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Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Country Funding Control group standard of care Length of follow-up Sanderson NR Yes 12 weeks 1999 China Kukin SKB Yes 6 months 1999 Metra CARIPLO funds University of Brescia Yes 44 months 2000 Beta blockers Page 315 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12 purchase discount sildalis on line erectile dysfunction and diabetes type 1. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Randomization Allocation Groups similar at Country described? Metoprolol European Trial (COMET) Beta blockers Page 316 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12 purchase online sildalis erectile dysfunction pills from canada. Quality assessments of head-to-head trials of beta blockers for heart failure Author Eligibility Outcome Care Patient Year criteria assessors provider unaware of Country Exclusion criteria for recruitment specified blinded blinded treatment Metra Patients with an acute ischemic event or a coronary revascularization Yes Yes Yes Yes 2002 procedure within 3 months; a history of alcohol abuse; primary valve US generic sildalis 120 mg without a prescription diabetes-induced erectile dysfunction epidemiology pathophysiology and management, Italy disease or congenital heart disease; frequent ventricular premature beats and/or runs of ventricular tachycardia; contraindications to beta-blocker therapy; concomitant treatment with other beta-blockers buy proscar discount, a-antagonists generic antabuse 500 mg without prescription, calcium antagonists or antiarrhythmic agents (except amiodarone) Poole-Wilson Recent change in treatment within 2 weeks before randomization; Yes Yes Yes Yes 2003 requirement for intravenous inotropic therapy; current treatment with non- Europe dihydropyridine calcium channel blockers (diltiazem generic zenegra 100 mg online, verapamil); amiodarone (>200 mg per day); class-I antiarrhythmic drugs; unstable Carvedilol Or angina; myocardial infarction; coronary revascularisation or stroke within Metoprolol the previous 2 months; uncontrolled hypertension (SBP >170 mm Hg or European Trial DBP >105 mm Hg); hemodynamically significant valvular disease; (COMET) symptomatic and sustained ventricular arrhythmias within the past 2 months note adequately treatment with antiarrhythmic drugs or implantation of an automatic defibrillator; pregnancy; women with childbrearing potential on inadequate contraception; known drug or alcohol misuse; poor compliance; any other serious systemic disease; contraindication to beta blockers Beta blockers Page 317 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Maintenance of Reporting of attrition, Year Intention-to-treat comparable crossovers, adherence, Loss to follow-up: Country (ITT) analysis groups and contamination differential/high Score Metra No NR Attrition reported; Others None Fair 2002 NR US, Italy Poole-Wilson Yes NR 31. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Country Funding Control group standard of care Length of follow-up Metra NR Yes 9-12 months 2002 US, Italy Poole-Wilson F Hoffman La Roche and GlaxoSmithKline; Yes 58 months 2003 first author has served as a consultant to or Europe received travel expenses, payment for speaking at meetings or funding for Carvedilol Or research from one or more of the major Metoprolol pharmaceutical companies European Trial (COMET) Beta blockers Page 319 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Randomization Allocation Groups similar at Country described? Beta blockers Page 320 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Eligibility Outcome Care Patient Year criteria assessors provider unaware of Country Exclusion criteria for recruitment specified blinded blinded treatment Galatius Patients who had contraindications for BB treatment; and those who had Yes No No No 2004 been admitted, had attended an emergency room, or who had been treated in the heart failure clinic for acute decompensation within 2 weeks prior to randomization. Patients were excluded from data analysis if they died before two months of follow-up. Lombardo SBP <90mm Hg; DBP <60mm Hg; HR <50 bpm; cerebral vascular Yes No No No 2006 accidents w/in previous 6 months; heart or vascular surgery or MI w/in Italy previous 3 months; serious valvular conditions that required surgery; atrioventricular conduction abnormalites; milignancies; serious liver, kidney, connective tissue, respiratory, or hematologic disease; history of