Efficacy and tolerability of subcutaneous sumatriptan administered using the IMITREX® STATdose™ System

Mushet, George R.; Cady, Roger; Baker, C. Camak; Clements, Bill; Gutterman, Donna; Davis, Randy

doi:10.1016/s0149-2918(96)80219-0

Cited by 25 publications

(46 citation statements)

References 8 publications

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“…While a direct comparison is not possible, Kayser and colleagues also found a non-monotonic relationship for the effect of both sumatriptan and zolmitriptan, injected subcutaneously, in reducing mechanical hypersensitivity after chronic constriction injury to the infraorbital nerve in male rats (Kayser et al, 2002). While there is some data on dose dependence of the anti-migraine effect of triptans (Cady et al, 1991, Visser et al, 1992, Tfelt-Hansen, 1993, Mushet et al, 1996, Brandes et al, 2009, Derry et al, 2014), similar data for its pronociceptive effects have not been reported.…”

Section: Discussionmentioning

confidence: 97%

“…Sumatriptan-induced injection-site reactions, the most common adverse event, is reported in 58.7% of patients with moderate to a severe migraine treated with sumatriptan (6 mg, administered subcutaneously) compared with 23.8% of placebo controls (Cady et al, 1991). Moreover, in a double-blind, placebo-controlled study by Mushet and colleagues (Mushet et al, 1996) injection-site reaction was reported in 34% of patients with moderate to a severe migraine treated with sumatriptan 6 mg (patient-administered via single-dose syringe cartridges) compared with 18% of placebo controls. Although Burstein and colleagues had already demonstrated, more than decade ago, that triptans acutely sensitize dural nociceptors (Burstein, 2001, Burstein et al, 2004, Burstein and Jakubowski, 2004), there remains a paucity of information regarding the mechanism underlying triptan-induced nociceptor sensitization, their dose-response curves and sex differences in this effect.…”

Section: Introductionmentioning

confidence: 99%

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Marked sexual dimorphism in 5-HT 1 receptors mediating pronociceptive effects of sumatriptan

et al. 2017

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Amongst the side effects of triptans, a substantial percentage of patients experience injection site pain and tenderness, the underlying mechanism of which is unknown. We found the dose range from 10 fg – 1000 ng (intradermal) sumatriptan induced a complex dose-dependent mechanical hyperalgesia in the male rat, with distinct peaks, at 1 pg and 10 ng, with no hyperalgesia at 1 ng. In female rats, there was 1 broad peak. The highest dose (1000 ng) did not produce hyperalgesia in either sex. We evaluated the receptors mediating sumatriptan hyperalgesia (1 pg, 1 and 10 ng). In male rats, while the injection of an antagonist for the serotonin (5-hydroxytryptamine, 5-HT) receptor subtype 1B (5-HT1B), but not 5-HT1D, markedly inhibited sumatriptan (1 pg hyperalgesia, at 10 ng a 5-HT1D receptor antagonist completely eliminated hyperalgesia. In contrast, in female rats, the 5-HT1D, but not 5-HT1B, receptor antagonist completely blocked sumatriptan (1 pg and 10 ng) hyperalgesia. Both 5-HT1B and 5-HT1D receptor antagonists attenuated hyperalgesia (1 ng) in females. Sumatriptan (1 ng)-induced hyperalgesia in female rats is G-protein-coupled estrogen receptor 30 dependent. While selective 5-HT1B, but not 5-HT1D, receptor agonists produces a robust hyperalgesia, when co-injected the hyperalgesia induced by 5-HT1B receptor agonist was attenuated. The mechanical hyperalgesia induced by sumatriptan (1 pg and 10 ng) is dependent on the Gi-protein α subunit and protein kinase A (PKA). Understanding the mechanisms responsible for the complex dose dependence for triptan hyperalgesia may provide useful information for the design of anti-migraine drugs with improved therapeutic profiles.

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Section: Discussionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

Marked sexual dimorphism in 5-HT 1 receptors mediating pronociceptive effects of sumatriptan

et al. 2017

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“…one was published twice [18], one was an interim analysis of a trial that was later published in full [19], one was a subgroup analysis of patients in two trials which had been published previously [20], one contained inconsistencies about the number of patients with adequate pain relief [21], one assessed pain relief but not at 2 h [22], and two did not provide data on the first administration in a cross-over design [23,24]. Thus a total of 22 trials, reported in 20 publications, were included in the analysis [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44], including three trials in which the 2-h relief rates were obtained from the authors [30,34,39].…”

