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With reduced renal function discount 40 mg citalopram amex symptoms vaginal yeast infection, use half-dose with creatinine clearance of 15 to 50 ml/min order citalopram 20 mg amex medicine dictionary. High intravenous doses also cause myelotoxicity (anemia, neu- tropenia), nausea, vomiting, headache, raised transaminases. Treatment can often be continued in cases of mild allergy. Suspension for children can be used for desensitization. Co-trimoxazole can increase levels of anticoagulants and phenytoin and reduce the efficacy of oral contraceptives. In view of the side effects seen with the drug, the EMA recommended in February 2011 that the drug “should only be used when there are no appropriate alternatives, and for the shortest possible time”. Peripheral neuropathy, especially in combination with ddI (up to 24%). Less frequent: diarrhea, nausea, headache, hepatic steatosis and pancreatitis. Very rare, but potentially fatal are lactic acidosis, which occurs mostly in combination with ddI (especially in pregnancy). Drug Profiles 687 Comments: this thymidine analog was long-considered an important alternative to AZT. Due to the mitochondrial toxicity, the use of d4T is no longer recommended. Since 2011, use is severely restricted in both adults and children. For detailed information see page: 74 Daclatasvir Manufacturer: Bristol-Myers Squibb. Indications and trade name: chronic hepatitis C, used in different combinations depending on the genotype (GT) being targeted. Europe: GT1 or GT4 without cirrhosis: daclatasvir + sofosbuvir 12 weeks (cirrhosis 24 weeks, shortening to 12 weeks may be considered for previously untreated patients with low baseline viral load). GT3 with compensated cirrhosis and/or treatment experienced: daclatasvir + sofosbuvir + ribavirin 24 weeks. In the US, daclatasvir is approved for GT3 only (+ sofosbuvir, 12 weeks). Dosage should be reduced to 30 mg QD with regimens containing ritonavir or cobicistat and increased to 90 mg QD with NNRTIs except rilpivirine. No dose adjustment is required for patients with renal impairment. Interactions, warnings: duration and combination depend on prior treatment, liver function and HCV genotypes. Dose adjustments required in combination with boosted PIs, cobicistat, and several NNRTIs. Coadministration with strong CYP3A4 inducers and P-glycoprotein transporters should be avoided. These include but are not limited to phenytoin, carbamazepine, rifampicin, rifabutin, and the herbal product St John’s wort. Comments: this pan-genotypic NS5A replication complex inhibitor was approved in 2014. Efficacy in HIV-coinfected patients was shown in the ALLY-2 trial. Should be initiated and monitored by a physician experienced in the management of HIV/HCV coinfection. For detailed information see page: 459 Dapsone Manufacturer: Fatol. Indications: rarely used reserve drug for prophylaxis of PCP and cerebral toxoplas- mosis. Other (rare) areas of application are in dermatology (bullous pemphigoid), rheumatology and leprosy. Alternative: 50 mg QD + pyrimethamine 50 mg/week + folinic acid 30 mg/week. Frequently hemolytic anemia (with almost obligatory elevation of LDH), hepatitis. Comments: dapsone is contraindicated in severe anemia and must be used with caution in G6PD deficiency. Not to be taken simultaneously with ddI, antacids or H2 blockers (to be taken at least two hours apart). Indications and trade names: to be used in either ART-naïve or pretreated HIV patients, adults and children. In patients with extensive pretreatment (and/or limited resistance mutations), it is recommended to use 600 mg BID (1 tablet of 600 mg) + 100 mg ritonavir BID. In 2009, darunavir was also approved for children aged 6 years and older. Recommended dosage is 375/50 mg BID (Wt 20 kg to <30 kg), 450/60 BID (Wt 30 kg to <40 kg).

