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By I. Chris. King College. 2019.

What are the comparative incidence and nature of complications (serious or life- threatening or those that may adversely effect compliance) of different triptans in adult patients being treated for migraine? Fixed-dose combination tablets containing a triptan compared with triptan monotherapy purchase kamagra polo 100 mg. buy kamagra polo 100 mg fast delivery. generic 100 mg kamagra polo with amex................................................................................................................................... Fixed-dose tablets containing a triptan compared with co-administration of its individual triptan and analgesic components.................................................................................... Are there subgroups of patients based on demographics, other medications, or comorbidities for which one medication or preparation is more effective or associated with fewer adverse effects?................................................................................................................................ Triptans and triptan fixed-dose combination products.............................................................. Pooled absolute rates of 2-hour pain-free and pain-relief (95% confidence intervals)........... Head-to-head trials of eletriptan compared with the encapsulated conventional tablet form of sumatriptan 100mg: Comparison of 2-hour pain-free outcomes from published analyses of per-protocol populations to estimates of all-treated populations using a worst-case scenario approach................. One-hour and 2-hour outcomes in head-to-head trials comparing rizatriptan with the conventional tablet form of sumatriptan................................................................................................ Pain-free at 2 hrs in placebo-controlled trials: Pooled relative risk and number needed to treat for conventional and reformulated sumatriptan.................................................................................... Pooled relative risks (95% confidence interval) for pain-free outcomes in placebo- controlled trials of early treatment with triptans..................................................................................... EVIDENCE TABLES are available as a separate document Triptans Page 3 of 80 Final Report Update 4 Drug Effectiveness Review Project The medical literature relating to this topic is scanned periodically. Prior versions of this report can be accessed at the DERP website. Acknowledgments We thank Leah Williams, our publications editor, for putting this report into its present form for you to read. We also thank Arkady Mak, PhD, MD, for editorial suggestions, Miranda Walker, MA, for assistance with data abstraction and quality assessment of studies, and Sujata Thakurta, MPA:HA and Theresa Nguyen for retrieval of articles and assistance with editing and formatting. Suggested citation for this report Helfand M, Peterson K. These organizations selected the topic and had input into the Key Questions for this review. The content and conclusions of the review are entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report. Triptans Page 4 of 80 Final Report Update 4 Drug Effectiveness Review Project INTRODUCTION Triptans, also called serotonin 5-hydroxytryptamine (5-HT) receptor agonists, are used to treat migraine and certain other headaches. Scientists have 1 several hypotheses to explain how triptans work. Triptans may be taken subcutaneously, orally as tablets, capsules, or quick-dissolving wafers, or intranasally as a spray. The first triptan, sumatriptan, was introduced in 1991. Currently, 7 triptans are available in the United States (Table 1). As of June 2003, the original ® oral tablet form of sumatriptan was replaced by a rapid release tablet (RT Technology) that was designed to facilitate early absorption into the bloodstream. Reformulated sumatriptan was approved as bioequivalent to original sumatriptan based on entire area under the curve (AUC0- infinity) and maximum concentration (Cmax) and the patent life was not extended. However, in vitro dissolution testing using USP II apparatus in 0. In early 2009, the first generic forms of sumatriptan became