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The other study compared fluticasone 100 mcg either once or twice daily to beclomethasone 168 mcg or placebo twice daily in 466 adults and adolescents as young as 12 52 years for 6 months purchase discount lexapro anxiety while pregnant. The outcome measures were expressed as reduction of total symptom scores using a visual analog scale (0-100 for each of 4 nasal symptoms) discount lexapro 5mg visa anxiety upon waking. The study found no significant differences in efficacy between any of active drugs cheap 5mg lexapro fast delivery anxiety symptoms requiring xanax, both of which showed at least 45% reduction in total symptom score. It was noted that equivalent dosages of beclomethasone (400 mcg) and fluticasone (200 mcg) also had similar efficacy and safety in an unpublished 4- week randomized double-blind placebo-controlled parallel group trial of 286 adult patients with 70 perennial rhinitis that was identified in the dossier provided by the manufacturer of fluticasone. Drop-out rates for beclomethasone, fluticasone 100 and 200 mcg, and placebo (28% compared with 23% compared with 14% compared with 28%) in the published trial were noted to be relatively higher than in other similar trials. Mometasone Mometasone was associated with generally similar reductions in rhinitis symptoms 56 57 relative to beclomethasone and fluticasone across 2 head-to-head trials (Table 10). One double-blind RCT compared beclomethasone 400 mcg twice daily to mometasone 200 mcg once 56 daily in 427 adults and adolescents as young as age 12 with perennial allergic rhinitis. The study population included 45-54% patients with seasonal allergies and 18-24% with concomitant asthma. The primary outcome in this 12-week study was measured with mean percent reduction in total morning and evening symptom scores within the first 15 days. A trial comparing fluticasone to mometasone revealed mixed results for differences in 57 efficacy. One double-blind multicenter RCT compared fluticasone 200 mcg to mometasone 200 mcg in 550 adults and adolescents as young as 12 years with confirmed perennial allergic rhinitis. The primary outcome of mean percent reduction in total nasal symptom score had to be estimated from figures provided in the article. Although mometasone resulted in greater reduction of the total nasal symptom score, this patient-rated outcome was not significantly different between the 2 drugs. There was, however, a significantly greater reduction in the same physician-rated secondary outcomes of nasal congestion, nasal discharge, and overall condition with mometasone. Budesonide One trial found budesonide to be more efficacious in treating combined nasal symptoms 12 than fluticasone (Table 10). This 6-week Canadian/Spanish study investigated budesonide 256 mcg compared with fluticasone 200 mcg compared with placebo in 273 adults with confirmed 12 perennial allergic rhinitis. There was a significantly greater reduction in combined nasal symptoms scores with budesonide (-2. Moreover, they found that budesonide was significantly better than placebo at reducing nasal blockage than was fluticasone, while improvement in all other individual symptom scores was similar for both drugs. The onset of action, measured in hours before significant step-score reductions, was NCS Page 26 of 71 Final Report Update 1 Drug Effectiveness Review Project quicker for budesonide than fluticasone (36 h compared with 60 h). The secondary outcome of percentage of patients who reported substantial or total symptom control did not differ significantly between the 2 drugs. The only head-to-head study investigating budesonide and mometasone for perennial rhinitis found the 2 drugs comparable for nasal symptom scores and overall symptom control. One fair-quality European RCT compared budesonide 256 mcg or 128 mcg to mometasone 200 58 mcg or placebo in 438 adults with confirmed perennial allergic rhinitis. The primary efficacy outcome, nasal symptom score (morning and evening combined), was not significantly different in the 2 medications. Furthermore, there was no statistically significant difference for the secondary outcomes: percentage of patients experiencing no symptom control, consumption of rescue medication, and onset of action. We have identified unpublished quality of life data from this study in the dossier supplied by the manufacturer of budesonide that found no significant differences between treatments except that budesonide is superior to placebo for general health and vitality. Flunisolide: New compared with old formulations The randomized double-blind parallel-group study compared 2 different formulations of flunisolide aqueous in 215 patients with confirmed perennial allergic rhinitis and found similar 59 efficacy in both treatments. Dosages were equivalent in both the old and new formulations, which reduced propylene glycol from 20% to 5%, increased polyethylene glycol from 15% to 20%, and added 2. There were no significant differences in mean reduction of total symptom and individual symptom scores between formulations. Further, patients rated acceptability of nasal burning/stinging on a 100- point visual analog scale. The original formulation had a mean score of 52 while the new formulation was rated as 87 (P<0.

