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R. Fabio. Colby-Sawyer College.

Almost half of the microthrombosis on biopsy buy aricept 5 mg free shipping, and alternate diagnoses for the throm- botic findings generic aricept 5 mg overnight delivery. Preliminary criteria for the classification of CAPS Although APS and CAPS share similar features discount aricept 10mg, the CAPS registry Criteria has highlighted unique aspects to the latter condition buy generic aricept 10 mg line. Evidence of involvement of 3 or more organs generic 10mg aricept free shipping, systems and/or patients with CAPS, a precipitating factor can be identified, with tissues* infection and surgery being the most common. Development of manifestations simultaneously or in 1 week manifestations of CAPS differ in their distribution compared with 3. Confirmation by histopathology of small vessel occlusion in at least patients with APS. In contrast to APS, in which involvement of the 1 organ or tissue† deep veins of the extremities and pulmonary embolism predomi- 4. Laboratory confirmation of the presence of aPL antibodies‡ nate, patients with CAPS manifest with small vessel occlusion and Classification criteria most commonly present with abdominal pain and intraabdominal Definite CAPS All 4 criteria present thrombosis (kidneys, adrenal glands, spleen, pancreas, and mesen- Probable CAPS tery). The multiorgan involvement of CAPS typically manifests All 4 criteria but with involvement of only 2 organs, systems, and/or with renal failure (present in 71% of patients), respiratory failure tissues (64%), and central nervous system involvement (62%). Another All 4 criteria but with the absence of repeat detection of aPLs at important feature of CAPS is the systemic inflammatory response least 12 weeks apart due to the early death of a patient who syndrome, which is triggered in response to the tissue necrosis from had never been tested for aPLs before the CAPS event underlying small vessel occlusion. The treatment of CAPS is Criteria 1, 2, and 4 therefore based on addressing thrombosis as well as the inflamma- Criteria 1, 3, and 4 and the development of a third event after more tory response. Renal In contrast to the original Sapporo Criteria, the Sydney Criteria involvement defined by 50% rise in serum creatinine, severe systemic hypertension ( 180/100mmHg),and/orproteinuria( 500mg/24h). An understanding of the antigenic target of pathologic aPLs thrombosis or pregnancy morbidity, with ORs for thrombosis may explain these laboratory findings. There 194 patients with persistent LA and/or aCL, the highest incidence of appear to be 2 types of aCL: anti- 2GPI–dependent aCLs, which are thrombosis was found in patients with persistent LA who were also associated with thrombosis and pregnancy complications, and positive for anti- 2GPI and anti-prothrombin antibodies measured anti- GPI–independent aCL antibodies, which appear to be associ- at 8. The latter antibodies are generally transient whether aPL profiles will affect APS classification and influence and are not associated with thrombosis. Similarly, autoantibodies against 2GPI were risk have not been specifically studied in patients with CAPS or in subsequently identified to have LA activity. Patients with SLE have an increased risk of thrombosis compared with the general population, and those who also have The laboratory assays measuring LA, aCLs, and anti- 2GPI antibod- 30 isolated but persistently positive aPL appear to be at further risk. Assays for LA appear to detect the pathologic aPLs Antithrombotic treatment of APS better than aCL or anti- GPI assays. However, the optimal 2 2 Antibodies that bind domain I of GPI appear to correlate with antithrombotic agent, intensity of anticoagulation, and duration of 2 thrombosis and pregnancy complications compared with antibodies treatment remain controversial, particularly for nonvenous throm- that bind other domains. Further complicating treatment in patients with APS is appear to result in triple positivity in the laboratory assays, the balance between thrombosis and hemorrhage, because many of identifying patients who are at highest risk of thrombotic complica- these patients have thrombocytopenia, coagulopathy, and other comorbidities that contribute to increased bleeding risks. Other factors that predict thrombosis appear to be persistence of aPLs and a high aPL titer, which resulted in the inclusion of these criteria in the Sydney Criteria. Similarly, there appears to be no There have been 2 randomized trials comparing standard-intensity association between thrombosis or pregnancy loss in patients only 24 (INR 2. In contrast, LA appears to be more 34,35 17 patients with APS meeting the current criteria. The majority of strongly associated with thrombosis and pregnancy complications, the patients in these studies had a first episode venous thrombosis, although there are conflicting data that suggest isolated LA may not 22,25 and the study results have since been interpreted as being applicable be associated with elevated thrombotic risk. The ELISA assays to this specific subset of patients with APS. These studies found no for aCLs and anti- 2GPI have been plagued by poor standardization 26 difference in the rates of recurrent thrombosis or major bleeding, and unreliable results. In contrast, assays for LA have better supporting the use of standard-intensity anticoagulation. Further, patients whose initial event occurred been specifically studied in these patients to date. Although anticoagulation is the mainstay of APS treatment, non- anticoagulant treatments have been evaluated. In patients with SLE, Patients with aPLs and arterial thromboembolism hydroxychloroquine has been shown to reduce the risk of an initial Recurrent arterial thrombosis appears to be more common than thrombotic event in patients with or without aPL40 and is frequently venous recurrence in patients with APS. The Warfarin versus The use of hydroxychloroquine in patients without SLE is uncertain, Aspirin Recurrent Stroke Study (WARSS) compared warfarin although hydroxychloroquine has been shown to protect the annexin (target INR 1.

