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The relationship between depression and interferon beta-1a therapy in patients with multiple sclerosis warfarin 2mg without a prescription blood pressure zona plus. Multiple sclerosis and depression: influence of interferon beta therapy effective 1mg warfarin quitting high blood pressure medication. Borras C purchase 1mg warfarin visa blood pressure higher in right arm, Rio J cheap 5mg warfarin free shipping blood pressure normal lying down, Porcel J, Barrios M, Tintore M, Montalban X. Emotional state of patients with relapsing-remitting MS treated with interferon beta-1b. Glatiramer acetate in treatment- naive and prior interferon-beta-1b-treated multiple sclerosis patients. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Glatiramer acetate (Copaxone): comparison of continuous versus delayed therapy in a six-year organized multiple sclerosis trial. A prospective open-label study of glatiramer acetate: over a decade of continuous use in multiple sclerosis patients. Debouverie M, Moreau T, Lebrun C, Heinzlef O, Brudon F, Msihid J. A longitudinal observational study of a cohort of patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate. Long-term (up to 22 years), open-label, compassionate-use study of glatiramer acetate in relapsing-remitting multiple sclerosis. Ten years of adverse drug reaction reports for the multiple sclerosis immunomodulatory therapies: a Canadian perspective. Jordy SS, Tilbery CP, Fazzito MM, Jordy SS, Tilbery CP, Fazzito MM. Immunomodulator therapy migration in relapsing remitting multiple sclerosis: a study of 152 cases. Pollmann W, Erasmus LP, Feneberg W, Then Bergh F, Straube A. Interferon beta but not glatiramer acetate therapy aggravates headaches in MS. Comparison of glatiramer acetate (Copaxone) and interferon beta-1b (Betaferon) in multiple sclerosis patients: an open-label 2-year follow-up. Immunomodulatory treatment of multiple sclerosis in denmark: a prospective nationwide survey. Depressive symptoms in a treated multiple sclerosis cohort. Cancer incidence in multiple sclerosis and effects of immunomodulatory treatments. Disease-modifying drugs for multiple sclerosis Page 95 of 120 Final Report Update 1 Drug Effectiveness Review Project 178. Long-term follow up of glatiramer acetate compassionate use in Belgium. Flechter S, Kott E, Steiner-Birmanns B, Nisipeanu P, Korczyn AD. Copolymer 1 (glatiramer acetate) in relapsing forms of multiple sclerosis: open multicenter study of alternate-day administration. Tolerability, adverse events and compliance to glatiramer acetate in 28 patients with multiple sclerosis using the drug continuously for at least six months. Safety profile of copolymer 1: analysis of cumulative experience in the United States and Israel. Lipoatrophy in patients with multiple sclerosis on glatiramer acetate. Sheremata WA, Vollmer TL, Stone LA, Willmer-Hulme AJ, Koller M. A safety and pharmacokinetic study of intravenous natalizumab in patients with MS. Efficacy of natalizumab in multiple sclerosis patients with high disease activity: a Danish nationwide study. New insights into progressive multifocal leukoencephalopathy. Langer-Gould A, Atlas SW, Green AJ, Bollen AW, Pelletier D. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. Intravenous mitoxantrone and cyclophosphamide as second-line therapy in multiple sclerosis: an open-label comparative study of efficacy and safety. Use of low-dose mitozantrone to treat aggressive multiple sclerosis: a single-centre open-label study using patient self-assessment and clinical measures of multiple sclerosis status. An open-trial evaluation of mitoxantrone in the treatment of progressive MS. Escalating immunotherapy with mitoxantrone in patients with very active relapsing-remitting or progressive multiple sclerosis. Disease-modifying drugs for multiple sclerosis Page 96 of 120 Final Report Update 1 Drug Effectiveness Review Project 195. Cardiac adverse effects associated with mitoxantrone (Novantrone) therapy in patients with MS. Frequency and risk factors of mitoxantrone-induced amenorrhea in multiple sclerosis: the FEMIMS study. Mitoxantrone as induction treatment in aggressive relapsing remitting multiple sclerosis: treatment response factors in a 5 year follow-up observational study of 100 consecutive patients. Early mitoxantrone-induced cardiotoxicity in secondary progressive multiple sclerosis. A study of therapy-related acute leukaemia after mitoxantrone therapy for multiple sclerosis. Response to interferon beta-1a treatment in African American multiple sclerosis patients. Pregnancy outcomes during treatment with interferon beta-1a in patients with multiple sclerosis. Multiple sclerosis, immunomodulators, and pregnancy outcome: a prospective observational study. The reproductive effects of beta interferon therapy in pregnancy: a longitudinal cohort. Wolinsky JS, Shochat T, Weiss S, Ladkani D, Group PRTS.

