Shashidhar Kori

Gastric Stasis in Migraine: More Than Just a Paroxysmal Abnormality During a Migraine Attack

Objective.—The aim of this article is to evaluate gastric motility and emptying in the ictal and interictal period in migraine.

MAP0004, Orally Inhaled DHE: A Randomized, Controlled Study in the Acute Treatment of Migraine

(Headache 2011;51:507‐517)

Gastric Stasis Occurs in Spontaneous, Visually Induced, and Interictal Migraine

Objective.— To evaluate and compare gastric motility and emptying during spontaneous migraine to previous observations from induced migraine.

The Headache Management Trial : A Randomized Study of Coordinated Care

Context.— Headache is a common, disabling disorder that is frequently not well managed in general clinical practice.

A Randomized, Double Blind, Placebo‐Controlled Study of MAP0004 in Adult Patients With Migraine

Background.— Dihydroergotamine mesylate (DHE) is an effective treatment for acute migraine, but its effective use is often limited by the inconvenience and inconsistency of intranasal, intramuscular, or subcutaneous routes of administration. A new formulation of DHE delivered through the lungs by the novel Tempo® inhaler is being developed and is designed to offer fast onset, consistent dosing, and sustained response.

Gastric stasis in migraineurs: Etiology, characteristics, and clinical and therapeutic implications

Background Migraine is a disabling neurological disorder often complicated by gastrointestinal conditions such as gastric stasis. The association between migraine and gastric stasis has received very little attention in the literature, but the existing evidence suggests that they may share a common etiology. Results Patients with migraine and those with gastric stasis exhibit abnormal autonomic nervous system function. Furthermore, empirical studies demonstrate that migraineurs experience significant delays in gastric emptying, both during and outside of attacks, when compared to non-migrainous controls. Conclusion More research is needed to establish the relationship between gastric stasis and migraine burden and to determine the impact of gastric stasis on migraine treatment.

Efficacy and Safety of MAP0004, Orally Inhaled DHE in Treating Migraines With and Without Allodynia

Background.— Central sensitization develops once migraine attacks become established and can be clinically detected by the development of cutaneous allodynia. The efficacy of triptans for migraine resolution has been shown to be markedly reduced when administered in patients with established cutaneous allodynia.

Dihydroergotamine (DHE) use during gestation and the risk of adverse pregnancy outcomes.

Background.— Dihydroergotamine (DHE) is perceived to be associated with a higher risk of adverse pregnancy events, but it has significantly less vasoconstrictive and uterotonic effects compared with ergotamine, and has demonstrated no teratogenic effect in animals. The objectives of this study were to quantify the risk of major congenital malformations (MCMs), prematurity, low birth weight (LBW), and spontaneous abortions (SAs) associated with gestational use of DHE, triptans, and nonsteroidal anti‐inflammatory drugs (NSAIDs).

MAP0004, Orally Inhaled Dihydroergotamine for Acute Treatment of Migraine: Efficacy of Early and Late Treatments

OBJECTIVE To evaluate the efficacy of MAP0004, an orally inhaled dihydroergotamine, for acute treatment of migraine when administered at various time points from within 1 hour to more than 8 hours after migraine onset. PATIENTS AND METHODS This post hoc subanalysis was conducted using data from 902 patients enrolled in a randomized, double-blind, placebo-controlled, 2-arm, phase 3, multicenter study conducted from July 14, 2008, through March 23, 2009. End points were 2-hour pain relief and pain-free rates in patients who treated a migraine in ≤1 hour, from >1 hour to ≤4 hours, from >4 to ≤8 hours, or in >8 hours after onset of migraine, given that patients may be unwilling or unable to initiate treatment at headache inception. RESULTS Treatment with MAP0004 was significantly more effective than placebo in relieving pain at all treatment points (≤1 hour after start of migraine: 66% [74/112] for MAP0004 vs 41% [48/118] for placebo, P<.001; >1 to ≤4 hours: 60% [91/153] vs 35% [58/168], P<.001; >4 to ≤8 hours: 53% [36/68] vs 30% [16/54], P=.008; and >8 hours: 48% [25/52] vs 24% [11/46], P=.007). Pain-free rates were also significantly higher with MAP0004 than placebo for treatment within 8 hours after migraine onset (≤1 hour: 38% [43/112] for MAP0004 vs 13% [15/118] for placebo, P<.001; >1 to ≤4 hours: 28% [43/153] vs 10% [17/168], P<.001; >4 to ≤8 hours: 22% [15/68] vs 7% [4/54], P<.025) but not at >8 hours (19% [10/52] vs 9% [4/46], P=.106). CONCLUSION This post hoc subanalysis shows that MAP0004 was effective in treating migraine irrespective of the time of treatment, even more than 8 hours after onset of migraine pain.

Treatment Persistence and Switching in Triptan Users: A Systematic Literature Review

To conduct a systematic review to evaluate persistence to and switching of triptan therapy for the acute treatment of migraine.