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We distinguish between efficacy (explanatory) studies and effectiveness (pragmatic) studies by using a validated tool proposed by the Research Triangle Institute- 25 International-University of North Carolina Evidence-based Practice Center 10mg aricept fast delivery. Studies conducted in community-based settings that use less stringent eligibility criteria (i purchase 5mg aricept visa. Studies conducted in more highly selected populations over shorter periods of time are characterized as efficacy studies purchase 10mg aricept with amex. We summarize the results of efficacy and effectiveness studies separately as the results of effectiveness studies are more generalizable than results from highly selected populations (i generic 5mg aricept visa. However cheap aricept 5mg otc, effectiveness studies may have lower internal validity because of a higher risk of bias. For assessing efficacy, effectiveness, and safety our review includes methodologically valid controlled clinical trials, placebo-controlled trials, fair- or good-quality systematic reviews, and fair- or good-quality observational studies. Table 4 summarizes outcome measures and study eligibility criteria. Outcome measures and study eligibility criteria Outcome Outcome measures Study eligibility criteria • Outpatient study population • Health outcomes: o Quality of Life • Head-to-head randomized controlled clinical o Functional capacity trials or meta-analyses comparing one TIM to o Pain another o Reduction in the number of o Good or fair quality swollen or tender joints o >12 weeks study duration o Response o Remission • When sufficient evidence was not available for o Reduction of affected body head-to-head comparisons we evaluated Efficacy / placebo-controlled trials Effectiveness surface area o Hospitalizations o Good or fair quality o Mortality o >12 weeks study duration o Steroid withdrawal • Head-to-head observational studies were reviewed for quality of life, functional capacity, • If no studies with health outcomes hospitalizations and mortality - outcome were available, we included measures rarely assessed in controlled trials intermediate outcomes: o Good or fair quality o Radiological outcomes o > 12 weeks study duration o N > 100 • Head-to-head randomized controlled clinical trials or meta-analyses comparing one TIM drug to another o Good or fair quality o > 12 weeks study duration • Overall adverse events • When sufficient evidence was not available for • Withdrawals because of adverse head-to-head comparisons we evaluated events placebo-controlled trials • Serious adverse events o Good or fair quality Safety/ o > 12 weeks study duration Tolerability • Specific adverse events, including: o Serious infectious diseases • Head-to-head observational studies were o Lymphoma reviewed for harms o CHF o Good or fair quality o Autoimmunity o > 12 weeks study duration o N ≥ 100 • Observational studies o Good or fair quality o > 6 months study duration o N > 1000 Abbreviations: CHF, congestive heart failure; TIM, targeted immune modulator. Targeted immune modulators 21 of 195 Final Update 3 Report Drug Effectiveness Review Project As equipotency among the reviewed biologics is not well established, we assume that comparisons made within the recommended dosing range are appropriate (Table 2). Dose comparisons made outside the recommended daily dosing range are acknowledged in our report, but we do not use them to determine the quality of the evidence. The primary focus of this review is health outcomes (see Table 4). For head-to-head studies, however, we also include radiographic outcomes. Many clinicians view radiographic changes as important parameters of treatment success or failure. To date, however, the exact relationship between radiographic progression and incapacitating joint destruction remains unclear. Several instruments for scoring radiological changes exist, using plain radiographs of hands and feet. The most widely used methods are the modified Sharp and the Larsen scores. Both methods determine joint damage and the progression of radiological damage on continuous scales. Currently, no consensus exists on how much progression constitutes a clinically important progression that would have an effect on health outcomes. A re-analysis of published data of 185 patients with early rheumatoid arthritis assessed changes on the modified Sharp score and their association with functional disability (Health 26 Assessment Questionnaire Disability Index). Results indicated that the relation between Sharp score and Health Assessment Questionnaire Disability Index was dependent on the amount of damage (suggesting a threshold effect) and on patients’ age. With lower age, no effect of radiographic joint damage on functional capacity could be demonstrated. Overall a progression of 6 points on the Sharp score was associated with an increase of 0. An international expert panel assessed the minimal clinically important difference in joint damage (from a clinician’s perspective). They used hand and foot radiographs to correlate their findings with the smallest detectable difference on the Sharp/van der Heijde and the Larson/Scott 29 methods. Results suggested that the smallest detectable difference on the Sharp/van der Heijde score reflected a minimal clinically important difference, while the Larson/Scott method was too insensitive to determine relevant changes. This study, however, did not take minimal important differences from a patient perspective into consideration. METHODS Literature Search To identify articles relevant to each key question, for Update 3 we searched PubMed, EMBASE, CINAHL, Centre for Reviews and Dissemination, The Cochrane Library, and International Pharmaceutical Abstracts from 2009 (January) to 2011 (October) using included drugs (abatacept, adalimumab, alefacept, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, natalizumab, rituximab, tocilizumab, and ustekinumab), indications (rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis), and study designs as search terms (see Appendix B for complete search strategies). We attempted to identify additional studies through hand searches of reference lists of included studies and reviews. In addition, we searched the US Food and Drug Administration Center for Drug Evaluation and Research website for medical and statistical Targeted immune modulators 22 of 195 Final Update 3 Report Drug Effectiveness Review Project reviews of individual drug products. Finally, we requested dossiers of published and unpublished information from the relevant pharmaceutical companies for this review. All received dossiers were screened for studies or data not found through other searches. All citations were imported into an electronic database (Endnote X4, Thomson Reuters).

