By I. Ressel. Trinity College, Washington DC.

The standard error decreases as the sample size increases purchase 10mg aciphex with amex. Standard treatment: The treatment or procedure that is most commonly used to treat a disease or condition aciphex 20mg line. In clinical trials buy aciphex 10mg, new or experimental treatments sometimes are compared to standard treatments to measure whether the new treatment is better. Statistically significant: A result that is unlikely to have happened by chance. Study: A research process in which information is recorded for a group of people. The data are used to answer questions about a health care problem. Study population: The group of people participating in a clinical research study. The study population often includes people with a particular problem or disease. It may also include people who have no known diseases. Subgroup analysis: An analysis in which an intervention is evaluated in a defined subset of the participants in a trial, such as all females or adults older than 65 years. Superiority trial: A trial designed to test whether one intervention is superior to another. Surrogate outcome: Outcome measures that are not of direct practical importance but are believed to reflect outcomes that are important; for example, blood pressure is not directly important to patients but it is often used as an outcome in clinical trials because it is a risk factor Overactive bladder Page 61 of 73 Final Report Update 4 Drug Effectiveness Review Project for stroke and heart attacks. Surrogate endpoints are often physiological or biochemical markers that can be relatively quickly and easily measured, and that are taken as being predictive of important clinical outcomes. They are often used when observation of clinical outcomes requires long follow-up. Survival analysis: Analysis of data that correspond to the time from a well-defined time origin until the occurrence of some particular event or end-point; same as time-to-event analysis. Systematic review: A review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research and to collect and analyze data from the studies that are included in the review. The extent to which a drug’s adverse effects impact the patient’s ability or willingness to continue taking the drug as prescribed. These adverse effects are often referred to as nuisance side effects, because they are generally considered to not have long-term effects but can seriously impact compliance and adherence to a medication regimen. Treatment regimen: The magnitude of effect of a treatment versus no treatment or placebo; similar to “effect size”. Can be calculated in terms of relative risk (or risk ratio), odds ratio, or risk difference. Two-tailed test (two-sided test): A hypothesis test in which the values that reject the null hypothesis are located in both tails of the probability distribution. For example, testing whether one treatment is different than another (rather than testing whether one treatment is either better than another). Type I error: A conclusion that there is evidence that a treatment works, when it actually does not work (false-positive). Type II error: A conclusion that there is no evidence that a treatment works, when it actually does work (false-negative). Validity: The degree to which a result (of a measurement or study) is likely to be true and free of bias (systematic errors). Variable: A measurable attribute that varies over time or between individuals. Variables can be • Discrete: taking values from a finite set of possible values (e. Washout period: [In a cross-over trial] The stage after the first treatment is withdrawn, but before the second treatment is started. The washout period aims to allow time for any active effects of the first treatment to wear off before the new one gets started. Overactive bladder Page 62 of 73 Final Report Update 4 Drug Effectiveness Review Project Appendix B. Search strategy Search Strategies for Update 4 Database: EBM Reviews - Cochrane Central Register of Controlled Trials <4th Quarter 2008> Search Strategy: -------------------------------------------------------------------------------- 1 (oxybutinin or tolterodine or flavoxate or darifenacin or scopolamine or hyoscyamine or solifenacin or trospium). Methods used to assess quality of studies Study quality was objectively assessed using predetermined criteria for internal validity, which were based on a combination of the US Preventive Services Task Force and the National Health Service Centre for Reviews and Dissemination criteria. All included studies, regardless of design, were assessed for quality and assigned a rating of “good,” “fair,” or “poor”.