It should be noted that this fair-quality review excluded observational studies which can be relevant for evaluation of safety and tolerability in more broadly inclusive populations and over longer time periods discount warfarin 1 mg online blood pressure ranges by age and gender. Central nervous system adverse events Adverse events of the central nervous system cheap warfarin 5 mg on line blood pressure glucose chart, such as confusion and reduced cognition 1mg warfarin with mastercard blood pressure in children, can occur with anticholinergic and antimuscarinic drugs for incontinence discount warfarin 2 mg line hypertension 40 years, but we found only very limited comparative evidence on the relative incidence or severity of these adverse events. A subanalysis of central nervous system adverse events in the OPERA trial (tolterodine extended- release compared with oxybutynin extended-release) showed a similar low incidence of these 29 specific adverse events in both drugs. The incidence of withdrawal from the study due to central nervous system adverse events was 0. No other studies of comparative central nervous system adverse events were found. Withdrawal from studies due to adverse events Withdrawals due to adverse events may be a better indicator of drug tolerability than overall incidence of adverse events. And of course a large number of withdrawals also negatively impact the overall effectiveness of a drug. In 3- to 12-month open-label extension studies of tolterodine (extended-release or immediate-release) the rate of withdrawal due to adverse event ranged from 8% to 15%, with the higher rates in the longer studies. Observational studies reported much lower rates of withdrawal due to adverse event (3% to 5%), reflecting a less sensitive measure of reason for withdrawal. The one 3-month open-label extension study of oxybutynin extended- release reported a withdrawal rate of 8%. A 54-week trial comparing oxybutynin immediate- release with trospium reported an overall withdrawal rate of 25. Withdrawals related to adverse events felt associated with the drugs were higher for oxybutynin, 6. Three 12-month extensions of randomized controlled trials looking at tolterodine immediate-release (2 mg twice daily), tolterodine extended-release (4 mg once daily), and solifenacin (5 mg or 10 mg once daily) reported withdrawal rates due to adverse events of 113 126 119 15%, 10. The extension study of 126 tolterodine extended-release (4 mg once daily), with a withdrawal rate of 10%, included 113, 119 somewhat older patients (mean 64 years) while the other 2 studies included slightly 119 younger patients (mean 56 to 60 years). In the study of solifenacin, which had the lowest rate of withdrawal, 22% of participants were men, whereas the tolterodine extended-release and immediate-release studies had 34. In short-term head-to-head trials, the rate of withdrawal due to adverse event with tolterodine immediate-release ranged from 5% to 15%, with oxybutynin immediate-release 127 ranged from 4% to 17%, and with trospium was 6%. The rates of withdrawal due to adverse event for tolterodine extended-release ranged from 5% to 6%; for oxybutynin extended-release, 3% to 14%; and for transdermal oxybutynin, 3% to 11%. Six of 7 studies comparing tolterodine Overactive bladder Page 34 of 73 Final Report Update 4 Drug Effectiveness Review Project with oxybutynin in any formulation found a lower rate of withdrawal with tolterodine that 21, 32, 36, 44 reached statistical significance in 4 studies. An additional 9-week study comparing oxybutynin immediate-release with oxybutynin extended-release showed slightly higher withdrawal rates due to adverse events for the 24 immediate-release form (20% compared with 17%). The single short-term trospium trial reported 16% all-cause withdrawal with oxybutynin 39 immediate-release and 6% withdrawal with trospium. In another study, withdrawals due to adverse events were lower in the tolterodine extended-release group (5. Three studies comparing immediate-release to extended-release forms of one drug (tolterodine or oxybutynin) found no significant difference in the rate of withdrawals based on the formulation used. In a fair-quality study of tolterodine extended-release and oxybutynin extended-release 31 (OPERA trial), withdrawal from the study due to adverse events did not differ between the groups (5. In addition, the number lost to follow-up was noticeably higher in the oxybutynin extended-release group than the tolterodine extended-release group (13 compared with 3). Subanalysis of the OPERA trial showed that withdrawal due to adverse events of the central nervous system occurred in 0. An additional post hoc analysis of the OPERA study showed a non-significant difference in withdrawal due to 125 dry mouth. A study of transdermal oxybutynin compared with extended-release tolterodine found a significantly higher rate of withdrawal in the transdermal oxybutynin group (11% compared with 32 1. A small study comparing transdermal with immediate-release oxybutynin found no difference in withdrawal rate, with only 1 withdrawal per group in the 6-week study. A fair-quality systematic review found that tolterodine extended-release was associated 16 with significantly fewer all-cause withdrawals than placebo. This review also reported significant differences in the active-control comparisons, which favored oxybutynin extended- release, tolterodine immediate-release, and tolterodine extended-release over oxybutynin immediate-release. A very short trial comparing darifenacin with oxybutynin reported 3 treatment-related 26 withdrawals due to adverse events overall. The study, designed as a crossover, 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.

