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Im m ediate R elease (ER vs IR ) Tolterodine ER vs Tolterodine IR VanK errebroeck TolE R 4m g oncedailyorTolIR 2m g or nonereported m icturitiondiaryassessedatbaselineand12wks 2001 Placebotwicedaily 1weekf/u x 12wks Swift TolE R 4m g (n= 417)oncedailyvs cheap glimepiride 2mg on line. TolIR O thertreatm entsforO ABnotm icturitiondiaryassessedatbaselineand12wks 2003 2m g twicedaily(n= 408)vs buy glimepiride 4mg line. Pla(n= 410) perm itted,ex ceptestrogen 1weekf/u R e-analysisof data for12wks. K errebroeck2001 study(above) *Padtest= patientfillsbladderto300m l,thenperform saseriesof m aneuvers,i. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 40 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials N um berscreened/ A ge O th erpopulation A uth or, eligible/ G ender ch aracteristics N um berwith drawn/ Y ear enrolled Eth nicity (diagnosis,etc) lostto fu/analyz ed Extended R elease vs. Im m ediate R elease (ER vs IR ) Tolterodine ER vs Tolterodine IR VanK errebroeck 1529random iz edinto m edianage60yrs M eannum berincontinence 187(12%) 2001 study 81% F em ale episodes/wk: TolE R :507 E R 22,IR 23,Placebo23 TolIR :514 M eannum berm icturitions/d: placebo:508 E R 11,IR 11,Placebo11 previoustherapyforU I E R :53%,IR 54%,Placebo52% poorefficacy E R :3%,IR 38%,Placebo41% Swift ScreenedN R M eanage= 59 Previousdrug therapyforO AB= 55% 143(12%) 2003 E ligible N R Allfem ale M eannum berincontinenceepisodes/wk R e-analysisof data E nrolled= 1235 95% white E R 22,IR 23,Placebo24 forwom enonlyinVan 4% black M eannum bervoluntarym icturitions/d: K errebroeck2001 1% other E R 11,IR 11,Placebo11 study(above) previoustherapyforU I E R :56%,IR 54%,Placebo55% *Padtest= patientfillsbladderto300m l,thenperform saseriesof m aneuvers,i. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 41 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials A uth or, Y ear O utcom es Extended R elease vs. Im m ediate R elease (ER vs IR ) Tolterodine ER vs Tolterodine IR VanK errebroeck M eanchangeinincontinenceepisodes/wk: 2001 E R -11. Plastatisticallysignificant) *Padtest= patientfillsbladderto300m l,thenperform saseriesof m aneuvers,i. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 42 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials A uth or, A dverse effects assessed? Im m ediate R elease (ER vs IR ) Tolterodine ER vs Tolterodine IR VanK errebroeck Spontaneouslyreported eventswerecategoriz edandcausationassigned 2001 drym outh furthercategoriz ed D rym outh:E R 23%,IR 30%,Placebo8% Constipation:E R 6%,IR 7%,Placebo4% Headache:E R 6%,IR 4%,Placebo5% Swift R eporting detailsN R. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 43 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials A uth or, Y ear W ith drawals due to adverse events C om m ents Extended R elease vs. Im m ediate R elease (ER vs IR ) Tolterodine ER vs Tolterodine IR VanK errebroeck 88(5. R e-analysisof data Pla 26/410(6%) forwom enonlyinVan K errebroeck2001 study(above) *Padtest= patientfillsbladderto300m l,thenperform saseriesof m aneuvers,i. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 44 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials A uth or, Study Design Y ear Setting Eligibility criteria Exclusioncriteria Extended R elease vs. Tolterodine IR Appell R CT O veractivebladder O thercausesof incontinence 2001 M ulticenter between7and50episodesperweekof urge postvoidresidualvolum em orethan150m l U SA incontinence deliveredbabypelvic bladdervaginalorprostatesym ptom sinpast6 10+voids/24hr m onths m ix edstressandurgeincontinenceif the riskof com pleteurinaryretention m ajorityof accidentswererelatedtourinary clinicallyim portantm edicalproblem s incontinence organabnorm alities hem aturia positiveurineculture narrow angleglaucom a pelvic organprolapse gastric conditions anticholindrugsm ustbediscontinued knownallergy alcoholordrug abuse(current) unabletofollow directionorschedules notabletoswallow tabletswhole *Padtest= patientfillsbladderto300m l,thenperform saseriesof m aneuvers,i. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 45 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials A uth or, Interventions (drug,regim en, O th erinterventions/ M eth od ofO utcom e A ssessm entand Tim ing of Y ear duration) m edications A ssessm ent Extended R elease vs. Tolterodine IR Appell E R O x y10m g oncedaily N otgiven Safetym onitoring 2001 Tol2m g twicedaily patientreporting ateach studyvisit2,4,8,12weeks 12weekstudy num berof urgeincontinenceepisodesat12weeksvs. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 46 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials N um berscreened/ A ge O th erpopulation A uth or, eligible/ G ender ch aracteristics N um berwith drawn/ Y ear enrolled Eth nicity (diagnosis,etc) lostto fu/analyz ed Extended R elease vs. Tolterodine IR Appell 378random iz ed(O x y M eanAge:59yrs D rug naïve O verall:46 (21Tol,25O x yE R ) 2001 E R 185,Tol193) F em ale:83% O x yE R :109 L osttoF ollow-up 332com pleted(O x yE R E thnicity: Tol:119 O x yE R :3 160,Tol172) W hite87% Tol:3 AfricanAm erican6% Hispanic 4% Asian2% O ther1% *Padtest= patientfillsbladderto300m l,thenperform saseriesof m aneuvers,i. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 47 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials A uth or, Y ear O utcom es Extended R elease vs. Tolterodine IR Appell M eannum berof urgeincontinenceepisodes/wk 2001 O x yE R -19. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 48 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials A uth or, A dverse effects assessed? Tolterodine IR Appell Patientreported 2001 drym outh occurredinequalproportionineach group both groupshadsim ilarratesof drym outh andotheradverseeffects *Padtest= patientfillsbladderto300m l,thenperform saseriesof m aneuvers,i. R CT = R andom ControlledTrial,U TI = U rinaryTractInfection,N S = N ostatisticaldifference Overactive bladder 49 of 217 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. C om parative clinicaltrials A uth or, Y ear W ith drawals due to adverse events C om m ents Extended R elease vs. Tolterodine IR Appell O x yE R 14 2001 Tol15 *Padtest= patientfillsbladderto300m l,thenperform saseriesof m aneuvers,i.

