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Determinants of adherence to methylphenidate and the impact of poor adherence on maternal and family measures order genuine triamcinolone treatment for strep throat. Barbaresi WJ order triamcinolone 40 mg amex medications emt can administer, Katusic SK order 15mg triamcinolone fast delivery medications like gabapentin, Colligan RC, Weaver AL, Jacobsen SJ. Modifiers of long- term school outcomes for children with attention-deficit/hyperactivity disorder: does treatment with stimulant medication make a difference? Attention deficit hyperactivity disorder 129 of 200 Final Update 4 Report Drug Effectiveness Review Project 89. Effects of amphetamine therapy and prescriptive tutoring on the behavior and achievement of lower class hyperactive children. The effects of a multimodal intervention with attention-deficit hyperactivity disorder children: a 9-month follow-up. Journal of the American Academy of Child & Adolescent Psychiatry. Kupietz SS, Winsberg BG, Richardson E, Maitinsky S, et al. Effects of methylphenidate dosage in hyperactive reading-disabled children: I. Journal of the American Academy of Child & Adolescent Psychiatry. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Vicissitudes of follow-up studies: differential effects of parent training and stimulant medication with hyperactives. Pharmacotherapy in ADD adolescents with special attention to multimodality treatments. National Institute of Mental Health Multimodal Treatment Study of ADHD follow-up: 24-month outcomes of treatment strategies for attention- deficit/hyperactivity disorder. Journal of the American Academy of Child & Adolescent Psychiatry. MTA at 8 years: Prospective follow-up of children treated for combined-type ADHD in a multisite study. Brown RT, Borden KA, Wynne ME, Schleser R, Clingerman SR. Methylphenidate and cognitive therapy with ADD children: a methodological reconsideration. A double-blind, placebo-controlled withdrawal trial of dexmethylphenidate hydrochloride in children with attention deficit hyperactivity disorder. A continuous long- term placebo-controlled follow-up. Do the beneficial effects of extended methylphenidate treatment in boys with attention-deficit hyperactivity disorder dissipate rapidly during placebo treatment? Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD. Journal of the American Academy of Child & Adolescent Psychiatry. A comparison of morning-only and morning/late afternoon Adderall to morning-only, twice-daily, and three times-daily Attention deficit hyperactivity disorder 130 of 200 Final Update 4 Report Drug Effectiveness Review Project methylphenidate in children with attention-deficit/hyperactivity disorder. A comparison of Ritalin and Adderall: efficacy and time-course in children with attention-deficit/hyperactivity disorder. Chronis AM, Pelham WE, Gnagy EM, Roberts JE, Aronoff HR. The impact of late- afternoon stimulant dosing for children with ADHD on parent and parent-child domains. A double-blind, placebo-controlled study of Adderall and methylphenidate in the treatment of attention-deficit/hyperactivity disorder. Journal of the American Academy of Child & Adolescent Psychiatry. Challenges to determining adolescent medication response in an outpatient clinical setting: Comparing Adderall and methylphenidate for ADHD. Differential effectiveness of methylphenidate and Adderall in school-age youths with attention-deficit/hyperactivity disorder. Journal of the American Academy of Child & Adolescent Psychiatry. Double-blind, placebo-controlled study of single-dose amphetamine formulations in ADHD. Journal of the American Academy of Child & Adolescent Psychiatry. A double-blind, placebo-controlled trial of dexmethylphenidate hydrochloride and d,l-threo-methylphenidate hydrochloride in children with attention-deficit/hyperactivity disorder. Journal of the American Academy of Child and Adolescent Psychiatry. The effect of a stimulant drug (methamphetamine) on cognitive impulsivity, planning, new learning, and social behavior in hyperactive children [School-age], Hall, Peter H. A randomized, double-blind, placebo- controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. Efficacy of a methylphenidate transdermal system versus t. Varying the wear time of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder. Journal of the American Academy of Child & Adolescent Psychiatry. McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. Wilens TE, Hammerness P, Martelon M, Brodziak K, Utzinger L, Wong P. A controlled trial of the methylphenidate transdermal system on before-school functioning in children with attention-deficit/hyperactivity disorder. Attention deficit hyperactivity disorder 131 of 200 Final Update 4 Report Drug Effectiveness Review Project 117. Biederman J, Boellner S, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine Dimesylate and Mixed Amphetamine Salts Extended Release in Children with ADHD: A Double-Blind Placebo Controlled, Crossover, Analog, Classroom Study. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study.