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Medications associated with constipation Class Generic Name Brand Name Manufacturer Indication Rx/OTC 5-HT4 Tegaserod Zelnorm Novartis Chronic idiopathic Rx serotonin maleate* constipation in men receptor and women <65 agonist Short term treatment of IBS in women Bulking Psyllium Metamucil Proctor and Gamble Occasional OTC agents (ispaghula) Fiberall Heritage Consumer constipation Genfiber Goldline Consumer Natural Psyllium Plus Pharma Restoration of Fiber regularity Hydrocil Numark Konsyl Konsyl Pharm Reguloid Rugby Natural Fiber Apothecary Laxative Syllact Wallace Serutan Manley and James Chloride Lubiprostone Amitiza Sucampo Chronic idiopathic Rx channel constipation in adults activator Osmotic Polyethylene Glycolax Schwarz Occasional OTC laxatives glycol 3350 MiraLax Braintree constipation Generic Multiple Lactulose Chronulac Sanofi Aventis Chronic constipation Rx Generic Multiple Portal systemic enecephalopathy Stool Docusate sodium Docusate sodium Multiple Occasional OTC softeners Ex-lax Novartis constipation Dioctyn Dixon-Shane Colace Purdue D-S-S Magno-Humphries Dulcolax Boehringer Silace Silarx Stool softener Rugby Regulan SS Republic Genasoft Goldline Sof-lax Fleet Diocto multiple Docu Hi-Tech Pharm D purchase warfarin 5mg overnight delivery blood pressure ranges. Goldline Docusate calcium Docusate calcium multiple Occasional OTC Stool softener Apothecary constipation Sulfolax Major Surfak Liquigels Pharmacia and Upjohn DC Softgels Goldline *Marketing suspended March buy generic warfarin 2mg on-line blood pressure chart by race, 2007 because of increased risk of serious cardiovascular events Constipation Drugs Page 11 of 141 Final Report Drug Effectiveness Review Project Table 4 discount 5 mg warfarin mastercard blood pressure medication safe for breastfeeding. Drugs for constipation: product information and directions for administration Generic Name Dosage Strength Frequency Onset of Usual Daily Directions Form Action Dose Docusate Capsules 240 mg/ capsule Once daily 12-72 240 mg Take with calcium hours water Docusate Tablets 100mg/tab purchase warfarin 2mg otc zopiclone arrhythmia. One to three 12-72 Adults: Take with a sodium times a day hours Up to glass of water 300 mg Capsules 50mg/capsule Children: Syrup/liquid 100mg/capsule Up to may be Soft gels 50mg/gel 100 mg mixed with 100mg/gel milk or juice 250mg/gel Syrup 20mg/5ml 50mg/15ml 60mg/15ml 100mg/30ml Liquid 10mg/ml 150mg/ml Lactulose Solution 10g/15ml Once daily 24-48 Adults: Dissolve in (twice daily hours 20-30 g 120ml water Crystals 10g/packet if needed) Children: 20g/packet 5g Lubiprostone Soft gelatin 24mcg/capsule Twice daily Within 48 mcg Take with capsules 24 hours food Polyethylene Powder 17g/packet Once daily 48-96 17 g Dissolve in glycol 3350 packets hours 8oz water Powder 17g/capful 17 g Psyllium Capsules 0. Our review covers the use of the following in adults and children with chronic constipation and IBS-C: docusate calcium, docusate sodium, lactulose, lubiprostone, polyethylene glycol Constipation Drugs Page 12 of 141 Final Report Drug Effectiveness Review Project 3350, psyllium, and tegaserod. Our review does not include drugs for intermittent or short-term constipation, such as stimulant laxatives. In March 2007 the FDA issued a public health advisory to inform patients and health care professionals that the sponsor of tegaserod (Zelnorm) agreed to stop selling the medication because a recent analysis of data from 29 RCTs including 11,614 patients treated with tegaserod found an increased risk of heart 12 attack, stroke, and unstable angina in patients taking the medication. Of the 13 patients taking tegaserod having these events, four had a heart attack (1 died), six had unstable angina, and three had a stroke. The average age of subjects in these studies was 43 years and 88% were women. The FDA has agreed to allow access to the medication through a special program when the benefits outweigh the risks of series adverse events or for patients with no other treatment options. The FDA also indicated that it will consider limited re-introduction of the medication at a later date. The RTI-UNC