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The most important subtypes are myeloid DC and plasma- cytoid DC (Miller 2013 generic 10mg claritin, Tsunetsugu-Yokota 2013) discount 10mg claritin visa. The most important function of DCs is their role as professional antigen-presenting cells discount claritin 10mg fast delivery. For this reason they express high levels of human leukocyte antigen (HLA) class II. DCs are represented in dif- ferent tissues and organs, take up antigens and migrate to lymphatic tissues. Therefore they represent a key function for inducing the adaptive immune response. HIV infection gets started for the most part in rectal or vaginal mucosa. As these mucus membranes are rich in DCs, it is assumed that DCs are the first target of HIV (Piguet 2007). However, HIV producing DCs can rarely be verified in the mucosa (Tsunetsugu-Yokota 2013). Still it is assumed that infected DCs migrate to the lymph nodes or other secondary lymph organs where CD4 T cells are infected with HIV. They play an important role in primary HIV infection. In the chronic phase of infec- tion, memory T cells are an important reservoir for latent HIV (Pierson 2000). In these resting CD4 T cells HIV is integrated but does not replicate. Via the interac- tion between DCs and resting CD4 T cells, these CD4 T cells can be activated and HIV replication begins. DCs are therefore also key cells for activation of HIV from latent reservoirs. HIV-1 itself directly and indirectly influences the function of DCs in order to inhibit the formation of an effective immune response as well as to force immune activa- Pathogenesis of HIV-1 Infection 33 tion (Miller 2013). Myeloid DCs (mDC) are not able to recognize HIV adequately, leading to the failure of a complete maturation of these cells and consequently lim- iting their role in induction of innate and adaptive immune responses (Granelli- Piperno 2004, Sabado 2010, Miller 2012). Only partly mature mDC can lead to the formation of regulatory T cells (Treg) (Krathwohl 2006). In the chronic phase of HIV infection the function of mDC is clearly limited. The ability to produce IL-12 is a defect which leads to a restricted differentiation of naïve T cells to Th1 cells (Fan 2007, Miller 2012). Plasmacytoid DCs (pDC) are activated strongly by HIV-1 and they produce interferon- as a response (Fonteneau 2004, Idoyaga 2011). Ex vivo studies show increased interferon- levels by pDC in acute and chronic HIV-1 infec- tion (O’Brien 2011). This is an important contribution to the well-known immune activation in HIV infection (see chapter on Immune Activation). In spite of this acti- vation, the maturation of pDC is not complete which renders them less effective as antigen-presenting cells (Fonteneau 2004, O’Brien 2011). In addition, HIV-1 induces the production of indoleamine-2, 3-dioxigenase (IDO) in pDC which leads to further induction of Treg (Manches 2008). This limits HIV-specific immune responses although it can improve immune activation. The effects of HIV-1 on DC are well described (Miller 2013). However even this short chapter the different and partly contrary roles that DC play in HIV infection are highlighted. This renders them an important component with regard to therapeu- tic and prophylactic vaccines. Natural killer (NK) cells NK cells are lymphocytes not considered T or B lymphocytes nor do they express antigen-specific receptors. They are important in the control of viruses and malig- nant tumors and belong to the innate immune system. NK cells express many different receptors, toll-like receptors (TLR) and killer immunoglobulin-like recep- tors (KIR) among them. KIR recognize HLA class I molecules on healthy cells which protect these cells against NK cell attack. NK cells can eliminate HIV-infected cells rapidly either via direct cytolysis or via secretion of cytokines (Walker 2013). Population-wide genetic studies show an impor- tant influence of NK cells on disease progression (Jost 2013). Certain parts of the HLA class I alleles (mainly Bw4) lead to a slower disease progression (Flores-Villanueva 2001). This effect is even stronger when combined with KIR3DL1 (Martin 2007). In addition, single nucleotide polymorphisms (SNP) within the HLA-C allele have been identified which influence disease progression. The HLA-C molecule is the ligand for the KIR2D receptor and thereby influences the function of NK cells (Jost 2013).

