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Topic: Triptan safety--latest statement (Read 512 times) |
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Bob_Johnson
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Triptan safety--latest statement
« on: Jun 1st, 2004, 9:47am » |
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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.)
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Consensus Statement: Cardiovascular Safety Profile of Triptans (5-HT1B/1D Agonists) in the Acute Treatment of Migraine
Headache 44(5):414-425, 2004. © 2004 Blackwell Publishing
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.
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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.
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