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Advances in investigative research (e.g., functional magnetic resonance imaging) have made it possible to study putative migraine processes and better understand the pathophysiology of the disorder. Consequently, the apparent opposing vascular and neuronal theories of migraine are now reconciled into a neurovascular hypothesis that pieces together migrainous events and allows us to better target such events in the hope of providing safe and effective therapies. Parallel discoveries in the fields of pharmacology, physiology, genetics and other biomedical disciplines will lead to the development of optimal migraine therapeutics. Such discoveries have already yielded some major enhancement in acute migraine treatment with the development of sumatriptan (Imitrex, GlaxoSmithKline) and other triptans and the trajectory is likely to be exponential. Novel targets, such as calcitonin gene-related peptide antagonists and inhibitors of excitatory glutamatergic receptors, are leading the pack but many other promising targets are in development. The post-sumatriptan decades will witness treatment strategies that will improve the therapeutic index of acute therapies and others which will effectively and safely prevent migraine attacks.
There is evidence that serotonin may be implicated in the pathophysiology of myofascial pain (MFP). Because of this, we used oral sumatriptan (Imitrex, Glaxo), a peripherally acting agonist of 5-HT1D receptors, in a double-blind, randomized, placebo-controlled double crossover pilot study of 7 patients with episodic MFP of the temporalis muscles. The results showed that there was a significant reduction in pain intensity and increase in pain relief over time with both the active medication and the placebo, but no significant difference between treatments. All but 1 patient reported that they are not interested in retaking the same medication. These data suggest that oral sumatriptan may not be the drug of choice in the control of episodic MFP.
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Both weight and BMI correlated negatively with each exposure metric for each treatment group. Across all treatment groups, AUC0-2 for subjects with BMI less than or equal to median value was 1.03-1.12 times the value for subjects with BMI more than median value. For subjects with BMI less than or equal to median value receiving DFN-11, median AUC0-2 was slightly less than that for subjects with BMI more than median value receiving Imitrex 4 mg and larger than that for subjects with BMI more than median value receiving Imitrex 3 mg. Results were similar for the other exposure metrics and for weight. Exposure was higher in women than in men, which can be attributed in part to differences in weight. There was no relationship between exposure and age. For DFN-11, AUC0-2 and AUC0-∞ were lower in nonwhites compared with whites; the ratio of median values was 0.84 and 0.89, respectively. A similar, nonstatistically significant, trend was observed in the other products (ratio of median values ranging from 0.84 to 0.89).
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The recent publication of drug formularies by third-party payers has serious implications for the practice of medicine. These formularies list the medications for which the consumer can be reimbursed by the third-party payer. The most restrictive of the five formularies I have received lists only two agents for the treatment of migraine headaches: Cafergot (at an incorrect dose of 1/100 mg) and Ergotrate which is no longer available. The most liberal of the formularies lists analgesics, Cafergot, Midrin, and Imitrex for the treatment of acute attacks, and as prophylactic agents, Inderal, Sansert, and analgesics (known to cause rebound headaches when used in this fashion in migraine patients). Abortive agents of proven value, such as DHE-45 and NSAIDs, and preventative medications, such as calcium channel blockers, tricyclic antidepressants, serotonin reuptake inhibitors, methylergonovine, and divalproex sodium, are not available. No one could quarrel with a goal of developing a cost-effective formulary. However, the authors of these formularies have clearly demonstrated their inability to provide even a current, accurate, and adequate formulary by existent standards of care in the treatment of migraine headache. While it is easy to criticize these formularies, it is more difficult to develop a comprehensive list that would satisfy the practitioners' need to provide relief for their patients with a minimum of side effects, and the needs of third-party payers (presumed) to provide quality care at the most economical level.
A 13-year-old boy died suddenly at night while asleep. A colloid cyst filled the third ventricle, obstructed the flow of cerebral spinal fluid, and led to prominent hydrocephalus. Acute ventricular distension with brain herniation resulted in death, whereas repeated previous episodes had led to cerebral compression and edema. Complaints included only episodic headache in the month prior to death. His pediatrician prescribed a course of Imitrex (sumatriptan) because of lack of neurologic signs or other symptoms and a family history of migraine headaches. The headaches persisted, however, and within 1 month the patient died. The difficulty of accurate clinical diagnosis in this case is common. Subtle signs or even lack of symptoms of increased intracranial pressure may prevent a timely diagnosis before the occurrence of deadly complications. This case report helps to remind both forensic medical examiners and clinicians that this entity, although rare, should remain in the differential diagnosis of headache in children and young adults and of hydrocephalus at autopsy. Timely diagnosis of this benign lesion can lead to a surgical cure.
Several sumatriptan subcutaneous autoinjector devices for acute treatment of migraine patients are available, each device differs with respect to design and features. Determining device preference and ease of use is important because patients experiencing a migraine attack are often functionally impaired.
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Sumavel DosePro needle-free delivery system is a new presentation of s.c. sumatriptan that delivers drug effectively, is bioequivalent to the existing needle auto-injector when used at the thigh or abdomen, and is easy to use.
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In the comparison with commercially available intranasal sumatriptan 20 mg, DFN-02 had a more rapid absorption profile; tmax was 15 minutes for DFN-02 monodose, 10.2 minutes for DFN-02 multidose, and 2.0 hours for commercially available intranasal sumatriptan 20 mg. Compared with 4 and 6 mg subcutaneous sumatriptan, DFN-02's median tmax (10 minutes) was significantly earlier (15 minutes; P < .0001). Mean sumatriptan exposure metrics were similar for DFN-02 and 4 mg sumatriptan: AUC0-2 : 35.12 and 44.82 ng*hour/mL, respectively; AUC0-∞ : 60.70 and 69.21 ng*hour/mL, respectively; Cmax : 51.79 and 49.07 ng/mL, respectively. With 6 mg subcutaneous sumatriptan, these exposure metrics were about 50% larger (AUC0-2 : 67.17 ng*hour/mL; AUC0-∞ : 103.78 ng*hour/mL; Cmax : 72.75 ng/mL). Inter-subject variability of AUC0-2 , AUC0-∞ , and Cmax was 42-58% for DFN-02, 15-22% for 4 mg subcutaneous sumatriptan, and 15-25% for 6 mg subcutaneous sumatriptan. DDM exposure was low (mean Cmax : 1.63 ng/mL), tmax was 30 minutes, and it was undetectable by 4 hours. There were no serious adverse events, discontinuations due to adverse events, or remarkable findings for vital signs, physical examinations (including nasal and injection site examinations), or clinical laboratory assessments. The overall incidence of adverse events was comparable across treatments, and all treatment-related events were mild in severity. Adverse events occurring in ≥10% of subjects were dysgeusia (19%), headache (18%), nausea (15%), paresthesia (15%), and dizziness (12%).
There were 295 evaluable patients. At 2 hours, 73.1% of the patients treated with dihydroergotamine and 85.3% of those treated with sumatriptan had relief (P = .002). There was no statistical difference in headache relief between the groups at 3 or 4 hours. Headache relief was achieved by 85.5% of those treated with dihydroergotamine and by 83.3% of those treated with sumatriptan by 4 hours. By 24 hours 89.7% of dihydroergotamine-treated patients and 76.7% of sumatriptan-treated patients had relief (P = .004). Headache recurred within 24 hours after treatment in 45% of the sumatriptan-treated patients and in 17.7% of the dihydroergotamine-treated patients (P < or = .001).