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Effect sizes of treatments were similar between short-term studies and trials lasting 3 months 2.5mg oxytrol visa treatment xdr tb. None of the studies addressed the question of when to switch therapies in non-responders. What is the comparative tolerability and safety of drugs used to treat chronic constipation and chronic constipation associated with Irritable Bowel Syndrome? We included 22 RCTs, one systematic review, one open-label extension of an RCT, six observational studies and two pooled data analyses. Most studies that examined the comparative efficacy of our drugs of interest also examined their harms. Methods of adverse events assessment, however, differed greatly. Most studies combined patient-reported adverse events with a clinical examination and laboratory values. Often determining whether assessment methods were unbiased and adequate was difficult due to limited reporting in the articles. Rarely were adverse events pre-specified and defined. Short study durations and small sample sizes additionally limited the validity of adverse events assessment with respect to rare but serious adverse events. Most importantly, the quality of most of the included studies was poor. Chronic constipation and constipation associated with IBS in adults A. Summary of findings General tolerability and safety The evidence is generally poor quality and sparse. We found no studies on the general tolerability and safety of docusate calcium, docusate sodium, or lactulose that met our eligibility criteria. Studies assessing the tolerability and safety of lubiprostone have been published as abstracts only. Therefore, the available information is insufficient to critically appraise the underlying methods and draw firm conclusions. The abstracts consistently reported a higher incidence of nausea in lubiprostone treated Constipation Drugs Page 39 of 141 Final Report Drug Effectiveness Review Project subjects than in those treated with placebo. The most common adverse events reported were nausea, headache, diarrhea, and bloating. Discontinuations due to adverse events ranged from 3% to almost 20%. Three placebo-controlled RCTs and one open-label observational study examined the tolerability and safety of PEG 3350. The largest and only fair quality RCT (N = 151) found no significant differences in adverse events. Patients treated with PEG 3350 had lower rates of severe cramping and severe gas than patients on placebo. The other three studies were poor quality and were consistent in reporting only minor adverse events (nausea, gas, cramps, and diarrhea). All four studies were funded by the makers of PEG formulations. We found only two poor quality RCTs meeting our inclusion criteria that examined the general tolerability and safety of psyllium. Both enrolled subjects with chronic constipation and were funded by the makers of psyllium preparations. The studies consistently reported that psyllium was well tolerated. None of the studies reported statistically significant differences in adverse events between psyllium and placebo and none reported any serious adverse events. Given the poor quality of these studies, results must be interpreted cautiously. Sixteen studies reported data on the general tolerability and safety of tegaserod for the treatment of chronic constipation and IBS-C in adults. Most report a greater incidence of diarrhea with tegaserod than placebo.

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For children and adults with type 1 or type 2 diabetes discount oxytrol 2.5mg on line medications john frew, does pramlintide differ in efficacy, effectiveness, and in harms for achieving glycemic control when added to prandial insulin compared to conventional insulin therapy? For children and adults with type 1 diabetes, does pramlintide differ in efficacy, effectiveness, or harms in achieving glycemic control when added to prandial insulin compared with conventional insulin therapy? Are there subgroups of patients with type 1 diabetes for which pramlintide is more or less suitable than other hypoglycemic agents?................................................................ For children and adults with type 2 diabetes, does pramlintide differ in efficacy, effectiveness, or harms in achieving glycemic control when added to prandial insulin compared with conventional insulin therapy? Are there subgroups of patients with type 2 diabetes for which pramlintide is more or less suitable than other hypoglycemic agents?................................................................ For children and adults with type 2 diabetes, does exenatide differ in efficacy, effectiveness, and in harms for achieving glycemic control when compared to other hypoglycemic agents as monotherapy or combined therapy? For children and adults with type 2 diabetes, does exenatide differ in efficacy, effectiveness, and in harms for achieving glycemic control when compared to other hypoglycemic agents as monotherapy or combined therapy? Or when added to other hypoglycemic agents compared to conventional insulin therapy?................................................. Are there subgroups of patients for which exenatide is more or less suitable than other hypoglycemic agents? For children and adults with type 2 diabetes, does sitagliptin differ in effectiveness, efficacy, and in harms for achieving glycemic control when compared to other hypoglycemic agents as monotherapy, combined therapy, or when compared to placebo? For children and adults with type 2 diabetes, does sitagliptin differ in efficacy, effectiveness, and in harms for achieving glycemic control when compared to placebo, when compared to other hypoglycemic agents as monotherapy or combined therapy, or when added to other hypoglycemic agents? Are there subgroups of patients for which sitagliptin is more or less suitable than other hypoglycemic agents? Change in A1c in placebo-controlled studies of exenatide...................................................... Meta-analysis of sitagliptin studies for weight loss................................................................... Characteristics of pramlintide, exenatide, and sitagliptin............................................................ Characteristics of pramlintide placebo-controlled trials in adults with type 1 diabetes.............. Characteristics of pramlintide placebo-controlled trials in adults with type 2 diabetes.............. Characteristics of exenatide active-controlled trials in adults with type 2 diabetes................. Characteristics of exenatide placebo-controlled trials in adults with type 2 diabetes.............. Characteristics of exenatide observational studies in adults with type 2 diabetes.................. Characteristics of sitagliptin placebo-controlled trials in adults with type 2 diabetes.............. Characteristics of sitagliptin active-controlled trials with or without placebo study arms in adults with type 2 diabetes...................................................................................................................... Sitagliptin or placebo added to one oral hypoglycemic agent................................................. Sitagliptin or placebo added to two oral hypoglycemic agents................................................ Initial combination of sitagliptin plus metformin compared with placebo and individual agents................................................................................................................................................................. Adverse events of sitagliptin compared with oral hypoglycemic agents................................. Quality assessment methods for drug class reviews for the Drug Effectiveness Review Project...................................................................................................................................................... Drug class review on newer drugs for the treatment of diabetes mellitus. These organizations selected the topic and had input into the Key Questions for this review. The content and conclusions of the review are entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report. Acknowledgments: We extend our appreciation to the clinical advisors listed below for their thoughtful advice and input during our research process.

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Pegylated interferon alpha-2b oxytrol 5 mg with mastercard symptoms exhaustion, ribavirin and amantadine for chronic hepatitis C. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in previously untreated patients infected with HCV genotypes 2 or 3. Pharmacokinetics and pharmacodynamics of pegylated interferon alfa-2A or alfa-2B with ribavirin in treatment naive patients with genotype 1 chronic hepatitis C. Pegylated Interferon alfa-2B and fixed versus weightbased Ribavirin dosing for treatment naive patients with chronic hepatitis C. Pegylated interferons for hepatitis C Page 49 of 65 Final Report Drug Effectiveness Review Project 123. Pharmacokinetics and response of obese patients with chronic hepatitis C treated with different doses of PEG-IFN alpha 2A (40 KD) (PEGASYS). Peginterferon alfa-2a (40KD) plus ribavirin in pegylated interferon alfa-2b (12 KD)/ribavirin non-responders: week 12 efficacy and safety outcomes of the REPEAT study. Peginterferon alfa-2a (40 KD) (PEGASYS) plus ribavirin (COPEGUS) is an efficacious and safe treatment for chronic hepatitis C (CHC) in patients with compensated cirrhosis. Peginterferon alfa-2a (PEGASYS) plus ribavirin (COPEGUS) for 16 or 24 weeks in patients with HCV genotype 2 or 3. Peginterferon alfa-2a and ribavirin in African American and Causcasian patients with chronic hepatitis C, genotype 1. Gartlehner G, Hansen RA, Nissman D, Lohr KN, Carey TS. A simple and valid tool distinguished efficacy from effectiveness studies. The IDEAL Study: A major clinical study for patients with hepatitis C. Weight-based ribavirin dosing (WBD) increases sustained viral response (SVR) in patients with chronic hepatitis C (CHC): Final results of the WIN-R study, a US community based trial. Bruchfeld A, Lindahl K, Reichard O, Carlsson T, Schvarcz R. Pegylated interferon and ribavirin treatment for hepatitis C in haemodialysis patients. The relationship between study design, results, and reporting of randomized clinical trials of HIV infection. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Pegylated interferons for hepatitis C Page 50 of 65 Final Report Drug Effectiveness Review Project Appendix A. Literature Search Strategies Database: Ovid MEDLINE(R) <1966 to July Week 4 2006> Search Strategy: -------------------------------------------------------------------------------- 1 exp Hepatitis C/ or hepatitis C. Quality assessment methods for drug class reviews for the Drug Effectiveness Review Project The purpose of this document is to outline the methods used by the Oregon Evidence-based Practice Center (EPC), based at Oregon Health & Science University, and any subcontracting EPCs, in producing drug class reviews for the Drug Effectiveness Review Project. The methods outlined in this document ensure that the products created in this process are methodologically sound, scientifically defensible, reproducible, and well documented. This document has been adapted from the Procedure Manual developed by the Methods Work Group of the United States Preventive Services Task Force (version 1. All studies or systematic reviews that are included are assessed for quality, and assigned a rating of “good”, “fair” or “poor”. Studies that have a fatal flaw in one or more criteria are rated poor quality; studies which meet all criteria, are rated good quality; the remainder are rated fair quality. As the “fair quality” category is broad, studies with this rating vary in their strengths and weaknesses: the results of some fair quality studies are likely to be valid, while others are only probably valid. A “poor quality” trial is not valid—the results are at least as likely to reflect flaws in the study design as the true difference between the compared drugs. For Controlled Trials: Assessment of Internal Validity 1. Was the assignment to the treatment groups really random?

