Bob Johnson
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Title: Triptan safety--latest statement Post by Bob_Johnson on Jun 1st, 2004, 9:47am --------------------------------------------------------------------------------
Since this is a report on medications and not on the condition being treated, I believe it would be O.K. to apply these findings to folks with Cluster. NOTE: there are no comments about using triptans at the high/multiple dosing which is often done by cluster patients. (Treat everything below the line as a quotation. These are selected para. from the total report.) --------------------------------------------------------------------------------
Consensus Statement: Cardiovascular Safety Profile of Triptans (5-HT1B/1D Agonists) in the Acute Treatment of Migraine
Headache 44(5):414-425, 2004.
Posted 05/25/2004 Abstract Background: Health care providers frequently cite concerns about cardiovascular safety of the triptans as a barrier to their use. In 2002, the American Headache Society convened the Triptan Cardiovascular Safety Expert Panel to evaluate the evidence on triptan-associated cardiovascular risk and to formulate consensus recommendations for making informed decisions for their use in patients with migraine. Objective: To summarize the evidence reviewed by the Triptan Cardiovascular Safety Expert Panel and their recommendations for the use of triptans in clinical practice. Participants: The Triptan Cardiovascular Safety Expert Panel was composed of a multidisciplinary group of experts in neurology, primary care, cardiology, pharmacology, women's health, and epidemiology. Evidence and Consensus Process: An exhaustive search of the relevant published literature was reviewed by each panel member in preparation for an open roundtable meeting. Pertinent issues (eg, cardiovascular pharmacology of triptans, epidemiology of cardiovascular disease, cardiovascular risk assessment, migraine) were presented as a prelude to group discussion and formulation of consensus conclusions and recommendations. Follow-up meetings were held by telephone. Conclusions: (1) Most of the data on triptans are derived from patients without known coronary artery disease. (2) Chest symptoms occurring during use of triptans are generally nonserious and are not explained by ischemia. (3) The incidence of serious cardiovascular events with triptans in both clinical trials and clinical practice appears to be extremely low. (4) The cardiovascular risk-benefit profile of triptans favors their use in the absence of contraindications.
---------- These data should be interpreted in view of characteristics of the patient population in migraine clinical trials. Generally, controlled clinical trials with triptans excluded patients with cardiovascular risk factors including known ischemic heart disease, symptoms or signs consistent with ischemic heart disease, cardiac arrhythmias requiring medication, and supine diastolic blood pressure >95 mm Hg and/or systolic blood pressure >160 mm Hg. Thus, the clinical trials data cannot be generalized to migraine sufferers with cardiovascular risk factors.
Triptans are associated with a modestly elevated incidence of chest symptoms (ie, triptan sensations) relative to placebo in well-controlled clinical trials that excluded patients with significant cardiac risk factors or known ischemic heart disease. The chest symptoms in clinical trials were generally transient, mild, and nonserious.
Given the widespread use of triptans, the risk of serious cardiovascular adverse events during postmarketing surveillance appears to be very low. While the risk of a serious cardiovascular event during triptan use appears to be very small, it cannot be dismissed. Serious cardiovascular events, some of which resulted in death, have been reported in association with triptans during postmarketing surveillance. The causal association of triptan use with serious cardiovascular adverse events is difficult to determine based on the postmarketing surveillance data alone. =========== Expert Opin Pharmacother. 2010 Nov;11(16):2727-37. Sumatriptan therapy for headache and acute myocardial infarction. Barra S, Lanero S, Madrid A, Materazzi C, Vitagliano G, Ames PR, Gaeta G. SourceAntonio Cardarelli Hospital, Cardiology Unit, Via Antonio Cardarelli, 9, 80131 Naples, Italy. giovanni.gaeta@tin.it
Abstract IMPORTANCE OF THE FIELD: Migraine is a common, debilitating, chronic neurovascular disorder. Triptans are considered the drugs of choice to treat migraine attacks; however, their use is limited owing to concerns about cardiovascular safety.
AREAS COVERED IN THIS REVIEW: The aim of this review is to describe: the mechanisms of action of triptans; the case-reports of acute myocardial infarction (AMI) associated with sumatriptan use; and the results of studies evaluating its tolerability and safety.
WHAT THE READER WILL GAIN: Sumatriptan administration can be followed, in close temporal relationship, by AMI in young or adult migraine patients. Some of these cases have developed in subjects taking their first dose. Based on the results of prospective studies,
THE RISK OF SEVERE CARDIOVASCULAR ADVERSE EVENTS AFTER THE USE OF A TRIPTAN IS ESTIMATED AT 1:100,000 TREATED ATTACKS. THESE ADVERSE EVENTS, ALBEIT VERY INFREQUENT, HIGHLIGHT THE IMPORTANCE OF CAREFUL ADHERENCE TO THE SUMATRIPTAN PRESCRIBING INFORMATION.
TAKE HOME MESSAGE: Inherent in its mechanism of action, sumatriptan could produce (coronary) vasospasm sometimes followed by AMI. The drug should not be prescribed to patients with history, symptoms or signs of ischemic vascular disease; an in-depth evaluation should be carried out in subjects at intermediate cardiovascular risk.
PMID:20977405[PubMed
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