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Effect size/estimate of effect: The amount of change in a condition or symptom because of a treatment (compared to not receiving the treatment) purchase 100mcg proventil mastercard asthma 5 month old baby. It is commonly expressed as a risk ratio (relative risk) best 100 mcg proventil asthma treatment hospital, odds ratio order proventil 100mcg line asthmatic bronchitis causes, or difference in risk 100mcg proventil amex asthma definition 2013. Efficacy: The extent to which an intervention produces a beneficial result under ideal conditions in a selected and controlled population. Equivalence level: The amount which an outcome from two treatments can differ but still be considered equivalent, as in an equivalence trial, or the amount which an outcome from treatment A can be worse than that of treatment B but still be considered noninferior, as in a noninferiority trial. Equivalence trial: A trial designed to determine whether the response to two or more treatments differs by an amount that is clinically unimportant. This lack of clinical importance is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence level of clinically acceptable differences. Exclusion criteria: The criteria, or standards, set out before a study or review. Exclusion criteria are used to determine whether a person should participate in a research study or whether an individual study should be excluded in a systematic review. Exclusion criteria may include age, previous treatments, and other medical conditions. External validity: The extent to which results provide a correct basis for generalizations to other circumstances. For instance, a meta-analysis of trials of elderly patients may not be generalizable to children. Studies are assumed to be measuring the same overall effect. Fixed-dose combination product: A formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Forest plot: A graphical representation of the individual results of each study included in a meta- analysis and the combined result of the meta-analysis. The plot allows viewers to see the heterogeneity among the results of the studies. The results of individual studies are shown as squares centered on each study’s point estimate. A horizontal line runs through each square to show each study’s confidence interval—usually, but not always, a 95% confidence interval. The overall estimate from the meta-analysis and its confidence interval are represented as a diamond. The center of the diamond is at the pooled point estimate, and its horizontal tips show the confidence interval. Antiemetics Page 65 of 136 Final Report Update 1 Drug Effectiveness Review Project Funnel plot: A graphical display of some measure of study precision plotted against effect size that can be used to investigate whether there is a link between study size and treatment effect. Half- life: The time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%. Harms: See Adverse Event Hazard ratio: The increased risk with which one group is likely to experience an outcome of interest. For example, if the hazard ratio for death for a treatment is 0. Head-to-head trial: A trial that directly compares one drug in a particular class or group with another in the same class or group. Health outcome: The result of a particular health care practice or intervention, including the ability to function and feelings of well-being. For individuals with chronic conditions – where cure is not always possible – results include health-related quality of life as well as mortality. Heterogeneity: The variation in, or diversity of, participants, interventions, and measurement of outcomes across a set of studies. I is the proportion of total variability across studies that is due to heterogeneity and not chance. It is calculated as (Q-(n- 1))/Q, where n is the number of studies. Incidence: The number of new occurrences of something in a population over a particular period of time, e. Indication: A term describing a valid reason to use a certain test, medication, procedure, or surgery. In the United States, indications for medications are strictly regulated by the Food and Drug Administration, which includes them in the package insert under the phrase "Indications and Usage". Indirect analysis: The practice of using data from trials comparing one drug in a particular class or group with another drug outside of that class or group or with placebo and attempting to draw conclusions about the comparative effectiveness of drugs within a class or group based on that data. For example, direct comparisons between drugs A and B and between drugs B and C can be used to make an indirect comparison between drugs A and C. Intention to treat: The use of data from a randomized controlled trial in which data from all randomized patients are accounted for in the final results. Trials often incorrectly report results as being based on intention to treat despite the fact that some patients are excluded from the analysis. Internal validity: The extent to which the design and conduct of a study are likely to have prevented bias. Generally, the higher the interval validity, the better the quality of the study publication. Inter-rater reliability: The degree of stability exhibited when a measurement is repeated under identical conditions by different raters. Intermediate outcome: An outcome not of direct practical importance but believed to reflect outcomes that are important. For example, blood pressure is not directly important to patients but it is often used as an outcome in clinical trials