Evidence-based Practice Center wrote preliminary key questions, identifying the populations, interventions, and outcomes of interest, and based on these, the eligibility criteria for studies. These were reviewed and revised by representatives of organizations participating in the Drug Effectiveness Review Project (DERP). The participating organizations of DERP are responsible for ensuring that the scope of the review reflects the populations, drugs, and outcome measures of interest to both clinicians and patients. The participating organizations approved the following key questions to guide this review: 1. What is the general effectiveness of drugs used to treat chronic constipation and chronic constipation associated with Irritable Bowel Syndrome? Given general effectiveness, what is the comparative effectiveness of drugs used to treat chronic constipation and chronic constipation associated with Irritable Bowel Syndrome? Does treatment duration influence the effectiveness of drugs used to treat chronic constipation and chronic constipation associated with Irritable Bowel Syndrome? When should treatments be switched in patients not responding to a given drug? What is the comparative tolerability and safety of drugs used to treat chronic constipation and chronic constipation associated with Irritable Bowel Syndrome? Constipation Drugs Page 13 of 141 Final Report Drug Effectiveness Review Project 4. Are there subgroups of patients based on demographics (age, racial or ethnic groups, and gender), other medications, or co-morbidities, including Irritable Bowel Syndrome, for which one symptomatic treatment is more effective or associated with fewer adverse events? Constipation Drugs Page 14 of 141 Final Report Drug Effectiveness Review Project METHODS Literature Search To identify articles relevant to each key question we searched MEDLINE, Embase, The Cochrane Library, and the International Pharmaceutical Abstracts; we used either Medical Subject Headings (MeSH or MH) as search terms when available or key words when appropriate. We combined terms for selected indications (chronic constipation, irritable bowel disorder), drug interactions, and adverse events with a list of seven specific constipation drugs (docusate calcium, docusate sodium, lactulose, lubiprostone, polyethylene glycol, psyllium, tegaserod) and their trade names. We limited the electronic searches to “human” and “English language”; we searched sources from 1985 to 2007 (April) to delimit literature relevant to the scope of our topic. We used the National Library of Medicine publication type tags to identify reviews, randomized controlled trials (RCTs), and meta-analyses; we also manually searched reference lists of pertinent review articles and letters to the editor. All citations were imported into an electronic database (EndNote, version X). Additionally, we hand-searched the Center for Drug Evaluation and Research (CDER) database to identify unpublished research submitted to the FDA. Further, the Center for Evidence-based Policy at the Oregon Health and Science University (OHSU) contacted pharmaceutical manufacturers and invited them to submit dossiers, including citations, using a protocol available at www. We received dossiers from two pharmaceutical companies (Novartis and Takeda Pharmaceuticals). Our searches found 434 citations, unduplicated across databases; we found an additional 89 articles from manually reviewing the reference lists of pertinent review articles and an additional 12 articles in the pharmaceutical dossiers. The total number of citations included in the database was 535. For further details on the search strategy, see Appendix A. Study Selection Two people independently reviewed each abstract; if both reviewers agreed that the study did not meet eligibility criteria, it was excluded. We obtained the full text of all remaining articles. Records were considered for exclusion if they did not meet pre-established eligibility criteria with respect to study design, patient population, interventions, outcomes, and comparisons to medications outside our scope of interest. Constipation Drugs Page 15 of 141 Final Report Drug Effectiveness Review Project All