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Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Sumatriptan SC - pain outcomes Sumatriptan Earliest Author Dosage (mg) Notes 30-min outcomes 1-hour outcomes 2-hour outcomes relief (min) Dahlof 1992 S 8 mg 8 mg NR NR NR 30 General well-being (MSEP): S>P Diener 1999 6mg NR NR Relief: 91 prinivil 5 mg line. Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Sumatriptan SC - pain outcomes Sumatriptan Earliest Author Dosage (mg) Notes 30-min outcomes 1-hour outcomes 2-hour outcomes relief (min) Winner order 2.5 mg prinivil free shipping, 2006 S 6mg Morning migraines NR NR Free: 48 vs 18 10 (Study 1) Winner generic prinivil 5mg on line, 2006 S 6mg Morning migraines NR NR Free: 57 vs 19 10 (Study 2) Wendt, 2006 S 4mg Acute migraine attacks Relief: 43 vs 18 Relief: 67 vs 25 Relief: 70 vs 22 10 in clinic Free: 10 vs 3 Free: 34 vs 7 Free: 50 vs11 Triptans Page 165 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Almotriptan Freitag, 2008 Almotriptan N=378 Functional disability and A vs Pla 12. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Almotriptan Freitag, 2008 24 hour QOL social function domain p<0. Eletriptan Wells, 2000 Total Time Loss: Median Hours E40: 4. Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Martin 2005 40mg N=160 Patients who failed on Normal functioning at 2 Hours 37 Fiorinal and/or Fioricet 69% of E40 85% Female Open label Silberstein, 2006 20, 40mg N=613 Work productivity outcomes Functional response based on FIS criteria Mean age (years) E40: 75% vs Pla: 45% (p<0. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Martin 2005 MSQ Scores Pre-treatment: 57. Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Anonymous 1991 6mg, 8mg N=639 Normal function at 60: 45 vs 9; p<0. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Anonymous 1991 Bousser Duration of inability to work: 5 h 40 m vs. Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Gross 1994 S 6 mg (novel N=86 Self-injected at home self-injector) 43. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Gross 1994 Ability to return to work within 2 hours: 61% vs 27%; p=0. Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Russell, 1994 6mg N=230 Auto-injector Improvement of severity of headache: 44 S6 had 48% more success than Placebo at 82% Female both 1 and 2 hours; (p<0. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Russell, 1994 Headache: none/mild after treatment: S6: 29% vs Placebo: 9% Schulman, 2000 Productivity loss in min. Triptan compared with placebo: Summary of orally disintegrating drug results Sample Size Mean age (yrs) Author, Year Dose % Female Results at 1 Hour Results at 2 hours Functional/Return to Normal Zolmitriptan Loder, 2005 2. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Almotriptan Mathew, 2007 12. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Goadsby, 2008 Almotriptan 491 NR 1) A 12. Sustained pain-free (2- 24 hrs) 46% vs 30% vs 16% vs 11% Differences: 1 vs. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Frovatriptan Cady, 2004 2. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Cady 2006 10mg N=331 NR Pain Freedom at 2 Functional Disability at 2 Study 2 41 Hours Hours 88% Female R10: 59% vs Pla: R10: 34% vs Pla: 56% 31% (p<0. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Jelinski, 2006 50 & 100mg N=361 Pain-Free at 1 Hour Pain-Free at 2 Hours NR 40 S50: 24% Pla: 7% S50: 40% vs Pla: 16% 85 (p<0. Triptan compared with placebo: Summary of early treatment results Sample size Mean Age (yrs) Functional/Return to Author, Date Dose % Female Results at 1 hour Results at 2 hours Normal Activities Zolmitriptan Klapper, 2004 2. 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: July 2007 Beth Smith, DO Susan Carson, MPH Rochelle Fu, PhD Marian McDonagh, PharmD Tracy Dana, MLS Benjamin KS Chan, MS Sujata Thakurta, MPA-HA Andrew Gibler, PharmD 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 1 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. Disease-modifying drugs for multiple sclerosis Page 2 of 120 Final Report Update 1 Drug Effectiveness Review Project STRUCTURED ABSTRACT Purpose We compared the effectiveness and safety of disease-modifying drugs for the treatment of ® ® ® multiple sclerosis: Glatiramer acetate (Copaxone ), interferon beta-1a (Avonex , Rebif ), ® ® ® interferon beta-1b (Betaseron , Extavia ), mitoxantrone (Novantrone ), and natalizumab ® (Tysabri ). Data Sources ® We searched Ovid MEDLINE and the Cochrane Library and the Database of Abstracts of Reviews of Effects through December 2009. For additional data we also hand searched reference lists, government web sites and dossiers submitted by pharmaceutical companies. Review Methods Study selection, data abstraction, validity assessment, grading the strength