Januvia

By E. Ramon. James Madison University.

Overall buy discount januvia 100mg blood sugar not going down, Multicenter assessed by coronary there were 15 events in the simvastatin and 19 Coronary angiography cheap januvia 100mg on-line diabetic ulcer of foot icd 9. Per-patient change in percent N/A Cardiac and noncardiac 22 lovastatin vs. Placebo-controlled trials of patients with atherosclerosis Author Year Study Name Comments/Conclusions Bestehorn et al. There were no statistical differences in clinical events 1997 in the simvastatin vs. Fair to poor in Multicenter quality to assess differences in clinical event due to Coronary duration of trial, however was a relatively small Intervention Study sample size. MARS was not designed with sufficient power to 1993 detect differences in clinical events. However there The Monitored was a trend in favor of lovastatin. Fair-poor in quality Atherosclerosis to assess differences in clinical events. The Pravastatin, only significant difference was in the combined Lipids, and endpoint of nonfatal MI plus any deaths. Not much Atherosclerosis in detail provided in clinical event section, for the Carotid observation of other clinical events that were not Arteries significantly reduced with pravastatin. Fair-poor in (PLAC-II) quality to assess difference in clinical events. BID=twice a day, CHD=coronary heart disease, IMT=intimal-medial thickness, MLD=minimum lumen diameter, MI=myocardial infarction, qpm=every evening Statins Page 238 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. Placebo-controlled trials of patients with atherosclerosis Author Study Mean Percent LDL- Year Patient Duration Baseline LDL- c Reduction Study Name Study Characteristics Characteristics Intervention (mean) c from baseline Furberg et al. Lovastatin was randomized Progression Study treat analysis. Placebo-controlled trials of patients with atherosclerosis Author Primary Endpoint Year Results (clinical Clinical Outcomes Study Name Primary Endpoint health outcome only) Measured Clinical Outcome Results Furberg et al. Overall mortality: One death walls, near and far, of the events. All 6 cardiovascular deaths occurred bilaterally measured by B-mode in lovastatin-placebo groups. Time to Coronary assessed by coronary peripheral vascular, and these events showed a trend towards benefit Atherosclerosis angiography. Need for revascularization was Study (LCAS) first CABG, PTCA, MI, reduced with fluvastatin 8. Although Statin Study obstruction diameter per patient nonscheduled PTCA or nonsignificant, there were 12 nonfatal MI in the (REGRESS) determined by coronary CABG, Stroke or TIA, and placebo vs. Unscheduled PTCA were reduced significantly in the pravastatin vs. BID=twice a day, CHD=coronary heart disease, IMT=intimal-medial thickness, MLD=minimum lumen diameter, MI=myocardial infarction, qpm=every evening Statins Page 240 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. Placebo-controlled trials of patients with atherosclerosis Author Year Study Name Comments/Conclusions Furberg et al. Carotid Artery the lovastatin-placebo groups in patients with early Progression Study carotid atherosclerosis. Fair-good in quality to (ACAPS) determine differences in clinical events. However, there Coronary was a trend observed in favor of fluvastatin. In this Atherosclerosis study, there were 909 patients screened, but only 429 Study (LCAS) randomized. The major reasons were for lipid ineligibility and lack of cooperation. There were some minor difference in baseline characteristics between groups.

