through the analysis of pharmaceutical prescriptions and the hospitalizations, focusing the attention towards admissions related to cardiovascular and kidney disease.
Materials and Methods: Databases present at the Pharmaceutical Department have been used. The data found were extracted from the databases “Assistenza Farmaceutica Territoriale’’ (AFT) and ‘’Scheda Dimissione Ospedaliera’’(SDO). The periods taken in consideration concern Triptan prescriptions given to each patient which were detected by the Tax Code in 2012 and 2013 (AFT) and hospitalizations observed in the same period (SDO). Classes of patients with high-dose were investigated and therefore with a most likely potential toxicity and such an age that there are few data about the safety.
Results: By the analysis of over ten thousand Tax Codes there have been highlighted 965 patients older than 65 years (Group A) and 34 patients with prescription per year bigger than 100 pieces (Group B). The study shows that about 7% of group A patients had one or more hospitalizations for contraindicated diseases in the data sheet of all drugs belonging to the class of Triptans.
Also 12% of group B patients was hospitalized as a result of the use of an amount of the drug upper than the maximum dose permitted.
Conclusions: The increasing use of Triptans in patients potentially at clinical risk could confirm the high number of hospitalizations for contraindicated diseases in the data sheet of the Triptans. The survey therefore could be subject to further studies, since the results obtained. Regulatory agencies, consequently, could promote independent safety studies to recruit a greater number of patients, so that, although it is not always possible to determine with certainty the relationship between the drug and an adverse event that causes the disease, the prescriber should be made capable of carefully evaluating the risk/benefit connection, especially in patients with cardiovascular disease.
Key woeds: triptans, migraine, pharmacovigilance, clinical risk, cardiovascular disease