Needle-free subcutaneous sumatriptan (Sumavel DosePro): bioequivalence and ease of use.

Abstract:

BACKGROUND:Subcutaneous (s.c.) injection of sumatriptan is currently associated with needle aversion in some patients, and sharps disposal issues. OBJECTIVES: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. METHODS:Two clinical trials. Study A: Pharmacokinetics and bioequivalence was studied in normal adult volunteers (n = 57 total), directly comparing needle-free (Sumavel DosePro) with needle-based (Imitrex STATdose System) administration of 6 mg s.c. sumatriptan. An incomplete, randomized, partial factorial, crossover design was used. Each subject received 2 administrations of each product, at 2 of the 3 anatomical sites (abdomen, thigh or arm). There were appropriate "washout" periods between each. Pharmacokinetic sampling was at standard time points, and tests for bioequivalence then followed. Study B: The term "ease of use" was used for clinical acceptability and utility of the needle-free system when it was assessed among 52 outpatients treating migraine attacks. Instructional materials were used as would be provided after ordinary prescription. The primary endpoint was successful use of the needle-free system to administer sumatriptan at the first attempt, including appropriate injection site selection. Second and subsequent uses of the needle-free system were also documented. RESULTS:For administration sites in the thigh and the abdomen, but not the arm, the needle-free and needle-based systems were bioequivalent (for all pharmacokinetic endpoints the mean ratios between the 2 devices were always between 90.1% and 115%). Among outpatients treating a migraine attack with the needle-free system, 51 of 52 on first attempt used the needle-free system successfully when treating a migraine attack. CONCLUSIONS: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.

journal_name

Headache

journal_title

Headache

authors

Brandes JL,Cady RK,Freitag FG,Smith TR,Chandler P,Fox AW,Linn L,Farr SJ

doi

10.1111/j.1526-4610.2009.01530.x

subject

Has Abstract

pub_date

2009-11-01 00:00:00

pages

1435-44

issue

10

eissn

0017-8748

issn

1526-4610

pii

HED1530

journal_volume

49

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

相关文献

HEADACHE文献大全
  • Longitudinal Analysis of Patient-Reported Outcomes From an Interdisciplinary Pediatric Pain Rehabilitation Program for Children With Chronic Migraine and Headache.

    abstract:BACKGROUND:Many children suffering from chronic headache and migraine present with comorbid functional disability, including physical, social, emotional, and academic activities. For children severely impaired by headache, intensive interdisciplinary pain rehabilitation treatment (IIPT) can improve functioning. However...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/head.13389

    authors: Benore E,Webster EE,Wang L,Banez G

    更新日期:2018-11-01 00:00:00

  • Alteration of central excitation circuits in chronic headache and analgesic misuse.

    abstract::Central excitatory circuits could be involved in the pathophysiology of pain; particularly, the genesis of chronic pain. The "second pain" is the sensation that follows the initial pain after an appropriate nociceptive stimulus. The second pain is amplified by repeating the stimulus after brief intervals (temporal sum...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1046/j.1526-4610.1997.3708486.x

    authors: Fusco BM,Colantoni O,Giacovazzo M

    更新日期:1997-09-01 00:00:00

  • Botulinum toxin for the treatment of chronic migraine: the placebo effect.

    abstract::Botulinum toxin A used to treat headache evokes prominent placebo effects and it is likely that these effects are solely responsible for its apparent effectiveness. ...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.2011.01915.x

    authors: Solomon S

    更新日期:2011-06-01 00:00:00

  • Transcranial Doppler ultrasonographic features during drug withdrawal from drug-induced headache. A transcranial Doppler follow-up study.

    abstract:BACKGROUND:A vascular component in ergotamine-induced headache has been proposed. No study has been carried out to evaluate cerebral hemodynamic changes by means of transcranial Doppler during withdrawal from migraine medication; in particular, ergotamine-containing drugs. METHOD:We examined 21 patients suffering from...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1046/j.1526-4610.1998.3809679.x

    authors: Haase CG,Diener HC

    更新日期:1998-10-01 00:00:00

  • Periaqueductal gray matter dysfunction in migraine: cause or the burden of illness?

    abstract:OBJECTIVE:The periaqueductal gray matter (PAG) is at the center of a powerful descending antinociceptive neuronal network. We studied iron homeostasis in the PAG as an indicator of function in patients with episodic migraine (EM) between attacks and patients with chronic daily headache (CDH) during headache. High-resol...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1046/j.1526-4610.2001.041007629.x

    authors: Welch KM,Nagesh V,Aurora SK,Gelman N

    更新日期:2001-07-01 00:00:00

  • Persistent trigeminal artery causing "double" neurovascular conflict.