of the evidence, and data synthesis were all carried out according to standard Drug Effectiveness Review Project review methods. Results In patients with relapsing remitting multiple sclerosis, little difference in relapse outcomes were ® ® found between interferon beta-1a SC (Rebif ) and interferon beta-1b (Betaseron ), while ® ® interferon beta-1a IM (Avonex ) was less effective than interferon beta-1a SC (Rebif ) and ® interferon beta-1b (Betaseron ) based on 4 fair-quality head-to-head trials. Direct evidence from 5 fair-quality head-to-head trials was conflicting on disease progression outcomes between the interferons. Pooled analysis of direct and indirect trial data found no difference between the ® interferons on changes in disability and no difference between interferon beta-1a SC (Rebif ) ® and interferon beta-1a IM (Avonex ) on disease progression but did find interferon beta-1b ® ® (Betaseron ) to be superior to interferon beta-1a IM (Avonex ) on disease progression (relative risk, 0. There was no difference in relapse or disease progression ® ® between glatiramer and interferon beta-1a SC (Rebif ) or interferon beta-1b (Betaseron ) based on 2 head-to-head trials. Evidence is insufficient to make any judgments regarding effectiveness in primary progressive or secondary progressive multiple sclerosis. Evidence suggested that all 3 interferon beta-1 products and glatiramer reduced the probability of converting from clinically isolated syndrome to clinically definite multiple sclerosis over 2 to 5 year periods. Evidence for interferon beta-1b SC ® ® (Betaseron ) and interferon beta-1a SC (Rebif ) indicated that consistent positive neutralizing antibody status with high titer increased relapse rates, by one-half to two-thirds, during longer Disease-modifying drugs for multiple sclerosis Page 3 of 120 Final Report Update 1 Drug Effectiveness Review Project periods of follow-up. This difference was not seen with follow-up of 2 years or less, and there was inadequate evidence to conclude that there is an impact on disease progression. No difference was found in withdrawal rates among beta interferons in head-to-head trials. Transaminase elevations were common with all beta interferon products, with little difference in rates of occurrence. There was a lower rate of depression in patients taking ® interferon beta-1a (Rebif ) compared with the other interferons based on limited trial data. Interferon beta-1b SC (Avonex ) was associated with ® the lowest rates of injection site reactions whereas interferon beta-1b SC (Betaseron ) and ® interferon beta-1b SC (Rebif ) had similar rates. Significant long-term concerns included 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. There was some evidence that response to beta interferons and glatiramer differs in men and women, but there was no evidence that this difference favors one product over another. Evidence is insufficient to make conclusions about the safety of these drugs in pregnancy. A post ® hoc subgroup analysis of a head-to-head trial of interferon beta-1a products (Avonex and ® Rebif ) found that African-American patients experienced more exacerbations and were less likely to be exacerbation-free compared with white patients over the course of the study.
Use of plasma should take into consideration the dilution factor that may be produced because of the anticoagulant cheap prinivil 10mg amex. Isotype of aCL and anti- 2GPI IgG and IgM isotypes are recommended for both aCL and anti- 2GPI prinivil 10mg sale. Anti- 2GPI: 2GPI of human origin should be used on a negatively charged (“high” binding or gamma-irradiated) plate buy 5 mg prinivil overnight delivery. Quantitation of results The test signal is converted into antibody units derived from the calibration curve. Anti- 2GPI are expressed in arbitrary units; universal units of measurement are not available. Development/establishment of international/universal units of measurement is recommended. Standards Manufacturers and test users are strongly encouraged to select a reliable standard to prepare secondary calibrators (polyclonal or monoclonal). The proposed secondary calibrators should be compared and validated against the primary standard using published and accepted procedures. Selected groups of actual patient sera should be used if possible to further establish the extent of agreement in the assay/test system. Most importantly, the production and the quality control of the standards should be subjected to FDA Good Manufacturing Practices guidelines or an equivalent quality assurance program. A record of traceability from the recommended standards to any secondary calibrators is required. Calibration curves Multipoint calibration and use of statistically correct ﬁtting and calculation methods are required. The