allergy; intolerance to ACE inhibitors; unstable angina, DM; digitalis intolerance; BMI >30; excercise tolerance limited by other disorders; pregnancy. Beta blockers Page 321 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Maintenance of Reporting of attrition, Year Intention-to-treat comparable crossovers, adherence, Loss to follow-up: Country (ITT) analysis groups and contamination differential/high Score Galatius No; excluded 3 NR Yes NR Poor 2004 patients that died No prior to completing 2 No months of treatment No Lombardo Yes Yes Yes NR Fair 2006 No Italy No No Beta blockers Page 322 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Country Funding Control group standard of care Length of follow-up Galatius Danish Pharmacy Foundation, Merck Sharp Yes 10. Outcomes in head-to-head trials of beta blockers for heart failure Sample Worsening Trial Interventions* size Duration Baseline EF Mortality heart failure Sanderson Carvedilol 51 12 weeks 26% NR NR 1999 Metoprolol Fair Kukin Carvedilol 67 6 months 18-19% NR car=3/37(8. Outcomes in head-to-head trials of beta blockers for heart failure Change in EF following Trial NYHA Class Exercise capacity treatment Sanderson # patients at NYHA class I/II/III/IV Improvement in 6-min walk(feet) Mean EF at Week 12 (% 1999 car car=72(6. Outcomes in head-to-head trials of beta blockers for heart failure Trial Quality of life Sanderson Minnesota QOL mean reduction in symptom 1999 score (%) car=9. Randomized controlled trials of beta blockers for arrhythmia Author Year Study design Country Setting Eligibility criteria Exclusion criteria Head-to-head trials Katritsis RCT Patients subjected to cardioversion of Terminal illness, age > 80 years, left ventricular 2003 multicenter persistent AF (> 7 days) ejection fraction <30, concomitant treatment with class I or III antiarrhythmic drugs, amiodarone use Fair quality within 3 months before randomization, previous treatment with bisoprolol or carvedilol, and contraindications to beta blockade, such as conduction disturbances, asthma, or severe chronic obstructive pulmonary artery disease Beta blockers Page 327 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 14. Randomized controlled trials of beta blockers for arrhythmia Author Allowed other Method of outcome Age Year Interventions (drug, regimen, medications/ assessment and timing of Gender Country duration) interventions assessment Ethnicity Head-to-head trials Katritsis Bisoprolol 10 mg daily (or 5 mg No restrictions, with Clinic visits at months 1, 3, Mean 2003 daily if LVEF < 40%) exception of class I 6 and 12 age=65. Randomized controlled trials of beta blockers for arrhythmia Number Author Number screened/ withdrawn/ Year Other population characteristics eligible/ lost to fu/ Country (diagnosis, etc) enrolled analyzed Outcomes Head-to-head trials Katritsis Heart rate=71. Randomized controlled trials of beta blockers for arrhythmia Author Year Method of adverse Adverse effects Withdrawals due to adverse events Country effects assessment?

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The primary endpoint was the number of “renal events order discount sildalis on line erectile dysfunction causes tiredness,” defined as acute renal failure purchase 120 mg sildalis free shipping erectile dysfunction drugs walmart, rapidly progressive renal failure sildalis 120mg without a prescription erectile dysfunction and pump, or hospitalization due to any renal failure event or electrolyte abnormality buy 20mg levitra professional fast delivery. No participants in any treatment arm reached this primary endpoint buy 120mg silvitra overnight delivery. They also examined changes in proteinuria between treatment groups levitra extra dosage 40mg with mastercard. Combination therapy was only noted to be statistically superior to monotherapy in terms of reduction in proteinuria with maximal dose combination therapy (valsartan 160 and benazepril 5 or 10 mg per day) compared with monotherapy (valsartan 160 mg per day) (P=0. The lower dose combination therapy (valsartan 80 and benazepril 5 or 10 mg per day) was not statistically superior for reduction in proteinuria compared with monotherapy. Comparison of changes in creatinine clearance was not reported between groups, but creatinine changes were numerically similar in each group. Diastolic blood pressure was not equivalent between groups, and was statistically lower in those on maximum dose combination therapy as compared with valsartan monotherapy (P=0. Adverse events were