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N o adverse events reported Skeletal Muscle Relaxants Page 126 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4 discount claritin 10mg on-line. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Basmajian O verallassessmentofantispasticactivity: F A IR cheap claritin 10mg overnight delivery. N otclearif Subjective overallclinicalresponse: dantrolene Dantrolene vs generic claritin 10 mg visa. N ausea: 2 patients N ausea and diarrh ea: 3 patients Bjerre M otortest: M eth od evaluatingmotorage PO O R. Baseline lowerlimbs) A ny adverse event: N otreported ch aracteristics not F atigue: 2/42 reported. H igh loss to W eakness/h ypotonia: 2/42 follow-upormissingdata N ausea: 1/42 (17/44). Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Brar R andomiz ed A : Baclofentitrated Patients age 24- 38 M eanage notreported 74 crossovertrial from 5 mg/day upto 54 with clinically 70% female 1991 20 mg/day definite,mild- 30 R ace notreported U nited States moderate M S B: Placebo M ultiple Sclerosis Single center 5. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Brar M uscle tone (A sh worth Scale) F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Denh off R andomiz ed A : Dantrolene 1 N otreported 18 A ge range 18 month s to 12 years 88 crossovertrial mg/kgqid titrated to F emale gender43% 1975 maxof3 mg/kgqid 18 U nited States Diagnoses B: Placebo Spasticquadriplegia: 15/28(54% ) Single C enter Spastich emiplegia: 7/28(25% ) 6 week intervention,2 Spasticdiplegia: 4/28(14% ) weeks wash out,6 M ixed spasticity/ath etosis: 1/28(4% ) weeks crossover M ixed spasticity/rigidity: 1/28(4% ) Degrees ofseverity M ild: 14/28(50% ) M oderate: 5/28(18% ) Severe: 9/28(32% ) Duncan R andomiz ed A : Baclofen5 mg/TID Durationof 25 A verage age: M ultiple sclerosis group=36. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Denh off *M easurementscales notspecified F A IR. R andomiz ation, R esistance to passive movement: A =11/20(55% ) W ith drawals (due to adverse 89 scale atth e pretreatmentvisit(A =normal; allocationconcealment, vs. B=2(11% ), F requentadverse events severe ateach visit Blindingmeth od p<0. Impressionofcurrenttreatment: Improvement Vomiting: A =1,B=0 interventionph ase reported as A =14/22(64% )vs. B=2/22(9% ),p- Diz z iness: A =1,B=1 Investigatorth erapy preference: rated before value notreported butdescribed as "significant" L egedema:A =1,B=0 code broken Investigatorth erapy preference: Improvement Posturalh ypotension: A =1,B=0 reported as A =14/22(64% )vs. B=0/22(0% ),p- value notreported butdescribed as "significant" Skeletal Muscle Relaxants Page 132 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics F eldman R andomiz ed A :Baclofen15-80 A dult 33 M eanage 43 76 crossovertrial mg/day Establish ed G endernotreported 1978 diagnosis ofM S 23 R ace notreported U nited States B:Placebo Spontaneous flexor Establish ed diagnosis ofM ultiple Sclerosis Single center 1 week wash out,4 contractions/spast M eanspasticity severity notreported. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events F eldman Daily spasm frequency:meth od unspecified F A IR. W ith drawals: N one reported on 1978 R esistance to passive movement: a (normal concealmenttech niques 2/18 (11% ) treatment resistance)to f(immobile) notreported. F requentadverse events (n=23) A mbulation/transferactivity:M eth od 0/12 (0% ) Drowsiness: 4 vs. M uscularstrength :no significantdifferences steady) C lonus: no significantdifferences H eadach e:2/24 vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics G elenberg C rossover(notclearif A :Dantrolene 50-800 Patients with 20 M eanage=49 90 randomiz ed) mg(meandose not moderate-severe 55% M ale 1973 reported) spasticity 20 R ace unreported U. M ultiple Sclerosis Single center M oderate-Severe Spasticity (M eanunreported) 5 weeks intervention, 1 to 3 weeks wash out, Previous muscle relaxantuse notreported 5 weeks crossover H aslam R andomiz ed A : Dantrolene C h ildrenwith 26 M eanage (years):6. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events G elenberg Spasticity,strength ,clonus and tendonreflexes PO O R. F requentadverse events: minimal Tone:0=normalto 4=marked increase Passive range ofmotion,spontaneous range of leth argy th atresolved with firsttwo R eflexes:0=normalto 4=very brisk motion,muscle spasticity: N o differences days Scissoring:0=absentto 4=paraplegia-in-flexion betweentreatments M otorfunctions: stepclimbing,sittingposition time,h and-knee position,roll-overtime as measured by ph ysicalth erapists;meth ods unspecified Self-h elpskills: reach for/transferobjects, pegboard test,wh eelch airoperationas measured by ph ysicalth erapists;meth ods unspecified Daily activities: bath ing,bracing,dressing, wh eelch airtransferas measured by nursing staff;meth ods unspecified A ssessed ondays 4,8,11 and 15 ofeach treatmentperiod Skeletal Muscle Relaxants Page 136 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics H inderer R andomiz ed A : Baclofen,40-80 Patients with 5 A ge range of20-42 77 mg/day spasticity 100% male 1990 U nited States 5 R ace notreported B: Placebo Single C enter Spinalcord lesions ofunspecified traumaticetiologies 2. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events H inderer Spasticity:unspecified meth od PO O R. R andomiz ation, Spasticity: 0 subjects demonstrated th erapeutic N otreported 91 A nxiety: Beck Inventory Scale blindingtech niques not reductionofspasticity measurements wh ile taking 1990 described,intention-to- baclofen A ssessed twice perweek treatanalysis not A nxiety: 1/5 h ad significantly reduced Beck performed. H udgson Spasticity: 5 pointA sh worth scale F A IR. W ith drawals (adverse events):1/25 1971 and 53 tech niques not 0. A llocation Study stopped due to excess with drawals,no data W ith drawals (adverse events):5/9 92 Spasticity concealment,eligibility to assess efficacy. A ssessments completed initially and atweekly intervals th ereafter Skeletal Muscle Relaxants Page 138 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Jones R andomiz ed A : Baclofen15 H ospitaliz ed 6 A ge range (years): 17-41 170 crossovertrial mg/day titrated to 60 patients with F emale gender:2/6 1970 mg/day quadripareticor 6 R ace: notreported A ustralia quadriplegic B: Placebo spinalcord injury Durationofillness: 5/6 less th an12 month s Single center Priormuscle relaxantuse: A llpreviously ondiaz epam 15-30 14 days intervention mg/day followed by 14 days crossover Joynt R andomiz ed A : Dantrolene 4 C h ildrenwith 21 C h ildren,meanages notreported 92 mg/kg/day titrated to cerebralpalsy and G ender: notreported 1980 U nited States maximum of12 spasticity 20 R ace: notreported mg/kg/day interferingwith Single center function Diagnosticetiologies B: Placebo Diplegia: 7/20(35% ) Q uadriplegia: 7/20(35% ) 6 weeks H emiplegia: 5/20(25% ) Paraplegia: 1/20(5% ) Previous muscle relaxantuse: notreported Skeletal Muscle Relaxants Page 139 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Jones Spasticity: 0 (normal)to 4 (rigid) F A IR. R eflexes: N o differences F atigue: N otclear R eflexes: 1 (normal)to 4 (markedly increased) Diz z iness: N one reported N umberofspasms Dry mouth : N one reported W eakness: N one reported A ssessed daily A ny adverse event: N otclear W ith drawals: N one reported Joynt F amily observations: muscle spasm,range of F A IR. A ny adverse events: 10/11 (91% ) treatmentbaseline score (h igh ernumbers described. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics K atrak R andomiz ed A : Dantrolene 25 mg A ge 35-85; 38 A verage age 60. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events K atrak Tone: 0-5 scale (1=flaccid;5=severe) F A IR. A ctivities ofdaily living: N o between-group specified) differences L eth argy/drowsiness: 14/20 vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics K nutsson R andomiz ed A : Tiz anidine, N otreported 13 G ender: 4/17 (24% )female 101 crossovertrial maximum 10 mg/day A ge range: 23-80 1982 12 R ace: notreported Sweden B: Placebo Illness duration: 2 month s to 42 years Single center 3-4 weeks intervention,3-4 W h eelch air-bound: 3/17 (18% ) weeks crossover W alking-aid dependent: 8/17 (47% ) Priorantispasticmedicationuse Baclofen: 4/14 (29% ) Dantrolene sodium: 1/4 (25% ) K urtz ke R andomiz ed A : M etaxalone 400 Patients with 36 M etaxalone vs.