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What percentage of infected hosts recover and survive? What is the rateofdeathamongsurviving hosts (population memory decay) relative to the rate at which naive buy aricept 10mg cheap, newborn hosts enter the population? Again cheap aricept 10mg line, these interacting quantitative factors can be combined into a mathematical model generic aricept 10mg online. A model would suggest what conditions must be met for archival antigenic variation to be an effective strategy to avoid host immune memory aricept 5 mg with mastercard. Various processes tend to promote or destroy coexis- tence order aricept 5 mg fast delivery. PARASITE ESCAPE WITHIN HOSTS 103 R R R + – + – x y x y x y + + – + – + I x I y I x I y I x I y (a) (b) (c) Figure 7. Effectsovermorethan one step are obtained by multiplying the signs along the paths. For example, an increase in y has a negative effect on R,whichinturnhas a positive effect on x,whichhas apositive effect on Ix. Thus, an increase in y depresses Ix becausetheproduct of the two positive arrows and one negative arrow is negative. A change in y has an additional, indirect effect on Ix via its pathway to Iy. Thepath to Iy from y is positive, and the return path to y is negative, yielding a net negative effect. Continuing on from y to Ix produces another negativecomponent, so the product of the entire indirect pathway is positive. PREDATOR-PREY FEEDBACK WITH SPECIFIC IMMUNE CELLS Consider two variants, x and y,eachvariant attacked by specific im- munity, Ix and Iy. Inthesimplest case of persistence, each matching pair fluctuates independently. Thus, as x increases, Ix rises and causes x to decline. A decline in x lowers stimulation and causes Ix to fall, which allows x to rise, and so on. A similar cycle happens with the predatory immune type, Iy,preyingontheantigenic type, y. RESOURCE COMPETITION It could be that the two cycles progress independently, with coexis- tence of the antigenic types. Or there can be various forms of coupling between the cycles. For example, the parasite types x and y may com- pete for a host resource, R,suchashostcells to infect or the uptake of alimiting nutrient (Smith and Holt 1996). Direct competition between the parasite variants creates indirect in- teractions between the specific immune types. Adrop in R depresses x,which in turn lowers stimulation to Ix. Overall, if we ignore all feedbacks, an increase in y enhances Iy,anddepresses x and Ix. Feedbacks occur, and their consequences must be followed. Analysis requires mathemat- ical models (Nowak and May 2000). For this particular example, it turns out that resource competition by itself typically reduces the potential for coexistence of antigenic variants compared with the case in which no competition occurs. If Iy drives y to extinction in the absence of competition, then additional competition for resources will usually not save y. Rather,thecom petition from x further decreases y’s chances for survival. Several studies suggest that resource competition between parasites may sometimes influence the within-host dynamics of infection.