reported by treatment group by percent effected. Total percent of adverse events was numerically greatest among those on monotherapy with valsartan (45%), and DRIs, AIIRAs, and ACE-Is Page 66 of 144 Final Report Drug Effectiveness Review Project was similar among those on full and half dose combination therapy (25% and 33. Statistical analysis of adverse event rates between groups was not reported, but the event rate of hyperkalemia (potassium greater than 6 millimoles per liter) was highest among those on maximum dose combination therapy (11. Additional percent rates for treatment groups can be found in Evidence Table 9, although no statistical comparison is reported. Diabetic Nephropathy Summary of findings Comparison of aliskiren to placebo when added to an AIIRAs or ACE-Is • When added to losartan o Effectiveness/Efficacy: When added to losartan, aliskiren was superior to placebo in reducing urinary albumin-to-creatinine ratio, which appeared independent of change in systolic blood pressure. Analysis of correlation with diastolic blood pressure was not reported. Additionally, a significantly greater proportion of participants achieved a reduction of 50% or more in albuminuria in the aliskiren group. The differences between aliskiren and placebo in deaths, change in estimated glomerular filtration rate or overall withdrawals were not significant, however. Comparison of AIIRA and ACE-I monotherapies Effectiveness/efficacy/harms • Telmisartan compared with enalapril (1 trial, fair quality) o 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 monotherapy with an AIIRA and an ACE-I in adults with diabetes. Telmisartan and enalapril also had similar effects on other secondary outcomes including all-cause mortality, death due to cardiovascular causes, nonfatal myocardial infarction, congestive heart failure, cerebrovascular accident, kidney failure/required dialysis, increased serum creatinine (greater than 2. Consistent findings of no differences in reduction of albumin levels DRIs, AIIRAs, and ACE-Is Page 67 of 144 Final Report Drug Effectiveness Review Project or change in glomerular filtration rate across 2 trials. Consistent findings of no differences in overall withdrawals across 3 trials.

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Slavin MA purchase 120 mg sildalis with amex impotence vitamins supplements, Osborne B purchase genuine sildalis on-line erectile dysfunction muse, Adams R sildalis 120 mg with amex erectile dysfunction doctors jacksonville fl, Levenstein MJ buy aurogra 100 mg overnight delivery, Schoch HG extra super viagra 200mg overnight delivery, J Natl Compr Canc Netw generic propecia 5 mg with mastercard. Efficacy and safety of fluconazole prophylaxis for fungal 17. Flowers CR, Seidenfeld J, Bow EJ, Karten C, Gleason C, et al. Micafungin versus fluconazole for prophylaxis J Clin Oncol. Marti FM, Cullen MH, Roila F; ESMO Guidelines Working tients undergoing hematopoietic stem cell transplantation. Management of febrile neutropenia: ESMO clinical Infect Dis. Winston DJ, Maziarz RT, Chandrasekar PH, Lazarus HM, 19. Lingaratnam S, Slavin MA, Koczwara B, Seymour JF, Szer J, et Goldman M, et al. Introduction to the Australian consensus guidelines for the intravenous and oral fluconazole for long-term antifungal management of neutropenic fever in adult cancer patients, prophylaxis in allogeneic hematopoietic stem-cell transplant 2010/2011. Australian Consensus Guidelines 2011 Steering recipients. Lehrnbecher T, Phillips R, Alexander S, et al; International 36. Marr KA, Crippa F, Leisenring W, Hoyle M, Boeckh M, et al. Guideline for Itraconazole versus fluconazole for prevention of fungal infec- the management of fever and neutropenia in children with tions in patients receiving allogeneic stem cell transplants. Ullmann AJ, Lipton JH, Vesole DH, Chandrasekar P, Langston 21. Guyatt GH, Oxman AD, Kunz R, Falck-Ytter Y, Vist GE, et al. Posaconazole or fluconazole for prophylaxis in severe Going from evidence to recommendations. Wingard JR, Carter SL, Walsh TJ, Kurtzberg J, Small TN, et al. Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Randomized, double-blind trial of fluconazole versus voricona- Schu¨nemann HJ. What is “quality of evidence” and why is it zole for prevention of invasive fungal infection after allogeneic important to clinicians? Slavin MA, Lingaratnam S, Mileshkin L, Booth DL, Cain MJ, 5118. Use of antibacterial prophylaxis for patients with neutro- 39.

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