Subgroups • No trials reported subgroup analyses based on demographics purchase lexapro 20mg mastercard anxiety guidelines, comorbidities order lexapro 10mg with mastercard anxiety 8 weeks pregnant, or concomitant medication use lexapro 10mg free shipping anxiety symptoms handout. Combination therapy with AIIRAs and ACE-Is • Effectiveness/Efficacy DRIs, AIIRAs, and ACE-Is Page 68 of 144 Final Report Drug Effectiveness Review Project o Overall: No trials reported health outcomes, including all-cause mortality, development of chronic kidney disease, end-stage renal function, need for dialysis or transplantation, hospitalizations, or quality of life o Losartan plus enalapril (2 trials, both fair quality): Results did not clearly establish that combination therapy had a significantly greater benefit over monotherapy for decrease in urinary protein excretion that was independent from blood pressure control, regression from microalbuminuria to normo albuminuria, creatinine clearance, or overall withdrawals. However, independence from superior overall blood-pressure control was not established. No advantage for combination therapy in albumin, serum creatinine or creatinine clearance. No advantage for combination therapy in glomerular filtration rate or creatinine. No significant advantage was found for combination therapy in effects on creatinine, but there was noted to be a significantly greater reversible reduction in glomerular filtration rate during the 8- week study period. Detailed assessment Aliskiren used in combination with an AIIRA or an ACE-I We included 1, fair-quality, multicenter, international trial, the Aliskiren in the Evaluation of Proteinuria in Diabetes (AVOID) trial, that compared treatment with aliskiren (150 mg for 3 DRIs, AIIRAs, and ACE-Is Page 69 of 144 Final Report Drug Effectiveness Review Project months, then increased to 300 mg for another 3 months) or placebo, in addition to losartan 100 118 mg in 599 adults with type 2 diabetes and macroalbuminuria. Effectiveness/efficacy The primary efficacy measure was the percentage reduction in the early-morning urinary albumin-to-creatinine ratio, which was 20% greater for aliskiren compared with placebo (95% CI, 11 to 29). The greater reduction in urinary albumin-to-creatinine ratio for aliskiren decreased slightly, but remained significant after adjustment for change in systolic blood pressure (18%; 95% CI, 5 to 30). Results following adjustment for change in diastolic blood pressure were not reported. As for secondary outcomes, a significantly greater proportion of participants in the aliskiren group achieved a reduction of 50% or more in albuminuria (25% compared with 12%, P<0. Incidence of overall withdrawals was similar for aliskiren (14%) compared with placebo (11%). Harms In both treatment groups, incidence of overall adverse events was 67% and 6% of participants withdrew due to adverse events. There were no significant differences between aliskiren and placebo in incidence of hypotension (4% compared with 1%), hyperkalemia (5% compared with 6%), cough (2% in both groups), peripheral edema (4% compared with 8%), diarrhea (3% in both groups), or any other specific adverse events. Subgroups In subgroup analysis, greater reductions in the albumin-to-creatinine ratio were found regardless of sex, race (White or non-White), or age (below median or at or above median). Comparison of AIIRA and ACE-I monotherapies in adults with diabetic nephropathy 119-132, 133l, 134, 135 136 We included 16 trials and 1 good-quality Cochrane review that compared monotherapy with an AIIRA to monotherapy with an ACE-I. Losartan was compared with 119, 123, 128, 133, 135 129 enalapril in 5 trials and to quinapril in 1 trial. Telmisartan was compared with 120-122 enalapril in the Diabetics Exposed to Telmisartan and enalapril (DETAIL) trial. Irbesartan was 130 125 compared with perindopril in 1 trial. Valsartan was compared with benazepril in 1 trial, to 127 134 enalapril in 1 trial, and to captopril in 1 trial. Data abstraction and quality assessment can be 126 found in Evidence Tables 20 and 21, respectively. Only 1 trial was rated good quality, 12 were 118, 119, 122, 124, 125, 127-129, 131-133, 135 123, 130, 134 rated fair quality, and 3 were rated poor quality. We found no trials involving comparisons of either eprosartan or olmesartan to an ACE-I and no trials involving comparisons of cilazapril, moexipril or trandolapril to an AIIRA. DRIs, AIIRAs, and ACE-Is Page 70 of 144 Final Report Drug Effectiveness Review Project Telmisartan Telmisartan compared with enalapril With a sample size of 250 participants and a follow-up period of 5 years, the Diabetics Exposed to Telmisartan and enalapril (DETAIL) trial is the largest and longest-term trial that compared 120-122 monotherapy with an AIIRA and an ACE-I in adults with diabetes. We rated DETAIL as fair quality due to their exclusion of 14% of patients from the analysis of their primary outcome. The DETAIL trial enrolled adults with type 2 diabetes, mild to moderate hypertension, normal renal function, and either microalbuminuria (82%) or macroalbuminuria (18%) from across 39 center in northern Europe. Use of concomitant antihypertensive drugs during the trial was allowed after 2 months if resting systolic blood pressure was above 160 mm Hg or if resting diastolic blood pressure was above 100 mm Hg and these included diuretics in 52% of participants, beta blockers in 39%, calcium channel blockers in 46% and “other”, unspecified antihypertensive agents in 35%. DETAIL was a noninferiority trial designed to evaluate the hypothesis that telmisartan was not worse than enalapril on the primary outcome of change in 2 glomerular filtration rate by more than the predefined margin of 10. After 5 2 years, mean change in glomerular filtration rate was –17.