W h ite Ptswith historyof allergytoanyof thepotentialstudym edications purchase 100 mg januvia diabetes test questionnaire,pregnancy discount januvia 100 mg with mastercard diabetes mellitus type 2 cpt code,breastfeeding, N R /N o N R /N R /220 15/N R /205 2006 activem enstruation,vom iting orretching within24h beforetheoperation,adm inistrationof antiem etic or M ulticenter antiem etic orpsychoactivem edicationwithin24h beforesurgery,ahistoryof severe(or psychoactive U SA unstable)cardiovascular,respiratory,m etabolic,endocrineorneurologic disease,active m edication alcoholordrug abuse,aswellasim pairedrenalorhepatic function. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A ttrition A uth or G roups Eligibility C rossover Y ear sim ilarat criteria C are provider Patients A dh erence L oss to Setting R andom iz ation A llocation baseline specified m asked m asked C ontam ination follow up Janicki Yes N R Yes Yes Yes Yes Yes L ow 2006 N o HersheyM edical Yes Center N o N aguib N R N R Yes Yes N R ,"double N R Yes N o 1996 blind" N o N R N o N o K h an Yes N R Yes Yes N R N R N R N R 2005 N R G eneralhospital N R N R O ksuz Yes Yes Yes Yes Yes Yes Yes N o 2007 N R N R N R N R W h ite Yes Yes Yes Yes Yes Yes Yes N o 2006 N R M ulticenter N R U SA N R O ndansetron: O DT vs IV Dem iraran Yes N R Yes Yes Yes Yes Yes N R 2005 N R SingleSite N R Turkey N R Antiemetics Page 375 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Y ear Intention-to-treat Postram dom iz ation C ontrolled group Setting analysis exclusions Q uality rating standard ofcare F unding Janicki N R N O F air N o R ocheL aboratories 2006 HersheyM edical Center N aguib Yes N o F air Yes N R 1996 N R K h an N R N o Poor Yes N R 2005 G eneralhospital O ksuz N R N o F air Yes N R 2007 N R W h ite N R N o F air N o W hiteM ountainInstitute 2006 M ulticenter U SA O ndansetron: O DT vs IV Dem iraran N R N o F air Yes N R 2005 SingleSite Turkey Antiemetics Page 376 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Screened/ W ith drawn/ Y ear R un-in/W ash Eligible/ L ostto fu/ Setting Exclusioncriteria out Enrolled A nalyz ed Pirat Ptswith historyof m otionsicknessorPO N V,preoperativepruritus,treatm entwith opioidsor N R /N o N R /N R /150 N R /N R /150 2005 antiem eticswithin48hoursof surgery,hypersensitivitytoondansetron,m orphine,or antiem etic N R bupivacaine,andcontraindicationfororrefusalorspinalanesthesia. Casesinwhich dural within48hours puncturecouldnotbeperform edoropioidswererequiredtocontrolintraoperativeor of surgery postoperativepainwerealsoex cluded. A prepitantvs ondansetron Diem unsch E x clusioncriteriaincludedpregnancy/breastfeeding status,needforanasogastric ororal- N o/no 1004/N R /922 56/0/304 for 2007 gastric tube,useof neuroax ial-orpropofol-m aintainedanaesthesia,vom iting within24h prophylactic safety and 866 M ulticenter beforesurgeryorof anyorganic aetiology,allergytoanym edicationstobeusedbefore antiem etics operationorintra-operatively,pre-establishedneedforintensivecareorstep-downunitcare within24h for efficacy afteroperation,evidenceof diseaseorhistoryof illnesswhich according totheinvestigator beforesurgery renderedthepatientinappropriateforthestudy,abnorm alpreoperativelaboratoryvalues (aspartateam inotransferase>2. M edicationsknowntoinduce CYP3A4wereprohibitedwithin30daysof thestudystartandCYP3A4inhibitorswere prohibited7daysbeforestartof study. G an Patientswhowerepregnantorbreast-feeding,undergoing