    abstract::We report the case of a 73-year-old woman who presented with right VI nerve palsy and homolateral atypical trigeminal neuralgia; standard neuroradiological investigation of orbital/retroorbital regions and intracranial arteries excluded the most commonly demonstrable underlying causes while brain magnetic resonance (T...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.2008.01258.x

    authors: Clerici AM,Merlo P,Rognone F,Noce M,Rognone E,Bono G

    更新日期:2009-03-01 00:00:00

  • Cognitive development in children with migraine and their healthy unaffected siblings.

    abstract::The discussion about neuropsychological sequalae from migraine occurring in adults is controversial. The purpose of our study was to examine whether children with migraine may be at risk for impaired intellectual development compared with their siblings free of migraine. ...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1046/j.1526-4610.2002.02179.x

    authors: Haverkamp F,Hönscheid A,Müller-Sinik K

    更新日期:2002-09-01 00:00:00

  • Post-traumatic migraine: chronic migraine precipitated by minor head or neck trauma.

    abstract::Minor trauma to the head or neck is occasionally followed by severe chronic headaches. We have evaluated 35 adults (27 women, 8 men) with no prior history of headaches, who developed recurrent episodic attacks typical of common or classic migraine following minor head or neck injuries ("post-traumatic migraine"-PTM). ...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.1991.hed3107451.x

    authors: Weiss HD,Stern BJ,Goldberg J

    更新日期:1991-07-01 00:00:00

  • Comparative tolerability of oral 5-HT1B/1D agonists.

    abstract:OBJECTIVES:To compare the relative tolerability of 5-HT1B/1D agonists and to investigate the relationships (if any) among systemic exposure, lipophilicity, and clinical tolerability for 5-HT1B/1D agonists. METHODS:Post hoc correlations were sought among the following variables: absolute dose (= administered dose x ora...

    journal_title:Headache

    pub_type: 杂志文章

    doi:

    authors: Fox AW

    更新日期:2000-07-01 00:00:00

  • Migraine without aura and reproductive life events: a clinical epidemiological study in 1300 women.

    abstract::A retrospective study was conducted on 1300 women suffering from migraine without aura referred to the Headache Centers of Parma and Pavia from 1984 to 1990. All the data concerning their reproductive life, and the modifications induced by it on the course of headache were obtained from record-charts. Migraine frequen...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.1993.hed3307385.x

    authors: Granella F,Sances G,Zanferrari C,Costa A,Martignoni E,Manzoni GC

    更新日期:1993-07-01 00:00:00

  • Costs and outcomes of early versus delayed migraine treatment with sumatriptan.

    abstract:OBJECTIVE:To evaluate the impact on costs and outcomes of early migraine treatment with sumatriptan while pain is mild versus sumatriptan treatment of moderate to severe pain. BACKGROUND:Migraines result in substantial pain, impairment, and costs. Recent clinical studies have shown that early treatment with sumatripta...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1046/j.1526-4610.2002.02228.x

    authors: Halpern MT,Lipton RB,Cady RK,Kwong WJ,Marlo KO,Batenhorst AS

    更新日期:2002-11-01 00:00:00

  • No microstructural white matter alterations in chronic and episodic migraineurs: a case-control diffusion tensor magnetic resonance imaging study.

    abstract:BACKGROUND:In patients with episodic migraine (EM), diffusion tensor imaging (DTI) revealed microstructural white matter alterations in various brain regions related to pain processing. Some of these changes were correlated with migraine duration and attack frequency, suggesting that migraine is a progressive disease w...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/head.12496

    authors: Neeb L,Bastian K,Villringer K,Gits HC,Israel H,Reuter U,Fiebach JB

    更新日期:2015-02-01 00:00:00

  • Internalizing Symptoms in Pediatric Migraine: A Systematic Review Protocol.

    abstract:OBJECTIVES:The primary objective of the proposed systematic review is to determine if there is an association between internalizing disorders and symptoms (ie, subclinical symptoms) and migraine in children and adolescents. METHODS:We will perform a peer-reviewed Peer Review of Electronic Search Strategies search of M...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/head.13778

    authors: Falla K,Ronksley P,Noel M,Orr SL

    更新日期:2020-04-01 00:00:00

  • Migraine With Exclusive Olfactory Aura: Case Report and Literature Review.