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Allreturnedtobaselinewithin1m onth of stopping study drug cheap 10mg claritin. ChangesinG rim elius- positive Proton pump inhibitors Page 146 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 8 discount claritin 10 mg on-line. Duodenalulcerrecurrence rates onm aintenance th erapy A uth or buy 10 mg claritin with visa, Y ear A ge,G ender,R ace,O th erPopulation N um berScreened/Eligible/ Setting C h aracteristics Interventions C ontrol Enrolled R usso M eanage44 If lansopraz ole30m g If rabepraz oleduring healing Healing:132enrolled(68 1997 68% m ale during healing trial: trial:ranitidineorplacebo150 lansopraz ole,64ranitidine) Italy 55% sm okers(43% > 15/day ) lansopraz ole15m g or m g oncedaily x 12m onthsor M aintenance:108enrolled(30 M ulticenter 32% alcoholusers placebooncedaily x 12 recurrence (lansopraz ole30m g/lansopraz ole H. Duodenalulcerrecurrence rates onm aintenance th erapy A uth or, Y ear Q uality Setting O utcom es R eported N um berofA dverse Effects R ating C om m ents R usso R ecurrence:(ITT) M aintenance: H ealing: Healing:lansopraz ole30 1997 3 month s:7% (lansopraz ole/lansopraz ole),14% R eportedas3% (lansopraz ole/lansopraz ole), G ood/F air m g orranitidine. Italy (lansopraz ole/placebo),8% (ranitidine/ranitidine),27% 18% (lansopraz ole/placebo),0% M aintenance: baselineinform ationon M ulticenter (ranitidine/placebo) (ranitidine/ranitidine); F air/Poor m aintenancephase 6 month s:17% (lansopraz ole/lansopraz ole),32% (ranitidine/placebo) notreported participantsnotreported. R esultsfor (lansopraz ole/placebo),38% (ranitidine/ranitidine), sy m ptom sduring healing 50% (ranitidine/placebo) phasenotreported. Duodenalulcerrecurrence rates onm aintenance th erapy A uth or, Y ear A ge,G ender,R ace,O th erPopulation N um berScreened/Eligible/ Setting C h aracteristics Interventions C ontrol Enrolled G raham M eanage48om epraz ole,50ranitidine,47 N one N one 240enrolled(80% of om epraz ole, 1992 placebo 63% of ranitidineand27% of U SA % m ale:75% om epraz ole,67% ranitidine,69% placebopatientseligibleenrolled) M ulticenter placebo M eanindex ulcersiz ecim etidine: 0. Duodenalulcerrecurrence rates onm aintenance th erapy A uth or, Y ear Q uality Setting O utcom es R eported N um berofA dverse Effects R ating C om m ents G raham L ifetableanaly sisrelapserates:78% om epraz ole, N onereported F air F ollowup study of 1992 60% (ranitidine),50% placebo(N S) om epraz ole20m g vs U SA ranitidineorom epraz ole M ulticenter 20m g vsplacebo Proton pump inhibitors Page 150 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 9. R andom iz ed controlled trials ofgastriculcertreatm ent A ge,G ender,R ace, A uth or O th erPopulation N um berScreened/ Y ear C h aracter- Eligible/ Setting istics Interventions C ontrol Enrolled O utcom es R eported (R esults) D ekkers M eanage55 R abepraz ole20m g 20m g of 227enrolled H ealing rates by ITT: 1998 57% m ale oncedaily. Py loripositive stated,butassum edto 3 weeks:58% (r),63% (o) Ireland,N etherlands, 24% antaciduse be6weeksbasedon 6 weeks:93% (rando) Poland,Spain, 96% had> /= 0. R andom iz ed controlled trials ofgastriculcertreatm ent A uth or Y ear Setting N um berofA dverse Effects Q uality R ating D ekkers 60patientsreportedatleastoneadverseevent. Slightly elevatedcreatinephosphokinaseat6weeks Belgium ,E ngland, wasfoundin6(o) patients. Them eanelevationsinserum