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The speed of an antibody response may be enhanced by CD4+ mem- ory cells generic 1 mg glimepiride overnight delivery. This raises some interesting questions concerning the selective pressures that influence antigenic variation in parasites best glimepiride 1 mg. Suppose, for example, that during initial exposure a host produces a dominant im- mune response to a parasite’s B cell epitope, b,andtoaCD4+ Tcell epitope, t. Thus, we can writetheinitial parasite genotype as b/t. Forexample, how much advantage does the host gain by CD4+ memory against a parasite with an altered Bcellepitope, or from the parasite’s point of view, what is the fitness of the parasite genotype b /t relative to b /t in a host previously exposed to b/t? Ifthedifference in fitness is sufficiently large, then the selective intensity on the epitope t may be strong. This would be interesting to know because most attention currently focuses on the obviously strong selective pressure for changes in the epitope b. Helper T cells cross-react between influenza strains (Hurwitz et al. This cross-reactivity does not protect hosts against secondary infection, but it can accelerate antibody response and reduce thetime until clearance (Scherle and Gerhard 1986; Marshall et al. In influenza infections, the dominant epitopes of helper T cells focus on hemagglutinin, a major surface molecule of influenza. The T cell epitopes are very near the B cell epitopes that dominate protective im- munity (Wilson and Cox 1990; Thomas et al. It may be that amino acid changes in hemagglutinin between antigenically variant strains are sometimes selected by memory helper T cells. However, for amino acid replacements in hemagglutinin, it isdifficulttoseparate the potential role of memory helper T cells from the obviously strong effects of anti- body memory. The level of memory helper T cells can be measured by the time re- quired for naive B cells to switch from initial IgM secretion to later IgG se- cretion. When assessed by this functional response, helper T cell mem- oryappears to be short-lived for influenza (Liang et al. In mice infected with VSV, memory T cell help that ac- celerated the IgM to IgG switch lasted only fourteen to twenty-one days. Other assays find that memory helperTcells remain for several months after initial infection (Gupta et al. It will beinteresting to learn whether lim- IMMUNOLOGICAL VARIABILITY OF HOSTS 129 ited functional helper T cell memory applies generally to all vertebrates or varies for different hosts or host-parasite combinations. CD4+ cells have other functions in addition to stimulating B cells. For example, CD4+ cells influence CTL response and the response of other effectors such as macrophages. The limited evidence available does not demonstrate a strong role for CD4+ memory with regard to these effector-stimulating functions (Stevenson and Doherty 1998); however, the potentially diverse memory effects for these cells must be consid- ered (Whitmire et al. CTL MEMORY Important attributes of memory include the speed and intensity of response to antigen and the time decay of these quantitative responses (Seder and Hill 2000). CTL memory has been measured in various ways, for different hosts and different kinds of parasites (Zinkernagel et al. Preliminary data suggest that patterns of immunodominance in the primary response do notnecessarily carry through to the memory pool (Belz et al. In some cases, it seems that T cell clones increased to high abundance in the primary response suf- fer greater reductions as the cellular populations are regulated in the memory phase (Rickinson et al. Afewgeneralconclusions arise from this work: secondary CTL re- sponses are typically faster and moreintensethanprimary response, and the strength of the secondary response can decay over time. More important, the relations between CTL response and clearance depend strongly on the kinds of parasites. The parasites race against immune effectors, which may eventually kill parasites faster than they are born. Each kind of parasite has its particular site of infec- tion, pattern of spread between tissues, and rate of increase. Immuno- logical memory therefore influences the host-parasite race in a different way for each kind of parasite. I discuss memory-parasite in- teractions with regard to the type of immune cell involved, the kinetics of parasite spread, and the kinetics of immune effector response. There are four main classes of immune cells that canbeenhanced by primary infection to provide greater protection against later infections: plasma B cells, memory B cells, effector T cells, and memory T cells (Ahmed and Gray 1996). These effector B cells usually pro- duce mature immunoglobulins such as IgG in systemic sites and IgA on mucosal surfaces. Circulating IgG often remains at significant titers throughout life.