    abstract:OBJECTIVES:To report the case of a patient enduring migraine attacks preceded by hallucinatory olfactory symptoms, with characteristics which typically define migraine with aura (MWA). BACKGROUND:MWA accounts for about 30-40% of the total cases of migraine and is almost always preceded by visual disorders; and in rare...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/head.14014

    authors: Tiriticco M,Vanotti A,Mantica D,Coppola A

    更新日期:2020-11-01 00:00:00

  • Frequency of pediatric migraine with aura in a clinic-based sample.

    abstract:OBJECTIVE:To assess the prevalence and risk factors for pediatric migraine with aura (MWA) among patients presenting to pediatric neurology clinics. BACKGROUND:Headache is a common complaint among children, and the prevalence of migraine is about 8%. Up to one third of adults with migraine report experiencing aura; ho...

    journal_title:Headache

    pub_type: 杂志文章,多中心研究

    doi:10.1111/head.12741

    authors: Genizi J,Khourieh Matar A,Zelnik N,Schertz M,Srugo I

    更新日期:2016-01-01 00:00:00

  • The examination of headache activity using time-series research designs.

    abstract::The majority of research conducted on headache has utilized cross-sectional designs which preclude the examination of dynamic factors and principally rely on group-level effects. The present article describes the application of an individual-oriented process model using time-series analytical techniques. The blending ...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.2005.05095.x

    authors: Houle TT,Remble TA,Houle TA

    更新日期:2005-05-01 00:00:00

  • Orthostatic headache as the presenting symptom of cervical spine metastasis.

    abstract::Orthostatic headache is a key symptom of intracranial hypotension; however, not all orthostatic headaches are caused by cerebrospinal fluid leaks leading to intracranial hypotension. We report here the unusual case of a 68-year-old man presenting with orthostatic headache in which compression of the C3 spinal nerve ro...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.2007.00982.x

    authors: Kim JH,Choi JY,Kim HJ,Oh K

    更新日期:2008-01-01 00:00:00

  • The development of a survey to measure completeness of response to migraine therapy.

    abstract:OBJECTIVE:To assess the psychometric properties of a new patient-reported migraine instrument, the Completeness of Response Survey (CORS), which measures a comprehensive set of factors important to patients' decisions regarding the initiation and continuation of treatment. BACKGROUND:Traditionally, migraine treatments...

    journal_title:Headache

    pub_type: 杂志文章,多中心研究

    doi:10.1111/j.1526-4610.2012.02099.x

    authors: Coon CD,Fehnel SE,Davis KH,Runken MC,Beach ME,Cady RK

    更新日期:2012-04-01 00:00:00

  • Headache in patients with baroreflex failure.

    abstract::Two cases of baroreflex failure presented with tension-type/exertional headache. The usefulness of noninvasive physiological tests in diagnosing baroreflex failure and the role of baroreceptors in trigeminal nociception are discussed. ...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.2006.00514_3.x

    authors: Khurana RK

    更新日期:2006-07-01 00:00:00

  • Hemicrania continua evolving from cluster headache responsive to valproic acid.

    abstract::Hemicrania continua (HC) is a rare type of primary headache characterized by a prompt and enduring response to indomethacin. We describe a patient who suffered from cluster headache evolving into ipsilateral HC, who does not tolerate a long-term indomethacin therapy. The case was complex in terms of diagnosis, associa...

    journal_title:Headache

    pub_type: 信件

    doi:10.1111/j.1526-4610.2008.01249.x

    authors: Lambru G,Castellini P,Bini A,Evangelista A,Manzoni GC,Torelli P

    更新日期:2008-10-01 00:00:00

  • Triptans--why once?

    abstract:OBJECTIVE:To evaluate triptan use patterns in a large Israeli HMO district. BACKGROUND:Triptans, 5HT(1B/1D) agonists, provide an effective and safe relief of headache and accompanying symptoms during an acute migraine attack. METHOD:We retrospectively reviewed the computerized prescription filling data of 1498 patien...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.2006.00435.x

    authors: Ifergane G,Wirguin I,Shvartzman P

    更新日期:2006-09-01 00:00:00

  • Sports-related concussion: the role of the headache specialist.

    abstract::Over the past few years, sports-related concussion has received significant media attention making it one of the most, if not highest profile neurological disorder. Thirty-one states now have passed sports concussion laws, with 14 states pending legislation. Most concussions are managed by primary care physicians, ie,...

    journal_title:Headache

    pub_type: 杂志文章,评审

    doi:10.1111/j.1526-4610.2012.02138.x

    authors: Conidi FX

    更新日期:2012-05-01 00:00:00

  • Cluster-tic syndrome and basilar artery ectasia: a case report.

