ABSTRACT
Title
Triptans and cardiovascular events: data mining of the FDA Adverse Event Reporting System (AERS)
Authors
G. Roberto
Doctorate School in Pharmacology Sciences
Dep.t of Pharmacology – University of Bologna, Italy
Doctorate School in Pharmacology Sciences
Dep.t of Pharmacology – University of Bologna, Italy
Abstract
Migraine is a common, debilitating, chronic neurovascular disorder that affects about 10% of the population, more frequent in the midlife and among women[1]. The first pharmacological approach is represented by traditional analgesics (aspirin, NSAIDs, acetaminophen)[2], but, when previous options have not been properly effective, the mainstay of the therapy is represented by triptans, which are labelled exclusively for migraine attacks, at any degree of severity. Triptans activate the 5-HT1B and 5-HT1D receptors within the trigeminovascular system, impairing both cerebral vessels and, to a much lesser extent, coronary arteries, and causing a vasoconstrictor effect[3]. As the incidence of severe cardiovascular events (CVE) after triptan use appear to be very rare (1:100,000 treated attacks)[4], spontaneous reports can play a relevant role in assessing the safety profile of this class of drugs.
In order to add further data regarding the cardiovascular safety profile of triptans, I analyzed all the cardiovascular event (CVE) reports, suspected to be associated with triptan assumption, collected in the public version of FDA Adverse Event Reporting System (AERS) database from January 2004 to December 2009. I tried to critically evaluate such data in the light of what is already known on triptan CVE-liability. Moreover, to refine signal detection, I identified CVE cases without the presence of CV co-medications suggesting a pre-existing CV risk.
In the considered period, the FDA-AERS database registered 1099 reports of triptan-related CVE codified as “Cardiac disorder” or “Vascular disorders” (MedDRA System-Organ Class). Over the half of these reports was regarding sumatriptan. The distribution of cases by age showed a peak between 41 and 50 years for both genders and a female:male ratio of 5:1. Among all reports, 22 deaths, 130 life threating reactions, 54 adverse events resulting in a permanent disability and 253 hospital admission or prolonged hospitalization were retrieved. The most frequent MedDRA preferred terms codifying for a severe CVE were “myocardial infarction” (86 cases) and “cerebrovascular accident” (51 cases).
Large spontaneous reporting databases represent an important source for signal detection of rare adverse drug reactions (ADR), such as serious and life-threatening CVE after triptan use. The results of this study will be useful for a further reassessment of the safety profile of this drug class, however no incidence rate can be obtained from this type of data.
1) Barra S. et al. (2010) - Expert opinion on pharmacother, 11: 2727–37
2) Olesen J. (2005) - Rev Neurol, 161: 689-91
3) Jamieson DG (2002) - Am J Med, 112:135-40.
4) Martin VT et al. (2005) - Am J Med, 118(suppl 1), 36S–44S
In order to add further data regarding the cardiovascular safety profile of triptans, I analyzed all the cardiovascular event (CVE) reports, suspected to be associated with triptan assumption, collected in the public version of FDA Adverse Event Reporting System (AERS) database from January 2004 to December 2009. I tried to critically evaluate such data in the light of what is already known on triptan CVE-liability. Moreover, to refine signal detection, I identified CVE cases without the presence of CV co-medications suggesting a pre-existing CV risk.
In the considered period, the FDA-AERS database registered 1099 reports of triptan-related CVE codified as “Cardiac disorder” or “Vascular disorders” (MedDRA System-Organ Class). Over the half of these reports was regarding sumatriptan. The distribution of cases by age showed a peak between 41 and 50 years for both genders and a female:male ratio of 5:1. Among all reports, 22 deaths, 130 life threating reactions, 54 adverse events resulting in a permanent disability and 253 hospital admission or prolonged hospitalization were retrieved. The most frequent MedDRA preferred terms codifying for a severe CVE were “myocardial infarction” (86 cases) and “cerebrovascular accident” (51 cases).
Large spontaneous reporting databases represent an important source for signal detection of rare adverse drug reactions (ADR), such as serious and life-threatening CVE after triptan use. The results of this study will be useful for a further reassessment of the safety profile of this drug class, however no incidence rate can be obtained from this type of data.
1) Barra S. et al. (2010) - Expert opinion on pharmacother, 11: 2727–37
2) Olesen J. (2005) - Rev Neurol, 161: 689-91
3) Jamieson DG (2002) - Am J Med, 112:135-40.
4) Martin VT et al. (2005) - Am J Med, 118(suppl 1), 36S–44S