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The migraine-specific triptans have revolutionized the treatment of migraine and are usually the drugs of choice to treat a migraine attack in progress. Sumatriptan (Imitrex) has been available for the longest time within the class, is most flexible in form and has been given successfully to the most number of patients. It is useful for the full range of attacks experienced by a migraine suffer. The aim of this review is to provide an overview of the first 10 years of the use of sumatriptan.
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Intranasal sumatriptan (Imitrex(®) ) may be an alternative for patients who refuse injections and cannot tolerate oral agents, but due to low bioavailability and slow absorption, the clinical utility of the currently marketed formulation is limited, highlighting an unmet need for an effective non-oral migraine medication with a rapid onset of action. To overcome the slow absorption profile associated with intranasal administration, we evaluated the impact of 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM, Intravail A-3™), a permeation enhancer, on sumatriptan's pharmacokinetic profile by comparing the pharmacokinetic characteristics of two commercial sumatriptan products, 4 mg subcutaneous and 6 mg subcutaneous in healthy adults, with DFN-02 - a novel intranasal agent comprised of sumatriptan 10 mg plus 0.20% DDM. We also determined the pharmacokinetic characteristics of DDM and evaluated its safety and tolerability.
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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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In this human factors study, 54 migraineurs used simulated injections to compare three sumatriptan subcutaneous delivery devices. Zembrace SymTouch, a two-step device, was most preferred compared with Sumavel DosePro and Imitrex STATdose. It also ranked highest for ease of use and various other measures. In this study, migraine patients preferred the autoinjector that they rated as simpler and more intuitive.
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This randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy and tolerability of oral sumatriptan (Imitrex tablets) in 259 migraineurs. In the clinic, patients received oral sumatriptan 25 mg, 50 mg, or 100 mg, or placebo for the treatment of a migraine attack. The results indicate that by 2 hours post-dose, 50 to 56% of patients treated with any of the three doses, compared with 26% of patients treated with placebo, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). By 4 hours postdose, 68 to 71% of sumatriptan-treated patients, compared with 38% of placebo-treated patients, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). Oral sumatriptan was similarly effective at relieving nausea and photophobia and at reducing clinical disability. The pattern and incidence of adverse events did not differ between treatment groups. All doses--25 mg, 50 mg, and 100 mg--of sumatriptan were effective and generally well tolerated. Dosing should be individualized according to the needs of the patient.
Double-blind, randomized trial with parallel treatment arms.
Weight and BMI appear to be important covariates for sumatriptan exposure: subjects with lower values for either metric of body size have higher systemic exposure compared with subjects with higher values. Additional studies are required to determine if doses of subcutaneous sumatriptan may be adjusted based on BMI for comparable efficacy and a potentially improved tolerability profile.
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To investigate whether a needle-free system can deliver s.c. sumatriptan. If so, to examine whether needle-free administration is bioequivalent to a 26-gauge needle-based auto-injector. Lastly, to assess the needle-free system for clinical acceptability and ease of use during migraine attacks.
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In healthy subjects, DFN-02, an intranasal spray containing 10 mg sumatriptan plus DDM, had a more rapid absorption profile than commercially available intranasal sumatriptan 20 mg, and systemic exposure from a single-dose administration of DFN-02 was similar to 4 mg SC sumatriptan and two-thirds that of 6 mg SC sumatriptan. With DFN-02, plasma sumatriptan peaked 5 minutes earlier than with both subcutaneous formulations. Systemic exposure to sumatriptan was similar with DFN-02 and 4 mg subcutaneous sumatriptan; both yielded lower systemic exposure than 6 mg subcutaneous sumatriptan. Systemic exposure to DFN-02's excipient DDM was short-lived. DFN-02's safety and tolerability appear to be comparable to subcutaneous sumatriptan. Addition of a permeation enhancer improved the absorption profile compared with commercially available intranasal sumatriptan 20 mg.
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The objective of this human factors study was to compare migraine patients' device use performance and preferences for three sumatriptan subcutaneous autoinjectors: a disposable two-step device (Zembrace(®) SymTouch(®)), a disposable three-step device (Sumavel(®) DosePro(®)), and a multistep reloadable device (Imitrex(®) STATdose(®)), using simulated injections.
