Focus on trial endpoints of clinical relevance and the use of almotriptan for the acute treatment of migraine

Sandrini, Giorgio; Dahlöf, Carl; Mathew, Ninan T.; Nappi, Giuseppe

doi:10.1111/j.1368-5031.2005.00692.x

Cited by 12 publications

(9 citation statements)

References 69 publications

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“…A meta‐analysis of 53 clinical trials of six oral triptans reported that almotriptan had the highest SPF rate of all the triptans [16]. When SNAE was calculated from the meta‐analysis data, this high SPF rate along with a low AE rate translated to almotriptan also having the highest SNAE rate [17]. The results of this current trial are consistent with the high SPF and SNAE rates for almotriptan reported earlier, almost twice that achieved here by ergotamine plus caffeine.…”

Section: Discussionmentioning

confidence: 99%

Crossover, double‐blind clinical trial comparing almotriptan and ergotamine plus caffeine for acute migraine therapy

Láinez

Galván

Heras

et al. 2007

Euro J of Neurology

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In this randomized, double-blind, crossover clinical trial, adult patients treated two migraine attacks: one with almotriptan 12.5 mg and the other with ergotamine 2 mg plus caffeine 200 mg. Treatment with almotriptan was associated with a significantly greater proportion of patients achieving 2-h pain free (20.9% vs. 13.7%; P < 0.05) and 2-h pain relief (57.7% vs. 44.5%; P < 0.01) compared with ergotamine plus caffeine therapy; significant differences were not seen at 1 h. Rates for sustained pain free and sustained pain free plus no adverse events (AEs) also were significantly greater after almotriptan treatment than after the use of ergotamine plus caffeine (P < 0.05). Almotriptan was associated with a significantly lower rate of photophobia at 90 min (P < 0.05), phonophobia at 60, 90, and 120 min (P < 0.05 to <0.01), and nausea and vomiting at 90 and 120 min (P < 0.01) compared with ergotamine plus caffeine. A significantly greater proportion of patients were more satisfied with almotriptan than with ergotamine plus caffeine (P < 0.05). Sixteen patients reported adverse events during almotriptan treatment and 27 patients reported AEs during the ergotamine plus caffeine therapy. Most AEs were mild-to-moderate and did not result in treatment-related discontinuations. In conclusion, almotriptan was associated with significantly greater efficacy for treating migraine compared with ergotamine plus caffeine, was generally well tolerated and was associated with greater rate of treatment satisfaction.

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Section: Discussionmentioning

confidence: 99%

Crossover, double‐blind clinical trial comparing almotriptan and ergotamine plus caffeine for acute migraine therapy

Láinez

Galván

Heras

et al. 2007

Euro J of Neurology

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“…The design for the simulations thus uses 3 5 = 243 conditions for the true distributions. Each condition was run with 1000 replications, thereby yielding 243 × 1000 = 243,000 simulation outcomes in total (based on 243,000 × 2 × 300 = 145,800,000 patients).…”

Section: Description Of the Simulationsmentioning

confidence: 99%

“…We refer to and treat these five estimates as the “true” values. We calculated z W for all 2 5 = 32 possible combinations of hypothesized and true parameter values, to enable us to assess how results could be affected by the misjudgment inherent in the hypothesized-versus-true discrepancy. Besides these 32 z W -values, we found the (single) values of z LRNF and z LRF .…”

Section: Examplementioning

confidence: 99%

“…There is substantial work on problems pertaining to composite or multiple endpoints, including papers by Borm et al, 1 Chi, 2 Lynch et al, 3 Quan et al, 4 Sandrini et al, 5 Song et al, 6 and Wong et al 7 However, none of those papers are concerned with the problem or approach covered in the present paper. Endpoints considered by previous authors often involved joint req.uirements on two or more components that make up a composite.…”

Section: Introductionmentioning

confidence: 99%

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A novel test to compare two treatments based on endpoints involving both nonfatal and fatal events

Potthoff

Halabi

2015

Pharmaceut. Statist.

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In a clinical trial comparing two treatment groups, one commonly-used endpoint is time to death. Another is time until the first nonfatal event (if there is one) or until death (if not). Both endpoints have drawbacks. The wrong choice may adversely affect the value of the study, by impairing power if deaths are too few (with the first endpoint) or by lessening the role of mortality if not (with the second endpoint). We propose a compromise that provides a simple test based on the time to death if the patient has died, or time since randomization augmented by an increment otherwise. The test applies the ordinary two-sample Wilcoxon statistic to these values. The formula for the increment (the same for experimental and control patients) must be specified before the trial starts. In the simplest (and perhaps most useful) case, the increment assumes only two values, according to whether or not the (surviving) patient had a nonfatal event. More generally, the increment depends on the time of the first nonfatal event, if any, and the time since randomization. The test has correct Type I error even though it does not handle censoring in a customary way. For conditions where investigators would face no easy (advance) choice between the two older tests, simulation results favor the new test. An example using a renal-cancer trial is presented.

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“…More recently, in order to represent more accurately what migraine patients want from their acute migraine therapy, composite endpoints encompassing the measures able to predict patient satisfaction (such as pain-free state, use of rescue medication, AEs) have been developed and introduced (Sandrini et al 2005). …”

Section: Introductionmentioning

confidence: 99%

Almotriptan in the treatment of migraine

Sandrini

Perrotta

Leal

et al. 2008

NDT

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Almotriptan is an orally administered, highly selective serotonin 5-HT(1B/1D) receptor agonist that is effective in the acute treatment of moderate to severe migraine attacks. Since its introduction on to the market in 2001, several studies involving a large number of migraine patients have confirmed its efficacy and tolerability profile. Almotriptan, was found to be among the best-responding triptans in terms of pain relief and pain-free rate at 2 h. It has been reported that almotriptan has the best sustained pain-free (SPF) rate and the lowest adverse events (AEs) rate of all the triptans. When these clinical characteristics were combined to form the composite endpoint SPF and no AEs (SNAE), almotriptan emerged as the triptan with the best efficacy and tolerability profile. It also showed a good efficacy profile during the early treatment (within 1 h of onset) of migraine attacks characterized by moderate pain intensity. On the basis of these findings, almotriptan may be considered a therapeutic option for the acute treatment of migraine attacks.

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Focus on trial endpoints of clinical relevance and the use of almotriptan for the acute treatment of migraine

Cited by 12 publications

References 69 publications

Crossover, double‐blind clinical trial comparing almotriptan and ergotamine plus caffeine for acute migraine therapy

Crossover, double‐blind clinical trial comparing almotriptan and ergotamine plus caffeine for acute migraine therapy

A novel test to compare two treatments based on endpoints involving both nonfatal and fatal events

Almotriptan in the treatment of migraine

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