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Patients with a higher BMI experienced greater weight loss order citalopram 20mg with visa medicine and health. Consistently proven 40mg citalopram treatment gastritis, studies comparing mirtazapine with other second-generation antidepressants reported higher weight gains for mirtazapine than for the comparator groups. In 88-90 three RCTs, these differences reached statistical significance. Second-generation antidepressants 77 of 190 Final Update 5 Report Drug Effectiveness Review Project Gastrointestinal bleeding 240 241, 242 Evidence from one good and two fair case-control studies indicate an increased risk of upper gastrointestinal tract bleeding during SSRI treatment. The good quality case control study matched 11,025 case patients suffering from bleeding abnormalities with 21,846 control patients. In addition, the study compared 1,008 patients with gastrointestinal bleeding with 1,990 control patients based on the ARNO database, a population-based database for drug use in Italy. This study excluded patients with a prescription for non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, antihemorrhagics and antithrombotic agents. Seven percent of case patients with any bleeding disorder and 6. None of the studied antidepressants of interest (citalopram, escitalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline, and venlafaxine) were individually associated with an increased risk for either bleeding abnormalities or gastrointestinal bleeding. Furthermore, SSRIs as a class also did not yield an increased risk of any bleeding abnormality (OR 0. With respect to gastrointestinal bleeding, SSRIs as a class exhibited a numerically increased risk that did not reach statistical significance (OR 1. The other two included studies confirm an increased risk for upper gastrointestinal 241, 242 bleeding for patients on second-generation antidepressants. In contrast to the Italian-based study reported above, the two studies also enrolled patients who were on NSAIDs and other drugs. One study matched 1,552 case subjects with 68,590 control subjects using the Manitoba Population Health Research Data Repository. SSRIs were associated with a statistically significant increase in the risk of upper gastrointestinal bleeding (adjusted OR 1. Furthermore, this study investigated the effect of the combination of different drugs with SSRIs. The risk of suffering from upper gastrointestinal bleeding was higher in case subjects being medicated with SSRIs and non-steroidal anti-inflammatory drugs (NSAID) (OR 3. Proton pump inhibitors had a protective effect (albeit not statistically significant) on upper gastrointestinal bleeding in patients on SSRIs (OR 0. The other case control study was based on data from the Health Improvement Network database in the United Kingdom and provided similar findings. The study revealed a statistically significant association between a higher risk of upper gastrointestinal tract bleeding and the use 242 of SSRIs (OR1. Fractures We identified two studies assessing the risk of fractures for subjects on antidepressant 243, 244 medication. Both studies reported an increased fracture risk for patients with antidepressant intake. The larger study, a well conducted case-control study including 498,617 subjects (124,655 cases and 373,962 controls) from a Danish national prescription database, reported a significant dose-response relationship for citalopram, fluoxetine and sertraline with 243 respect to an increase of the risk of fracture. Amongst SSRIs, high-dose citalopram, fluoxetine, paroxetine, and sertraline were associated with the highest risk for hip fracture (OR 1. Evidence regarding the impact of the duration of use on the risk of fractures was mixed for second-generation antidepressants. Findings of the Danish cohort study described above were consistent with results of a fair, population - based, prospective cohort study on the risk of nonvertebral fractures during 244 antidepressant treatment. This study on 7983 Dutch men and women, aged 55 years or older, revealed a 2. Subjects, who had been using SSRIs for at least six months had a 3. Hepatotoxicity Evidence from controlled trials and observational studies is also insufficient to conclude for or against an increased risk of liver toxicity during nefazodone treatment. Nevertheless, numerous case reports not included in this report contain low-level quality but potentially important 245 evidence citing an increased risk of liver toxicity during nefazodone treatment. One maker of nefazodone has announced that it is withdrawing the drug from the US market by June 2004 because of safety concerns (websource: www. An analysis of AERS data and a claims database on more than 60,000 patients who initiated duloxetine or venlafaxine found no difference in the risk of hepatic injury between the 246 two drugs. Hyponatremia Evidence from controlled trials and observational studies is insufficient to conclude for or against an increased risk of hyponatremia in patients treated with SSRIs. However, the methods of our report did not include case reports and case series.