Overview of head-to-head trials of skeletal muscle relaxants for spasticity Tizanidine Newman Multiple Spasticity: Ashworth scale No significant 11% (4/36) titrated to 16 76 sclerosis (32) or Functional status: Kurtzke and differences 1982 mg/day syringomyelia Pedersen scales between 17% (6/36) FAIR (4) interventions Baclofen titrated (Ashworth scale to 40 mg/day 36 scores not reported) Tizanidine mean Rinne Multiple Spasticity: Ashworth scale No significant 6% (1/16) 11 mg/day 71 sclerosis (24) or differences 1980 (2) cervical between 6% (1/16) Baclofen mean FAIR myelopathy (8) interventions 51 mg/day (Ashworth scale 32 scores not reported) Tizanidine 8 mg Smolenski Multiple Tone: Ashworth scale No significant None reported tid 77 sclerosis Spasticity: 5 point scale differences 1981 Muscle strength: 6 point scale between Baclofen 20 mg FAIR 21 Global assessment of change in interventions tid condition: Unspecified methods (Ashworth scale Tolerance to medication: scores not Unspecified methods reported) Tizanidine mean Stien Multiple Tone/spasticity: Ashworth scale No significant 6% (1/18) 23 mg/day 64 sclerosis Functional status: Kurtzke differences 1987 Expanded Disability Status Scale between 5% (1/20) Baclofen mean FAIR 40 Functional assessment: Pederson interventions 59 mg/day scale (Ashworth scale scores not reported) Tizanidine cheap 5mg aricept with amex, baclofen buy aricept 10 mg mastercard, or dantrolene versus diazepam Tizanidine mean Bes Post-stroke or Spasticity: 5 point scale No significant 12% (6/51) 17 mg/day 78 head-trauma Functional status: walking distance differences 1988 Severity of spasms: 5 point scale between 31% (17/54) Diazepam mean FAIR 105 Muscle strength: Unspecified interventions 20 mg/day methods Clonus: Unspecified methods Tizanidine mean Rinne Multiple Spasticity: Ashworth scale No significant 0% (0/15) 14 mg/day 71 sclerosis differences 1980 (1) between 27% (4/15) Diazepam mean FAIR 30 interventions 15 mg/day (Ashworth scale scores not reported) Skeletal Muscle Relaxants Page 48 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 2 order aricept 10 mg on-line. Overview of head-to-head trials of skeletal muscle relaxants for spasticity Baclofen 30 Cartlidge Multiple Spasticity: Ashworth scale No significant Not clear mg/day and 60 79 sclerosis differences 1974 mg/day between FAIR 40 interventions Diazepam 15 (mean Ashworth mg/day and 30 score mg/day improvement 0 aricept 5mg with visa. Reflexes order aricept 10 mg visa, qid station stability, and hand coordination favor dantrolene. Baclofen versus clonidine Skeletal Muscle Relaxants Page 49 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 2. Overview of head-to-head trials of skeletal muscle relaxants for spasticity Baclofen 20 mg Nance Spinal cord Spasticity: modified Ashworth scale No significant None reported qid 85 injury (1-5 scale with 0. Skeletal Muscle Relaxants Page 50 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 3. Overview of placebo-controlled trials of included skeletal muscle relaxants for spasticity Trial Population Medication Quality Number enrolled Main outcomes for spasticity/tone Skeletal muscle relaxants approved for use in patients with spasticity Baclofen 86 Various spasticity Favors baclofen based on "EMG and force Basmajian 1974 FAIR 15 recordings" (p not reported) Baclofen 87 Various spasticity Favors baclofen using unspecified method (p not Basmajian 1975 FAIR 14 reported) Baclofen 88 Multiple sclerosis Favors baclofen using Ashworth scale (p not Brar 1991 FAIR 38 reported) Baclofen 89 M. Overview of placebo-controlled trials of included skeletal muscle relaxants for spasticity Trial Population Medication Quality Number enrolled Main outcomes for spasticity/tone Dantrolene 100 Upper motor neuron Spasticity not assessed Basmajian 1973 POOR disease 25 Dantrolene 101 Athetoid cerebral palsy No measurable difference using 4 point scale Chyatte 1973 FAIR (children) 18 Dantrolene 102 Various spasticity Dantrolene superior for "neurologic measurements" Denhoff 1975 FAIR (children) using unspecified methods (p<0. Overview of placebo-controlled trials of included skeletal muscle relaxants for spasticity Trial Population Medication Quality Number enrolled Main outcomes for spasticity/tone Tizanidine 115 Various spasticity No significant difference using Ashworth scale Knutsson 1982 FAIR 13 Tizanidine 116 Multiple sclerosis No significant difference using unspecified method Lapierre 1987 FAIR 66 Tizanidine 117 Various spasticity No significant