because it is a risk factor for stroke and myocardial infarction (hear attack). Masking: See Blinding Mean difference: A method used to combine measures on continuous scales (such as weight) where the mean, standard deviation, and sample size are known for each group. Meta-analysis: The use of statistical techniques in a systematic review to integrate the results of included studies. Although the terms are sometimes used interchangeably, meta-analysis is not synonymous with systematic review. However, systematic reviews often include meta-analyses. Meta-regression: A technique used to explore the relationship between study characteristics (for example, baseline risk, concealment of allocation, timing of the intervention) and study results (the magnitude of effect observed in each study) in a systematic review. Mixed treatment comparison meta analysis: A meta-analytic technique that simultaneously compares multiple treatments (typical 3 or more) using both direct and indirect evidence. The multiple treatments form a network of treatment comparisons. Also called multiple treatment comparisons, network analysis, or umbrella reviews. Monotherapy: the use of a single drug to treat a particular disorder or disease. Multivariate analysis: Measuring the impact of more than one variable at a time while analyzing a set of data. N-of-1 trial: A randomized trial in an individual to determine the optimum treatment for that individual. Noninferiority trial: A trial designed to determine whether the effect of a new treatment is not worse than a standard treatment by more than a prespecified amount. Nonrandomized study: Any study estimating the effectiveness (harm or benefit) of an intervention that does not use randomization to allocate patients to comparison groups. There are many types of nonrandomized studies, including cohort studies, case-control studies, and before- after studies.

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Systems that produce LP-PRP often use a single safe 100 mcg proventil asthma treatment breathing exercises, slower centrifugation discount 100 mcg proventil visa asthmatic bronchitis 15, with the RBCs and WBCs layering out in the lower part of the test tube while the platelets The effectiveness of any treatment for tendinopathy is likely to be remain suspended in the plasma purchase proventil 100 mcg free shipping asthma treatment goals. LP-PRP systems typically produce directly correlated with the stage of tendinopathy the patient is in a platelet count 1 buy proventil 100 mcg on line asthma symptoms hoarseness. In earlier reactive stages of tendinopathy, produced will vary dependent on the baseline platelet count of the simple rest may be enough to initiate healing in some patients. In patient and the efficiency and variability of the PRP collecting patients further along the continuum, eccentric exercises, extracor- device (Table 1 lists the different types of PRP). When evaluating poreal shock wave therapy (ESWT), or physical therapy techniques studies using PRP, it is important to assess what type of PRP is involving deep mechanical pressure may be required to reverse the being used. The efficacy or lack thereof in some studies could be trend. Further still along the continuum, needling the tendon (also related to the quality of the PRP. Ideally, the exact content of the called tenotomy), autologous blood injection, or PRP injection may PRP injected would be consistent and characterized, but this is be needed. There are currently no commonly used clinical stages of rarely the case. PRP is typical used at IL receptor antagonist (IL-1RA) for musculoskeletal indications, the far end of the continuum, in severe degenerative tendinopathy, 620 American Society of Hematology Table 1. Different types of PRP Leukocytes Platelet count Brand names of commercially available systems LR-PRP Buffy coat based Yes 5-9 baseline Biomet GPS III, Harvest, Arteriocyte, Cytomedix Angel LP-PRP Plasma based Minimal 1. Both groups underwent similar rehabilitation consisting of rest for 48 hours, followed by stretching PRP in tendinopathy at 1 week after injection and a standard eccentric exercise program 4-11 beginning at 2 weeks. They are difficult to compare directly because they Results of this study showed that both groups improved. The PRP examine different tendons, use different types of PRP, include group improved their VISA-A score by 21. With so many variables, it is difficult to because there was no difference in outcome between the PRP group ascertain to which variables differences in outcomes may be and the saline group. This conclusion is problematic for several attributed; however, closer examination of the literature, particu- reasons. First, all participants in the DeVos study were eccentric larly the randomized trials, can provide a better understanding of the exercise naive. In a study by Rompe, eccentric exercises alone were potential benefits or lack thereof of PRP injections. Subjects were required to have symptoms for only 2 a difference between treatment groups. In addition, there was no months (although the average patient had symptoms for 9-10 true control group. A true control group would have been a months) and they could not have previously tried eccentric exercises wait-and-see group as in the Rompe study; however, a wait-and-see (exercises in which the muscle is lengthening as it is being used). A true, blinded, control group in invasive Eccentric exercises are standard first-line treatment for Achilles and tendinopathy treatment is difficult to achieve. Tenotomy alone has