Withdrawal for ADEs: 1 aorta buy 20 mg aciphex overnight delivery, 1 lova and 1 parva R cheap 10 mg aciphex amex, OL purchase aciphex 20 mg with mastercard, MC, not ITT LDL-c reduction from baseline: patient. No clinically important elevation in ALT, AST or CK observed in any aorta 37% (*p<0. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Gentile et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Hunninghake et al. Men or women 18-80 years at risk 344 patients randomized, efficacy analysis performed on 337 8-week optional dietary phase, 4-week 1998 for CHD and elevated cholesterol. Pregnancy or breast-feeding, secondary dietary run-in followed by randomization to R, OL, MC, not ITT hyperlipoproteinemia, uncontrolled endocrine disorders, hepatic or aorta 10 mg, fulva 20 mg, lova 20 mg or Mean baseline LDL-c renal impairment, MI, CABG, PTCA, unstable angina 1 month prior to simva 10 mg qd. Doses titrated at 12-week 344 patients Atorva 205 mg/dl screening, participation in another study, uncontrolled type 2 DM, type intervals until LDL-c goal achieved or randomized Fluva 201 mg/dl 1 DM, taking a drug with the potential for interaction with statins. No maximum dosage reached (aorta 80 mg, (n= 85 aorta, 82 fulva, Lova 206 mg/dl numbers provided for exclusion at each step. Colestipol added = aorta 2%, fulva 67%, lova 24%, simva 24%. Statins Page 63 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Hunninghake et al. Efficacy analysis for 337 patients (median dose/day). ADEs similar across treatment groups prior to addition of colestipol to statin 1998 LDL reduction from baseline at 54 weeks : therapy at 24 weeks. At 54 weeks there were more ADEs in the fulva and lova R, OL, MC, not ITT aorta 10 mg: 36% groups than in the aorta or simva groups primarily GI in nature. One randomized simva 20 mg: 33% lova-treated patient experienced an elevation in ALT >3x ULN. Other clinically (n= 85 aorta, 82 fulva, HDL increase at 54 weeks: insignificant elevations in ALT or AST occurred in all groups. One patient 83 lova, 87 simva) aorta 9 % receiving fulva experienced acute pancreatitis. Statins Page 64 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Hunninghake et al. One author R, OL, MC, not ITT employed by Parke- Davis. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Insull W, et al 2007 18 years or older, enrolled in a Active vascular disease , uncontrolled hypertension, a fasting serum 6 week dietary lead-in, randomized to (SOLAR) managed care health plan, and glucose level of 180 mg/dL or higher or a hemoglobin A1c level of 9% rosuvastatin at 10 mg/d, atorvastatin at 10 classified as high risk by NCEP or higher, active liver disease or dysfunction (alanine mg/d, or simvastatin at 20 mg/d, for 6 RCT (1:1:1), OL, MC, ATP III; LDL 130-250 and TG <400 aminotransferase [ALT], aspartate aminotransferase, or bilirubin weeks. Patients not reaching the NCEP ITT after dietary 6-week dietary run-in levels of ≥2 times the upper limit of normal [ULN]), unexplained serum ATP III high-risk LDL-C goal of less creatine kinase (CK) elevation of more than 3 times the ULN, and a than 100 mg/dL after 6 weeks had doses 1632 patients serum creatinine level of more than 2. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Insull W, et al 2007 proportion of patients who achieved NCEP ATP III high-risk LDL-C goal rosuva vs aorta vs. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Insull W, et al 2007 AstraZeneca (SOLAR) Pharmaceuticals LP RCT (1:1:1), OL, MC, ITT 1632 patients randomized (n = 542 rosuva, 544 aorta, 546 simva) 12 weeks Statins Page 68 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Jones et al. Secondary hyperlipidemia, type 1 or uncontrolled type 2 DM, hepatic randomization to one of 15 treatment R, OL, MC, not ITT or renal impairment, uncontrolled HTN, BMI >32 kg/m, MI, CABG, groups: aorta 10, 20, 40, 80 mg Mean baseline LDL-c PTCA unstable angina within 3 months of study, hypersensitivity to fulva 20 or 40 mg 534 patients randomized Range 192-244 mg/dl statins, taking a drug with the potential for interaction with statins. No lova 20, 40, or 80 mg 8 weeks numbers provided for exclusion at each step. Statins Page 69 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Jones et al. No aorta 40 mg: 51% (n=61) / aorta 80 mg: 54% (n=10) clinically important elevations in liver transaminase or CK. Simva 40 mg increase significantly greater than aorta. Trigs reduction: All similar, except aorta 40 mg produced a greater reduction. Statins Page 70 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Jones et al. Parke-Davis R, OL, MC, not ITT Research played role in some portion of the 534 patients randomized study.