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Two placebo- controlled trials showed topiramate was more effective than placebo in reducing migraine 116 order 2mg glimepiride otc, 117 116 frequency and monthly migraine days discount 4mg glimepiride with visa. In a study of 306 adults the change in mean monthly migraine days for topiramate was -6. An additional 121 trial showed similar findings but was rated poor. Although the collective result shows that topiramate is more effective than placebo, it is unclear whether the findings in patients with chronic migraine headache should be combined with results in patients without chronic headaches. Chronic pain Very little evidence was found to support the short-term use of tiagabine, topiramate, or 123-125 gabapentin for treatment of chronic pain conditions. No evidence was found for other antiepileptic drugs. Open-label tiagabine and gabapentin were directly compared in 91 patients with various 125 types of chronic pain despite ongoing treatment with analgesics or antidepressants. Most patients were diagnosed with either musculoskeletal headache or cervical pain. Most of the population was female (78%), and the mean age was 44 years. Study medications were available only at the patients’ expense and were given in addition to ongoing treatment regimens. After 3 months, tiagabine and gabapentin were associated with similar reductions in pain score (-2. Topiramate improved pain and associated difficulties significantly more than placebo in a 10-week, fair-quality, double-blind trial of 96 patients with chronic low-back pain who had never 124, 126 undergone back surgery. Overall, 75% of patients were male and their mean age was 49 years. Patients were required to discontinue analgesic or anti-inflammatory medications 1 week before randomization but were allowed to continue any prestudy antidepressant medications. Compared with placebo, topiramate significantly improved pain, associated disability, anger, and quality of life based on scores on the MPQ (-0. Gabapentin was found to have significant analgesic effect compared with placebo in a 12-week, fair-quality, double-blind trial of 50 patients with moderate to severe chronic pain of 123 the masticatory muscles of at least 6 months’ duration. All patients enrolled in this trial were female, with a mean age of 34 years. Although ongoing use of muscle relaxants and/or anti- inflammatory drugs was prohibited during the trial, acetaminophen was allowed for breakthrough pain. Patients were also allowed to continue ongoing psychotropic medication regimens (for example, tricyclic antidepressants, benzodiazepines, selective serotonin reuptake inhibitors). In addition to superior reductions in pain compared with placebo (51% compared with 24% reduction based on visual analog scale; P=0. Antiepileptic drugs Page 42 of 117 Final Report Update 2 Drug Effectiveness Review Project Key Question 2 For adult outpatients with bipolar disorder, fibromyalgia, migraine, or chronic pain, do antiepileptic drugs differ in safety or adverse events? The adverse event profiles of the antiepileptic drugs vary considerably, with overlap only in 127, 128 adverse effects that may affect tolerability, such as somnolence. Comparative assessments of common, overlapping adverse effects were undertaken where possible based on direct evidence from the populations of interest in this review. Emphasis was on the comparison of rates of any adverse event, withdrawals due to adverse events, and longer-term evidence in “real- life” populations (observational studies). For the purposes of this review, side effects that are unique to individual antiepileptic drugs are summarized based on existing reviews, including rare but serious adverse events such as birth defects. Because epilepsy and its treatment are complex and may affect the adverse events experienced with an antiepileptic drug, evidence relating to the population of patients with epilepsy was not reviewed other than to provide basic estimates of rates of adverse events or to provide evidence on harms with long-term effects, such as suicidal ideation. Suicide An FDA advisory to healthcare professionals warning of potentially increased risk of suicidality with antiepileptic drugs was published in February 2008. In May 2008 the FDA completed an initial analysis of data on suicide relating to antiepileptic drugs, in preparation for an advisory committee meeting to be held in July 2008 (http://www. Their analysis included 11 drugs: carbamazepine, divalproex, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, and zonisamide. The meta-analysis was based on 199 placebo-controlled trials, with reports of completed suicides or suicidal ideation/behavior as the primary outcomes. The conclusions of this report are that as a group, these drugs are associated with an increased risk of the patient experiencing a suicidal ideation or behavior; odds ratio compared with a placebo patient was 1. The number of suicide deaths was small (N=4) but greater than in the placebo groups (N=0), although numbers were insufficient to show statistical significance. Based on these results, the FDA asked for an advisory committee review to consider regulations requiring “black box” warnings be added to all antiepileptic drugs based on the fact that 8 of 11 drugs had a numerically increased odds ratio with only 2 (lamotrigine and topiramate) reaching statistical significance.