calibration curve should be rejected if the correlation coefﬁcient between assay readings and expected values of the calibrators is 0. Precision CV of manually performed ELISAs should be 20%, preferably 15%. Positive/negative controls Incorporation of at least 1 “external” positive control in every run to monitor interassay variation is recommended. Similarly, a “negative” control with values below the cutoff of the assay should be used in each run. A run should be rejected if the result with either the positive or the negative control falls out of the established range. Singlet/duplicate It is recommended to do duplicate testing, especially when inter-run and intra-run imprecision determined for a quality measurements control sample is 10%. If this is not feasible, manufacturers’cutoffs may be acceptable if local measurements on 20 or more healthy subjects yields similar results. Reporting of results Given the variability in assay methods, semiquantitative reporting is difﬁcult to deﬁne. Each test result above the 99th percentile cutoff should be regarded as positive and reported quantitatively. Imprecision of the method should be considered, especially for results around the cutoff. Manufacturers should disclose information based on evidence derived from clinical studies that may assist with the interpretation of results. As a point of contrast, CLSI (2014) advises arise either when there is an undiagnosed coagulopathy or if the aPL to normalize against the reference interval mean clotting time rather aAbs are sufﬁciently potent to fully prevent the reagent and excess than the NPP value. Mixing the patient’s plasma at a 1:1 ratio with type, which can systematically bias readings toward false-positive normal pooled plasma (NPP) and then undertaking the screen and or false-negative results if an NPP value is at the extreme of the conﬁrmatory tests may allow the detection of LAC by diluting the reference interval. NPP The index of circulating anticoagulant is one option for assessing samples can be used as normal controls to identify sudden analytical mixing study results; the other is to determine a mixing-study-speciﬁc difﬁculties. The concept is to use the framework of the Reporting screening test but, in addition, to add a higher concentration of It is encouraged by the various guidelines that a deﬁnitive summary phospholipid, which can take the form of either bilayer or hexagonal statement be given when reporting the results of the LAC assay (II) phase phospholipid. The use of freeze/thawed platelets as a results whether LAC is present or not detected. Terms such as source of phospholipid is not encouraged due to inconsistency in the borderline or weak positive are discouraged. Reporting of the conﬁrmatory test can be with the use of the following Solid-phase assays formula: percentage correction of ratio [(screen ratio conﬁrm Preanalytical variables ratio)/(screen ratio)] 100. Most ELISA systems recommend the use of serum samples. IgM rheumatoid factor is another variable that has been assays are used with paired screen and conﬁrm reagents, respec- noted on occasion (although not consistently) to cause interference tively, the normalized screen to conﬁrmatory ratio is recom- in IgM aCL and IgM anti- 2GPI ELISA assays and can lead to mended:15 normalized screen:conﬁrm ratio screen ratio/conﬁrm 47 false-positive readings. Testing patients on anticoagulants Calibrators and standard curves LAC testing in the setting of an individual taking a VKA is not an Interlaboratory variability seen with the performance of the aCL and absolute contraindication, although it is universally acknowledged anti- 2GPI ELISAs is due to the lack of uniformity in reference material for calibration. If the international normalized ratio (INR) subsequently been derived from this original set of standards and have been widely distributed. If, however, the reference calibrators are not used for routine day-to-day purposes, INR is between 1. BCSH (2012) and CLSI (2014) also advocate the use of 1:1 mixture with NPP when performing the results are expressed in IgG phospholipid (GPL) and IgM (MPL) screening and conﬁrmation tests, but do not restrict this practice to units. One GPL or MPL unit is deﬁned as the cardiolipin-binding individuals with an INR 3 alone. Testing on undiluted plasma in the context of an INR 1. One way of overcoming limitations in uniform calibrator availabil- Taipan snake venom time can be a useful screening test for LAC in ity was the development of the Sapporo standards, IgM and IgG patients taking VKA, and Ecarin time can serve as a conﬁrmatory isotopes that are chimeric mAbs against 2GPI, designated EY2C9 test in this context. The advantage of be corrected with mixing studies, thus allowing detection of LAC unlimited supply and