been shown to improve chronic punctures sites and 5 needle passes made at each site, for a total of tendinosis 60% of the time,21-24 and injection of any fluid with 15 passes in each tendon. The primary outcome measure was the subsequent disruption of the matrix of the tendon may have some Victorian Institute of Sport Assessment-Achilles questionnaire effect on tendon healing. What this study did show was that in a (VISA-A), a functional activity and pain score ranging from 0 to group of eccentric exercise-naive patients, PRP injection was no 100 that is commonly used for sports-related Achilles tendon more effective than saline injection. In the VISA-A, 0 represents no activity and maximum in combination with the Rompe study,20 the recommendation that pain and 100 represents full activity and no pain. Another randomized controlled study by Peerbooms et al looked at the use of PRP in chronic lateral epicondylosis. Subjects were required to have had pain for at least 6 months and to have failed prior treatment. They could not have received a corticosteroid injection in the previous 6 months. Injections were performed without ultrasound guidance at the point of maximal tenderness with 5 needle penetrations in a peppering technique. Rehabilitation for both groups was 24 hours of rest followed by 2 weeks of stretching and then an eccentric exercise program. The primary outcome measure was a 25% reduction in the Disabilities of the Shoulder, Arm, and Hand (DASH) score, a validated functional outcome score for the upper extremity. Results of this study showed that 73% of the PRP group and 49% of the corticosteroid group met the primary outcome measure at 1 year. The corticosteroid group had initial relief of pain and improvement Hematology 2013 621 622 American Society of Hematology Figure 2. DASH scores at 1 year in the PRP and corticosteroid groups in the Peerbooms et al study. The primary outcome measure was 8 weeks; however, by 12 weeks, the scores were nearly identical, the percentage of patients who rated their treatment as “good or after which time the corticosteroid group returned to near baseline excellent” as measured by the modified Blazina scale and an but the PRP group continued to improve. This cohort was followed improvement on the Victorian Institute Sport Assessment-Patella for an additional year and there was continued improvement in the (VISA-P), a validated pain and functional activity scale for patellar PRP group without similar improvement in the corticosteroid group tendon injury analogous to that used for the Achilles. The third randomized controlled trial was by Krogh et al comparing PRP (n 20), saline (n 20), and corticosteroid (n 20). There are 4 for 25 months; however, the PRP and saline group had only had randomized controlled studies but their numbers are small. Three of symptoms for 17 months whereas the corticosteroid group had these studies show benefit from PRP and one did not have an end symptoms for 36 months. The primary outcome measure was the point long enough to assess whether PRP was effective. Conclu- Patient Rated Tennis Elbow Evaluation (PRTEE) score, a validated sions that can be drawn at this point are that PRP should be pain and function score for the elbow. This study was initially considered after other conservative treatments have failed, in designed to look at outcomes at 6 months and 1 year; however, more particular eccentric exercises. In addition, if effective, PRP takes 3 than half of the study participants in all groups had dropped out by 6 to 6 months to show benefit, but healing can continue out to 2 years. At 1 month, the corticosteroid group had better PRTEE activity modification, which may adversely affect both physical and scores than the other groups; however, at 3 months, all groups had mental health. More research is needed, such as studies that include statistically equivalent scores. At the time the study was ended, the corticosteroid group was returning toward its baseline and the PRP group was trending toward improvement. It is PRP in arthritis unfortunate that 6- and 12-month data were not available as in other OA is a degenerative disease of the joints that affects the articular 6,12,14,25 cartilage, synovium, and subchondral bone. The complex The fourth randomized controlled study examined PRP versus balance of growth factors and cytokines involved in the regula- ESWT for chronic patellar tendinopathy. The average age in but PRP has been proposed as a physiologic combination of this study was 26 years, with an average duration of symptoms of 18 growth factors that can favorably affect the joint milieu in months. A 22-ga needle was used to inject LR-PRP with ultrasound osteoarthritic joints, thus halting or reversing the process. The ESWT group had 3 sessions 48 to 72 significant impact on quality of life have sought out alternative hours apart. One week after the last treatment session, a standard and emerging treatments and have embraced the concept of a stretching and strengthening protocol was started, with a return to biologic treatment for this disease. Hematology 2013 623 PRP and other biologics have long been used in race horses with OA, and there are basic science studies suggesting why it use may be efficacious; however, there are currently only 8 studies on the clinical use of PRP in OA in humans28-35 (Table 3) and all these studies have examined the effect of PRP in the osteoarthritic knee. None has reported any major adverse effect with the use of PRP and all have reported modest benefit on validated functional outcome scales.