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Antithymocyte remission acute myeloid leukemia in young and middle-aged globulin for graft-versus-host disease prophylaxis in transplants adults: benefits for whom? Graft-versus- tion generic lexapro 5 mg amex anxiety 54321, and late transplant-related mortality: long-term follow-up leukemia reactions after bone marrow transplantation order genuine lexapro anxiety symptoms throwing up. Risk factors for unrelated hematopoietic cell transplantation for acute myelog- lymphoproliferative disorders after allogeneic hematopoietic enous leukemia 10 mg lexapro overnight delivery anxiety 0 technique. Fludarabine- for natural killer cell receptor genes leads to superior survival melphalan conditioning for AML and MDS: alemtuzumab after unrelated transplantation for acute myelogenous leukemia. Microchimerism and allogeneic anti-tumor reactions after allogeneic hematopoietic cell trans- transplantation: We need the proof in the pudding. Immunogenetic consequences of vascular anastomo- expanded T regulatory cells in adults transplanted with umbili- ses between bovine twins. Claas FH, Gijbels Y, van der Velden-de Munck, van Rood 2011;117(3):1061-1070. Induction of B cell unresponsiveness to noninherited 26. The role of HLA maternal HLA antigens during fetal life. Effect of HLA- necessary not only for blood type but also for HLA? Bone matching recipients to donor noninherited maternal antigens on Marrow Transplant. High-resolution donor- tion for hematologic malignancy. Biol Blood Marrow Trans- recipient HLA matching contributes to the success of unrelated plant. HLA-C antigen plant outcome in hematological malignancies. Proc Natl Acad mismatch is associated with worse outcome in unrelated donor SciUSA. Indirect evidence that associate with adverse outcomes in hematopoietic stem cell maternal microchimerism in cord blood mediates a graft-versus- transplantation. Scaradavou A, Carrier C, Mollen N, Stevens C, Rubinstein P. Detection of maternal DNA in placental/umbilical cord blood Lancet Oncol. Effect of donor-recipient presence of maternal cells in human umbilical cord blood. Exp HLA matching at HLA A, B, C, and DRB1 on outcomes after Hematol. Survival after T dysplastic syndrome: a retrospective analysis. NK cells–from bench to haematopoietic cell transplantation from matched unrelated clinic. Donors with GvHD prophylaxis with or without anti-T-cell globulin ATG- group B KIR haplotypes improve relapse-free survival after fresenius. Young1 1Hematology Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD Historically viewed in isolation as an odd, rare, and invariably fatal blood disease, aplastic anemia is now of substantial interest for its immune pathophysiology, its relationship to constitutional BM failure syndromes and leukemia, and the success of both stem cell transplantation and immunosuppressive therapies in dramatically improving survival of patients. Once relegated to a few presentations in the red cell and anemia sessions of the ASH, the Society now sponsors multiple simultaneous sessions and plenary and scientific committee presentations on these topics. This update emphasizes developments in our understanding of immune mechanisms and hematopoietic stem cell biology and new clinical approaches to stem cell stimulation as a therapy, alone and in combination with conventional suppression of the aberrant immune system. Introduction There are abundant laboratory data supporting an immune Advances in BM failure syndromes now are almost annual topics in pathophysiology, but detailed mechanisms are lacking—as they the ASH Educational Program, and this review therefore empha- are for most human autoimmune or immune-mediated diseases. The reader is referred to more comprehen- lymphocytes and type 1 cytokines appear to be the proximate sive publications for fuller discussions and ample bibliographies. T-regulatory cells appeared to be deficient in quantity10 and function11 and their numbers were strikingly different in the Blood counts can be decreased in overwhelming infection (eg, bacterial sepsis) and secondary to a few diseases (eg, cirrhosis with randomized trial of horse versus rabbit ATG, with recovery hypersplenism, systemic lupus), but severe persistent pancytopenia correlating with better response.