better reproducibility over the long term is positivity, the coagulation effects caused by direct thrombin inhibi- countered by disadvantages such as not behaving as patient-derived tors (dabigatran and argatroban) and the fXa inhibitor (rivaroxaban) antibodies (mAbs are high afﬁnity, patient aAbs are of low afﬁnity) cannot be reversed by mixing studies. Therefore, these medications and, furthermore, mAbs do not capture the diverse speciﬁcities of interfere with all LAC assays and thus introduce a signiﬁcant risk of aPL aAbs present in APS. Strong recommendations have been made heparin neutralizers, which can be added to the sample plasma or for a concerted effort to establish international units for measure- can be found in most commercial dRVVT reagents. Anti- 2GPI testing, it is recommended that the reference range be 2. Cervera R, Serrano R, Pons-Estel GJ, et al; on behalf of the Euro- established by the nonparametric percentile method in view of the Phospholipid Project Group (European Forum on Antiphospholipid Antibodies). Morbidity and mortality in the antiphospholipid syndrome fact that autoantibody values do not tend to follow a Gaussian 24,45 during a 10-year period: a multicentre prospective study of 1000 distribution. A minimum of 120 reference subjects, taking into patients. Antiphospholipid antibodies and representative for each laboratory, are used to establish the refer- 45 the risk of recurrence after a ﬁrst episode of venous thromboembolism: a ence interval. Alternatively, for small laboratories that do not have systematic review. Guyatt GH, Akl EA, Crowther M, Gutterman DD, Schuu¨nemann HJ; appropriate to undertake a veriﬁcation process to afﬁrm the American College of Chest Physicians Antithrombotic Therapy and manufacturers’ reference ranges using a small number (minimum Prevention of Thrombosis Panel.
A very short trial comparing darifenacin with oxybutynin reported 3 treatment-related 26 withdrawals due to adverse events overall buy cheap prinivil 5mg on line. The study discount prinivil 2.5 mg line, designed as a crossover order prinivil 5mg fast delivery, included a total of only 65 participants, who were divided into 3 cohorts; not all members of each cohort participated in all of the measurements. The STAR trial, comparing the difference between solifenacin (5 mg or 10 mg) and tolterodine extended-release (4 mg) reported withdrawals due to adverse events for all patients 28 receiving solifenacin (3. Our statistical analysis found that this difference was not significant. A post hoc analysis comparing solely the Overactive bladder Page 35 of 73 Final Report Update 4 Drug Effectiveness Review Project 5 mg dose of solifenacin (the “no-dose-increase” subgroup) with tolterodine extended-release found that over 12 weeks both groups had a comparable incidence of withdrawal due to adverse 106 events (1. These differences were not statistically significant. Is there a difference in adverse events between long-acting and short-acting formulations? Immediate-release compared with extended-release tolterodine Short-term studies In a 12-week head-to-head placebo-controlled trial of extended-release and immediate release formulations of tolterodine, rate of dry mouth was 23% for extended-release tolterodine, 30% for immediate-release, and 8% for placebo. Rate of constipation was 6% for extended-release, 7% 46 for immediate-release, and 4% for placebo. Withdrawal due to adverse event was almost identical: for extended-release, 5. There were 2 additional short-term observational trials, one each measuring tolerability of 111, 116 tolterodine immediate-release and extended-release. All observational trials are summarized in Evidence Table 8. The study of varying doses of the short-acting formulation reported 4. It is not entirely clear how adverse events were assessed. In the trial of tolterodine extended-release 4 mg, authors reported that16% of patients had dry mouth and 8% 111 withdrew from the study due to adverse events. Long-term studies We found 5 longer-term observational studies, 3 for tolterodine extended-release and 2 for the 55, 113, 114, 121, 126 immediate-release formulation. All trials reported rates of dry mouth ranging from 7. The withdrawal rates due to adverse events were more consistent, ranging from 2. Overall rates of adverse events were inconsistently reported and were spread from 10% to 77%, thus not useful for conclusions. It is essential to note that trial designs varied from frequent provider visits and elicitation of adverse events to phone or postal surveys of experience with drugs; design could have substantially influenced the outcome of reported adverse events. Immediate-release compared with extended-release oxybutynin Short-term studies 22, 24, There were 4 studies comparing long-acting