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Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination Stewart buy citalopram 40 mg line medications on a plane,A buy citalopram 40 mg treatment tinnitus. Y es Y es Y es N o L TF U N o N o F air 1995 N o M ulticenter N o 4 N o W alsh Y es Y es Y es N one N o N o F airforacute 2004 N o Poorfordelayed M ulticenter N o 5 N o Y alcn Y es Y es N o N R Y es N o F air 1999 N o Single C enter N o 3 N o Z eidman N R N R Y es N one N o N o F air 1998 N o Single C enter N o 3,4,5 N o Antiemetics Page 164 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o Stewart,A. Y es 4 (of13)auth ors 1995 employed by G laxo M ulticenter 4 W alsh Y es Study supported inpart 2004 by unrestricted M ulticenter educationalgrantfrom 5 Smith K line Beech am Ph armaceuticals. Y alcn Y es N R 1999 Single C enter 3 Z eidman Y es N R 1998 Single C enter 3,4,5 Antiemetics Page 165 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o Dolasetronvs O ndansetron F auser women,priorch emo N R /N R N R /399/399 1/0/398 Y es N R Y es Y es 1996 M ulticenter 3,4 H esketh priorch emo N o/N R N R /N R /609 51/N R /558 Y es N R Some differences Y es 1996 (N S) M ulticenter 5 L ofters,Pater(2 corticosteroids N R /N R N R /N R /407 // N R N R Y es Y es papers on1 trial) 1997 M ulticenter 3 Antiemetics Page 166 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination Dolasetronvs O ndansetron F auser Y es Y es Y es N o Y es N o G ood 1996 N o M ulticenter N o 3,4 N o H esketh Y es,but Y es,but Y es N o Y es N o G ood 1996 not not N o M ulticenter described described N o 5 N o L ofters,Pater(2 Y es Y es Y es U nable to determine N o Y es F air papers on1 trial) N o 1997 N o M ulticenter N o 3 Antiemetics Page 167 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o Dolasetronvs O ndansetron F auser Y es H oesch tM arion 1996 R oussel,Inc. M ulticenter 3,4 H esketh Y es Supported by a grant 1996 from H oesch tM arion M ulticenter R oussel 5 L ofters,Pater(2 Y es Supported by th e papers on1 trial) N ationalInstitute of 1997 C anada and H oesch t M ulticenter M arionR oussel. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o Dolasetronvs G ranisetron A udh uy women,priorch emo N R /N R N R /N R /476 2/0/474 Y es N R Y es Y es 1996 M ulticenter 5 Tan none N A /N A N R /N R /26 0/0/26 N otrandomiz ed N ot Inadequate Y es 2002 randomiz ed Information Single C enter 4,5 Antiemetics Page 169 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination Dolasetronvs G ranisetron A udh uy Y es Y es Y es N o Y es,but2 excluded N o G ood 1996 N o because no drug M ulticenter N o received 5 N o Tan N R N R N o N o Y es U nable to determine Poor 2002 N o Single C enter N o 4,5 N o Antiemetics Page 170 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o Dolasetronvs G ranisetron A udh uy Y es Supported by a grant 1996 from H oesch tM arion M ulticenter R oussel,Inc. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o Palonsetron A apro none N o/N o N R /N R /673 6/0/667 Y es Y es Y es Y es 2006 M ulticenter 5 G ralla none N one/N A N R /N R /570 12/0/563 Y es Y es U nknown; Y es 2003 excluded 7 M ulticenter 4 Eisenberg none N R /N R N R /N R /592 23/0/569 Y es Y es U nknown, Y es 2003 because only M ulticenter reported B/L for 3 PPP Antiemetics Page 172 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination Palonsetron A apro U nclear Y es N R N one Y es N o F air 2006 N o M ulticenter Y es 5 N R G ralla U nclear U nclear Y es N one N o N o F air 2003 N o M ulticenter N o 4 N o Eisenberg Y es Y es Y es N one N o N o F air 2003 N o M ulticenter N o 3 N o Antiemetics Page 173 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o Palonsetron A apro N o H elsinnH ealth care 2006 M ulticenter 5 G ralla Y es H elsinnH ealth care 2003 M ulticenter 4 Eisenberg Y es H elsinnH ealth care SA 2003 M ulticenter 3 Antiemetics Page 174 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o G ranisetronivvs G ranisetronpo A bang BM T,PBPC T, nr/nr N R /N R /60 9/0/51 Y es N R Y es Y es 2000 women M ulticenter 4 L -758,298 vs O ndansetron C ocquyt N one N R /N o use of N R /N R /53 N R /N R /53 Y es Y es Y es Y es 2001 antiemeticagent M ulticenter with in1 week of study day 1 VanB elle N one N R /N o use of N R /N R /177 2/N R /177 Y es N R Y es Y es 2002 antiemeticagent M ulticenter with in72 h ours of study day 1 O ndansetronvs O ndansetron Antiemetics Page 175 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination G ranisetronivvs G ranisetronpo A bang Y es Y es Y es N one N o,only excluded 1 N o F air 2000 N o M ulticenter N o 4 N o L -758,298 vs O ndansetron C ocquyt Y es Y es N R N one N R N o F air 2001 N o M ulticenter N R N R