difference using Penn Spasm Meythaler 2001 FAIR 17 Frequency Scale, favors tizanidine using Ashworth scale (p=0. O verview ofh ead-to-h ead trials ofskeletalm uscle relaxants form usculoskeletalconditions Interventions Study Population O verall Dose Y ear N um berenrolled M ainoutcom es assessed M ainresults with drawals Tiz anidine versus ch lorz oxaz one Tiz anidine 2 m g tid Bragstad Back spasms M uscle tension: 4 pointscale N o significantdifferences 0% (0/14) 123 Painintensity: 4 pointscale betweeninterventions 1979 C h lorz oxaz one 500 Tenderness: 4 pointscale 8% (1/13) m g tid F A IR 120 Interference with normalactivities: 4 pointscale C yclobenz aprine versus m eth ocarbam ol C yclobenz aprine 10 Preston L ocaliz ed acute M uscle spasm: 9 pointscale N o significantdifferences 14% (12/87) m g tid 20 muscle spasm L ocalpainand tenderness: 9 pointscale betweeninterventions except 1984 L imitationofnormalmotion: 9 pointscale sligh tly greaterproportionof 13% (12/94) M eth ocarbam ol F A IR 227 Interference with normalactivities: 9 pointscale patients with improvementinlocal 1500 m g qid painwith cyclobenz aprine (48% vs. O verview ofh ead-to-h ead trials ofskeletalm uscle relaxants form usculoskeletalconditions Interventions Study Population O verall Dose Y ear N um berenrolled M ainoutcom es assessed M ainresults with drawals C arisoprodol350 Boyles A cute back sprainor M uscle spasm: 5 pointscale C arisoprodolsuperiorto 10% (4/40) m g qid 129 strainwith spasms Tenderness: 5 pointscale diaz peam formuscle stiffness 1983 M obility restriction: 5 pointscale (p<0. O verview ofh ead-to-h ead trials ofskeletalm uscle relaxants form usculoskeletalconditions Interventions Study Population O verall Dose Y ear N um berenrolled M ainoutcom es assessed M ainresults with drawals C yclobenz aprine 30- Sch einer A cute back or M uscle spasm: 5 pointscale C yclobenz aprine more effective 8% (2/26) 40 m g tid 128 neck spasms Pain: 5 pointscale th andiaz epam (p<0. Overview of placebo-controlled trials of skeletal muscle relaxants for musculoskeletal conditions Population Main outcomes (included skeletal muscle relaxant Medication Trials Number enrolled versus placebo) Skeletal muscle relaxants approved for use in patients with musculoskeletal conditions Carisoprodol 138 Low back syndrome No significant difference for pain using 4 point scale, Baratta 1976 FAIR 105 carisoprodol superior to placebo for various functional measurements and for sleep Carisoprodol 139 Acute back or neck syndrome Carisoprodol superior for pain, spasm, and limitation Cullen 1976 FAIR 65 of movement using unspecified methods (all p<0. Skeletal Muscle Relaxants Page 57 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 5. Overview of placebo-controlled trials of skeletal muscle relaxants for musculoskeletal conditions Population Main outcomes (included skeletal muscle relaxant Medication Trials Number enrolled versus placebo) Cyclobenzaprine Borenstein Nonspecific low back pain Cyclobenzaprine 5 mg tid superior to placebo using 5 (2. Cyclobenzaprine Borenstein Acute low back syndrome Cyclobenzaprine + naprosyn superior to naprosyn (+naprosyn in both 148 40 alone for functional capacity using 4 point scale 1990 arms) POOR (p<0. Overview of placebo-controlled trials of skeletal muscle relaxants for musculoskeletal conditions Population Main outcomes (included skeletal muscle relaxant Medication Trials Number enrolled versus placebo) Cyclobenzaprine Steingard Back or neck spasm No significant differences for global evaluation, pain, 152 121 (including diazepam arm) muscle spasm, or functional measurements using 1980 FAIR unspecified methods Metaxalone 43 Acute skeletal muscle disorders Metaxolone superior for muscle spasm, local pain, Dent 1975 POOR (not specified) limitation of normal motion, and interference with daily 228 activities using unspecified scales Metaxalone 153 Muscle pain and spasm, No significant difference using 5 point scale for Diamond 1966 FAIR unspecified locations muscle spasm or 4 point scale for pain 100 Metaxalone 44 Low back pain Metaxolone superior for global therapeutic response Fathie 1964 (1) FAIR 100 using 4 point scale, range of motion using 5 point scale, and palpable spasm using 5 point scale Metaxalone 44 Low back pain Metaxolone superior for global therapeutic response Fathie 1964 (2) FAIR 100 using 4 point scale, range of motion using 5 point scale, and palpable spasm using 5 point scale Metaxalone 56 Muscle pain and spasm, No significant differences