L imitationofactivities ofdaily living notreported 10 days oruntil 118 acute musculoskeletalstrain *A llrecorded using5-pointratingscale patientbecame 2 post-traumaticorigin (1=absentto 5=severe) asymptomatic M oderate-severe spasticity A ssessment#1 completed 2-3 h ours post-first Previous muscle relaxantuse not dose oftestdrug;#2 with indays 2-4;#3 with in reported days 5-7;#4 with indays 8-12 Basmajian R andomiz ed A : C yclobenz aprine A cute 205 enrolled A ge purchase triamcinolone 10mg with amex symptoms and diagnosis,gender discount 40 mg triamcinolone with visa symptoms definition,race notreported Pain discount triamcinolone 15mg with visa medicine ketoconazole cream,spasm,tenderness,range ofmotion, 144 5 mgbid musculoskeletal forallarms activities ofdaily living: meth ods ofassessment 1989 C anada painwith C linicalconditions notreported notreported B: Placebo associated spasm 175 analyz ed 18 centers ofth e neck orlow (Diflunisaland back 88 in C yclobenz aprine + cyclobenz aprin diflunisalarms e orplacebo excluded) arms 7-10 days Skeletal Muscle Relaxants Page 187 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 6. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events Baratta F A IR. Placebo W ith drawal(due to adverse events): 0 142 concealmentmeth od not 1982 reported. M uscle spasm meandecrease (meanscore difference) A ny adverse event: 25/58(43% )vs. Skeletal Muscle Relaxants Page 188 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 6. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events Bennett F A IR. Tenderpointanalysis: significantreductioninnumberand severity oftender points atweek 2 and 4 (A >B;p<0. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent Berry R andomiz ed A : Tiz anidine,4 mg Patients with low 105 Tiz anidine vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events Berry PO O R. R estrictionofmovement: no significantdifferences betweengroups G astro-intestinal: A =3(6% ),B=11(20% ); Sciatica (marked improvement): A >B (p=0. H elpfulness oftablets: no significantbetweengroupdifferences 5/53(9% );p=0. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent Bianch i R andomiz ed A : C yclobenz aprine A tleast 48 C yclobenz aprine vs. B: C yclobenz aprine moderate or F emale gender: 57% vs. Patientrated relieffrom startingbackach e: 0 M ulticenter severe painful 14% (no relief)to 4 (complete relief)scale C : Placebo muscle spasm of Ph ysicianratingofmuscle spasm: 0 (no th e lumbarand/or Baseline severity and duration: N ot h ardness)to 4 (severe,boardlike h ardness) 7 days cervicalregion reported L umbarpain: 66% vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events Bianch i F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent Borenstein R andomiz ed A : C yclobenz aprine O utpatients >18 668 C yclobenz aprine 2. B: C yclobenz aprine moderate or F emale gender: 60% vs. Patientrated relieffrom startingbackach e: 0 M ulticenter severe painful 10% (no relief)to 4 (complete relief)scale C : Placebo muscle spasm of Ph ysicianratingofmuscle spasm: 0 (no th e lumbarand/or Baseline severity and duration: N ot h ardness)to 4 (severe,boardlike h ardness) 7 days cervicalregion reported L umbarpain: 55% vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events Borenstein F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent Borenstein R andomiz ed A =N aprosyn;500 Patients with mild- 40 N aprosynvs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events Borenstein PO O R. F unctionalC apacity (cumulative score forintervention): 15 vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent C arette R andomiz ed A : A mitriptyline 18 years ofage or 208 A mitriptypline vs. Visualanalogassessments: Pain(0=none; 149 10mg/day week 1, older; placebo 10=severe);F atigue(0=none;10=severe 1994 C anada 25 mg/day weeks 2- A mericanC ollege 186 fatigue);Sleep(0=no difficulty;10=extreme 12,50 mg/day for ofR h eumatology M eanage (years): 44. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events C arette F A IR. Visualanalogscale scores: Significantimprovementforeach variable (no data 11/78 vs. N o oth erinformationprovided 1988 allocationconcealment,and Painbeh avior(improvement):90% at3 days and 100% at4 days vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent C ullen R andomiz ed A : C arisoprodol Patients with 65 C arisoprodolvs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events C ullen F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent Dent R andomiz ed A : M etaxalone 400 A cute painful 228 M etaxalone vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events Dent PO O R. Skeletal Muscle Relaxants Page 204 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 6. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent F ath ie (2) R andomiz ed A : M etaxalone 800 L ow back pain 100 Demograph ics and baseline severity G lobalth erapeuticresponse: 4 pointscale 44 mgqid and discomfort notreported (none to marked) 1964 U. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events F ath ie (2) F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent H amaty R andomiz ed A : C yclobenz aprine Patients with 11 M eanage (years): 49 Pain: 0-100 VA S 58 crossover 10-40 mg/day fibromyalgis forat G ender:91% female U nrefresh ed sleep: 0-15 VA S 1989 least3 month s 11 R ace notreported U nited States B: Placebo and welldefined Bioch emicalmeasures (notreported h ere) tenderpoints, Durationofsymptoms notreported Single center 5 month s h istory ofsleep problems,and normallabtests H indle R andomiz ed A : carisoprodol350 L ow back pain, 48 C arisoprodolvs. Pain: 4-pointscale (1=none;4=severe) 140 mgTID nototh erwise placebo Spasm: 4-pointscale (1=none;4=severe) 1972 U nited States reported 43 G ender(overall): 44% female Interference with daily activities: 4-pointscale B: butabarbital15 M eanage (years):37 vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events H amaty F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent L ance R andomiz ed A : C h ronictension 20 A ge range: 19-66 H eadach e severity: rated on3-pointscale 150 crossover C yclobenz aprine,30-h eadach e,not F emale center: 60% ("virtually h eadach e free","conditionmore th an 1972 60 mg/day oth erwise 20 R ace: notreported 50% improved","conditionunch anged") A ustralia reported B: Placebo Illness durationrange: mean8 years Single center H eadach e ch aracteristics: 19/20(95% ) O ne month bilateral;13/20(65% )bifrontal; 2/20(10% )bitemporal;1/20(5% ) occipital;3/20(15% )"alloverth e h ead" L atta R andomiz ed A : O rph enadrine Elderly patients in 59 M eanage (years):64 N umberofnocturnallegcramps ina 1 month 154 crossovertrial 100 mgqh s care facilities with F emale gender: 35/59 period 1989 painfulnocturnal 59 R ace: N otreported U. B: Placebo legcramps Baseline severity ofnocturnalleg Single center 1 month cramps: N otreported intervention,1 month crossover Previous muscle relaxantuse: N ot reported Skeletal Muscle Relaxants Page 209 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 6. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events L ance PO O R. W ith drawals (adverse events): N one reported Skeletal Muscle Relaxants Page 210 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 6. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent L episto R andomiz ed A : Tiz anidine 2 Betweenage 18 30 Tiz anidine vs. A ssessments were made usinga 4-pointscale 155 paracetamol,doses patients;aged 18- paracetamol ofseverity,rangingfrom normality to severe 1983 England notreported 70;sufferingfrom 28 F emale gender:64% vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events L episto F A IR. R andomiz ation, Paininth e back: no significantgroupdifferences Tiz anidine vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions Interventions Enrolled A uth or Type ofStudy,Dose Eligibility M eth od ofO utcom e A ssessm entand Tim ing Y ear Setting Duration C riteria A nalyz ed PopulationC h aracteristics ofA ssessm ent M urros R andomiz ed A : Tiz anidine M enand women, 201 Tiz anidine 6 mgvs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with m usculoskeletalconditions A uth or O verallR ating and Y ear com m ents O utcom es A dverse Events M urros F A IR. R andomiz ation, VA S: no significantgroupdifferences W ith drawals (due to adverse events): 14,group 164 allocationconcealment, Days free ofh eadach e: no significantgroupdifferences notspecified 2000 blindingtech niques not Daily durationofh eadach e: no significantgroupdifferences W ith drawals (overall): 25,groupnotspecified described. U se ofparacetamol: no significantgroupdifferences F requentadverse events Tiredness: *A +B=21(17% )vs. R andomiz ationand F atigue: no significantgroupdifferences C yclobenz aprine vs.