VanB elle N R N R N R N one N R N o F air 2002 N R M ulticenter N R N R O ndansetronvs O ndansetron Antiemetics Page 176 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o G ranisetronivvs G ranisetronpo A bang Y es Supported by a 2000 research grantfrom M ulticenter Smith K line Beech am 4 Ph armaceuticals L -758,298 vs O ndansetron C ocquyt N o N R 2001 M ulticenter VanB elle N o M erck & C o,Inc 2002 M ulticenter O ndansetronvs O ndansetron Antiemetics Page 177 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o Pectasides N one N R /N o medications N R /N R /134 N R /N R /N R /134 Y es N R Y es Y es 2007 with antiemetic Single C enter activity or medications wh ich could confound th e efficacy evaluation inth e 24 h ours prior to inclusion Antiemetics Page 178 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination Pectasides N R N R N R N one N R N o F air 2007 N R Single C enter N R N R Antiemetics Page 179 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o Pectasides Y es N R 2007 Single C enter Antiemetics Page 180 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear A ge C ountry Study Design Interventions (drug R egim ent, G ender C h em o L evel Setting duration) Eligibility criteria Eth nicity A prepitant N avari M ulticenter A:D ay1:Apr400m g po Cisplatin-naïvepatients ≥18yearswho M ean:61. W om en Hesketh chem olevel5 B:D ay1:Apr400m g po of child-bearing agehadtohavea % M ale:62. E thnicity:N R C:D ays1-5:placebo PtsreceivedG ran+D ex 30m in beforecisplatinonD ay1 corticosteroids givenconcomitantly (see "A llowed oth ermedications") N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 181 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or N um ber N um ber Y ear screened/ with drawn/ C ountry eligible/ lostto A llowed oth erm edications/ C h em o L evel O th erpopulationch aracteristics enrolled fu/analyz ed interventions A prepitant N avari M eancisplatindose:79. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry M eth od ofadverse effects C h em o L evel R esults assessm ent A prepitant N avari A llcom parisons: G roupA vs. C 1999 A cute results (day 1): U SA N ovom iting:93% vs94% vs67% (p<0. C h em oth erapy:placebo-controlled trials A uth or Y ear Totalwith drawals; C ountry with drawals due to adverse C h em o L evel A dverse Effects R eported events A prepitant N avari C omparisons are made betweenG roups A vs B vs C ;and p=N S forall 1999 comparisons U SA (N umbers reported are % ofpts with th e A E) Hesketh chem olevel5 Clinicalevents: Constipation:19% vs13% vs18% D iarrhea:17% vs7% vs10% D ehydration:6% vs6% vs14% Headache:22% vs17% vs20% Hiccups:15% vs17% vs14% Asthenia:26% vs26% vs25% Hem atologic changes: D ecreaseintotalwhitecellcount:2% vs2% vs2% D ecreaseinneutrophils:0% vs2% vs2% Serum am inotransferaseelevations(transientincrease>2. C h em oth erapy:placebo-controlled trials A uth or Y ear C ountry C h em o L evel C om m ents A prepitant N avari 1999 U SA Hesketh chem olevel5 N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 186 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or Y ear A ge C ountry Study Design Interventions (drug R egim ent, G ender C h em o L evel Setting duration) Eligibility criteria Eth nicity C h awla M ulticenter A:D ay1:Apr40m g po Cisplatin-naïveptsage ≥18yrswhohad M ean:56. F em aleptsof childbearing potentialwere % W hite:58. D ays2-5:pts tookAprorplacebobetween8AM and10AM C orticosteroids givenconcomitantly; see "A llowed oth ermedications" N C I:N ationalC ancerInstitute;U L N :U pperlimitofnormal Antiemetics Page 187 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 3. C h em oth erapy:placebo-controlled trials A uth or N um ber N um ber Y ear screened/ with drawn/ C ountry eligible/ lostto A llowed oth erm edications/ C h em o L evel O th erpopulationch aracteristics enrolled fu/analyz ed interventions C h awla M eancisplatindose:81. C h em oth erapy:placebo-controlled trials A uth or Y ear M eth od ofO utcom e C ountry A ssessm entand Tim ing of C h em o L evel DefinitionofO utcom es A ssessm ent C h awla Prim aryresponse:Com pleteresponse(C R ):noem etic episodesand Ptdiaryforem etic episodes 2002 norescuetherapyforD ays1-5 anduseof rescue International Hesketh chem olevel5 Totalcontrol(TC ):noem etic episodes,nouseof rescuetherapy,and 100m m N auseavisual m ax im um nauseaVAS<5m m analog scale(VAS): 0m m = nonausea Com pleteprotection(CP):noem esis,norescuetherapy,andno 100m m = nauseaasbadasit significantnausea(VAS<25m m ) couldbe N oem esis Ptsm arkedthisnauseaVAS everym orning (8AM -10AM ) N orescuetherapy forthenauseathey ex periencedthepreviousday. N onausea(m ax im um VAS <5m m ) Ptshadapost-studyvisit N osignificantnausea(m ax.