gastrinlevelsat6 G erm any ,Iceland, weekswere12. Ireland,N etherlands, Poland,Spain, Sweden M ulticenter Ando,2005 8adverseeventsreportedin5patients F air R :abdom inalpain,nausea,headaches O :diarrhea,abdom inalpain,nauseaflatulence,headache Proton pump inhibitors Page 152 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 9. R andom iz ed controlled trials ofgastriculcertreatm ent A ge,G ender,R ace, A uth or O th erPopulation N um berScreened/ Y ear C h aracter- Eligible/ Setting istics Interventions C ontrol Enrolled O utcom es R eported (R esults) F lorent1994 M eanage56 L ansopraz ole30m g 20m g of 126enrolled H ealing R ates by PP: F rance 64% m ale oncedaily om epraz ole 4 weeks:82% (l),68% (o) 49% sm okers 4to8weeks 8 weeks:93% (l),82% (o) PainR elief: Daytime:86% (l),60% (o) N octurnalpain: 100% (l),70% (o) Time to daytime painrelief: 6. After ranitidine) M aintenancestudy both gastric and healing: 58. R andom iz ed controlled trials ofgastriculcertreatm ent A uth or Y ear Setting N um berofA dverse Effects Q uality R ating F lorent1994 23adverseeventswerereported(8(l),15(o)). Them ostcom m onadverse Poor-openlabel,high drop-outrate, F rance eventwith L wasdiarrhea,andwasheadacheanddiarrheawith O. R andom iz ed controlled trials ofgastriculcertreatm ent A ge,G ender,R ace, A uth or O th erPopulation N um berScreened/ Y ear C h aracter- Eligible/ Setting istics Interventions C ontrol Enrolled O utcom es R eported (R esults) K ovacs M eanage58(pl),57 L ansopraz ole15or Placebooncedaily 52patientseligible, R ecurrence: 1999 (l15),58(l30) 30m g oncedaily forup forup to12 49enrolled m edian<2m onths(pl),> 12m onths(lgroups) U SA 85% m ale to12m onths(if m onths(if A t1 month :40% (pl),0% (l15),7% (l30) M ulticenter 67% sm okers recurrenceoccurred, recurrence 12 month s:0% (pl),17% (l15),7% (l30) (P<0. Proton pump inhibitors Page 155 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 9. R andom iz ed controlled trials ofgastriculcertreatm ent A uth or Y ear Setting N um berofA dverse Effects Q uality R ating K ovacs 39patientsreported1or> adverseeventsreported(13(pl),14(l15),12(l30), F air 1999 N S. Them ostcom m onadverseeventsthatwerepossibly orprobably related U SA tostudy drug werediarrhea(0%(pl),0% (l15),13. N oclinically significantlab changes,vitalsigns,orE CG seen. Proton pump inhibitors Page 156 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 9. R andom iz ed controlled trials ofgastriculcertreatm ent A ge,G ender,R ace, A uth or O th erPopulation N um berScreened/ Y ear C h aracter- Eligible/ Setting istics Interventions C ontrol Enrolled O utcom es R eported (R esults) CooperativeStudy M eanage:57(o),61 O m epraz ole40m g R anitidine150m g 46enrolled(21(o), H ealing (PP): 1990 (ran) oncedaily x 2to8 twicedaily x 2to8 25(ran)) 4 weeks:81% (o),58% (ran)(N S) U K 54% m ale weeks weeks 27enrolledin 8 weeks: 93% (o),87% (ran)(N S) M ulticenter 65% sm okers followup study (12 Painfree (baseline notreported) 74% alcoholusers (o),15(ran)) 2 weeks:53% (o),42% (ran)(N S) 4 weeks:73% (o),38% (ran)(N S) 8 weeks:50% (o),44% (ran) (N S) N ighttim epainat2weeks(o) <(r),datanotreported,(P<0. R andom iz ed controlled trials ofgastriculcertreatm ent A uth or Y ear Setting N um berofA dverse Effects Q uality R ating CooperativeStudy 1death judgedtobeunrelatedtostudy. U K M ulticenter Proton pump inhibitors Page 158 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 