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BM produces a hepcidin-suppressing mediator in response to Because humans have no physiological mechanism for iron excre- physiologic erythropoietin or pathophysiologic ineffective erythro- tion generic lexapro 20 mg fast delivery anxiety reddit, the control of intestinal iron absorption is the primary poiesis order lexapro online pills anxiety symptoms chest pains. Growth differentiation factor 15 (GDF15) and twisted- mechanism for determining overall iron balance lexapro 20mg low price anxiety symptoms all the time. A small fraction of gastrulation 1 (TWSG1) are BMP family members postulated to be dietary iron is imported into the enterocyte and only a fraction is suppressors of hepcidin in thalassemia26,27; however, their contribu- exported from the enterocyte into the plasma. Inappropriately elevated levels of liver and filtered into the urine. As a negative regulator, decreased iron-refractory iron deficiency anemia). Conversely, inappropriately Hematology 2014 203 Figure 1. Hepcidin is a common effector of 4 known regulators of iron homeostasis. Iron stores, erythropoietic demand, hypoxia, and inflammation all act by modulating hepatocyte production of hepcidin. Increased iron stores and inflammation both appear to increase hepcidin expression, primarily through signal transduction via the SMAD and JAK/STAT pathways, respectively. Increased/ineffective erythropoietic drive and hypoxia appear to decrease hepcidin expression, although the mechanisms of their control of hepcidin expression remain to be fully elucidated. Although HFE hemochromatosis has a worldwide distribution, it is Iron overload states the most common autosomal recessive disorder of northern Euro- Although the earth is an iron-rich environment, acquired iron pean heritage, apparently having descended from a common Celtic ancestor. The estimated iron metabolism result in iron overload rather than iron deficiency. Clinically significant hereditary iron overload is almost exclusively an adult phenomenon, but there are rare pediatric forms. Some clinical laboratories commonly report other HFE mutations. A summary of these disorders and their genetics can be found in The p. His63Asp (H63D) amino acid substitution is occurs in 20% Table 1. Ser65Cys (S65C) amino acid substitution is also reported by some, but the clinical relevance is HFE hemochromatosis not clear. Other very rare (“private”) HFE mutations can be found in Originally recognized in the mid-19th century, this form of heredi- trans to the C282Y and can explain some cases of rapid iron overload out of keeping with the C282Y carrier status. HFE is widely expressed and is known to bind with TFR131 to decrease its affinity for iron-loaded TF. Only a small fraction of matosis, whichi s associated with a predilection for hepatocellular C282Y/H63D heterozygotes appear to develop biochemical evi- iron deposition. FPN1 hemochromatosis FPN1 hemochromatosis appears to be the most common form of HFE hemochromatosis was classically described as the triad of 51 non-HFE hemochromatosis. It is distinguished from other iron cirrhosis, diabetes mellitus, and skin hyperpigmentation developing th th overload disorders by its autosomal-dominant inheritance and 2 in the in the 4 -7 decade of life and thus earning the description phenotypic subtypes depending on the functional consequences of “bronze diabetes. Serum ferritin levels rise early and quency of classically related nonspecific symptoms (eg, fatigue, out of proportion to TF saturation, a pattern in contrast to the early arthralgias, affective disorders) and symptoms of end organ damage elevation in TF saturation seen in HFE hemochromatosis. Although (eg, cardiomyopathy, arrhythmias, diabetes mellitus, sexual dysfunc- 41 FPN1 hemochromatosis is generally milder than HFE hemochroma- tion) are uncommon, and in one study they did not differ 37 tosis, the complete spectrum of iron overload morbidity has been significantly from wild-type controls. Phlebotomy is a generally effective therapy; how- likely to have symptomatic iron overload than women and, ever, given the frequent presence of mild anemia and sequestration although this has been attributed to physiologic blood loss of of iron within macrophages, patients usually require a gentler iron menstruation and pregnancy or sex-related disease modifier genes,44 52 depletion program. Genetic linkage analysis of multiple affected families revealed 2 distinct genetic entities with a common phenotype. Homozygous or compound heterozygous Aceruloplasminemia mutations in HJV or hepcidin (HAMP)45 result in the juvenile Ceruloplasmin is a plasma copper-containing protein synthesized hemochromatosis phenotype. Both genotypes appear to have high primarily in the liver. It is also expressed in a glycosylphosphatidy- penetrance, but HJV mutations are responsible for a majority of linositol-linked isoform on glial cells of the CNS. As discussed previously, hemojuvelin is a critical BMPR coreceptor critical for SMAD-dependent signaling and hepcidin transcription. Aceruloplasminemia is an extremely rare, autosomal-recessive Mutations in HJV or hepcidin itself results in severely decreased disorder caused by missense/nonsense mutations in the ceruloplas- hepcidin transcription and plasma levels with increased intestinal min gene (CP) found on chromosome 3q21.