Section: Search For Studies and Inclusion Criteriamentioning

confidence: 99%

Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos

Craen¹,

Tijssen²,

Gans

et al. 2000

Journal of Neurology

242

157

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We carried out a meta-analysis of 22 trials to determine the comparative placebo effect of (a) subcutaneous vs. oral and (b) in-hospital vs. at-home administration in the treatment of migraine. The headache relief rates were combined from the placebo arms of these randomised clinical trials assessing the value of sumatriptan in acute treatment of migraine. The main outcome measure was the proportion of patients reclassified from severe or moderate headache severity to no or mild headache severity 2 h after the beginning of treatment. In the oral regimen 222 of 865 patients (25.7%) reported no or mild headache severity after 2 h, compared to 279 of 862 patients (32.4%) of those receiving subcutaneous placebo (6.7% difference; 95% CI 2.4-11.0%). Adjusting for treatment setting and severity of headache at baseline did not change the observed difference. After placebo treatment at home 285 of 1,054 patients (27.0%) reported no or mild headache severity after 2 h, compared to 216 of 673 patients (32.1%) among those receiving placebo in hospital (5.1 % difference; 95% CI 0.6-9.5%). When adjusted for route of administration and severity of headache at baseline, the difference in relief rates between home and hospital setting disappeared. These findings indicate that subcutaneous administration enhances the placebo effect of acute treatment of migraine. Future trials of antimigraine drugs assessing the relative efficacy of various routes of administration should use a double-dummy technique. The interpreting of placebo-controlled trial results must therefore consider that the effect in the drug arm of the trial depends in part on the route of administration.

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“…The efficacy of abortive migraine treatments between ethnic populations is unexplored. Subcutaneous (SQ) sumatriptan 6 mg has consistently demonstrated rapid and effective treatment for migraine pain and associated symptoms 5‐8 . The long‐term tolerability of sumatriptan SQ has also been demonstrated 9 .…”

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confidence: 99%

“…The long‐term tolerability of sumatriptan SQ has also been demonstrated 9 . However, most patients in sumatriptan clinical trials have been predominantly female (80% to 89%) 5‐7 and Caucasian (91% to 95%) 8 …”

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confidence: 99%

Efficacy and Tolerability of Subcutaneous Sumatriptan for Acute Migraine: A Comparison Between Ethnic Groups

et al. 2001

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Objective.-To evaluate efficacy and tolerability of subcutaneous sumatriptan 6 mg versus placebo for acute migraine between ethnic groups.Background.-Patients in previous sumatriptan studies have been predominantly Caucasian and the effects of sumatriptan between different ethnic groups are unknown.Methods.-This was a multicenter, 3-phase, 12-attack study. Phases I and III (inclinic) were randomized, double-blind, placebo-controlled, crossover designs. Phase II (outpatient) was a single-blind design. Sumatriptan was compared to placebo across 2 groups (non-Caucasian and Caucasian) and individual ethnic subgroups (black, Hispanic, and others). Headache response, pain-free response, associated symptoms, and clinical disability were assessed. Tolerability assessments included the incidence of adverse events, physical examinations, vital signs, electrocardiograms, and clinical laboratory data.Results.-Two hundred patients treated at least one migraine attack (150 non-Caucasians: 46 blacks, 68 Hispanics, 36 others). Two hours postdose, significantly more inclinic sumatriptan-treated patients reported headache response (non-Caucasians, 81% versus 37% placebo; Caucasians, 87% versus 19% placebo; P Ͻ .001) and mild or no clinical disability, compared with placebo (non-Caucasians, 87% versus 50% placebo; Caucasians, 90% versus 38% placebo; P Ͻ .001). Blacks (80%), Hispanics (83%), and others (74%) reported similar patterns of headache response at 2 hours. Similar results were reported during the outpatient phase. The incidence of adverse events following sumatriptan during the inclinic phase was similar between ethnic groups (non-Caucasian, 75%; Caucasian, 79%) and higher than placebo (non-Caucasian, 51%; Caucasian, 31%). Overall, adverse events in the outpatient phase of the study were lower than in the inclinic phase.Conclusion.-Sumatriptan injection is effective and well tolerated in non-Caucasians and Caucasians for the treatment of acute migraine attacks. Only minor differences in efficacy or tolerability were observed between blacks, Hispanics, and others.

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Efficacy and tolerability of subcutaneous sumatriptan administered using the IMITREX® STATdose™ System

Cited by 25 publications

References 8 publications

Marked sexual dimorphism in 5-HT 1 receptors mediating pronociceptive effects of sumatriptan

Marked sexual dimorphism in 5-HT 1 receptors mediating pronociceptive effects of sumatriptan

Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos

Efficacy and Tolerability of Subcutaneous Sumatriptan for Acute Migraine: A Comparison Between Ethnic Groups

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