surgeryrequiring routine N o/no 903/N R 805 72/0/766for 2007 placem entof anasogastric ororal-gastric tube,orreceiving spinalregionalorpropofol- prophylactic safety,733for M ulticenter m aintainedanesthesia. Ptswhom werevom iting of anyorganic etiology,hadvom itedforany antiem etics efficacy reasonwithin24hoursof surgery,orhadabnorm allaboratoryvaluesasspecifiedbythe within24hours protocol(alanineam inotransferaseof aspartateam inotransferase>2. Thosetaking m edicationsm etaboliz edbyCYP3A4wereex cluded. Dolvs G ranvs O nd Antiemetics Page 377 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A ttrition A uth or G roups Eligibility C rossover Y ear sim ilarat criteria C are provider Patients A dh erence L oss to Setting R andom iz ation A llocation baseline specified m asked m asked C ontam ination follow up Pirat Yes Yes Yes Yes Yes Yes N R N o 2005 N R N R N R N R A prepitantvs ondansetron Diem unsch Yes Yes Yes Yes Yes Yes Yes N o 2007 N o M ulticenter Yes N R G an Yes Yes Yes Yes Yes Yes Yes N o 2007 N o M ulticenter Yes Yes Dolvs G ranvs O nd Antiemetics Page 378 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Y ear Intention-to-treat Postram dom iz ation C ontrolled group Setting analysis exclusions Q uality rating standard ofcare F unding Pirat N R N o F air Yes N R 2005 N R A prepitantvs ondansetron Diem unsch 30/922 (3. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Screened/ W ith drawn/ Y ear R un-in/W ash Eligible/ L ostto fu/ Setting Exclusioncriteria out Enrolled A nalyz ed C h ildren Dolvs O nd K aram anlioglu Childrenwhoreceivedantiem eticsorantihistam inesinthe24h beforesurgerywereex cluded, N one/N A N R /N R /150 0/0/150 2003 aswerechildrenwith diabetesm ellitusorgastro-esophagealreflux. Anychildunableto swallow them ethylenebluecapsuleorthestudydrugsorwhovom itedthem beforethe inductionof anesthesiawasex cludedfrom thestudy. O lutoye Ptswith ASA physicalstatusof ≥ III,aprevioushistoryof gastroesophagealreflux ,vom iting N o/N o N R /225/216 9/3/204 2003 from organic causes,obesity(>95th percentileof weightforage),em ergencysurgery, SingleCenter antiem etic therapywithin24h beforesurgeryortheuseof neurax ialanesthesiaordrugs knowntohaveantiem etic effects(e. Childrenundergoing tonsillectom y andadenoidectom yprocedureswereex cludedbecausetheyroutinelyreceivesteroidsatthis institution. A historyof PO V orm otionsicknesswasnotedduring thepreanaesthetic evaluationbutdidnotprecludeenrollm ent. Sukhani Childrenwhoreceivedantiem etics,antihistam inics,orpsychoactivedrugswithin24h before N o/N R N R /N R /150 1/2/147 2002 surgerywereex cluded. Antiemetics Page 383 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A ttrition A uth or G roups Eligibility C rossover Y ear sim ilarat criteria C are provider Patients A dh erence L oss to Setting R andom iz ation A llocation baseline specified m asked m asked C ontam ination follow up C h ildren Dolvs O nd K aram anlioglu Yes N R Yes Yes Yes Yes Yes N o 2003 N o N o N o O lutoye Yes N R Yes Yes Yes N R Yes N o 2003 N o SingleCenter N o N o Sukhani N R N R Yes Yes Yes Yes Yes N o 2002 N o SingleCenter N o N o Antiemetics Page 384 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 10. Q uality assessm entofth e h ead-to-h ead trials forth e preventionofpostoperative nauseaand vom iting A uth or Y ear Intention-to-treat Postram dom iz ation C ontrolled group Setting analysis exclusions