Disease-modifying drugs for multiple sclerosis Page 69 of 120 Final Report Update 1 Drug Effectiveness Review Project Table 33 buy triamcinolone once a day symptoms breast cancer. Adverse events: Glatiramer acetate compared with interferons in relapsing-remitting multiple sclerosis Interferon beta-1b SC Interferon beta-1a ® (Betaseron ) SC Glatiramer acetate 59 ® 58 ® 58 proven triamcinolone 40mg treatment lupus, 59 Adverse event 250µg or 500µg (Rebif ) 44 µg (Copaxone ) 6% (BEYOND) purchase 15 mg triamcinolone overnight delivery symptoms quivering lips, P<0. An additional 6 publications in relapsing-remitting multiple sclerosis provided data on 165-170 the long-term safety of glatiramer acetate use. Miller et al provided the longest safety data with up to 22 years of follow-up. In 1978 a placebo-controlled randomized pilot study was 170 initiated for patients with relapsing-remitting multiple sclerosis. Patients enrolled in this trial were allowed to participate in an open-label, compassionate-use trial of glatiramer acetate SC 20 mg daily in 1986. Adverse events were reported monthly using a self-evaluation form. Forty-six patients were included in the long-term safety analysis with the duration of therapy ranging from 0. The most common adverse event was injection site reactions. Additionally, 33% of the 18 planning to continue glatiramer acetate beyond the October 2004 study close date had reported lipoatrophy. These patients had been on the study drug the longest of the cohort. Disease-modifying drugs for multiple sclerosis Page 70 of 120 Final Report Update 1 Drug Effectiveness Review Project 166-168 Results of this study have been reported at 6, 8, and 10 years following randomization. Of 232 who received at least 1 dose of glatiramer acetate, 108 (47%) were still enrolled at the 10- year follow-up. In this study, adverse events accounted for the greatest number of withdrawals (87/124; 70%), however, patients stayed on the drug for an extended period of time with a Kaplan-Meier estimate of median time from initiation of therapy with glatiramer acetate to withdrawal of 9. No serious adverse events were reported over the course of follow-up. Injection-site reactions and post-injection systemic reactions were the most commonly reported 168 adverse events, although incidence of both appeared to dissipate with long-term use. These data should be interpreted as representing a highly selected population of patients tolerant to and receiving benefit from glatiramer acetate. An open-label trial compared the effects of glatiramer acetate in relapsing-remitting ® multiple sclerosis patients who were prior users of interferon beta-1b SC (Betaseron ) compared 165 with treatment-naive patients. Reported adverse events (most commonly injection-site reactions) and rates were similar between the 2 groups and to those reported in the placebo-controlled trials. For both groups in this study, withdrawal rates due to adverse events were significantly higher when compared with the placebo-controlled trials (10. The reason for this difference may be due to study design. The open-label trial enrolled patients based on compassionate-use and used very few exclusion criteria, while the placebo-controlled trials were more restrictive in enrolling patients. Another open-label observational study conducted in France between 1997 and 2002, when glatiramer acetate was restricted to patients with relapsing-remitting multiple sclerosis that had contraindications or intolerance to beta interferons, also found that the drug was well 169 tolerated. While these data appeared to support the superiority of glatiramer acetate in tolerability over interferon, the fact that no difference was found in the direct comparison studies raises the concern that potentially important differences among the population treated with glatiramer acetate compared with the others may have contributed to these results. Further good-quality direct comparison studies are needed to confirm the findings. The