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Studies anywhere on the continuum from efficacy to effectiveness can be useful in comparing the clinical value of different drugs buy 37.5 mg effexor xr with mastercard. Effectiveness studies are more applicable to practice discount effexor xr 37.5 mg with visa, but efficacy studies are a useful scientific standard for determining whether characteristics of different drugs are related to their effects on disease purchase 37.5mg effexor xr free shipping. Systematic reviews thoroughly cover the efficacy data in order to ensure that decision makers can assess the scope, quality, and relevance of the available data. This thoroughness is not intended to obscure the fact that efficacy data, no matter how large the quantity, may have limited applicability to practice. Clinicians can judge the relevance of studies’ results to their practice and should note where there are gaps in the available scientific information. Unfortunately, for many drugs there exist few or no effectiveness studies and many efficacy studies. Yet clinicians must decide on treatment for patients who would not have been included in controlled trials and for whom the effectiveness and tolerability of the different drugs are uncertain. Systematic reviews indicate whether or not there exists evidence that drugs differ in their effects in various subgroups of patients, but they do not attempt to set a standard for how results of controlled trials should be applied to patients who would not have been eligible for them. With or without an evidence report, these decisions must be informed by clinical judgment. In the context of development of recommendations for clinical practice, systematic reviews are useful because they define the strengths and limits of the evidence, clarifying whether assertions about the value of an intervention are based on strong evidence from clinical studies. Judgment, reasoning, and applying one’s values under conditions of uncertainty must also play a role in decision making. Users of an evidence report must also keep in mind that not proven does not mean proven not; that is, if the evidence supporting an assertion is insufficient, it does not mean the assertion is untrue. The quality of the evidence on effectiveness is a key component, but not the only component, in making decisions about clinical policy. Additional criteria include acceptability to physicians and patients, potential for unrecognized harm, applicability of the evidence to practice, and consideration of equity and justice. DRIs, AIIRAs, and ACE-Is Page 11 of 144 Final Report Drug Effectiveness Review Project Scope and Key Questions The goal of this report is to compare the effectiveness and harms between aliskiren and placebo and between AIIRAs and ACEIs in the treatment of diagnosed coronary heart disease, hypertension, left ventricular dysfunction, heart failure, nondiabetic chronic kidney disease, or diabetic nephropathy. The Oregon Evidence-based Practice Center wrote preliminary key questions, identifying the populations, interventions, and outcomes of interest, and, based on these, eligibility criteria for studies. A draft of these questions and inclusion and exclusion criteria were posted on the Drug Effectiveness Review Project website for public comment. Then, a group of clinicians specializing in nephrology and hypertension were consulted for clinical insight into the proposed key questions. The draft was reviewed and revised by representatives of the organizations participating in the Drug Effectiveness Review Project. Revision took into consideration input from the public, clinical advisors, and the organizations’ desire for the key questions to reflect populations, drugs, and outcome measures of interest to clinicians and patients. These organizations approved the following key questions to guide the review for this report: 1. For adults with diagnosed coronary heart disease, hypertension, left ventricular dysfunction, heart failure, nondiabetic chronic kidney disease, or diabetic nephropathy, what is the effectiveness and efficacy and what are the harms of aliskiren compared with placebo? When used in combination with angiotensin converting enzyme inhibitor (ACE-I) and angiotensin II receptor blocker (AIIRA) drugs? For adults with diagnosed coronary heart disease, hypertension, left ventricular dysfunction, heart failure, nondiabetic chronic kidney disease, or diabetic nephropathy, what are the inter-class differences in effectiveness and efficacy between direct renin inhibitor (DRI), ACE-I and AIIRA drugs? For adults with diagnosed coronary heart disease, hypertension, left ventricular dysfunction, heart failure, nondiabetic chronic kidney disease, or diabetic nephropathy, what are the inter-class differences in harms between DRI, ACE-I and AIIRA drugs? Are there subgroups based on demographics (age, racial groups, gender), other medications, or co-morbidities for which there are inter-class differences between DRI, ACE-I and AIIRA drugs? DRIs, AIIRAs, and ACE-Is Page 12 of 144 Final Report Drug Effectiveness Review Project METHODS Inclusion Criteria Populations Adults with any of the following indications: • Diagnosed coronary heart disease (including post-myocardial infarction) • Hypertension • Left ventricular dysfunction • Heart failure • Nondiabetic chronic kidney disease, with or without proteinuria • Diabetic nephropathy, defined as documented diabetes, with either microalbuminuria or macroalbuminuria, and any level of renal function.