Q uality rating standard ofcare F unding C h ildren Dolvs O nd K aram anlioglu Yes N o F air Yes N R 2003 O lutoye N o,lostn= 9forprotocol Yes F air Yes N R 2003 violation,attritionn= 3 SingleCenter Sukhani Yes Yes F air Yes N R 2002 SingleCenter Antiemetics Page 385 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 11. Preventionofpostoperative nauseaand vom iting:A ctive-controland placebo-controlled trials A uth or Y ear Design Surgery type Inclusioncriteria Intervention Setting A dults:A ctive- controlled trials Dolasetron A:D ol12. Preventionofpostoperative nauseaand vom iting:A ctive-controland placebo-controlled trials A uth or A ge/ Screened/ R un-in/ Y ear A llow oth erm edication G ender/ O th erpopulationch aracteristics Eligible/ W ash out Setting Eth nicity Enrolled A dults:A ctive- controlled trials Dolasetron Historyof PO N V:35% M eanage:48y Burm eister R ange:20-77y Historyof m otionsickness:27. Preventionofpostoperative nauseaand vom iting:A ctive-controland placebo-controlled trials A uth or W ith drawn/ Y ear L ostto fu/ R esults -Satisfaction R esults -R esource utiliz ation Setting A nalyz ed A dults:A ctive- controlled trials Dolasetron Ptrating foranagesic properties,A vsB,p= 0. Preventionofpostoperative nauseaand vom iting:A ctive-controland placebo-controlled trials A uth or Y ear Design Surgery type Inclusioncriteria Intervention Setting A:O nd4m g iv+sham electro- G an Consecutivenon-pregnantpts acupointstim ulation M ajorbreastsurgery(100%) 2004 ACT of ASA I,II,orII statuswithout B:activeelectro-acupoint SingleCenter D B pacem akersandwhowere stim ulation D urationof surgery:210. Preventionofpostoperative nauseaand vom iting:A ctive-controland placebo-controlled trials A uth or A ge/ Screened/ R un-in/ Y ear A llow oth erm edication G ender/ O th erpopulationch aracteristics Eligible/ W ash out Setting Eth nicity Enrolled M eanAge:45. Preventionofpostoperative nauseaand vom iting:A ctive-controland placebo-controlled trials A uth or W ith drawn/ Y ear L ostto fu/ R esults -Satisfaction R esults -R esource utiliz ation Setting A nalyz ed M eanscoreforPatientSatisfaction(onscaleof 0-10,with 10 G an being m ostsatisfied) 2004 A:10(range:8-10) 2/0/75 N R SingleCenter B:8. C Patientsatisfaction(score:0-10"m ostsatisfied") J okela A:9(range:0-10) 2002 21/N R /179 B:9(range:0--10) N R M ulticenter C:10(range:0-10),p = 0. Preventionofpostoperative nauseaand vom iting:A ctive-controland placebo-controlled trials A uth or Y ear Design Surgery type Inclusioncriteria Intervention Setting Studygroup:IV dex am ethasone 8m g in2m L volum eafter successfulintubation,andIV ondansetron4m g within15m in beforetrachealex tubationatthe endof anesthesia,thenO D T of ASA I-II patientsundergoing ondansetron8m g atthetim eof outpatientlaparoscopic dischargefrom PACU andonthe gynecologicalsurgerieswith Pan m orning of postoperativeday1 generalanesthesia;aged 2008 and2athom e. R CT,D B L aparoscopic gynecologicalsurgeries >18years;having allthree TwoSites patientspecific em etic risk U S Controlgroup:IV placeboof 2m L factors;abilitytofollow study norm alsalineaftersuccessful protocolinstructions;andwilling intubation,andIV ondansetron tocom pletethedailydiary 4m g within15m inbeforetracheal ex tubationatendof anesthesia, thenplaceboO D T atdischarge andonthem orning of postoperativeday1and2at hom e. A:30% ox ygeninnitrogenand ASA I-III fem alesaged18-75 Purhonen saline2m li.