using unspecified outcome Morey 1963 FAIR unspecified locations measures 61 Methocarbamol 20 Acute local muscle spasm No differences for muscle spasm; favors Preston 1984 FAIR 227 (including cyclobenzaprine cyclobenzaprine for local pain, limitation of motion, arm) and daily activities (p not reported) using 9 point scales Methocarbamol 42 Acute local muscle spasm Methocarbamol superior for muscle spasm and local Tisdale 1975 FAIR 180 pain at 48 hours using 5 point scales; methocarbamol superior for limitation of motion and daily activities at 1 week (p<0. Overview of placebo-controlled trials of skeletal muscle relaxants for musculoskeletal conditions Population Main outcomes (included skeletal muscle relaxant Medication Trials Number enrolled versus placebo) Tizanidine (+ Sirdalud Ternelin Acute neck or low back Tizanidine superior for pain using 4 point scale diclofenac in both Asia-Pacific Study syndromes (p<0. A dverse events,h ead-to-h ead trials ofskeletalm uscle relaxants forspasticity W ith drawals due Som nolence or Diz z iness or to adverse Study Interventions fatigue W eakness ligh th eadedness Dry m outh events Tiz anidine versus baclofen B ass Tiz anidine mean17 mg/day 29% 21% N otreported 23% 8% (4/52) 58 Baclofenmean35 mg/day 19% 35% N otreported 14% 25% (12/48) 1988 C orston Tiz anidine mean22 mg/day N otreported N otreported N otreported N otreported N one reported 1981 Baclofenmean40 mg/day N otreported N otreported N otreported N otreported N one reported Eysette Tiz anidine 24 mg/day 30% Infrequent(data not N otreported 28% 6% (3/49) 59 reported) 1988 Baclofen60 mg/day 20% 20% N otreported Infrequent(data not 6% (3/49) reported) H oogstraten Tiz anidine 12-24 mg/day 57% 33% 14% 36% 11% (1/9) 60 Baclofen15-60 mg/day 29% 57% 14% 14% 14% (1/7) 1988 M edici Tiz anidine mean20 mg/day 33% 0% 0% 7% 0% (0/15) 61 Baclofenmean50 mg/day 29% 7% 7% 0% 20% (3/15) 1989 N ewm an Tiz anidine titrated to 16 mg/day 15% 8% 8% 0% 6% (2/36) 62 1982 Baclofentitrated to 40 mg/day 19% 15% 15% 4% 17% (6/36) R inne Tiz anidine mean11 mg/day 62% (6% severe) 19% (0% severe) 25% (0% severe) 50% 6% (1/16) 57 1980 (2) Baclofenmean51 mg/day 80% (20% severe) 38% (40% severe) 60% (13% severe) 27% 6% (1/16) Skeletal Muscle Relaxants Page 62 of 237 Final Report Update 2 Drug Effectiveness Review Project Sm olenski Tiz anidine 24 mg/day 45% 18% N one reported 9% 0% (0/11) 63 N one reported 1981 Baclofen60 mg/day 0% 30% 10% 0% (0/10) Skeletal Muscle Relaxants Page 63 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 6. A dverse events,h ead-to-h ead trials ofskeletalm uscle relaxants forspasticity (continued) W ith drawals due Som nolence or Diz z iness or to adverse Study Interventions fatigue W eakness ligh th eadedness Dry m outh events Stien Tiz anidine mean23/day 33% (also includes N otreported separately N otreported N otreported separately 6% (1/18) 49 weakness and dry 1987 mouth ) Baclofenmean59 mg/day 25% (also includes N otreported separately N otreported N otreported separately 4% (1/20) weakness and dry mouth ) Tiz anidine,baclofen,ordantrolene versus diaz epam B es Tiz anidine mean17 mg/day 44% 2% N one reported 11% 12% (6/51) 64 Diaz epam mean20 mg/day 44% 18% N one reported 3% 28% (15/54) 1988 R inne Tiz anidine mean14 mg/day 53% (0% severe) 13% (8% severe) 7% 33% 0% (0/15) 57 Diaz epam mean15 mg/day 87% (47% severe) 53% (27% severe) 13% 0% 27% (4/15) 1980 (1) C artlidge Baclofen30 mg/day and 60 14% 11% 3% 3% 30% (11/37) 65 mg/day 1974 Diaz epam 15 mg/day and 30 11% 16% 0% 0% 38% (14/37) mg/day F rom Baclofenmean61 mg/day 31% 19% 6% N otreported 6% (1/16) 67 Diaz epam mean21 mg/day 69% 12% 6% N otreported 0% (0/16) 1975 R oussan Baclofenmean47 mg/day 8% N otreported N otreported N otreported 0% (0/13) 66 Diaz epam mean28 mg/day 38% N otreported N otreported N otreported 0% (0/13) 1985 Skeletal Muscle Relaxants Page 64 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 6. A dverse events,h ead-to-h ead trials ofskeletalm uscle relaxants forspasticity (continued) W ith drawals due Som nolence or Diz z iness or to adverse Study Interventions fatigue W eakness ligh th eadedness Dry m outh events G lass Dantrolene 100 mgqid N otreported N otreported N otreported N otreported 19% (3/16) 76 Diaz epam 5 mgqid N otreported N otreported N otreported N otreported 6% (1/16) 1974 N ogen Dantrolene titrated to 75 mgqid N otclear N otreported N otreported N otreported N one reported 77 1976 Diaz epam titrated to 12 mg/day N otclear N otreported N otreported N