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Cancer: Data from 1 cohort study found a potentially increased risk of cancer development in women with either β interferon or glatiramer acetate use; these results are inconclusive buy 75 mg effexor xr with mastercard. Therapy- related acute leukemia was reported in 2/1620 patients taking mitoxantrone buy effexor xr 75 mg online. Cardiotoxicity: Two cases of congestive heart failure were Disease-modifying drugs for multiple sclerosis Page 83 of 120 Final Report Update 1 Drug Effectiveness Review Project Quality of the Key Question evidence Conclusion potentially linked to mitoxantrone use in 1 meta-analysis of 3 (2 unpublished) studies (incidence 0 buy 37.5 mg effexor xr visa. Tolerability ® Flu-like syndrome: Interferon β-1a IM (Avonex ) was associated with the highest rates of flu-like syndrome compared with the other β interferons (~62% compared with 28%). Systemic reactions: Post-injection systemic reactions were observed in patients receiving glatiramer acetate, although these were usually limited to a single episode. There were no events reported of this outcome in trials of β interferons, natalizumab or mitoxantrone. Long-term safety in observational studies Long-term safety data from comparative and non-comparative, non-randomized studies was consistent with that reported in trials. Significant concerns include progressive multifocal leukoencephalopathy in patients receiving natalizumab >12 months, lipoatrophy with prolonged use of glatiramer and permanent amenorrhea in older women receiving higher total dose of mitoxantrone. Key Question 6: Poor Observational studies did not show increased risk of adverse Are there pregnancy outcomes associated with exposure to beta subgroups of interferons or glatiramer, but studies were too small to make patients based on strong conclusions about the safety of MS drugs in pregnancy. Abbreviations: ALT, alanine aminotransferase; EDSS, Expanded Disability Status Scale; IM, intramuscular; DMD; disease-modifying drug; MS, multiple sclerosis; NAb, neutralizing antibody; PRMS, progressive relapsing multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; SPMS, secondary progressive multiple sclerosis; SC, subcutaneous. Disease-modifying drugs for multiple sclerosis Page 84 of 120 Final Report Update 1 Drug Effectiveness Review Project REFERENCES 1. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Prevalence Estimates for MS in the United States and Evidence of an Increasing Trend for Women. Costs and Quality of Life in Multiple Sclerosis: A Cross Sectional Study in the United States. Diagnostic Criteria for Multiple Sclerosis: 2005 Revisions to the "McDonald Criteria". Rating Neurological Impairment in Multiple Sclerosis: An Expanded Disability Status Scale (EDSS). Clinical Outcome Measures and Rating Scales in Multiple Sclerosis Trials. Multiple Sclerosis- The Plaque and its Pathogenesis. Copaxone (Glatiramer Acetate Injection) [Product Information] Kansas City MO, Teva Neuroscience Inc. Avonex (Interferon beta-1a) IM injection [Product Information]Cambridge, MA: Biogen Idec Inc. Rebif (Interferon Beta-1a) [Product Information]Rockland MA: Serono, Inc,. Betaseron (Interferon Beta-1b) [Product Information]Montville, NJ: Berlex Laboratories. Novantrone (mitoxantrone for injection concentrate) [Product Information] Rockland MA: Serono, Inc,. Extavia (Interferon beta 1-b) [product information]. Tysabri (natalizumab) [Product Information] Cambridge, MA: Biogen Idec Inc. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Grading the strength of a body of evidence when comparing medical interventions. Methods Guide for Comparative Effectiveness Reviews.