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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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Sleep and headache have both generated curiosity within the human mind for centuries. The relationship between headache and sleep disorders is very complex. While Lieving in 1873 first observed that headaches were linked to sleep, Dexter and Weitzman in 1970 described the relationship between headache and sleep stages. Though our understanding of sleep and headache relationship has improved over the years with expanding knowledge in both fields and assessment tools such as polysomnography, it is still poorly understood. Headache and sleep have an interdependent relationship. Headache may be intrinsically related to sleep (migraine with and without aura, cluster headache, hypnic headache, and paroxysmal hemicrania), may cause sleep disturbance (chronic migraine, chronic tension-type headache, and medication overuse headache) or a manifestation of a sleep disorder like obstructive sleep apnea. Headache and sleep disorder may be a common manifestation of systemic dysfunction-like anemia and hypoxemia. Headaches may occur during sleep, after sleep, and in relation to different sleep stages. Lack of sleep and excessive sleep are both considered triggers for migraine. Insomnia is more common among chronic headache patients. Experimental data suggest that there is a common anatomic and physiologic substrate. There is overwhelming evidence that cluster headache and hypnic headaches are chronobiological disorders with strong association with sleep and involvement of hypothalamus. Cluster headache shows a circadian and circannual rhythmicity while hypnic headache shows an alarm clock pattern. There is also a preferential occurrence of cluster headache, hypnic headache, and paroxysmal hemicrania during REM sleep. Silencing of anti-nociceptive network of periaqueductal grey (PAG), locus ceruleus and dorsal raphe nucleus doing REM sleep may explain the preferential pattern. Sleep related headaches can be classified into (1) headaches with high association with obstructive sleep apnea, which includes cluster headache, hypnic headache, and headache related to obstructive sleep apnea; and (2) headaches with high prevalence of insomnia, medication overuse, and psychiatric comorbidity including chronic migraine and chronic tension-type headache. The initial step in the management of sleep related headache is proper diagnosis with exclusion of secondary headaches. Screening for sleep disorders with the use of proper tests including polysomnography and referral to sleep clinic, when appropriate is very helpful. Control of individual episode in less than 2 hours should be the initial goal using measures to abort and prevent a relapse. Cluster headache responds very well to injectable Imitrex and oxygen. Verapamil, steroids and lithium are used for preventive treatment of cluster headache. Intractable cluster headache patients have responded to hypothalamic deep brain stimulation. Hypnic headache patients respond to nightly caffeine, indomethacin, and lithium. Paroxysmal hemicrania responds very well to indomethacin. Early morning headaches associated with obstructive sleep apnea respond to CPAP or BiPAP with complete resolution of headache within a month. Patient education and lifestyle modification play a significant role in overall success of the treatment. Chronic tension-type headache and chronic migraine have high prevalence of insomnia and comorbid psychiatric disorders, which require behavioral insomnia treatment and medication if needed along with psychiatric evaluation. Apart from the abortive treatment tailored to the headache types, - such as triptans and DHE 45 for migraine and nonsteroidal anti-inflammatory medication for chronic tension-type headache, preventive treatment with different class of medications including antiepileptics (Topamax and Depakote), calcium channel blockers (verapamil), beta blockers (propranolol), antidepressants (amitriptyline), and Botox may be used depending upon the comorbid conditions.
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To assess the efficacy and tolerability of subcutaneous dihydroergotamine mesylate (DHE-45) vs subcutaneous sumatriptan succinate (Imitrex) for the treatment of acute migraine with or without aura.
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Adults with migraine (n = 50) without 'medication overuse headache' were treated for up to 18 migraine attacks per 3-month study period with study medication; SNC during one study period and S/N during the other study period. For all endpoints, differences between treatments were compared with paired t tests.
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A total of 54 subjects participated and each subject performed two simulated injections with each of the three devices. Most subjects preferred the two-step device (88.9%) to the three-step (13.0%) and the reloadable (1.9%). The two-step device had higher mean overall preference ratings (F (2, 159)=56.6, P<0.01) and higher ratings for ease of use, intuitiveness, convenience, portability, and control. The two-step device had a first injection full-dose delivery success rate of 44.4%, higher than both the reloadable (24.1%) and the three-step (3.7%) devices. The number of errors with the two-step device (n=3) was ~90% lower than the three-step (n=49) and reloadable (n=44) devices.
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In the sumatriptan group, 11.1% (6 of 54) of eyes developed epithelial defects as compared to 9.3% (5 of 54) of eyes in the non-triptan group (P=.75, chi square). More recent sumatriptan exposure did not increase the incidence of epithelial defect (P=.47). In patients in whom sumatriptan was stopped >1 month prior to LASIK, 6.3% (1 of 16 eyes) had epithelial defects; in patients in whom sumatriptan was stopped <1 month prior to LASIK, 14.3% (4 of 28 eyes) developed epithelial defects; and 9.3% (5 of 54 eyes) of patients in whom no triptans had ever been used had epithelial defects (P=.70).
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Both sumatriptan and dihydroergotamine were effective in aborting migraine headaches. Headache recurrence was two and a half time as likely with sumatriptan as with dihydroergotamine.
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To investigate whether the incidence of epithelial defects during laser in situ keratomileusis (LASIK) was different in patients who were taking sumatriptan (Imitrex, Glaxo Smith Kline, Pittsburgh, Pa) for migraine headaches than in those who were not.
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Patients with moderate or severe head pain were randomized to receive either 1 mg of subcutaneous dihydroergotamine mesylate or 6 mg of subcutaneous sumatriptan succinate. Patients rated head pain, functional ability, nausea, and vomiting at baseline and at 0.5, 1, 2, 4, and 24 hours after the injection. Presence or absence of headache at 3 hours was calculated from collected data. If pain persisted after 2 hours, a second injection of the same study medication was allowed, and self-ratings were repeated 30 and 60 minutes later. Follow-up data were collected at 24 hours.
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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%).
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Efficacy and tolerability profiles of Treximet [sumatriptan/naproxen sodium combination tablet (SNC)] have been established in clinical trials but have to date been virtually unstudied in pragmatic research. The primary objective of this study was to compare the overall satisfaction of SNC to its monotherapy components, S/N [one 100 mg Imitrex tablet (S) and two Aleve (naproxen sodium) 220 mg tablets, total dose 440 mg (N)] administered concomitantly using the Patient Perception of Migraine Questionnaire -Revised (PPMQ-R).