otreported N one reported Sch m idt Dantrolene 75 mgqid 31% 67% 19% N otreported N otclear 78 Diaz epam 5 mgqid 67% 76% 19% N otreported N otclear 1976 B aclofenversus clonidine N ance Baclofen20 mgqid N otreported N otreported N otreported N otreported N one reported 79 C lonidine 0. A dverse events,placebo-controlled trials ofskeletalm uscle relaxants forspasticity Som nolence Diz z iness or W ith drawals due to adverse A ny adverse Intervention Study and year orfatigue ligh th eadedness Dry m outh events events B aclofen5 m g tid 86 0% 0% 0% 0% N one reported Basmajian1974 B aclofenuncleardose 87 N otreported N otreported N otreported 12% N otreported Basmajian1975 B aclofen5-20 m g/day 88 N otreported N otreported N otreported N otreported by intervention N otreported Brar1991 B aclofen5 m g tid to 100 m g/day 89 12% 24% 12% 0% 60% Duncan1976 B aclofen15-80 m g/day 90 17% N otreported 22% 0% N otreported F eldman1978 B aclofen40-80 m g/day 91 N otreported N otreported N otreported N otreported N otreported H inderer1990 B aclofen10 m g tid 92 78% N otreported N otreported 56% 78% H ulme 1985 B aclofen10 m g tid 52 4% 4% N otreported 4% 26% H udgson1971 and 53 1972 B aclofen15-60 m g/day 93 N otclear N one reported N one reported N one reported N otreported Jones 1970 B aclofen0. A dverse events,placebo-controlled trials ofskeletalm uscle relaxants forspasticity Som nolence Diz z iness or W ith drawals due to adverse A ny adverse Intervention Study and year orfatigue ligh th eadedness Dry m outh events events *Ratedgoodqualityforadverse eventassessment Tiz anidine 10 m g/day 115 33% N one reported 17% 0% N otreported K nutsson1982 Tiz anidine 2-32 m g/day 116 48% 3% 48% U nclear N otreported L apierre 1987 Tiz anidine 12-36 m g/day 117 41% N otreported 12% 0% N otreported M eyth aler2001* Tiz anidine 4-36 m g/day 118 41% 17% 39% 25% 81% N ance 1994 Tiz anidine titrated to m axim um 36 119 48% 19% 57% 13% 91% Smith 1994* m g/day Tiz anidine m ean25 m g/day U K Tiz anidine Trial N otreported N otreported 45% 13% 87% 120 by G roup1994* intervention (54% overall) C h lorz oxaz one 20 m g/lb/day 121 N one reported N otreported N otreported N otreported N otreported L osin1966 C yclobenz aprine 60 m g/day 122 N one reported 7% 7% 7% N otreported A sh by 1972 M etaxalone 400 m g bid to 800 m g qid 55 7% N otreported N otreported 14% 21% K urtz ke 1962 M eth ocarbam olm ean85 m g/kg/day 40 5% N otreported N otreported N otreported N otreported Bjerre 1971 *Ratedgoodqualityforadverse eventassessment Skeletal Muscle Relaxants Page 68 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 8. A dverse events,h ead-to-h ead trials ofskeletalm uscle relaxants form usculoskeletalconditions Diz z iness or W ith drawals due to A ny adverse Study Interventions Som nolence Dry m outh ligh th eadedness adverse events event H ead-to-h ead trials ofincluded skeletalm uscle relaxants B ragstad Tiz anidine 2 mgtid N otreported N otreported N otreported N one reported 0% 123 C h lorz oxaz one 500 tid N otreported N otreported N otreported N one reported 15% 1979 20 C yclobenz aprine 10 mgtid 58% 9% Included insomnolence 7% (6/87) 42% Preston,1984 M eth ocarbamol1500 qid 31% 1% Included insomnolence 6% (6/94) 31% 124 C yclobenz aprine 10 mgqid 40% 38% 8% 8% (3/37) 65% R ollings,1983 C arisoprodol350 mgqid 41% 10% 26% 8% (3/39) 62% H ead-to-h ead trials ofincluded skeletalm uscle relaxants versus diaz epam 129 C arisoprodol350 mgqid 12% N otreported 12% 2% (1/40) 22% B oyles,1983 Diaz epam 5 mgqid 30% N otreported 8% 5% (2/40) 35% 51 0% Sch einer,1976 C h lorz oxaz one 750 mgqid 27% 4% N one reported 27% Diaz epam 5 mgqid 81% 19% 44% N one reported 81% 125 C yclobenz aprine 10-20 mgtid 66% 5% 18% 3% (1/38) 76% A iken,1978a Diaz epam 5-10 mgtid 68% 3% 21% 0% (0/40) 72% 126 C yclobenz aprine 10-20 mgtid N otreported N otreported N otreported N one reported N otreported B asm ajian,1978 Diaz epam 5 mgtid N otreported N otreported N otreported N one reported N otreported 127 C yclobenz aprine 10 mgtid 44% 50% 25% N one reported N otreported B rown,1978 Diaz epam 5 mgtid 13% 13% 12% N one reported N otreported 128 C yclobenz aprine 30-40 mg/day 24% 29% 9% N one reported 32% Sch einer,1978 (1) Diaz epam 15-20 mg/day 28% 6% 28% N one reported 28% 128 C yclobenz aprine 30-40 mg/day 83% 46% 17% N one reported 50% Sch einer,1978 (2) Diaz epam 15-20 mg/day 67% 14% 52% N one reported 67% 130 Tiz anidine 4-8 mgtid 10% 10% 10% N one reported 20% F ryda-K aurim sky,1981 Skeletal Muscle Relaxants