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While mixed results were found for disease progression order 150mg effexor xr otc, relapse rates were more consistently affected by the beta interferons order effexor xr 75 mg with mastercard. Four trials indicated that beta interferon therapy reduces relapse and associated hospitalizations in patients with secondary progressive multiple 2 sclerosis compared with placebo buy cheap effexor xr 150 mg online. Body surface area dosing (160 µg/m ) of interferon beta-1b SC ® (Betaseron ) was generally less effective than the 250 µg dose. Health-related quality of life was Disease-modifying drugs for multiple sclerosis Page 40 of 120 Final Report Update 1 Drug Effectiveness Review Project measured in 2 studies using different tools, both finding a benefit of the respective beta 79, 80 interferon used. Glatiramer acetate and natalizumab ® ® No studies of glatiramer acetate (Copaxone ) or natalizumab (Tysabri ) in patients with secondary progressive multiple sclerosis were found. Primary progressive multiple sclerosis Beta interferons Indirect evidence The primary evidence of the effectiveness of drug treatment in primary progressive multiple ® sclerosis came from a single small (N=50) trial of interferon beta-1a IM (Avonex ) at doses of 85 30 µg, 60 µg, or placebo once weekly for 2 years. While no statistically significant differences were found between the groups at baseline, the baseline Expanded Disability Status Scale in the placebo group was 1 point lower (4. The time to sustained progression (increase of ≥1 point on Expanded Disability Status Scale at baseline ≤ 5. There was no sample size calculation completed by the study authors; the small sample size and potentially clinically important differences at baseline left the possibility of benefit in a larger trial open to speculation. Statistically significant differences on secondary outcome measures (the 10-minute walk test and the 9-hole peg test) were also not found. However, the authors suggested that a benefit in right hand side 9-hole peg test was seen with the beta interferon 30 µg group (P=0. While a pilot trial of interferon beta-1b SC (Betaseron ) has been done, it has 86 only been partially reported to date. Details in this publication were inadequate for inclusion here. One systematic review by Rojas et al of the Cochrane collaboration reviewed data from 36 both of these trials including unpublished data from the pilot trial by Montalban. This trial data ® found a no significant differences between interferon beta-1b SC (Betaseron ) and placebo in sustained progression of disease and mean Expanded Disability Status Scale change over a 2 36 year period. The review pooled data from both interferons, which did not allow interpretation for comparative effectiveness, however, they found no difference in relapse related and disease progression outcomes when the data was pooled. These results were limited by the small number (N=143). Glatiramer acetate One indirect fair quality study, N=943, compared glatiramer acetate to placebo in patients with 87 primary progressive multiple sclerosis. The duration of the study was intended to be 36 months but was stopped early due to lack of efficacy. At that time 60% of patients randomized to Glatiramer and 59% of those randomized to placebo had received the study drug for 24 months, and 18% and 15% respectively had received the study drug for 36 months. The study found no significant difference in delay to sustained disability (hazard ratio, 0. Disease-modifying drugs for multiple sclerosis Page 41 of 120 Final Report Update 1 Drug Effectiveness Review Project Natalizumab and mitoxantrone No studies of natalizumab or mitoxantrone in patients with primary progressive multiple sclerosis were found. One study of glatiramer acetate included a mixed population (see below). Mixed populations: Clinically isolated syndrome and relapsing-remitting multiple sclerosis ® One small single-blinded head-to-head trial (N=75) comparing interferon beta-1b (Betaseron ) 57 to glatiramer acetate evaluated clinical exacerbations over 2 years as a secondary outcome. Randomization was stratified by clinical site and presence of enhancement on screening magnetic resonance imaging, which introduced bias to the results. There was no specific criterion for defining relapse, including change in Expanded Disability Status Scale and/or a decrease in the Scripps Neurological Rating Scale of at least 7 points, and a neurological examination was performed by a blinded examining neurologist. Most of the patients had relapsing-remitting multiple sclerosis (79%) with a baseline median annualized relapse rate and Expanded Disability Status Scale score of 1. No ® difference was found in the annualized relapse rate (interferon beta-1b [Betaseron ] 0.

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