glatiramer acetate group experienced significantly more injection site reactions than the placebo group: soreness 83% compared with 47%, itchiness 61% compared with 17%, swelling 80% compared with 47%, and redness 85% compared with 30%; P=0. Significantly more patients taking glatiramer acetate reported vasomotor symptoms (flushing, palpitations, muscle tightness, difficulty breathing, and anxiety) transiently during treatment (24% compared with 5. No differences were seen between the groups in reporting of other adverse events. Withdrawals due to adverse events were not discussed in detail. A study by Tremlett and Oger reviewed the adverse drug reactions reported to the Canadian Adverse Drug Reaction Monitoring Program between 1995 and March 2006. A total of ® 171 888 reports were extracted concerning the interferons and glatiramer acetate (Copaxone ). The average age of the patients was 45 years, with 74% being female. There were 49 deaths with no clear pattern to the underlying reasons. Tolerability Two observational studies in patients with relapsing-remitting multiple sclerosis evaluated tolerability. One found no difference in discontinuation rate at 6 months but less discontinuation ® 62 of glatiramer acetate (Copaxone ) at 24 months compared with all 3 of the interferons. A Brazilian observational study also found a lower discontinuation rate with glatiramer acetate over 172 the beta interferons. This study followed patients with relapsing-remitting multiple sclerosis and analyzed those who had continuous use of at least 1 of the beta interferons or glatiramer 172 acetate for 3-5 years (N=152), comparing the rates and reasons for discontinuation. They found 32% discontinued the drug with a mean time to discontinuation of 2. Interferon ® beta-1a (Rebif ) had the greatest discontinuation rate but it took the longest time to do so. Only 1 patient discontinued glatiramer acetate but did so within the shortest amount of time (interferon ® ® beta-1a [Rebif ] 50%, 2. The main reason for discontinuation was lack of efficacy. There was little additional evidence regarding the comparative safety of interferons and glatiramer acetate based on data from observational and other non-randomized studies (Table 144, 173-175 34). While the types of adverse events reported in these studies and the rates of withdrawals due to adverse events were similar to those reported in controlled trials of these drugs, rates of other adverse events varied widely. These discrepant rates may have been the result of study design, as higher rates of flu-like syndrome, injection-site reactions, and fever were found in the trials, regardless of intervention. Tolerability outcomes of beta interferons compared with glatiramer acetate: trials compared with non-randomized studies Flu-like Injection-site Withdrawals due Intervention syndrome reaction Fever to AEs Non- Non- Non- Non- Trials RCTs Trials RCTs Trials RCTs Trials RCTs Interferon β-1a IM ® 62% 35% 9% 8% 20% 12% 4% 2% (Avonex ) Interferon β-1a SC ® 29% 6% 61% 6% 5% 3% 6% 8% (Rebif ) Interferon β-1b SC ® 42% 15% 59% 24% 33% 17% 8% 5% (Betaseron ) Glatiramer a 3% 0. Disease-modifying drugs for multiple sclerosis Page 72 of 120 Final Report Update 1 Drug Effectiveness Review Project Depression 176 A small (N=163) cohort study by Patten, et al used a Canadian reimbursement database to assess the incidence of depression in relapsing-remitting multiple sclerosis patients receiving any ® beta interferon (n=66) compared with glatiramer acetate (Copaxone ) (n=97). Specifically, the beta interferon-treated patients had slightly higher Expanded Disability Status Scale and depression scores and slightly lower quality of life scores at baseline. In addition, depression was common among multiple sclerosis patients, both at baseline (28. While glatiramer acetate-treated patients tended to have lower depression scores, there was no significant difference in depression score at 3-month follow-up between beta interferons and glatiramer acetate (40.