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Insomnia 295 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 9 discount 100mcg proventil otc asthma symptoms heart. O bservationalstudies A uth or R esults F unding Y ear C ountry Sch neeweiss proventil 100 mcg discount extrinsic asthma medical definition, Z olpidem (n=62)vs benz odiaz epine (n=567)vs none (n=6434) N R 2005 Patients ch aracteristics: U S A DL score >=1 point:54 cheap 100 mcg proventil amex asthmatic bronchitis natural cure. O bservationalstudies A uth or N Drugs (m ean Durationof Eligibility C riteria Y ear dose);durationof treatm ent C ountry treatm ent Sch lich buy proventil 100mcg low cost asthma symptoms 9dpo, 107 Z olpidem 6 month s O verage 40,clearevidence of 1991 insomnia defined as sleep F rance onsetlatency ofmore th an30 minutes,numberofnocturnal awakenings each nigh tgreater th antwo,and /ortotalduration ofsleepeach nigh tless th an6 h ours. W ang,2001 1,222 cases, Z olpidem, 6 month s subjects aged >= 65 onJuly 1,1993, U S 4,888 controls benz odiaz epines, and h ave filled one ormore claims fora oth er nonprescriptionservice between January 1,1994 and December31, 1994 and h ave filled atleastone prescriptionforany medicationth rough th e M edicaid orPA A Dprograms of N ew Jersey ineach offourconsecutive 6-month periods beginningJanuary 1, 1993. Insomnia 297 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 9. O bservationalstudies A uth or O th erpopulation Design Datasources Tim e period A dverse events Y ear ch aracteristics of assessm ent C ountry assessm ent Sch lich , 74 females; Before-after clinicalexaminations 6 month s malaise 1991 meanage=63. C ase C ontrol N ew Jersey M edicaid 6 month s N R U S Program N ew Jersey Ph armaceuticalA ssistance to th e A ged and Disable (PA A D)Program N ew Jersey M edicare Insomnia 298 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 9. O bservationalstudies A uth or R esults F unding Y ear C ountry Sch lich , Tolerance:no evidence 1991 A dverse events:z olpidem vs. W ang,2001 H ipF racture: N ationalInstitute U S A djusted O R (95% C I)- adjusted forage and gender ondrugA buse z olpidem:1. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Esz opiclone A dult visualand auditory (Duggal, 1 45-yearold male difficultysleeping H allucinations subsided h allucinations 2007) nigh tsh iftworker,h ad to wake up erraticsleeppattern aftertakingmedication only a few h ours aftertaking visualand auditoryh allucinations and sleepingforth e medicationand fallingasleep afterwakingupa few h ours after recommended 8 h ours no h istory ofpsych iatricillness takingmedication(lastingseveral negative drugscreen minutes) takingseveraloth ermedications (doses unch anged) Z aleplon A dult C N S side effect (Stillwell, 1 drugabuse C N S depressionincludingslow notreported 2003) concurrentuse ofoth erdrugs movements and reactions,poor coordination,lack ofbalance,and poorattention Z aleplon A dult h allucination (Bh atia, 1 h ealth yfemale ligh th eaded notreported illusions A rora,& nonsmoker,occasionaldrinker illusion depersonaliz ation Bh atia, visualh allucinations 2001) Z aleplon Pediatrics somnambulism (L iskow & 1 majordepressive disorder, somnambulism with complex notreported Pikalov, moderate beh avior 2004) no h istory ofsleepdeprivation Z olpidem A dult anterograde (Tsai, 3 adultwomen compulsive repetitive beh aviors adverse events stopped amnesia 2007) (eating,sh opping,and cleaning) afterdiscontinuationof compulsive combined with anterograde amnesia z olpidem repetitive beh aviors (no recollectionofbeh aviors) Z olpidem A dult C N S side effect (C anaday, 2 notreported amnesia notreported 1996) Z olpidem A dult C N S side effect (M arkowitz 2 depression visualh allucination h allucinationceased & no h istory ofdrugabuse auditory h allucination Brewerton, concurrentuse ofantidepressants, confusion 1996) serotonin-reuptake inh ibitors difficulties atwork and marital Z olpidem A dult C N S side effect (Toner, 3 motorveh icle accidentor nigh tmare nigh tmares,h allucination 1999) psych iatrich istory h allucination and visualillusionceased visualillusion difficulty inconcentration Z olpidem A dult C N S side effect (Tripodina 1 no epilepticseiz ure nordrugabuse th e patients increased th e dose to notreported kis,2003) h istory 600mgperday epigastricpain,nausea,epileptic seiz ures and depression Z olpidem A dult delirium (F reudenre 1 depression agitated and confused notreported h allucination ich & disorganiz ed M enz a, visualh allucinations 2000) Insomnia 300 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 10. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Z olpidem A dult dependence (A ragona, 1 h istory ofdrugabuse th e patientincreased th e dose upto epilepticseiz ure 2000) seiz ure h istory after 450-600mgperdayforanxiolytic benz odiaz epine discontinuation effect. Z olpidem A dult dependence (L iappas, 3 h istory ofdrugabuse patients increased th e dose upto confusion,amnesia or 2003) 300-600mgforsedation,reductionof epilepticseiz ure cocaine craving,stimulation,or euph oria. K aravatos, dependence and tolerance & K aprinis, M ild to severe with drawalsyndrome 2000) afterdiscontinuation. Insomnia 301 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 10. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Z olpidem A dult dependence (Sh aran, 5 h istory ofdrug/alcoh oldependence dependence (includingsymptoms of 2 patients diagnosed with Elderly delirium 2007) and/ormentalillness (depression, with drawal,cravings, z olpidem dependence: bipolardisorder,late-onset appreh ension/anxiety,restlessness, both successfully psych osis) irritability,insomnia,palpitations) detoxified with elderly patients (3)alltaking10mg delirium (agitation,talking clonaz epam (8 mg/day), z olpidem (recommended dose for irrelevantly,unable to recogniz e with one ofth e two th e elderly is 5 mg) relatives,disorientation, relapsingafter3 month s auditory/visual/tactile h allucinations, 3 patients diagnosed with restlessness,violentbeh avior) delirium induced by z olpidem:symptoms subsided afterz olpidem was discontinued Z olpidem A dult dependence (K ao, 1 h istory ofsubstance abuse IV administrationforstimulanteffect yawning,rh inorrh ea and tolerance 2004) and euph oria and increased upto lacrimation 300-400 mg/day Z olpidem A dult dependence (Q uaglio et 2 no commonch aracteristics increasingtolerance no with drawal tolerance al. Z olpidem A dult h allucination (Van 2 one with outh istoryofpsych iatric h allucination notreported amnesia Puijenbroe disorders,th e oth erwith major amnesia k,Egberts, depressive disorderfor6 month & K rom, 1996) Insomnia 302 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 10. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Z olpidem A dult h allucination (H oyler, 1 h istory ofpoth yroidism,mild agitated and disoriented to time and regained h erorientation, C N S side effect Tekell,& vasculardementia,and auditory place responded to redirection, Silva, h allucinations h allucinationand increased was able to communicate 1996) psych omotoractivity ath erusuallevelof efficiency,and h erbiz arre beh aviorwas resolved Z olpidem A dult H epaticproblem (C lark, 1 livertransplantation decline inmentality notreported 1999) h epaticenceph alopath y abdominalpain awoke ina stuporand was disoriented to place and time Z olpidem A dult h epaticproblem (K arsenti, 1 ch olecystectomy abdominalpain notreported Blanc, h epatotoxicity Bacq,& M elman, 1999) Z olpidem A dult oth ers-drug (O rtega 1 longterm benz odiaz epine user nervousness,irritability,fainting, allsymptoms disappeared interaction 1996) no psych iatrich istory asth enia,muscularcramps, excessive h earand sweating occasionalfebrile episodes,weigh t loss,and a surprisingsweettaste in th e mouth Z olpidem A dult seiz ure (G ericke & 1 depression consumed 150-280 mg/dayfor recurrence ofdepressive dependence L udolph , no seiz ure h istory stimulanteffect mood with apath y and tolerance 1994) drugcarving Z olpidem A dult sensory distortions (Pies, 1 