Triptan medications to treat acute migraine

Ferrari, Michel; Roon, Krista I.; Lipton, Richard B.; Goadsby, Peter J.

doi:10.1016/s0140-6736(02)08134-5

Cited by 5 publications

(6 citation statements)

References 3 publications

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“…Notable in the current study is the unusually high proportion of treated attacks in which headache pain was reported as 'severe'. In single-attack migraine treatment studies utilizing the conventional dosing strategy, the proportion of patients reporting headache pain as 'severe' is typically in the range of 35-40% (5,14). In the current multiple attack study, approximately 60.5% of patients overall reported at least two out of four treated attacks as severe.…”

Section: Discussionmentioning

confidence: 73%

“…Typically, studies report consistency data based on results from long-term extension phase studies (5,6). These studies may overestimate consistency as they lack a placebo control, are subject to selection bias (only acute phase responders enter the extension phase), are biased toward super-responders, as these are the subjects most likely to stay in an open-label study across a year, and consistency of response is calculated as a group mean across all attacks, instead of calculating a within-patient (intra-patient) mean.…”

Section: Introductionmentioning

confidence: 99%

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Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study

Almas

Tepper

Landy³

et al. 2013

Cephalalgia

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Objective: The current study evaluated the consistency of eletriptan response. Methods: Using a within-patient crossover design, patients with migraine completed a three-attack, open-label, lead-in period, before being treated, double-blind for four attacks, with either eletriptan 40 mg (ELE-40; N ¼ 539) or eletriptan 80 mg (ELE-80; N ¼ 432); placebo was randomly substituted for the treatment of one attack. Results: On an a priori analysis of within-patient consistency, double-blind treatment was associated with similar 2 hour headache response rates using a !2/3 response criterion for ELE-40 (77%) and ELE-80 (73%), and using a 3/3 response criterion for ELE-40 (46%) and ELE-80 (47%). Within-patient consistency in achieving pain-free status at 2 hours using a !2/3 criterion was slightly higher on ELE-40 (42%) compared with ELE-80 (38%), and was similar using the 3/3 criterion (18% on ELE-40, 17% on ELE-80). On a repeated measures logistic regression analysis across all treated attacks, the probability of achieving a headache response at 2 hours ranged from 71% to 74% on ELE-40 vs. 17% to 28% on placebo (p < 0.0001), and from 66% to 74% on ELE-80 vs. 21% to 27% on placebo (p < 0.0001). The incidence, per attack, of adverse events was low for both ELE-40 and ELE-80. Few adverse events occurred with incidence !10% on ELE-40 (asthenia, 5.0%) or ELE-80 (asthenia, 10%; nausea, 5.8%). Discontinuations because of adverse events were 0.2% on ELE-40, and 1.6% on ELE-80 Conclusion: In this multiple attack study, eletriptan was well-tolerated and demonstrated consistent and significant efficacy in the treatment of migraine.Clinicaltrials.Gov Identifier: NCT01859481

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Section: Discussionmentioning

confidence: 73%

Section: Introductionmentioning

confidence: 99%

Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study

Almas

Tepper

Landy³

et al. 2013

Cephalalgia

View full text Add to dashboard Cite

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“…[24][25][26][27][28][29] The issues raised included the use of active-to-placebo response-rate ratios versus placebo-subtracted rates, additive versus multiplicative models, homogeneity of data, encapsulation, the use of parameters from the number of patients for each outcome category rather than from the patients' records, meta-analytic pooling of data, and total adverse effect rates. Ferrari in his response noted, "the trials we included all had similar designs, populations of patients, and placebo responses.…”

Section: Published Meta-analytic Reports Of Number Needed To Treatmentioning

confidence: 99%

“…We are, therefore, confident in the validity of these results." 29 Meta-analytic techniques are a satisfactory alternative for aggregating and analyzing data. An update to the Ferrari et al meta-analysis would affect the assumptions used in our model.…”

Section: Published Meta-analytic Reports Of Number Needed To Treatmentioning

confidence: 99%

Triptans for Migraine Therapy: A Comparison Based on Number Needed to Treat and Doses Needed to Treat

Mullins¹

2005

JMCP

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anaged care and other decision makers need sound comparative information to support their formulary selection process and reimbursement decisions. While some migraine clinical trials provide comparative results, these data are typically focused on traditional clinical end points (e.g., headache response within 2 hours posttreatment). Clinical end points provide limited information for formulary, pricing, and reimbursement decisions and must be supported with data related to quality of life, other patient-reported outcomes, and economic measures. These types of end points generally have not been included in most existing studies. Thus, there is a need to make clinical end points more intuitively interpretable, practical, and useful for the formulary decision maker.Recent comparative reviews of 5-HT receptor agonists (triptans) in migraine therapy advocate the use of the end point "number needed to treat" (NNT) as a calculated measure of therapeutic effectiveness. [1][2][3][4][5] The primary advantage of NNT over other measures of efficacy is that NNT takes into account placebo effects, the underlying efficacy seen in patients randomized to placebo in clinical trials. Identifying and adjusting for placebo effects are important steps toward understanding the true efficacy of a treatment, especially in subjectively assessed disorders such as migraine, where the placebo effect has been well documented.Migraine is a condition particularly susceptible to placebo effects because migraineurs experience remitting and relapsing symptoms that occur in an unpredictable manner. Migraine symptoms can wax and wane, spontaneously remitting and relapsing during a migrainous period. Some patients will experience relief of their migraine symptoms and attribute that to a medication when, in fact, the natural history of their migraine was to resolve, independent of taking their medication. The placebo effect may be exacerbated by these cycles, and the magnitude of placebo effects can differ between studies.6 For example, it has been noted that the placebo effect is generally greater for injected treatments than for oral treatments for migraine.7 Consequently, it is considered especially important to not only include a placebo arm in any trial of a migraine therapy but also to account for the effect due to placebo when considering efficacy of migraine treatments. 6 Therapeutic gain is another end point that can be used to account for the placebo effect. It is a measure of the absolute effect of the treatment and is calculated by subtracting the response to placebo from the response to active treatment.2 The ABSTRACT OBJECTIVE: Managed care and other decision makers need sound comparative information to support the formulary selection process and reimbursement decisions for the treatment of migraine. The objective of this study was to compare currently marketed triptan therapies using number-needed-to-treat (NNT) and doses-needed-to-treat (DNT) measures. DNT was further used to derive triptan treatment cost to achieve 100 successfully ...

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“…27 Ferrari et al responded to these letters, including the notation that only placebocontrolled trials were included, thereby precluding the use of head-to-head clinical trials in the meta-analysis. 28 There is a robust and large literature on the methodological issues surrounding the determination of relative efficacy of the triptans for acute migraine. In their analysis of 51 published clinical trials of triptans for acute migraine, Fox et al concluded that while the distribution of active drug response rates passed a chi-squared goodness-of-fit test, consistent with a normal distribution, the placebo response rates were not normally distributed, and the distribution of therapeutic gains failed a test of normality (P = 0.018), as did the numbers needed to treat (NNTs) P < 0.001).…”

Section: Best Value For Money In Triptansmentioning

confidence: 99%

Best Value for Money in Triptans

Curtiss¹

2005

JMCP

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Triptan medications to treat acute migraine

Cited by 5 publications

References 3 publications

Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study

Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study

Triptans for Migraine Therapy: A Comparison Based on Number Needed to Treat and Doses Needed to Treat

Best Value for Money in Triptans

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