    abstract::A 54-year-old patient presented with two types of pain. The first was similar to trigeminal neuralgia and the second was similar to cluster headache. Clinical diagnosis was cluster-tic syndrome. Neuro-imaging studies disclosed an ectatic basilar artery. The significance of this finding is difficult to ascertain. ...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.1993.hed3309512.x

    authors: Ochoa JJ,Alberca R,Cañadillas F,Blanco A

    更新日期:1993-10-01 00:00:00

  • Platelet serotonin measures in migraine.

    abstract:OBJECTIVE AND BACKGROUND:Serotonergic mechanisms play an important role in the pathogenesis of headache. To search for potential indicators of altered serotonin homeostasis in migraine, we have investigated three parameters of the platelet serotonin (5HT) system, platelet serotonin level (PSL), platelet serotonin uptak...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1046/j.1526-4610.2002.02145.x

    authors: Jernej B,Vladić A,Cicin-Sain L,Hranilović D,Banović M,Balija M,Bilić E,Sucić Z,Vukadin S,Grgicević D

    更新日期:2002-07-01 00:00:00

  • Hemicrania continua: a case responsive to piroxicam-beta-cyclodextrin.

    abstract::The case of a 53-year-old woman is described, who since the age of 38 years had been suffering from a unilateral headache that was at first remitting, but then evolved into an unremitting course. The headache was burning in quality, located in the left forehead and face, and was accompanied by mild ipsilateral autonom...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.1992.hed3201039.x

    authors: Trucco M,Antonaci F,Sandrini G

    更新日期:1992-01-01 00:00:00

  • Two studies of the non-pharmacological treatment of menstrually-related migraine headaches.

    abstract::In order to evaluate the effect of non-pharmacological treatment on menstrual and non-menstrual migraine headache (HA), 2 studies have been conducted. In Study 1 which was a retrospective examination of between group reactions to non-drug treatments, 37 self-defined menstrual migraineurs and 62 non-menstrual migraineu...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.1992.hed3204197.x

    authors: Kim M,Blanchard EB

    更新日期:1992-04-01 00:00:00

  • Persistent migraine aura: new cases, a literature review, and ideas about pathophysiology.

    abstract:BACKGROUND:Persistent migraine aura without infarction (PMA) is a rare condition that is defined as an aura that lasts longer than 1 week in absence of infarction. Two types of PMA have been distinguished, notably persistent primary visual disturbance (PPVD) and typical aura (TA). OBJECTIVES:This case-based review art...

    journal_title:Headache

    pub_type: 杂志文章,评审

    doi:10.1111/head.12392

    authors: Thissen S,Vos IG,Schreuder TH,Schreurs WM,Postma LA,Koehler PJ

    更新日期:2014-09-01 00:00:00

  • Relationship between basilar-type migraine and migrainous vertigo.

    abstract:OBJECTIVE:This study compared clinical manifestations and audiovestibular function tests among subjects of basilar-type migraine (BtM), definite and probable migrainous vertigo (dMV and pMV), in order to investigate the relationship between them. BACKGROUND:Various diagnostic criteria such as BtM, dMV, and pMV have be...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.2008.01283.x

    authors: Wang CT,Lai MS,Young YH

    更新日期:2009-03-01 00:00:00

  • Obesity and migraine: the effect of age, gender and adipose tissue distribution.

    abstract:OBJECTIVE:To evaluate the prevalence of migraine/severe headaches in those with and without general obesity and abdominal obesity (Abd-O) and the effect of gender and age on this relationship. BACKGROUND:General, or total body obesity (TBO), as estimated by body mass index, is a risk factor for migraine chronification...

    journal_title:Headache

    pub_type: 杂志文章

    doi:10.1111/j.1526-4610.2009.01459.x

    authors: Peterlin BL,Rosso AL,Rapoport AM,Scher AI

    更新日期:2010-01-01 00:00:00

  • The Impact of Shift Work on Migraine: A Case Series and Narrative Review.

    abstract:OBJECTIVE:We present a case report of 2 migraine patients engaged in shift work, followed by a narrative review, to assess whether shift work influences headache-related disability and chronification of migraine. BACKGROUND:Numerous modifiable factors can lead to chronification of migraine and to higher headache-relat...

    journal_title:Headache

    pub_type: 杂志文章,评审

    doi:10.1111/head.13622

    authors: Sandoe CH,Sasikumar S,Lay C,Lawler V

    更新日期:2019-10-01 00:00:00