Peginterferon alfa-2a in patients with interferon discount januvia 100 mg visa diabetes prevention natural, monotherapy only) chronic hepatitis C purchase januvia 100mg with visa diabetes ii. Pegylated interferons in the treatment No original data (e. Pegylated interferons for hepatitis C Page 63 of 65 Final Report Drug Effectiveness Review Project A ppendix D. U npublish ed trials ofpegylated interferons forch ronich epatitis C infection Population ch aracteristics/ W ith drawals due to Study,year N C om parison Interventions N otes SVR A Es Studies ofpeginterferonalfa-2b C respo,2006 121 Peginterferonvs A :Peginterferonalfa-2b1. U npublish ed trials ofpegylated interferons forch ronich epatitis C infection Population ch aracteristics/ W ith drawals due to Study,year N C om parison Interventions N otes SVR A Es M arcellin, 377 Treatment A :Peginterferonalfa-2a 180 Treatmentnaïve A vs B vs C vs D: N otreported 2003 durationand µg/week plus ribavirin800 mgx C ompensated cirrh osis (O verallresults notreported) ribavirindose 24 weeks G enotype 1:26% vs 26% vs B:Peginterferonalfa-2a 180 28% vs 37% µg/week plus ribavirin1000-1200 G enotype non-1:71% vs mgx24 weeks 75% vs 67% vs 73% C :Peginterferonalfa-2a 180 µg/week plus ribavirin800 mgx 48 weeks D:Peginterferonalfa-2a 180 µg/week plus ribavirin1000-1200 mgx48 weeks Jensen,2006 950 Dose and A :Peginterferonalfa-2a 360 Patients wh o lacked R esults forSVR (72 weeks) N otreported duration µg/week x12 weeks followed by virologicresonse after notyetavailable. 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. Kimberly Peterson, MS Marian McDonagh, PharmD Susan Carson, MPH Sujata Thakurta, MPA: HA Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Copyright © 2008 by Oregon Health & Science University Portland, Oregon 97239. Final Report Update 1 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION.......................................................................................................................... Antiemetic drug indications approved by the US Food and Drug Administration........................... Quantity of head-to-head trials in adults undergoing chemotherapy........................................... Complete response rates for antiemetics in adults undergoing chemotherapy............................ Outcomes of head-to-head trials of dolasetron compared with ondansetron in adults................ Complete response rates with single-dose intravenous palonosetron 0. Quality-of-life outcomes in active-control trials of ondansetron.................................................... Rates of common adverse events in head-to-head trials of newer antiemetic drugs................... Relative risk of complete response at 24 hours: Palonosetron compared with ondansetron or dolasetron.................................................................................................................................................... US Food and Drug Administration recommendations for adult dosages............................... US Food and Drug Administration recommendations for pediatric dosages......................... Antiemetics Page 3 of 136 Final Report Update 1 Drug Effectiveness Review Project Note: A scan of the medical literature relating to the topic is done periodically (see the Drug Effectiveness Review Project website at http://www. The Drug Effectiveness Review Project governance group elected to proceed with another update of this report. Please see the timeline on the DERP website for details on the date of its release. Prior versions of this report can be accessed at the DERP website. Suggested citation for this report: Peterson K, McDonagh MS, Carson S, Thakurta S. These organizations selected the topic and had input into the key questions for this review. The content and conclusions of the review are 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. Antiemetics Page 4 of 136 Final Report Update 1 Drug Effectiveness Review Project INTRODUCTION Nausea and vomiting are major concerns for patients undergoing chemotherapy and radiation 1, 2 therapy. Risk factors associated with chemotherapy-induced nausea and vomiting include emetogenicity of the chemotherapy regimen, dose, speed of intravenous infusion, female gender, 3 age under 50 years, history of ethanol consumption, and history of prior chemotherapy. Factors predictive of radiation therapy-induced nausea and vomiting include site of irradiation (in particular, total body irradiation and radiation fields that include the abdomen), total field size, dose per fraction, age, and predisposition for emesis (history of sickness during pregnancy or 2 motion sickness). Secondary risks associated with nausea and vomiting induced by chemotherapy and radiation therapy include electrolyte imbalance, aspiration pneumonia, interruption of potentially curative therapy, and reduction in quality of life. Nausea and vomiting are also frequently associated with surgical procedures.