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Quality assessm en to fplacebo -co n tro lledtrialso fh arm so utco m es ExternalValidity Lo ssto fo llo w-In ten tio n - Auth o r purchase 5mg lexapro free shipping anxiety symptoms list, up: to -treat Po st- Num berscreen ed/ Year differen tial/h i(ITT) ran do m iz atio n Quality elig ible/ Co un try g h an alysis exclusio n s Ratin g en ro lled Exclusio n criteria Run -in /wash o ut Allen yes yes no fair NR /NR /150 c onditions th atm ig h taffec tg rowth 4-daysc reening 2002 orrequ irec onc om itant period U SA c ortic osteroidth erapy(exc eptfor asth m ac ontrolledb yas-needed Beta-ag onists adm inisteredon no m oreth an two days weekly) order lexapro 20 mg with mastercard anxiety symptoms muscle cramps,u se of inh aled buy lexapro mastercard symptoms 9f anxiety,intranasal,oral,optic al, orinjec tab lec ortic osteroids or >1% c u taneou s h ydroc ortisone with in onem onth of th efirst prestu dystadiom etry m easu rem ents andevidenc eof m alnu trition. Ho lm yes Notc lear no fair NR /NR /42 seriou s oru nstab ledisease, 4-week plac eb o ru n- 1998 infec tion of th eu ppreandlower in Neth erlan ds respiratorytrac t,stru c tu ral ab norm alities orintranasal sym patic om im etic th erapy, preg nantorlac tating wom en. Sko n er No yes no fair NR /NR /100 Patients taking m edic ations Wash ou tperiods for 2000 known to affec tg rowth du ring th e m edic ations known stu dy to affec tg rowth were estab lish ed,b u tnot reportedin ab strac t NCS Page 350 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable14. Quality assessm en to fplacebo -co n tro lledtrialso fh arm so utco m es Class Auth o r, n aïve Co n tro l g ro up Year patien ts stan dardo f Co un try o n ly care Fun din g Relevan ce Allen no yes GlaxoSm ith Kline yes 2002 su pportedstu dy U SA Ho lm no yes financ ialsu pport yes 1998 from Glaxo VB, Neth erlan ds Th eNeth erlands Sko n er no N/A NR yes 2000 NCS Page 351 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable14. Quality assessm en to fplacebo -co n tro lledtrialso fh arm so utco m es InternalValidity Repo rtin g o f attritio n , Auth o r, Allo catio n Elig ibility Outco m e cro sso vers, Year Ran do m iz atio n co n cealm en t Gro upssim ilarat criteria assesso rs Carepro vider Patien t adh eren ce,an d Co un try adequate? Quality assessm en to fplacebo -co n tro lledtrialso fh arm so utco m es ExternalValidity Lo ssto fo llo w-In ten tio n - Auth o r, up: to -treat Po st- Num berscreen ed/ Year differen tial/h i(ITT) ran do m iz atio n Quality elig ible/ Co un try g h an alysis exclusio n s Ratin g en ro lled Exclusio n criteria Run -in /wash o ut Sch en kel no yes no fair NR /NR /98 Nonereportedin ab strac t Wash ou tperiods for 2000 m edic ations known Abstract to affec tg rowth were estab lish edb ased on estim atedperiod of effec tandth ese m edic ations were proh ib iteddu ring th e stu dy,b u tnot reportedin ab strac t. Sh ortc ou rses os eith eroral prednisonelasting no long erth an 7dor low-potenc ytopic al derm atolog ic al c ortic osteroids lasting no long er th an 10dwere perm ittedif nec essary NCS Page 353 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable14. Quality assessm en to fplacebo -co n tro lledtrialso fh arm so utco m es Class Auth o r, n aïve Co n tro l g ro up Year patien ts stan dardo f Co un try o n ly care Fun din g Relevan ce Sch en kel no N/A NR yes 2000 Abstract NCS Page 354 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable14. Quality assessm en to fplacebo -co n tro lledtrialso fh arm so utco m es InternalValidity Repo rtin g o f attritio n , Auth o r, Allo catio n Elig ibility Outco m e cro sso vers, Year Ran do m iz atio n co n cealm en t Gro upssim ilarat criteria assesso rs Carepro vider Patien t adh eren ce,an d Co un try adequate? Quality assessm en to fplacebo -co n tro lledtrialso fh arm so utco m es ExternalValidity Lo ssto fo llo w-In ten tio n - Auth o r, up: to -treat Po st- Num berscreen ed/ Year differen tial/h i(ITT) ran do m iz atio n Quality elig ible/ Co un try g h an alysis exclusio n s Ratin g en ro lled Exclusio n criteria Run -in /wash o ut Cutler no no (~7% no fair NR /NR /56 Historyof anydisorderth atm ig h t NR 2006 exc lu ded interferewith stu dyevalu ation;any from final loc alorsystem ic infec tion w/in 4 analysis) weeks of stu dy;UR TIw/in 6 weeks of stu dy;u seof presc riotion orOTCdru g s oth er th an forAR w/in 2weeks of stu dy; u seof anyinvestig ationaldru g w/in 30days of stu dy;u seof IM c ortic osteroids w/in 1yrororalor orallyornasalinh aled c ortic osteroids w/in 6m os of stu dy;m u ltipledru g allerg ies or c ortic osteroidallerg ies;positive h ep Bsu rfac eantig en orC antib odytest NCS Page 356 of 357 Final Report Update 1 Drug Effectiveness Review Project Eviden ceTable14. Quality assessm en to fplacebo -co n tro lledtrialso fh arm so utco m es Class Auth o r, n aïve Co n tro l g ro up Year patien ts stan dardo f Co un try o n ly care Fun din g Relevan ce Cutler no yes Sc h ering Plou g h yes 2006 NCS Page 357 of 357 . 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. Original Report: November 2004 Update 1: April 2006 The literature on this topic is scanned periodically. Update 2 prepared by: Susan Carson, MPH Nancy Lee, PharmD Sujata Thakurta, MPA:HA Drug Effectiveness Review Project Marian McDonagh, PharmD, Principal Investigator Oregon Evidence-based Practice Center Mark Helfand, MD, MPH, Director Oregon Health & Science University Copyright © 2010 by Oregon Health & Science University Portland, Oregon 97239. Final Report Update 2 Drug Effectiveness Review Project The medical literature relating to this topic is scanned periodically. Prior versions of this report can be accessed at the DERP website. Antihistamines Page 2 of 72 Final Report Update 2 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION.......................................................................................................................... For outpatients with seasonal or perennial allergic rhinitis or urticaria, do newer antihistamines differ in effectiveness?................................................................................................... For outpatients with seasonal or perennial allergic rhinitis or urticaria, do newer antihistamines differ in harms?.............................................................................................................. Are there subgroups of patients based on demographics (age, racial groups, gender), concomitant medications (drug-drug interactions), co-morbidities (drug-disease interactions or pregnancy), for which one newer antihistamine is more effective or associated with fewer harms? Head-to-head trials in adults with seasonal allergic rhinitis...................................................... Total Symptom Score change from baseline in head-to-head trials in adults with seasonal allergic rhinitis......................................................................................................................................... Outcomes from trials in children with perennial allergic rhinitis................................................ Antihistamines Page 4 of 72 Final Report Update 2 Drug Effectiveness Review Project 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 MA, Laurie Huffman, MS, Miranda Walker, MA, for assistance with data abstraction and quality assessment of studies, and Jennifer Nguyen for retrieval of articles and assistance with editing and formatting. Suggested citation for this report Carson S, Lee N, Thakurta S. Funding The Drug Effectiveness Review Project, composed of 12 organizations including 11 state Medicaid agencies and the Canadian Agency for Drugs and Technology in Health commissioned and funded for this report. 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.

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