9. R andom iz ed controlled trials ofgastriculcertreatm ent A uth or Y ear Setting N um berofA dverse Effects Q uality R ating W alan 106patientsreportedadverseevents(34(o20),32(o40),40(ran)). Them ost G ood/F air 1989 com m onwereG I sy m ptom s,sim ilarinallgroups. N um berswithdrawnorlost Com m ent:Patientsenrolledin 13countries(prim arily tofollow up:21(o20),19(o40),22(ran) followup study notwelldescribed, E uropeanplus 3patientsdiedduring study (allon(o40)) of causesshowntobeunrelatedto attritionnotdescribed. Australiaand study drug,2patientswithdrawnduetoabnorm allabsalsoshowntobe Canada),45centers unrelatedtostudy drugs((1(o40),1(ran)). R ossini N onereportedineithergroup F air/poor 1989 Italy Singlecenter Proton pump inhibitors Page 160 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 9. R andom iz ed controlled trials ofgastriculcertreatm ent A ge,G ender,R ace, A uth or O th erPopulation N um berScreened/ Y ear C h aracter- Eligible/ Setting istics Interventions C ontrol Enrolled O utcom es R eported (R esults) Classen D atanotreported– O m epraz ole20m g R anitidine150m g 184enrolled H ealing (PP analysis only): 1985 statedtobesim ilar oncedaily x 4to6 twicedaily x 4to6 2 weeks:43% (o),45% (ran) (N S) G erm any weeks weeks 4 weeks:81% (o),80% (ran) (N S) M ulticenter 6 weeks:95% (o),90% (ran) N S Sym ptom s: "equally goodwith eitherdrug" Bardhan M eanages60(l60), L ansopraz ole30m g or R anitidine300m g 250enrolled H ealing rates: 1994 59(l30),57(r) 60m g onceaday x 4 every nightx 4to8 4 weeks: U nitedK ingdom and 57% m ales to8weeks weeks ofth ose with endoscopy: 78% (120),84% (160),61% (ran) Sweden 65% U K ITT: 72% (l30),73% (l60),52% (ran) M ulticenter 35% Sweden PP: 80% (l30),78% (l60) 57% (ran) 52% sm okers 8 weeks: 60% alcoholuse ofth ose w/endoscopy: 99% (l30),97% (l60),91% (ran) 11% N SAID use ITT: notreported PP: 98% (l30),100% (l60),90% (ran) Symptoms:proportionsy m ptom freeat4weeks: Pain:75% (l30),72% (l60),65% (ran) N ausea:88% (l30),89% (l60),76% (ran) Vomiting:100% (l30),87% (l60),89% (ran) Proton pump inhibitors Page 161 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 9. R andom iz ed controlled trials ofgastriculcertreatm ent A uth or Y ear Setting N um berofA dverse Effects Q uality R ating Classen N otreported Poor 1985 Com m ent:Thisappearstobea G erm any reportinE nglish of twotrials M ulticenter previously publishedinG erm an, thereforethequality of thetrialsm ay behigherthanappearsfrom this paper. Bardhan 69patientsex perienced91adverseevents,26% (l30),27% (l60),30% (ran). F air 1994 Them ostcom m onthoughtto bepossibly orprobably relatedtostudy drug U nitedK ingdom and werediarrheaandheadache. Sweden M ulticenter Proton pump inhibitors Page 162 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 9. R andom iz ed controlled trials ofgastriculcertreatm ent A ge,G ender,R ace, A uth or O th erPopulation N um berScreened/ Y ear C h aracter- Eligible/ Setting istics Interventions C ontrol Enrolled O utcom es R eported (R esults) M ichel M eanage52(l),56 L ansopraz ole30m g R anitidine150m g 158enrolled H ealing: 1994 (ran) oncedaily x 4to8 twicedaily x 4to8 4 weeks: F rance 69% m ale weeks weeks ITT 68% (l),56% (ran)N S M ulticenter 38% sm okers PP:80% (l),62% (ran)(p<0. R andom iz ed controlled trials ofgastriculcertreatm ent A uth or Y ear Setting N um berofA dverse Effects Q uality R ating M ichel 38patientsreportedadverseevents.