Certain concom itantm edicationswere restricted during the study purchase citalopram 10 mg online medications gerd,including corticosteroids(exceptforlow-potency topical preparationssuch as hydrocortisone) buy citalopram 10 mg mastercard symptoms you may be pregnant,m astcell stabiliz ers, antihistam ines(apartfrom rescue loratadine),decongestants,aspirin, nonsteroidal anti-inflam m atorydrugs, and system ic antibiotics. NCS Page 98 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2. Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Clas s Co ntro l Au tho r, naïv e gro u p Year, Ru n-in/ p atients s tandardo f Co u ntry Was ho u t o nly care Fu nding Relev ance H ebert Run-in:N o N o Yes N otspecifically 8. NCS Page 99 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2. Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Rep o rtingo f attritio n, cro s s o v ers , Au tho r, Allo catio n Eligibility Ou tco me Care adherence,and Year, Rando miz- co ncealment Gro u p s s imilarcriteria as s es s o rs p ro v ider co ntam- Co u ntry atio nadequ ate? Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Au tho r, Lo s s to fo llo w- Po s t-rando m- Nu mbers creened/ Year, u p :differential/ Intentio n-to -treat izatio n eligible/ Co u ntry high (ITT)analys is exclu s io ns Qu ality rating enro lled Exclu s io ncriteria Lum ry N o/N R N o N o F air N R/N R/152 Clinical evidence ofanysignificantphysical abnorm alities 2003 orabnorm al laboratoryvalues;nasal candidiasis,acute or U S A chronic sinusitis,significantnasal polyposisorothergross anatom ical deform ityofthe nose sufficienttoim pairnasal breathing;concurrentm edical conditionslik elytointerfer with the course ofthe study;use ofsystem ic corticosteroids in the previous42daysornasal orinhaled corticosteroids in the previous30days;use ofnasal crom olyn sodium in the previous28daysorastem iz ole in the previous60days; treatm entwith an investigational drug within 60days; com m encem entofim m unotherapywithin the previoussix m onths;use ofm edication forotherm edical conditionsthat m ightproduce orrelieve the signsand sym ptom sofallergic rhinitisforsixdayspriortoand throughoutthe treatm ent period;and pregnancy,lactation,orinadequate contraceptive precautionsin fem alesofchild-bearing potential NCS Page 101 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2. Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Clas s Co ntro l Au tho r, naïv e gro u p Year, Ru n-in/ p atients s tandardo f Co u ntry Was ho u t o nly care Fu nding Relev ance Lum ry Run-in:N o N o Yes Aventis 2003 W ash-out:Yesx P harm aceuticals, U S A 6days role notspecified NCS Page 102 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2. Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Rep o rtingo f attritio n, cro s s o v ers , Au tho r, Allo catio n Eligibility Ou tco me Care adherence,and Year, Rando miz- co ncealment Gro u p s s imilarcriteria as s es s o rs p ro v ider co ntam- Co u ntry atio nadequ ate? Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Au tho r, Lo s s to fo llo w- Po s t-rando m- Nu mbers creened/ Year, u p :differential/ Intentio n-to -treat izatio n eligible/ Co u ntry high (ITT)analys is exclu s io ns Qu ality rating enro lled Exclu s io ncriteria S m all N o/N R N o,efficacyn=223 N o F air N R/N R/233 W om en whowere pregnantorofchildbearing potential and 1997 and safetyn=233 notpracticiing approved m ethod ofbirth control;P tm eeting Canada atleastone ofthe following criteria were excluded:a clinicallysignificant,renal,hepatic,cardiac,respiratory (including asthm a),neurologic,collagen-vascular,or psychiatric disorder;cancer;untreated fungal,bacterial,or viral infections;nasal septal ulcerorperforation;nasal surgeryortraum a;physical nasal obstruction greaterthan 50%;a historyofhabitual abuse ofnasal decongestants; use ofanysystem ic,nasal,inhaled corticosteroidswithin 30daysofscreening visit;use ofnasal sodium crom oglycate,anticholinergics,vasoconstrictors,or antihistam ines(exceptastem iz ole)within 7daysofthe screening visit;use ofastem iz ole within 60daysofthe screening visit;use oftopical,oral orboth typesof decongestantsm ore than three tim esperweek forthe previous3m onths(90days):cardiovasculardrugs, horm ones,neurolepticsoranyotherdrugsthatcan cause, suppress,orexacerbate the sym ptom sofallergic rhinits; im m unotherapyunless on a m aintenance regim en atthe tim e ofscreening; historyofhypersensitivityornonresponse to corticosteroids;and participation in another investigational studywithin 30daysofthe screening visit. S teroidswere notperm itted,exceptfororal contraceptivesand estrogen replacem enttherapy. NCS Page 104 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2. Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Clas s Co ntro l Au tho r, naïv e gro u p Year, Ru n-in/ p atients s tandardo f Co u ntry Was ho u t o nly care Fu nding Relev ance S m all Run-in:N o N o Yes Grantfrom Rhone- Race not 1997 W ash-out:yesx P oulene Rorer reported,M/F Canada 5-14days Canada,Inc. O ne equal authorfrom this age range 12-70 source aswell W ide varietyof allergensdue to m ulticenter, P ollen countnot reported. N otIT T ,single blind k eepsfrom being rated good NCS Page 105 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2. Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Rep o rtingo f attritio n, cro s s o v ers , Au tho r, Allo catio n Eligibility Ou tco me Care adherence,and Year, Rando miz- co ncealment Gro u p s s imilarcriteria as s es s o rs p ro v ider co ntam- Co u ntry atio nadequ ate? Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Au tho r, Lo s s to fo llo w- Po s t-rando m- Nu mbers creened/ Year, u p :differential/ Intentio n-to -treat izatio n eligible/ Co u ntry high (ITT)analys is exclu s io ns Qu ality rating enro lled Exclu s io ncriteria LaF orce N o/N R N otclear,num bers N o F air-good N R/N R/238 Being treated with corticosteroidsorintranasal sodium 1994 notreported in crom olyn,required inhaled orsystem ic corticosteroid U S A resultsbutonly3 therapyforongoing asthm a,had an upperrespiratorytract outof238patients infection,oriftheywere scheduled toaltertheir withdrew from im m unotherapyregim en during the study,wom en atrisk of study pregnancy(postm enarchal orprem enopausal wom en and those notusing oral contraceptives)and patientswith any significantm edical disorderorim paired adrenal function as indicated byclinical laboratorytests. Bronsk y U nk nown N otclear,authors N o F air N R/N R/161 P regnancyorlactation,nasal polyps,sinusitis,significant 1987 reportthatof322 septal deviation,oranyothernasal disease;historyof U S A f/uvisits13were alcohol ordrug abuse;m ental im pairm ent;asthm a m issed com pletely, requiring corticosteroid therapyorsensitivitytoinhaled 30were outside the corticosteroid therapyorsensitivitytoinhaled appropriate corticosteroids;im m unotherapyforallergic rhinitisin the schedule. N o m onth priortothe trial;adm inistration ofanyinvestigational m ention ofm ade if drug within 30days,orcorticosteroid orcrom olyn sodium thisdata from within twoweek s,orantihistam ineswithin 24hourspriorto these ptswas the initiation ofthe trial. Qu ality as s es s ment o f head-to -headtrials inp atients withSAR Clas s Co ntro l Au tho r, naïv e gro u p Year, Ru n-in/ p atients s tandardo f Co u ntry Was ho u t o nly care Fu nding Relev ance LaF orce Run-in:Yes N o Yes Grantfrom Glaxo, 1994 W ashout:N o Inc. U S A Bronsk y Run-in:N o N o Yes N otdirectlystated 12-65yo 1987 W ash-out:N o butone authoris Multicenter,U S A U S A affiliated with Glaxo,M=F Inc. O r lactating Race included NCS Page 108 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR InternalValidity Rep o rtingo f attritio n, Lo s s to Au tho r, Allo catio n Gro u p s Eligibility Ou tco me cro s s o v ers , fo llo w-u p : Year, Rando mizatio n co ncealment s imilarat criteria as s es s o rs Carep ro v iderPatient adherence,and differential/ Co u ntry adequ ate? Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR External Validity Nu mber Clas s Co ntro l Au tho r, Intentio n-to -Po s t- s creened/ naïv e gro u p Year, treat (ITT) rando mizatio n Qu ality eligible/ Ru n-in/ p atients s tandard Co u ntry analys is exclu s io ns rating enro lled Exclu s io ncriteria Was ho u t o nly o f care Ratne r ye s no fair NR/NR/726 Clinic allysignific c antabnorm allabte st1we e k no ye s 2006a re sultsor physic alfind ingsof nasal base line run-in U S polypsor nasaltrac tm alform ations; e vid e nc e of oc ular he rpe ssim ple xor c atarac tsor historyof glauc om a; e vid e nc e of abronc hial,pulm onaryor RT Ior d iord e rsothe r than ARor asthm aw. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Au tho r, Year, Co u ntry Fu nding Relev ance Ratne r ALT ANAPharm a ye s 2006a U S NCS Page 111 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Rep o rtingo f attritio n, Lo s s to Au tho r, Allo catio n Gro u p s Eligibility Ou tco me cro s s o v ers , fo llo w-u p : Year, Rando mizatio n co ncealment s imilarat criteria as s es s o rs Carep ro v iderPatient adherence,and differential/ Co u ntry adequ ate? Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Nu mber Clas s Co ntro l Au tho r, Intentio n-to -Po s t- s creened/ naïv e gro u p Year, treat (ITT) rando mizatio n Qu ality eligible/ Ru n-in/ p atients s tandard Co u ntry analys is exclu s io ns rating enro lled Exclu s io ncriteria Was ho u t o nly o f care Ratne r ye s no fair 419/NR/327 Nasalpathologyinc lud ing nasalpolyps7-10d ay no ye s 2006b within 60d aysof stud ye ntry;c linic ally base line run-in U S re le vantre spiratorytrac t m alform ations;re c e ntnasalbiopsy; nasaltraum a;nasalsurge ry;atrophic rhinitis;rhinitism e d ic am e ntosa;ac tive asthm are quiring tre atm e ntwith inhale d or syste m tic c ortic oste roid s; routine use of be taagonists;known hype rse nsitivityto c ortic oste roid s; historyof RT Ior d isord e r within 14 d aysof sc re e ning;tre atm e ntwith syste m ic c ortic oste roid swithin 2 m onthsof stud y;tre atm e ntwith >1% topic alste roid swithin 1m onth of stud y NCS Page 113 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Au tho r, Year, Co u ntry Fu nding Relev ance Ratne r ALT ANAPharm a ye s 2006b U S NCS Page 114 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Rep o rtingo f attritio n, Lo s s to Au tho r, Allo catio n Gro u p s Eligibility Ou tco me cro s s o v ers , fo llo w-u p : Year, Rando mizatio n co ncealment s imilarat criteria as s es s o rs Carep ro v iderPatient adherence,and differential/ Co u ntry adequ ate? Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Nu mber Clas s Co ntro l Au tho r, Intentio n-to -Po s t- s creened/ naïv e gro u p Year, treat (ITT) rando mizatio n Qu ality eligible/ Ru n-in/ p atients s tandard Co u ntry analys is exclu s io ns rating enro lled Exclu s io ncriteria Was ho u t o nly o f care K aise r ye s no fair 428/NR/299 Signific antc onc om itantm e d ic al 5-21d ay no ye s 2007 c ond ition,inc lud ing unc ontrolle d base line run-in U S d ise ase of anybod ysyste m ;se ve re physic alnasalobstruc tion or injury; asthm a;rhinitism e d ic am e ntosa; bac te rialor viralinfe c tion within 2 we e ksof sud ye ntry;ac ute of c hronic sinusitis;glauc om a;c atarac ts;oc ular he rpe ssim ple x;c and id ainfe c tion of the nose ;psyc hiatric d isord e r;ad re nal insuffic ie nc y;use of syste m ic of inhale d c ortic oste roid within 8we e ks of stud ye ntry;use of inhale d NCS within 4we e ksof stud ye ntry;use of othe r m e d ic ationsthatc ould affe c tAR or the e ffe c tive ne ssof the stud yd rug NCS Page 116 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Au tho r, Year, Co u ntry Fu nding Relev ance K aise r GlaxoSm ithK line ye s 2007 R&D U S NCS Page 117 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Rep o rtingo f attritio n, Lo s s to Au tho r, Allo catio n Gro u p s Eligibility Ou tco me cro s s o v ers , fo llo w-u p : Year, Rando mizatio n co ncealment s imilarat criteria as s es s o rs Carep ro v iderPatient adherence,and differential/ Co u ntry adequ ate? Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Nu mber Clas s Co ntro l Au tho r, Intentio n-to -Po s t- s creened/ naïv e gro u p Year, treat (ITT) rando mizatio n Qu ality eligible/ Ru n-in/ p atients s tandard Co u ntry analys is exclu s io ns rating enro lled Exclu s io ncriteria Was ho u t o nly o f care Martin ye s ye s;1/642 fair NR/NR/642 Se ve re physic alobstruc tion of the 5-21d ay no ye s 2007 nose ;re c e ntnasalse ptalsurge ryor base line run-in U S pe rforation;asthm a;rhinitis m e d ic am e ntosa;uppe r RT I;c hronic use of m e d ic ationsthatwould affe c t alle rgic rhinitisor asse ssm e ntsof e ffic ac yof stud ym e d ic ation;c urre nt tobac c o use ;use of subc utane ous om alizum abwithin 5m onthsof stud y; c ortic oste roid s;antihistam ine s; d e c onge stants;intranasal antic holine rgic s;oralantile ukotrie ne s within 3d aysof stud y;intranasalor oc ular c rom olyn within 14d aysof stud y Fokke ns ye s no fair 425/NR/285 Se ve re physic alnasalinjuryor 5-21d ay no ye s 2007 obstruc tion;asthm a;rhinitis base line run-in Europe m e d ic am e ntosa;or anyothe r c hronic m e d ic alc ond ition thatc ould inte rfe re with the c ourse of the stud y;use of INS within 4we e ksof stud y;othe r c ortic oste roid within 8we e ks;any m e d ic ation thatc ould affe c tSAR sym ptom sor e ffe c tive ne ssof stud y m e d ic ation NCS Page 119 of 357 Final Report Update 1 Drug Effectiveness Review Project Ev idenceTable2a. Qu ality o f p lacebo -co ntro lledtrials inp atients withSAR Au tho r, Year, Co u ntry Fu nding Relev ance Martin GlaxoSm ithK line ye s 2007 U S Fokke ns GlaxoSm ithK line ye s 2007 Europe NCS Page 120 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Year Coun try Studydesign Allowedothermedication s/ TrialName Settin g Eligibilitycriteria In terven tion s Run -in /WashoutPeriod in terven tion s Ko b a ya shi R a n do m ized, Children a ged 5-13 b eclo m etha so n e Deco n gesta n ts24ho urs R escue m edica tio n : 1989 do ub le-b lin d, yea rs,with sea so n a l dipro pio n a te a queo us b efo re study chlo rhen ira m in e m a lea te 4m g pla ceb o -co n tro lled,a llergic rhin itis n a sa lspra y,42m cg pa ra llel Exclusio n :U se o f twice da ilyvspla ceb o Multicen ter system ic Studydura tio n :3weeks co rtico stero ids, b egin n in g hypo sen sitiza tio n trea tm en t,un derlyin g n a sa lpa tho lo gy,histo ry o fa dverse rea ctio n sto in ha led o rsystem a tic co rtico stero ids, co n curren tvira lin fectio n Strem 1978 R a n do m ized, Children a ged 6-15 flun iso lide n a sa lspra y, NR /NR NR do ub le-b lin d, yea rswith sea so n a l 50m cg three tim esda ily pla ceb o -co n tro lled a llergic rhin itis vspla ceb o Studydura tio n :4weeks NCS Page 121 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Number Year Age screen ed/ Coun try Methodofoutcomeassessmen t Gen der Otherpopulation eligible/ Numberwithdrawn / TrialName an dtimin gofassessmen t Ethn icity characteristics en rolled losttofu/an alyzed Ko b a ya shi Eva lua ted a tclin ic o n studyda ys4, Mea n a ge:8. Placebo-con trolledtrialsin children withSAR Author Year Coun try Studydesign Allowedothermedication s/ TrialName Settin g Eligibilitycriteria In terven tion s Run -in /WashoutPeriod in terven tion s G a le 1980 R a n do m ized, Children a ged 5-14 flun iso lide 50m cg fo ur NR /NR NR do ub le-b lin d, yea rswith sea so n a l tim esda ilyvspla ceb o pla ceb o -co n tro lled,a llergic rhin itis Studydura tio n :6weeks pa ra llel Sin gle-cen ter Mun k,1994 R a n do m ized, Children a ged 12-17 In tra n a sa lflutica so n e NR /NR chlo rphen ira m in e m a lea te do ub le-b lin d, yea rswith sea so n a l pro pio n a te 200m cg pla ceb o -co n tro lled,a llergic rhin itis,n a ive to o n ce da ilyvs100m cg pa ra llel in tra n a sa lflutica so n e twice da ilyvspla ceb o Multi-cen ter pro pio n a te,a n d/o rfa iled Studydura tio n :2weeks thera pywith o ther m edica tio n s NCS Page 124 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable3. Placebo-con trolledtrialsin children withSAR Author Number Year Age screen ed/ Coun try Methodofoutcomeassessmen t Gen der Otherpopulation eligible/ Numberwithdrawn / TrialName an dtimin gofassessmen t Ethn icity characteristics en rolled losttofu/an alyzed G a le 1980 P a tien tda ilydia ry Mea n a ge:9.

Citalopram
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