available on the market. However, it is not yet clear whether these generic sumatriptan oral tablet products are ® formulated using RT Technology or not. In some cases, patients may treat their migraines using a triptan in combination with other types of pain relievers, such as aspirin or a nonsteroidal anti-inflammatory drug. The first fixed-dose combination product containing a triptan was introduced in 2008. This product, called ® Treximet , contains sumatriptan 85 mg plus naproxen sodium 500 mg in a single tablet form. Triptans and triptan fixed-dose combination products Generic name Brand name Form and dose (mg) ® Almotriptan Axert Oral tablet (6. Triptans Page 5 of 80 Final Report Update 4 Drug Effectiveness Review Project Drugs for migraine are often classified by whether they are used to prevent migraine attacks (prophylaxis) or to shorten (abort) an attack. All of the triptans available in the United States and Canada are approved for the acute treatment of migraines in adults. None are approved for prophylaxis of migraine or for hemiplegic, ophthalmoplegic, or basilar migraine. Sumatriptan is the only triptan approved in the United States for cluster headache; it is not approved for this indication in Canada. The clinical efficacy and adverse effects of the different triptans are of considerable 3-8 9-12 interest to researchers and patients, and several review articles and meta-analyses have compared them between triptans. Comparing triptans is complex, however, because of the large variety of outcomes that can be measured in studies. In most studies, the primary outcome, severity of headache pain after 2 hours, is measured on a 4-point scale (severe, moderate, mild, none). Typically, patients must wait until they have a moderate to severe headache before taking the study medication. Two hours after taking the medication, the patient rates the severity of headache again. A “response” is defined as a reduction in headache from “moderate” or “severe” to “mild” or “none. The main criticism is that a 2-hour response may not be as important to patients as some other measures, such as pain-free response or time to response. Another criticism is that the change from moderate/severe pain to none/mild may not always be significant. This criticism is based on the premise that a reduction by only 1 point on the scale (for example, from “moderate” to “mild”) may not be associated with important differences in quality of life or function and should not 13 always be counted as a response. A patient choosing a triptan might consider many other aspects of effectiveness, such as the completeness, speed, and duration of a single response and the consistency of response from 14 headache to headache. Moreover, individual patients may differ in the value they place on each of these attributes of effectiveness and on how they weigh the benefits of treatment against the side effects. For example, suppose that one triptan is more likely to relieve migraine pain within 2 hours, while another is less likely to provide relief but, when it does, it works faster. Or suppose that one triptan is more likely to relieve pain within 2 hours, but more of the patients who experience relief suffer a recurrence of severe pain later in the day. Or suppose that one triptan is more likely to provide headache relief but is also more likely to cause side effects.

C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry C h em o L evel C om m ents H errington 2008 Tex as Hesketh L evel5 N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 204 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3 kamagra polo 100 mg fast delivery. C h em oth erapy:placebo-controlled trials A uth or Y ear A ge C ountry Study Design Interventions (drug R egim ent purchase genuine kamagra polo on-line, G ender C h em o L evel Setting duration) Eligibility criteria Eth nicity Herrstedt M ulticenter APR regim en Patients≥ 18years kamagra polo 100 mg with mastercard,diagnosedwith breastM ean:52yrs 2005 D B,R andom iz ed,D ay1:APR 125m g,O N D 8m g and carcinom aandhadreceivedasingle R ange:N R D enm ark parallel D E X 12m g beforechem otherapy cycleof M E C (Hesketh L evel≥ 3)inthe Hesketh L evel>3 andO N D 8m g 8hrslater coreprotocol. Controlregim en Ptsrequiredtosuccessfullycom plete D