Fluvoxamine in the treatment of panic disorder: a multi-center order aciphex 20 mg otc, double-blind generic 10 mg aciphex, placebo-controlled study in outpatients buy generic aciphex 10 mg online. A comparison of fluvoxamine, cognitive therapy, and placebo in the treatment of panic disorder. A randomized, double-blind comparison of duloxetine and venlafaxine in the treatment of patients with major depressive disorder. Can physiologic assessment and side effects tease out differences in PTSD trials? A double-blind comparison of citalopram, sertraline, and placebo. Second-generation antidepressants 129 of 190 Final Update 5 Report Drug Effectiveness Review Project 201. Comparison of nefazodone and sertraline for the treatment of posttraumatic stress disorder. Nefazodone versus sertraline in treatment of posttraumatic stress disorder. Davidson J, Rothbaum BO, Tucker P, Asnis G, Benattia I, Musgnung JJ. Venlafaxine extended release in posttraumatic stress disorder: a sertraline- and placebo-controlled study. Connor KM, Sutherland SM, Tupler LA, Malik ML, Davidson JR. Failed efficacy of fluoxetine in the treatment of posttraumatic stress disorder: results of a fixed-dose, placebo-controlled study. A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine, and pill placebo in the treatment of posttraumatic stress disorder: treatment effects and long-term maintenance. Treatment of posttraumatic stress disorder with venlafaxine extended release: a 6-month randomized controlled trial. Efficacy of Venlafaxine ER in patients with social anxiety disorder: a double-blind, placebo-controlled, parallel-group comparison with paroxetine. Efficacy and tolerability of escitalopram in 12 and 24week treatment of social anxiety disorder: randomised, doubleblind, placebo- controlled, fixeddose study. Venlafaxine extended release vs placebo and paroxetine in social anxiety disorder. The efficacy of the selective serotonin reuptake inhibitors for social anxiety disorder (social phobia): a meta-analysis of randomised controlled trials. Hansen RA, Gaynes BN, Gartlehner G, Moore CG, Tiwari R, Lohr KN. Efficacy and tolerability of second-generation antidepressants in social anxiety disorder (Structured abstract). Hedges DW, Brown BL, Shwalb DA, Godfrey K, Larcher AM. The efficacy of selective serotonin reuptake inhibitors in adult social anxiety disorder: a meta-analysis of double- blind, placebo-controlled trials. Montgomery SA, Nil R, Durr-Pal N, Loft H, Boulenger JP. A 24-week randomized, double-blind, placebo-controlled study of escitalopram for the prevention of generalized social anxiety disorder. Escitalopram in the treatment of social anxiety disorder: randomised, placebo-controlled, flexible-dosage study. Second-generation antidepressants 130 of 190 Final Update 5 Report Drug Effectiveness Review Project 216. Fluoxetine in social phobia: a double-blind, placebo-controlled pilot study. Fluoxetine, comprehensive cognitive behavioral therapy, and placebo in generalized social phobia. Mirtazapine treatment of social phobia in women: a randomized, double-blind, placebo-controlled study. Nefazodone in the treatment of generalized social phobia: a randomized, placebo-controlled trial. Selective serotonin reuptake inhibitors for premenstrual syndrome. Shah NR, Jones JB, Aperi J, Shemtov R, Karne A, Borenstein J. Selective serotonin reuptake inhibitors for premenstrual syndrome and premenstrual dysphoric disorder: a meta-analysis. Freeman EW, Rickels K, Yonkers KA, Kunz NR, McPherson M, Upton GV. Venlafaxine in the treatment of premenstrual dysphoric disorder. Landen M, Eriksson O, Sundblad C, Andersch B, Naessen T, Eriksson E.