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R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or discount claritin 10 mg with visa,year O utcom e M easure R esults sleepefficiency (% )-nigh t19-21 best claritin 10 mg, Z olpidem:69 discount 10 mg claritin free shipping. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults stage 2 sleeplatency -nigh t19-21, Z olpidem:55. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults totalsleeptime (min)-nigh t19-21, Z olpidem:334. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults Sleepefficiency z olpidem nigh t2,placebo Z olpidem:88; nigh t3,z olpidem nigh t4,placebo nigh t5 Placebo:83; Z olpidem:87; Placebo:87; :; P-value=0. Placebo:35; Z olpidem:; Placebo:; :; P-value=N S Insomnia 120 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults W aso (mins)z olpidem nigh t2 placebo nigh t Z olpidem:40; 3,z olpidem nigh t4,placebo nigh t5 Placebo:60; Z olpidem:17; Placebo:43; :; P-value=0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=N S sleeplatency (min),with pill Z olpidem:38. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=N S wake aftersleeponset(min),with pill Z olpidem:32. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value= Sleepefficiency,nigh t1,2 adjusted meanof Z olpidem:0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value= Sleeplatency atweek 3,minutes (not R amelteon4 mg:64. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value= sleepefficiency (% ),week 6 Z olpidem 10mg:83. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value= sleepquality (1=excellent;4=poor), Z olpidem 10mg:2. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value (1 mgvs placebo;2 mgvs placebo)=N S;0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value (1 mgvs placebo;2 mgvs placebo)=N S;0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value (1 mgvs placebo;2 mgvs placebo)=N S;0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value= numberofawakenings (% ),ch ange from Z olpidem 10mg:-34; baseline,day 35,with drawal,rebound Z olpidem 20mg:-15; Placebo:-16; :; :; P-value= sleepduration(min),ch ange from baseline, Z olpidem 10mg:32; day 28 Z olpidem 20mg:27; Placebo:14; :; :; P-value= sleepduration(min),ch ange from baseline, Z olpidem 10mg:32; day 35,with drawal,rebound Z olpidem 20mg:28; Placebo:16; :; :; P-value= sleeplatency (min),ch ange from baseline, Z olpidem 10mg:38; day 28 Z olpidem 20mg:28; Placebo:23; :; :; P-value= sleeplatency (min),ch ange from baseline, Z olpidem 10mg:36; day 35,with drawal,rebound Z olpidem 20mg:21; Placebo:9; :; :; P-value= sleepquality (1=poor;4=good),ch ange from Z olpidem 10mg:-27; baseline,day 28 Z olpidem 20mg:-29; Placebo:-30; Insomnia 137 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value= sleepquality (1=poor;4=good),ch ange from Z olpidem 10mg:-29; baseline,day 35,with drawal,rebound Z olpidem 20mg:-14; Placebo:-14; :; :; P-value= totalwake time (min),ch ange from baseline, Z olpidem 10mg:-28; day 28 Z olpidem 20mg:-15; Placebo:-22; :; :; P-value= totalwake time (min),ch ange from baseline, Z olpidem 10mg:-27; day 35,with drawal,rebound Z olpidem 20mg:-11; Placebo:-14; :; :; P-value= Soares Increase inTotalSleepTime over4 weeks, Esz opiclone:56. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=N R W alsh 2007 A bility to concentrate-ch ange from baseline Esz opiclone:7. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults Placebo:327. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; :; P-value=<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleepefficiency (% ),rebound insomnia, Esz opiclone 2mg:-2. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults nigh t1,15,29 average Esz opiclone 3mg:33. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults P-value=N S vs placebo Sleepquallity atweek 1 R amelteon8mg:3. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults :; P-value= Insomnia 153 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 5. C h aracteristics ofactive controltrials ofnewerinsom niadrugs A uth or,year InclusionCriteria ExclusionCriteria Demograph ics Screened W ith drawn Study Interventions (Q uality) Eligible L ostto followup Duration Enrolled A nalyzed A gnoli,1989 Patientswere aged20-50 yearswith Presence ofconcomitantgeneralillness; M eanage (SD): N R/ 0/ 1 days Z opiclone; (Poor) totalscore ofth e H amiltonRatingScale renalorh epaticfailure;effectivenessof 38. O th er groupsexcludedwere pregnantwomen, nursingmoth ers,womenofch ildbearing potential,andnigh tsh iftworkers. C h aracteristics ofactive controltrials ofnewerinsom niadrugs A uth or,year InclusionCriteria ExclusionCriteria Demograph ics Screened W ith drawn Study Interventions (Q uality) Eligible L ostto followup Duration Enrolled A nalyzed A nsoms,1991 O nlyinsomniacpatientsinth eir Patientswith th e followingcriteriawere M eanage (SD): N R/ 0/ 5 days Z opiclone; (F air) postalcoh olism with drawalperiodofat excluded:th ose beingtreatedduringth e 43. Patientsh avingusedh igh dosesof h ypnoticsorwith ah istoryofdrugabuse before th e studyperiodwere also excluded,aswellasth ose suffering from myasth eniagravis,with any disease accompaniesbypain,livingin anunstable fluctuatingconditionwith mentalorph ysicalstress,orpatients with asevere liverorkidneydisturbance.

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