with short-acting formulations of oxybutynin. Two of these trials have an unclear duration Overactive bladder Page 36 of 73 Final Report Update 4 Drug Effectiveness Review Project 22, 47 of follow-up but report significantly more dry mouth with oxybutynin immediate-release 22 than with oxybutynin extended-release (48% compared with 59%; P=0. Adverse event rates for extended-release and immediate-release formulations were 28% and 17% for blurred vision, 28% and 38% for dizziness, and 30% and 31% for constipation. Rate of withdrawal due to adverse event was 3% for extended-release and 6% for immediate-release in one trial and 4% for both groups in the other trial, overall very low. Without reporting statistical significance, another 4-week trial found that dry mouth was somewhat more frequent with oxybutynin immediate-release (72%) than extended-release (68%). For dry mouth considered moderate-to-severe, the incidence was 45% with immediate- 24 release oxybutynin and 38% with extended-release. Withdrawals due to adverse events were similar between formulations (immediate-release, 20%; extended-release, 17%). Another 4 week trial did not find higher rates of dry mouth in the immediate-release group (17%) than the extended-release group (23%); however, overall adverse events were higher for oxybutynin immediate-release (67%) than extended-release (55%). Statistical significance was not reported 25 for these comparisons. It is important to note that this trial included a run-in phase to establish tolerability, during which patients with adverse events were excluded. All of the above oxybutynin immediate-release compared with extended-release studies included some type of dose titration for both long- and short-acting formulations, which may have affected the adverse occurrences and made it difficult to make any conclusions about better tolerability. We found a 12-week observational trial of various doses of oxybutynin extended-release 118 that reported dry mouth in 59% of patient and withdrawal due to adverse event by 8%. Long-term studies There was only 1 longer-term study of oxybutynin immediate-release. No details of adverse events were contained, but an overall adverse event rate was reported as 34. Although the longest observational trial, it was administered as a single phone or postal questionnaire 2 years after baseline, limiting its value for conclusions. Are there subgroups of patients based on demographics (age, racial groups, gender), other medications, or comorbidities for which one anticholinergic incontinence drug is more effective or is associated with fewer adverse effects? The included studies generally enrolled ambulatory populations in the 50 to 60 year-old age range (mean), with more women than men. Age No head-to-head or observational studies conducted in long-term care facilities met inclusion criteria. A placebo-controlled study of oxybutynin added to a program of prompted voiding in a long-term facility found a statistically significant reduction in incontinence episodes in the 128 oxybutynin group (-2. A 12-week, randomized, 82 placebo-controlled trial found no significant difference in efficacy, safety, or tolerability Overactive bladder Page 37 of 73 Final Report Update 4 Drug Effectiveness Review Project between younger (<65 years) and older (≥65 years) women taking tolterodine extended-release 4 mg. Two studies examined effects of darifenacin in older adults with overactive bladder syndrome: a pooled analysis of data from the subgroups of patients >65 years old in 3 placebo- 129 controlled trials and an open-label extension study of patients >65 years from 2 of these 130 trials. Patients enrolled in the trials (pooled N=317, mean age 72 years) were highly functioning, ambulatory adults, although with numerous comorbidities. The difference in the median change in the number of incontinence episodes per week was statistically significantly greater with darifenacin 7. While statistical analyses were not performed, in darifenacin 7. The incidences of dry mouth, constipation, and dyspepsia were highest in the 15 mg group but cardiovascular and central nervous system adverse events were rare in all groups. From 2 of these trials, 217 patients entered a 2-year extension study where the dose was started at 7. Similarly, post hoc analyses of patients from 4 placebo-controlled trials (N=1045) and an extension study (N=509) of solifenacin 5 mg or 10 mg daily were done to examine effects in 131 patients >65 years old. The difference in the median change in the number of incontinence episodes per week compared with placebo was – 2. In this analysis, the incidence of dry mouth was also greater in the drug groups: 14% with 5 mg daily, 32% with 10 mg daily, and 4.
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