no h istory ofpsych osis or sensory distortions notreported tolerance 1995) substance abuse Z olpidem A dult sleeprelated eating (N ajjar, 1 46-yearold female sleeprelated eatingdisorderstarting complete recoveryafter disorder 2007) h istory ofdepression, 3 weeks afterstartingz olpidem, z olpidem was h ypoth yroidism,h ypertensionand resultinginweigh tgain(50 pounds discontinued insomnia overa one-yearperiod)and th e developmentofobstructive sleep apnea Z olpidem A dult somnambulism (H araz in& 1 depression somnambulism somnambulism stopped Berigan, 1999) Z olpidem A dult somnambulism (Sattar, 1 bipolardisorder somnambulism insomnia R amaswa h istory ofdrugabuse difficulty inconcentration my, h istory ofalcoh oldependence Bh atia,& mania Petty, takingvalproicatth e same time 2003) Insomnia 303 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 10. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Z olpidem A dult somnambulism (Y ang, 1 H eavy alcoh olconsumptionwith somnambulism no additionalepisodes of 2005) questionable delitium tremens but agitated and confused buth ad no sleepwalking h ad stopped drinkingalcoh ol20 psych oticexperiences years ago Traumatich ead injury Z olpidem A dult tolerance (C avallaro, 2 psych iatricdisorders increase dosage because of notreported 1993) tolerance with awakeningafter2-3 h. Z olpidem A dult abruption (A skew, 1 pregnantfemale cord blood testingresulted in with drawal-like symptoms vaginalspotting 2007) h istory ofz olpidem abuse (10–15 measurable z olpidem levels (possibly (nervousness,anxiety), periorbitalh eadach e tablets/nigh t) as h igh as peak plasma complained ofh eadach es abdominalpain concentrations aftera 5-mgdose of and inability to sleepafter respiratory problems th e drug),butno with drawal treatmentreduction trouble sleeping symptoms noted inth e neonate with drawal-like symptoms (nervousness, anxiety) Z olpidem A dult visualh allucinations (de H aas, 1 32-yearold male visualh allucinations starting20 adverse events subsided sleepiness 2007) negative psych iatricpersonalor minutes afterdrugintake and lasting aftera few h ours oftaking nausea family h istory 2 h ours th e medication diz z iness no concomitantmedicationorillicit sleepiness,nausea,diz z iness, diplopia drugs diplopia,and dysph asia (presentfor 3. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Z olpidem Elderly C N S side effect (Brodeur& 1 Extensive medicalh istory delirium notreported Stirling, psych osis 2001) restless amnesia Z olpidem Elderly delirium (H ill, 1 no significantpsych iatrich istory no h allucination notreported mania O berstar, family h istory ofmild depression no suicidalorh omicidalideation & Dunn, mania 2004) Z olpidem Elderly dependence (M adrak & 1 h istory ofalcoh oland drugabuse use upto 100mg/day forth e last1. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Z olpidem Pediatrics somnambulism (L ange, 1 depressive disorder somnambulism ch ange to citalopram 2005) h istory ofsomnambulism with outincident family h istory ofsomnambulism no epileptiform activity Z opiclone A dult dependence (A ranko, 1 depression th e patientincrease th e dose upto grand-mal-type convulsion H enriksso compulsive personality disorder 90mgperday foruninterrupted n,H ublin, h istory ofdrugabuse sleep. M emory difficulties & concurrentuse ofantidepressants cognitive impairments Seppalain dependence en,1991) Z opiclone A dult dependence (H aasen, 1 no h istory ofbenz odiaz epine or dependence R emainsymptom: M ueller- oth erpsych otropicsubstance use daily dosage of37. Z opiclone A dult dependence (Th akore & 1 depression dependence tach ycardia Dinan, h istory ofalcoh oldependency h and tremor 1992) h istory offluraz epam addiction weakness take z opiclone more due to anxiety panicattack and agoraph obia Insomnia 306 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 10. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Z opiclone A dult extreme agitation (M oloney, 2 3-month h istory ofdepression one patientdeveloped insomnia, afterz opiclone was 2007) concomitantalpraz olam and restlessness,agitation,and a with drawn,adverse antidepressantmedication complete inability to relax3 weeks events resolved with in24- afterstartingz opiclone 48 h ours A noth erpatientbecame extremely agitated,developed forgetfulness, inabilityto sitstill,insomnia, nocturnalwandering,and racing th ough ts one week afterstarting z opiclone Z opiclone A dult globalamnesia (F ava, 1 no currentpsych iatric globalamnesia no furth erepisodes of 1996) symptomatology globalamnesia were no drinkingh istory observed duringa 6- no oth ermedication month period Z opiclone A dult incidence ofcancer (Stebbing 32 notreported 2 weeks ofz opiclone. C ase R eports Drug Sub-group A dverse Events Study # of C ase C h aracteristics Effects during treatm ent Effects during treatm ent cases reductionor discontinuation Z opiclone Elderly respiratory (Vogal, 1 C O PD drowsy notreported depression 1998) ex-smokerwith a h istory ofeth anol respiratory acidosis abuse Z opiclone Pediatrics oth ers (Sullivan, 3 h istory ofdrugabuse no evidence ofdependence notreported M cBride,& alcoh olabuse C lee, 1995) A lderman,C. A buse,dependence,and epilepticseizuresafterzolpidem with drawal:R eview and case report. M isuse ofzopiclone and convulsionsduringwith drawal. F ataloverdose ofzopiclone inanelderly womanwith bronch ogeniccarcinoma. A mnesiapossibly associated with zolpidem administration. W orseningh epaticenceph alopath y secondary to zolpidem. Z olpidem-associated h allucinationsand serotoninreuptake inh ibition:apossible interaction. A mnesticsyndrome induced by zopiclone EuropeanJournalofC linicalPh armacology,50(6),509. Z olpidem-related delirium:A case reportJournalofC linicalPsych iatry,61(6),449-450. Z opiclone dependence afterinsomniarelated to torticollis. Z olpidem-Induced Delirium with M aniainanElderly W oman. Journalofth eA mericanA cademy ofC h ild & A dolescentPsych iatry,44(3),211-212. Insomnia 308 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 10. Z aleplonoverdose associated with sleepwalkingand complexbeh avior. Journalofth eA mericanA cademy of C h ild and A dolescentPsych iatry,43(8),927-928. Z olpidem abuse A mericanJournalofPsych iatry,158(8),1330-1331. Z olpidem and h allucinationsA nnalsofEmergency M edicine,29(2),300-301. Z olpidem-induced psych osisinanolderwomanJournalofth eA mericanG eriatrics Society,45(4),533-534. Dependence onzolpidem:Two case reportsofdetoxification with flumazenilinfusion. Somnambulism due to probable interactionofvalproicacid and zolpidem. Incidence ofcancerinindividualsreceivingch ronic zopiclone oreszopiclone requiresprospective study. Z opiclone abuse inSouth W ales:Th ree case reports. Ph ysicaldependence followingzopiclone usage:A case report. V isualh allucinationsand amnesiaassociated with th e use ofzolpidem International JournalofC linicalPh armacology and Th erapeutics,34,318% N 317. The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Mark Helfand, MD, MPH Kim Peterson, MS Drug Effectiveness Review Project Marian McDonagh, PharmD, Principal Investigator Oregon Evidence-based Practice Center Mark Helfand, MD, MPH, Director Oregon Health & Science University Copyright © 2009 by Oregon Health & Science University Portland, Oregon 97239. Final Report Update 4 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION.......................................................................................................................... How do effectiveness and efficacy outcomes (reduced severity and duration of symptoms, functional outcomes, quality of life, etc) differ for adult patients with migraine?............. Placebo-controlled trials: Rizatriptan orally disintegrating tablet.............................................. Zolmitriptan: Oral tablet, orally disintegrating tablet, nasal spray................................................. Direct comparisons: Zolmitriptan orally disintegrating tablets and nasal spray........................

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