Page 69 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 8. A dverse events,h ead-to-h ead trials ofskeletalm uscle relaxants form usculoskeletalconditions Diz z iness or W ith drawals due to A ny adverse Study Interventions Som nolence Dry m outh ligh th eadedness adverse events event Diaz epam 5-10 mgtid 50% 10% 50% N one reported 50% 131 Tiz anidine 4 mgtid N one reported N one reported N one reported 7% (1/15) 7% H ennies,1981 Diaz epam 5 mgtid N one reported N one reported N one reported 0% (0/15) N one reported Skeletal Muscle Relaxants Page 70 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 9. A dverse events,placebo-controlled trials ofskeletalm uscle relaxants form usculoskeletalconditions Som nolence or Diz z iness or W ith drawals due to A ny adverse Intervention Trials fatigue ligh th eadedness Dry m outh adverse events event C arisoprodol350 m g qid 124 N otreported N otreported N otreported N otreported N otreported Baratta 1976 C arisoprodol350 m g qid 125 12% 19% N otreported 3% N otreported C ullen1976 C arisoprodol350 m g tid 126 N otreported N otreported N otreported N one reported N otreported H indle 1972 C arisoprodol400 m g qid 127 8% 18% 0% 1% N otreported Soyka 1979 C yclobenz aprine 10-20 m g tid 128 84% 36% 4% 4% 96% A iken1978b C yclobenz aprine 10 m g tid 129 31% 36% 10% 0% 43% Baratta 1982 C yclobenz aprine 10 m g bid 130 N otreported N otreported N otreported N one reported N otreported Basmajian1989 C yclobenz aprine 10 m g qpm titrated to 40 m g/day 131 55% 11% 92% 8% 89% Bennett1988 C yclobenz aprine 20-40 m g/day 132 33% 11% 4% 0% N otreported Bercel1977 C yclobenz aprine 10 m g tid 129 29% 4% 8% N one reported 42% Bianch i1978 C yclobenz aprine 5 m g tid 46 29% ^ 3% ^ 21% ^ 5% 55% ^+ Borenstein2003 (1) C yclobenz aprine 10 m g tid 38% 4% 32% 8% 62% C yclobenz aprine 2. A dverse events,placebo-controlled trials ofskeletalm uscle relaxants form usculoskeletalconditions Som nolence or Diz z iness or W ith drawals due to A ny adverse Intervention Trials fatigue ligh th eadedness Dry m outh adverse events event *U nclearsam plesize,basedoninterventionsam pleof 90patients ^Resultspooledwithothertrialby Borenstein2003 +Patientsreporting m orethan1adverseevent Skeletal Muscle Relaxants Page 72 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 9. A dverse events,placebo-controlled trials ofskeletalm uscle relaxants form usculoskeletalconditions Som nolence or Diz z iness or W ith drawals due to A ny adverse Intervention Trials fatigue ligh th eadedness Dry m outh adverse events event Table 9. A dverse events,placebo-controlled trials ofskeletalm uscle relaxants form usculoskeletalconditions (continued) Som nolence or Diz z iness or W ith drawals due to A ny adverse Intervention Trials fatigue ligh th eadedness Dry m outh adverse events event M etaxalone 400 or800 m g qid 43 4% 3% N otreported 9% 14% Dent1975* M etaxalone 800 m g qid 153 N otreported N otreported N otreported N one reported N otclear Diamond 1966 M etaxalone 800 m g qid 44 N otreported N otreported N otreported N otreported N otreported F ath ie 1964 (1) M etaxalone 800 m g qid 44 N otreported N otreported N otreported N otreported N otreported F ath ie 1964 (2) M etaxalone 800 m g qid 56 0% 3% N otreported N one reported 13% M orey 1963 M eth ocarbam ol2000 m g qid initially,th en1000- 42 N otreported 11% N otreported 3% N otclear Tisdale 1975 1500 m g qid M eth ocarbam ol1500 m g qid 57 10% 8% 2% 10% N otclear Valtonen1975 (2) O rph enadrine 100 m g bid 23 N otclear N otclear N otclear N one reported 25% G old 1978 O rph enadrine 100 m g qh s 154 0% 0% 0% N one reported 3% L atta 1989 O rph enadrine dose unclear(+paracetam olinboth 155 N otreported N otreported N otreported 7% N otreported M cG uinness 1983 arm s) O rph enadrine 100 m g bid 156 5% 4% 0% N otreported N otreported Valtonen1975 B aclofen30-80 m g/day 157 49% 28% 5% 17% 68% Dapas 1985 Dantrolene 25 m g/day 158 N otreported N otreported N otreported N one reported N otreported C asale 1988 Dantolene 25 m g/day (+ ibuprofeninboth arm s) 159 N one reported N one reported N one reported 0% 3% Salvini1986 Skeletal Muscle Relaxants Page 73 of 237 Final Report Update 2 Drug Effectiveness Review Project Table 9. Sum m ary ofevidence K ey Q uestion C ondition L evelofEvidence C onclusions Efficacy 1. W h atis th e com parative efficacy of Spasticity: F A IR fortiz anidine vs. M ostofth ese trials evaluated patients with multiple sclerosis.

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