The study was rated poor quality primarily for attrition of almost 26% cheap 2.5 mg oxytrol with amex medicine 2015. This study was funded by makers of a PEG 3350 formulation. There were no significant differences in adverse events between the groups. The most common adverse events in the PEG 3350 group were dizziness (5%) and fatigue (3. Constipation Drugs Page 51 of 141 Final Report Drug Effectiveness Review Project Table 23. Summary of trials assessing the comparative harms of constipation drugs Author, year Study N; Study Comparisons Population, % Results Quality design duration female, rating setting LACTULOSE VS. French and No significant Poor (No 43 1999 single- weeks PEG 3350 Scottish differences in median ITT blind, patients with daily scores for analysis) open-label chronic diarrhea, abdominal constipation, pain, flatulence, or 82% female, bloating. Fewer days general and with flatulence in the geriatric PEG group (3. Mean number of liquid stools was higher in the PEG group (2. Adults with No significant Poor 66 1991 open-label weeks lactulose chronic differences for (High constipation, abdominal pain or for attrition) % female straining (P NR). Evidence profile ofth e generaltolerability and h arm s ofconstipationdrugs inadults Evidence Profile:G eneraltolerability and h arm s ofconstipationdrugs inadults N o. Evidence profile ofth e com parative tolerability and h arm s ofconstipationdrugs inadults Evidence Profile:C om parative tolerability and h arm s ofconstipationdrugs inadults N o. Summary of findings General tolerability and safety in children The evidence is very poor quality and sparse. We found no studies on the general tolerability and safety of docusate calcium, docusate sodium, lactulose, lubiprostone, and psyllium that met our expanded eligibility criteria. All of the studies we found were rated poor quality for the assessment of adverse events and results should be interpreted with caution. We found three poor quality studies that reported safety or tolerability information for PEG 3350 without a comparison group. The most common adverse events reported were diarrhea in 10-13%, bloating/flatulence in 6-18%, and pain/cramping in 2-5%. They found no significant laboratory abnormalities and reported that PEG 3350 was well tolerated by children. We found one RCT that reported on the tolerability and harms of tegaserod for the treatment of postpubertal adolescents with constipation predominant IBS. The study reported that no adverse events were observed in any patient and there were no dropouts. Comparative tolerability and safety in children The evidence was limited to one poor quality RCT comparing PEG 3350 with lactulose in children. This study reported more abdominal pain, pain at defecation, and straining at defecation in those treated with lactulose and worse palatability with PEG. The results should be interpreted cautiously due to the poor quality of the study. Detailed assessment General risk of harms Table 26 summarizes the trials assessing the general harms of constipation drugs in children; Table 29 summarizes the evidence profile for the general tolerability and safety of individual drugs. Docusate calcium, Docusate sodium, Lactulose, Lubiprostone, and Psyllium We did not find any studies on the general harms of these medications in children that met our eligibility criteria. Constipation Drugs Page 55 of 141 Final Report Drug Effectiveness Review Project Polyethylene glycol We found no studies reporting the general safety of PEG that included a placebo comparison group. The other study did not report a source of funding or any conflicts of interest, but was by the same group of authors as the prospective cohort study. The most common adverse events reported were diarrhea in 10-13%, bloating/flatulence in 6-18%, and pain/cramping in 2-5%. Results of these studies should be interpreted with caution due to the poor quality.

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