A 14-week cheap 10 mg triamcinolone mastercard 6 mp treatment, Randomized trusted triamcinolone 4mg treatment restless leg syndrome, Double-Blinded triamcinolone 4mg low cost treatment vaginitis, Placebo-Controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia. A randomized double blind placebo controlled phase III trial of pregabalin in the treatment of patients with fibromyalgia. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): A 6-month, double-blind, placebo- controlled trial with pregabalin Pain. Antiepileptic drugs Page 62 of 117 Final Report Update 2 Drug Effectiveness Review Project 109. Millan-Guerrero RO, Isais-Millan R, Barreto-Vizcaino S, et al. Subcutaneous histamine versus sodium valproate in migraine prophylaxis: a randomized, controlled, double-blind study. A comparative trial of prinodolol, clonidine and carbamazepine in the interval therapy of migraine. Efficacy of topiramate and valproate in chronic migraine. Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo- controlled trial. Low-dose topiramate versus lamotrigine in migraine prophylaxis (the Lotolamp study). Topiramate and triptans revert chronic migraine with medication overuse to episodic migraine. Efficacy and tolerability of topiramate 200 mg/d in the prevention of migraine with/without aura in adults: a randomized, placebo- controlled, double-blind, 12-week pilot study. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Silvestrini M, Bartolini M, Coccia M, Baruffaldi R, Taffi R, Provinciali L. Oxcarbazepine in migraine headache: a double-blind, randomized, placebo-controlled study. Shaygannejad V, Janghorbani M, Ghorbani A, Ashtary F, Zakizade N, Nasr V. Comparison of the effect of topiramate and sodium valproate in migraine prevention: a randomized blinded crossover study. Silberstein SD, Loder E, Forde G, Papadopoulos G, Fairclough D, Greenberg S. The impact of migraine on daily activities: effect of topiramate compared with placebo. Topiramate in migraine prophylaxis: a randomised double-blind versus placebo study. Brandes JL, Kudrow DB, Rothrock JF, Rupnow MFT, Fairclough DL, Greenberg SJ. Assessing the ability of topiramate to improve the daily activities of patients with migraine. Analgesic action of gabapentin on chronic pain in the masticatory muscles: a randomized controlled trial. Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study. Tiagabine and gabapentin for the management of chronic pain. Antiepileptic drugs Page 63 of 117 Final Report Update 2 Drug Effectiveness Review Project 126. Chou R, Huffman LH, American Pain S, American College of P. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Safety and tolerability of emerging pharmacological treatments for bipolar disorder. Newer anticonvulsants: comparative review of drug interactions and adverse effects. Goodwin FK, Fireman B, Simon GE, Hunkeler EM, Lee J, Revicki D. Suicide risk in bipolar disorder during treatment with lithium and divalproex. Fracture risk associated with use of antiepileptic drugs. Souverein PC, Webb DJ, Weil JG, Van Staa TP, Egberts ACG. Use of antiepileptic drugs and risk of fractures: case-control study among patients with epilepsy. Risk estimates for drugs suspected of being associated with Stevens-Johnson syndrome and toxic epidermal necrolysis: a case- control study. Rzany B, Correia O, Kelly J, Naldi L, Auquier A, Stern R. Risk of Stevens-Johnson syndrome and toxic epidermal necrolysis during first weeks of antiepileptic therapy: a case-control study. Study Group of the International Case Control Study on Severe Cutaneous Adverse Reactions. Risk of aplastic anemia in patients using antiepileptic drugs. Artama M, Auvinen A, Raudaskoski T, Isojarvi I, Isojarvi J. Antiepileptic drug use of women with epilepsy and congenital malformations in offspring. Artama M, Ritvanen A, Gissler M, Isojarvi J, Auvinen A. Congenital structural anomalies in offspring of women with epilepsy--a population-based cohort study in Finland. Cunnington M, Ferber S, Quartey G, International Lamotrigine Pregnancy Registry Scientific Advisory C. Effect of dose on the frequency of major birth defects following fetal exposure to lamotrigine monotherapy in an international observational study. Cunnington M, Tennis P, International Lamotrigine Pregnancy Registry Scientific Advisory C. Lamotrigine and the risk of malformations in pregnancy. Levetiracetam in pregnancy: preliminary experience from the UK Epilepsy and Pregnancy Register. In utero antiepileptic drug exposure: fetal death and malformations.