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Adverse event: A harmful or undesirable outcome that occurs during or after the use of a drug or intervention but is not necessarily caused by it cheap 5mg cialis. Adverse effect: An adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility discount cialis 20 mg. Active-control trial: A trial comparing a drug in a particular class or group with a drug outside of that class or group. Allocation concealment: The process by which the person determining randomization is blinded to a study participant’s group allocation. Applicability: see External Validity Before-after study: A type nonrandomized study where data are collected before and after patients receive an intervention. Before-after studies can have a single arm or can include a control group. Bias: A systematic error or deviation in results or inferences from the truth. Several types of bias can appear in published trials, including selection bias, performance bias, detection bias, and reporting bias. Bioequivalence: Drug products that contain the same compound in the same amount that meet current official standards, that, when administered to the same person in the same dosage regimen result in equivalent concentrations of drug in blood and tissue. Black box warning: A type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning. A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The US Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. Blinding: A way of making sure that the people involved in a research study — participants, clinicians, or researchers —do not know which participants are assigned to each study group. Blinding usually is used in research studies that compare two or more types of treatment for an illness. Long-acting opioid analgesics 46 of 74 Final Update 6 Report Drug Effectiveness Review Project Case series: A study reporting observations on a series of patients receiving the same intervention with no control group. Case study: A study reporting observations on a single patient. Case-control study: A study that compares people with a specific disease or outcome of interest (cases) to people from the same population without that disease or outcome (controls). Clinical diversity: Differences between studies in key characteristics of the participants, interventions or outcome measures. Clinically significant: A result that is large enough to affect a patient’s disease state in a manner that is noticeable to the patient and/or a caregiver. Cohort study: An observational study in which a defined group of people (the cohort) is followed over time and compared with a group of people who were exposed or not exposed to a particular intervention or other factor of interest. A prospective cohort study assembles participants and follows them into the future. A retrospective cohort study identifies subjects from past records and follows them from the time of those records to the present. Combination Therapy: The use of two or more therapies and especially drugs to treat a disease or condition. Confidence interval: The range of values calculated from the data such that there is a level of confidence, or certainty, that it contains the true value. The 95% confidence interval is generally used in Drug Effectiveness Review Project reports. If the report were hypothetically repeated on a collection of 100 random samples of studies, the resulting 95% confidence intervals would include the true population value 95% of the time. Confounder: A factor that is associated with both an intervention and an outcome of interest. Controlled clinical trial: A clinical trial that includes a control group but no or inadequate methods of randomization.

A randomized trial of the effects of rosiglitazone and metformin on inflammation and subclinical atherosclerosis in patients with type 2 diabetes discount cialis 20 mg without prescription. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis order 10mg cialis fast delivery. Combination therapy for type 2 diabetes: repaglinide plus rosiglitazone. Differential effect of glimepiride and rosiglitazone on metabolic control of type 2 diabetic patients treated with metformin: a randomized, double-blind, clinical trial. Influence of glucose control and improvement of insulin resistance on microvascular blood flow and endothelial function in patients with diabetes mellitus type 2. Impact of rosiglitazone on glycaemic control, insulin levels and blood pressure values in patients with type 2 diabetes. 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. Dan Jonas, MD, MPH Erin Van Scoyoc, MD, MPH Kate Gerrald, PharmD, BCPS Roberta Wines, MPH Halle Amick, MSPH Matthew Triplette, MPH Thomas Runge, MPH Produced by RTI-UNC Evidence-based Practice Center Cecil G. Sheps Center for Health Services Research University of North Carolina at Chapel Hill Tim Carey, M. Acknowledgments We thank Leah Williams, our publications editor, for putting this report into its present form for you to read. We also thank Patricia Thieda and Shannon Brode for assistance with data abstraction, Megan Van Noord for conducting literature searches, and Claire Baker for retrieval of articles and data entry. We extend our appreciation to the clinical advisors listed below for their thoughtful advice and input during our research process. Marshall Dahl, MD University of British Columbia Diane Elson, MD University of Wisconsin, Madison Suggested citation for this report Jonas D, Van Scoyoc E, Gerrald K, Wines R, Amick H, Runge T, Triplette M. Drug class review: Newer diabetes medications, TZDs, and combinations. These organizations selected the topic of the report and had input into its Key Questions. The content and conclusions of the report were entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report. STRUCTURED ABSTRACT Purpose To compare the effectiveness and adverse event profiles of amylin agonists, DPP-4 inhibitors, incretin mimetics, TZDs, and certain combination products for people with type 2 diabetes and for people with type 1 diabetes for pramlintide only. Data Sources To identify published studies, we searched MEDLINE, The Cochrane Library, Embase, International Pharmaceutical Abstracts, and reference lists of included studies through July 2010. We also requested dossiers of information from pharmaceutical manufacturers. Review Methods Study selection, data abstraction, validity assessment, grading the strength of the evidence (SOE), and data synthesis were all carried out according to standard Drug Effectiveness Review Project methods. Results Most of the evidence was limited to adult populations. Most of the included studies evaluated intermediate outcomes, such as HbA1c or weight. Very few studies reported health outcomes and few studies were longer than 6 months. For the amylin agonists, DPP-IV inhibitors, and GLP-1 agonists, we found no studies that focused on health outcomes as primary outcomes. Some studies of these drug classes reported some health outcomes such as all-cause mortality or number of people with macrovascular disease among secondary outcomes or adverse events, but overall evidence was generally insufficient to determine how medications in these classes compare with other treatments for their impact on health outcomes. For the newer diabetes drugs (pramlintide, sitagliptin, saxagliptin, exenatide, and liraglutide), all of the included medications were efficacious for reducing HbA1c compared with placebo. For reduction in HbA1c, pramlintide was similar to rapid acting insulin analog when added to insulin glargine or detemir (low SOE); sitagliptin monotherapy was less efficacious than metformin or glipizide monotherapy (low SOE); sitagliptin was not significantly different than rosiglitazone when either was added to metformin (moderate SOE); and there was no comparative evidence for saxagliptin (insufficient SOE).

Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy order cialis 5mg with mastercard, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics L osin R andomiz ed A : C h lorz oxaz one cialis 2.5mg amex, C h ildrenwith 30 M eanage (years): 10 107 average dose of20 severe spasticity, F emale gender: 37% 1966 U nited States mg/lb. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events L osin L imbposture,passive stretch resistance,pain: PO O R. G eneralnursingcare,feeding: Spasticity severity brownurine (5/0) increase for2/3 onch lorz oxaz one;no placebo Timingofassessmentnotreported data provided;no F eedingdata provided Serious adverse events (resulting indeath ): aspirationpneumonia (1/2) L uisto Spasticity: 1 (flaccid)to 6 (marked) F A IR. A ctivities ofdaily living: N o improvementoneith er 35% treatment Drowsiness:15/17 vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics M cK inlay R andomiz ed A : Bacofen0. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events M cK inlay M uscle tone: A sh worth scale F A IR. C linicalglobalimpressionscale (moderate of Diz z iness: 6/20 vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events M eyth aler M uscle Tone: A sh worth scale F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics M onster R andomiz ed A : Dantrolene 50 mg Patients with 200 A ge: R ange from 35 to 50 years dependingonunderlying 96 crossovertrial Q IDtitrated to 100 mg spasticity of diagnosis 1974 Q ID various causes 147 F emale gender: A bout50% U. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events M onster O verallclinicalresponse (O C R ): measured by F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics N ogen R andomiz ed trial A : Dantrolene titrated Pediatricpatients 21 A ge range: 7 month s to 19 years 97 to 5. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events N ogen Spasticity: U nspecified meth od F A IR. Passive movementresistance: insignificant F atigue:5/14 vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Sach ais R andomiz ed trial A :Baclofen,5 mgtid Inpatientor 166 M eanage=43 84 (outpatients)or10 mg outpatientadults 59% F emale 1977 U nited States tid (inpatients)titrated (18 years orolder) 106 92% W h ite to 70-80mg/day Spasticity 87% O utpatient M ulticenter secondary to M S B: Placebo (durationnot M ultiple Sclerosis C ombined inpatient specified) M eanDisease Duration-11 years and outpatientsetting 2-week titration,5- O ne-M onth Spasticity Stabiliz ation-70% week intervention Q uadraplegia -10/5 Paraplegia -30/33 H emiplegia -6/3 Previous muscle relaxantuse notreported Skeletal Muscle Relaxants Page 157 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Sach ais M entalState (Depression,Euph oria,Irritability); F A IR. Ph ysicianG lobalImpressions (5=marked; G lobalDisease Severity: -0. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Sawa R andomiz ed A : Baclofen5mgTID Patients with 21 M eanage of49 formales and 36 forfemales 85 crossovertrial titrated to a maximum clinically definite 29% male 1979 of60mg M S ofch ronic 18 R ace notreported C anada myelopath y B: Placebo (presumed M S) C linically definite M S ofch ronicmyelopath y (presumed M S) Single center M eandurationofillness of14 years formales and 9 years for 21-days intervention, females 7-days wash out,21- days crossover Previous muscle relaxantuse notreported Sh eplan R andomiz ed trial A : Dantrolene titrated M ales with N otreported M eanage=47. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Sawa Spasticity:0 (normal)to 5 (inth e absence of F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Smith R andomiz ed trial A :Tiz anidine titrated Patients with 256 M eanage (years): 45. M ulticenter(14) B:Placebo M uscle spasticity secondary to M S A verage baseline spasticity severity values 2 weeks titration,9 Tiz anidine -12. Tolosa R andomiz ed trial A : Dantrolene 25mg Patients with 23 A ge,genderand race notreported 99 Q IDtitrated to multiple sclerosis 1975 U nited States maximum 800 mg/day 23 M ultiple sclerosis 48% severely disabled/confined to wh eelch air Single center B: Placebo Previous muscle relaxantuse notreported 8 weeks intervention Skeletal Muscle Relaxants Page 161 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Smith Primary Efficacy: M eanmuscle tone (A sh worth F A IR. M eth od of M uscle tone/spasticity (ch ange inA sh worth score, (25% )vs. U nspecified (N S) pain/disability secondary to muscle suspected treatment Spasms/clonus daily count(percent A ny adverse event: 101/111(91% ) spasm/clonus (0-2 scale),muscle strength crossoverdeviations improvement): -61 vs. W ith drawals (adverse events): 2/12 (weakness,diarrh ea)vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics U nited R andomiz ed trial A :Tiz anidine mean Spasticity due to 187 M eanage (years):47 vs. A lloth er patients,except1 (placebo),h ad previously takenoth er unspecified medication(s)forspasticity. W eiser R andomiz ed A : Dantrolene 25 mg Symptomatic 35 A ge range: 28 to 76 100 crossovertrial qid titrated to 100 mg lowerlimb F emale gender: 21/35 1978 qid spasticity from 27 R ace notreported U nited K ingdom spinalcord injury B: Placebo M ultiple sclerosis: 9/35 Single center M yelopath y: 11/35 4 weeks intervention, H ereditary spasticparaplegia: 8/35 1 week wash out,4 Syringomyelia: 4/35 weeks crossover O th er: 3/35 Severity and durationnotreported Skeletal Muscle Relaxants Page 163 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4.

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