ay1:O N D 8m g andD E X 20m g each previouschem otherapycyclebefore beforechem otherapyandO N D 8m g continuing tothenex tcycleof treatm ent 8hourslater with thesam ehem otherapeutic regim en. N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 205 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or N um ber N um ber Y ear screened/ with drawn/ C ountry eligible/ lostto A llowed oth erm edications/ C h em o L evel O th erpopulationch aracteristics enrolled fu/analyz ed interventions Herrstedt R eceivedacom binationof 866/N R /744 94/N R /650 Perm ittedrescuem edicationswere5-HT3 2005 cyclophospham ideplusananthracyclineas antagonists,phenothiaz ines, D enm ark theirchem otherapyregim en:99% butyrophenones,andbenz odiaz epines Hesketh L evel>3 N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 206 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear M eth od ofO utcom e C ountry A ssessm entand Tim ing of C h em o L evel DefinitionofO utcom es A ssessm ent Herrstedt Proportionof patientswith com pleteresponse(CR ):noem esisandno Ptsreportedem esisoruseor 2005 useof rescuetherapy,acrossm ultiplecyclesof chem otherapy rescuem edicationovera120 D enm ark hourperiodafter Hesketh L evel>3 chem otherapy Com pletedadailynausea visualanalog scale(VAS:0 m m isnonausea,100m m is nauseaasbadasitcouldbe) N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 207 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry M eth od ofadverse effects C h em o L evel R esults assessm ent Herrstedt Com pleteR esponse Patientreport 2005 Cycle1:APR :50. C h em oth erapy:placebo-controlled trials A uth or Y ear Totalwith drawals; C ountry with drawals due to adverse C h em o L evel A dverse Effects R eported events Herrstedt Cycles2-4 94(noneareduetoAE s) 2005 Alopecia:APR :12. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry C h em o L evel C om m ents Herrstedt 2005 D enm ark Hesketh L evel>3 N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 210 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear A ge C ountry Study Design Interventions (drug R egim ent, G ender C h em o L evel Setting duration) Eligibility criteria Eth nicity H esketh M ulticenter A:D ay1:Apr125m g po Cisplatin-naïveptsage ≥18yrswhohad M ean:58. D ays2-4:placebo F em aleptsof childbearing potentialwere % W hite:3. C h em oth erapy:placebo-controlled trials A uth or N um ber N um ber Y ear screened/ with drawn/ C ountry eligible/ lostto A llowed oth erm edications/ C h em o L evel O th erpopulationch aracteristics enrolled fu/analyz ed interventions H esketh M eancisplatindose:80. C h em oth erapy:placebo-controlled trials A uth or Y ear M eth od ofO utcom e C ountry A ssessm entand Tim ing of C h em o L evel DefinitionofO utcom es A ssessm ent H esketh Prim aryresponse:Com pleteresponse(CR ):noem etic episodesand Ptdiaryfor#of em etic 2003 norescuetherapyforD ays1-5 episodesanduseof rescue International therapy. Hesketh chem olevel5 Totalcontrol(TC):noem esis,norescuetherapy,andnonausea 100m m N auseavisual (nauseaVAS<5m m ) analog scale(VAS) Com pleteprotection(CP):noem esis,norescuetherapy,nosignificant nausea(VAS <25m m ) N oem esis N orescuetherapy N onausea(m ax im um VAS <5m m ) N osignificantnausea(m ax. VAS<25m m ) Im pactof CIN V ondailylife,asm easuredbyanF L IE totalscoreof >108 N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 213 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry M eth od ofadverse effects C h em o L evel R esults assessm ent H esketh C omparisons are forgroups A (A pr125/80)vs. B(placebo) AE reportedup to14daysafter 2003 A cute (Day 1): treatm ent International CR :89. C h em oth erapy:placebo-controlled trials A uth or Y ear Totalwith drawals; C ountry with drawals due to adverse C h em o L evel A dverse Effects R eported events H esketh C om parisons m ade betweenG roups A (n=261)and B (n=264) 2003 % with ≥ 1clinicaladverseevent(AE ):65. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry C h em o L evel C om m ents H esketh 2003 International Hesketh chem olevel5 N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 216 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear A ge C ountry Study Design Interventions (drug R egim ent, G ender C h em o L evel Setting duration) Eligibility criteria Eth nicity Poli-B igelli M ulticenter A:D ay1:Apr125m g po Cisplatin-naïvepts>18yrswhohad M ean:53. N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 217 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or N um ber N um ber Y ear screened/ with drawn/ C ountry eligible/ lostto A llowed oth erm edications/ C h em o L evel O th erpopulationch aracteristics enrolled fu/analyz ed interventions Poli-B igelli M eancisplatindose:81m g/m 2 624/N R /569 A:D ay1:O nd32m g iv 2003 % ptswith acisplatindose ≥70-100m g/m 2: D ays2-4:D ex 8m g po L atinAm erica 82% Hesketh chem olevel5 Typeof cancer: B:D ay1:O nd32m g iv respiratory:38. C h em oth erapy:placebo-controlled trials A uth or Y ear M eth od ofO utcom e C ountry A ssessm entand Tim ing of C h em o L evel DefinitionofO utcom es A ssessm ent Poli-B igelli Prim arym easure:Com pleteresponse(C R ):noem etic episodesand Acuteresults:D ay1results 2003 nouseof rescuetherapy only L atinAm erica Hesketh chem olevel5 Com pleteprotection(C P):noem esis,norescuetherapy,andnausea D elayedresults:D ays2-5 VAS <25m m O verall:D ays1-5 Totalcontrol(TC ):noem esis,norescuetherapy,nauseaVAS <5m m N oE m esis N ouseof rescuem edication Im pactof CIN V ondailylife(asm easuredbyanF L IE score>108) N osignificantnausea(VAS <25m m ) N onausea(VAS <5m m ) N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 219 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry M eth od ofadverse effects C h em o L evel R esults assessm ent Poli-B igelli forallresults,comparisons are forG roupA vs. G roupB 2003 A cute results (day 1): L atinAm erica CR :82. C h em oth erapy:placebo-controlled trials A uth or Y ear Totalwith drawals; C ountry with drawals due to adverse C h em o L evel A dverse Effects R eported events Poli-B igelli C omparisons made betweenA prepitant(n=282)and Placebo (n=285) 2003 % with ≥ 1clinicaladverseevent(AE ):72. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry C h em o L evel C om m ents Poli-B igelli 2003 L atinAm erica Hesketh chem olevel5 N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 222 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear A ge C ountry Study Design Interventions (drug R egim ent, G ender C h em o L evel Setting duration) Eligibility criteria Eth nicity W arr M ulticenter A:(N = 438)D ay1:Apr125m g po1 Patients≥18yearswith breastcancer Age:52. N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 223 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or N um ber N um ber Y ear screened/ with drawn/ C ountry eligible/ lostto A llowed oth erm edications/ C h em o L evel O th erpopulationch aracteristics enrolled fu/analyz ed interventions W arr M otionsickness:18. Hesketh chem olevel4 A:D ay1:O nd8m g po30-60m inbefore chem o+dex 12m g po30m inbeforechem o O nd8m g po8hrsafterfirstdose D ay2-3:placebopobid B:D ay1:O nd8m g po30-60m inbefore chem o+dex 20m g po30m inbeforechem o O nd8m g po8hrsafterfirstdose D ay2-3:8m g pobid N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 224 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear M eth od ofO utcom e C ountry A ssessm entand Tim ing of C h em o L evel DefinitionofO utcom es A ssessm ent W arr Com pleteresponse:novom iting andnorescuetherapythroughoutthe Patientdiaryforem etic 2005 acuteanddelayedphases(120hrs) episodes,useof rescue International(95centers) m edication,anddailynausea Hesketh chem olevel4 ratings(onaVAS where0= "n from D ay1today6. F L IE questionnaire(9item s onvom iting and9item son nausea)adm inisteredonday 1andday6;"m inim alorno im pactof CIN V ondailylife"is definedforthisstudyas averagescoreof >6onthe7- pointscaleforeach item. N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 225 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry M eth od ofadverse effects C h em o L evel R esults assessm ent W arr Aprepitantvsplacebo Safetyandtolerability 2005 Com pleteresponsefor0-120hours:51% vs42%,p= 0. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry C h em o L evel C om m ents W arr 2005 International(95centers) Hesketh chem olevel4 N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 228 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear A ge C ountry Study Design Interventions (drug R egim ent, G ender C h em o L evel Setting duration) Eligibility criteria Eth nicity O th eroutcom es B arrenetxea Single-center A:D ay1:O nd8m g iv Breastcancerptswhowereeligibleif they Age:N R 1996 D B D ay2-4:O nd8m g poX 3 hadreceivednopreviouschem o,were ≥ Spain parallel 18yrs,andhadaK arnofskystatusof ≥ G ender:N R B:D ay1:O ng 8m g iv 60%. Ptswerereceiving eitheraregim en D ays2-4:m etoclopram ide10m g of CM F [cyclophospham ide500m g day1,E thnicity:N R poX 3 m ethotrex ate50m g ondays1& 8,and5- fluouracil600m g days1& 8]every28 C:D ay1:O nd8m g iv daysorof F E C [cyclophospham ide500 D ays2-4:placeboX 3 m g day1,epirubicin75m g day1,and5- fluorouracilonday1]every21days. N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 229 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or N um ber N um ber Y ear screened/ with drawn/ C ountry eligible/ lostto A llowed oth erm edications/ C h em o L evel O th erpopulationch aracteristics enrolled fu/analyz ed interventions O th eroutcom es B arrenetxea Cancer:100% breastcancer N R /N R /N R N R /N R /N R N o 1996 Spain N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 230 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear M eth od ofO utcom e C ountry A ssessm entand Tim ing of C h em o L evel DefinitionofO utcom es A ssessm ent O th eroutcom es B arrenetxea Prim aryefficacym easure:N um berof em etic episodes: F L IC questionnairecom plete 1996 Com pleteresponse:noem etic episode during a5dayperiod Spain M ajorresponse:1-2em etic episodes following chem o;thedegree M inorresponse:3-5em etic episodes of nauseaanddisabilitywere F ailure:>5em etic episodes recordedeach dayona7- C+M response= Com plete+m ajorresponses pointscale. F ailurerate= M inor+failureresponses Q ualityof L ife:F unctionalL iving Index (F L IC): 7ptsscale,with 7= goodand1= poor N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 231 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry M eth od ofadverse effects C h em o L evel R esults assessm ent O th eroutcom es B arrenetxea (Data givenfornumberofemeticepisodes,butnotreported h ere) N R 1996 F L IC scores are approximates because th ey are read from a graph Spain C M F Pts F L IC scores by day,A vs B vs C : D ay1:5. C h em oth erapy:placebo-controlled trials A uth or Y ear Totalwith drawals; C ountry with drawals due to adverse C h em o L evel A dverse Effects R eported events O th eroutcom es B arrenetxea "N osevereorunex pectedeventwasreportedbythepts. Constipationandhot N R ;N R 1996 flushestendedtobem orefrequentam ong ptsreceiving O ndfor3days(group A) Spain thaninptsassignedtoG roupsBorC. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry C h em o L evel C om m ents O th eroutcom es B arrenetxea 1996 Spain N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 234 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 4. Q uality assessm ents ofch em oth erapy placebo-controlled trials InternalValidity A uth or Y ear A llocation O utcom e C ountry R andom iz ation concealm ent G roups sim ilarat Eligibility criteria assessors C are provider Patient C h em o L evel adequate? A prepitant N avari Yes N R Yes Yes N R Yes Yes 1999 U SA Hesketh chem olevel 5 C h awla Yes N R Yes Yes N R Yes Yes 2002 International Hesketh chem olevel 5 Antiemetics Page 235 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 4.

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Methylphenidate versus dexamphetamine in children with attention deficit hyperactivity disorder: A double-blind, crossover trial. Long-term follow-up of children with mental retardation/borderline intellectual functioning and ADHD. Research Units on Pediatric Psychopharmacology Autism Network. Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Ahmann PA, Theye FW, Berg R, Linquist AJ, Van Erem AJ, Campbell LR. Placebo- controlled evaluation of amphetamine mixture-dextroamphetamine salts and amphetamine salts (Adderall): efficacy rate and side effects. Handen BL, Feldman H, Gosling A, Breaux AM, McAuliffe S. Adverse side effects of methylphenidate among mentally retarded children with ADHD. Journal of the American Academy of Child & Adolescent Psychiatry. Efficacy of methylphenidate among preschool children with developmental disabilities and ADHD. Journal of the American Academy of Child & Adolescent Psychiatry. 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