controlled, prospective studies were eligible for inclusion, regardless of sample size or study duration. For adverse events we also included case series and retrospective studies. Eligibility criteria and outcomes of interest are presented in Table 5. Eligibility criteria Outcome Outcome Measures Study Eligibility Criteria KQ1A: Study Design: General Efficacy/ • General subjective measures Any prospective, controlled study Effectiveness e. Trained reviewers abstracted data from each study and assigned an initial quality rating. A senior reviewer read each abstracted article and evaluated the completeness of the data abstraction. We Constipation Drugs Page 16 of 141 Final Report Drug Effectiveness Review Project abstracted the following data from included trials: study design, eligibility criteria, intervention (drugs, dose, duration), additional medications allowed, methods of outcome assessment, population characteristics, sample size, loss to follow-up, withdrawals attributed to adverse events, results, and adverse events reported. We recorded intention-to-treat results if available. Quality Assessment We assessed the internal validity (quality) of trials based on predefined criteria (Appendix B) developed 13 by the US Preventive Services Task Force (ratings: good-fair-poor) and the National Health Service 14 15 Centre for Reviews and Dissemination. External validity (generalizability) was assessed and reported but did not influence quality ratings. We did not rate the quality of descriptive studies (case series). Two independent reviewers assigned quality ratings; they resolved any disagreements by discussion and consensus or by consulting a third, independent party. Elements of internal validity assessment for RCTs included, among others, randomization and allocation concealment, similarity of compared groups at baseline, use of intention-to-treat analysis, and overall and differential loss to follow-up. Items assessed included selection of cases or cohorts and controls, adjustment for confounders, methods of outcomes assessment, length of follow-up and statistical analysis. Loss to follow-up was defined as the number of persons randomized who did not reach the endpoint of 17 the study, independent of the reason and the use of intention-to-treat analysis.

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Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes best 1 mg warfarin arterial line. Gastaldelli A buy generic warfarin 2 mg line prehypertension due to anxiety, Ferrannini E cheap warfarin 5 mg blood pressure 8060, Miyazaki Y generic warfarin 1mg mastercard arrhythmia or panic attack, Matsuda M, Mari A, DeFronzo RA. Thiazolidinediones improve beta-cell function in type 2 diabetic patients. A randomized, double-blind, placebo-controlled, clinical trial of the effects of pioglitazone on glycemic control and dyslipidemia in oral antihyperglycemic medication-naive patients with type 2 diabetes mellitus. Kipnes MS, Krosnick A, Rendell MS, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycemic control in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study. Metabolic effects of pioglitazone in combination with insulin in patients with type 2 diabetes mellitus whose disease is not adequately controlled with insulin therapy: Results of a six-month, randomized, double-blind, prospective, multicenter, parallel-group study. McMahon GT, Plutzky J, Daher E, Bhattacharyya T, Grunberger G, DiCarli MF. Effect of a peroxisome proliferator-activated receptor-(gamma) agonist on myocardial blood flow in type 2 diabetes. Improved glycemic control and enhanced insulin sensitivity in type 2 diabetic subjects treated with pioglitazone. Miyazaki Y, Mahankali A, Wajcberg E, Bajaj M, Mandarino LJ, DeFronzo RA. Effect of pioglitazone on circulating adipocytokine levels and insulin sensitivity in type 2 diabetic patients. The effect of pioglitazone on the liver: role of adiponectin. Pioglitazone reduces blood pressure in non- dipping diabetic patients. A randomized comparison of pioglitazone to inhibit restenosis after coronary stenting in patients with type 2 diabetes. Rosenblatt S, Miskin B, Glazer NB, Prince MJ, Robertson KE. The impact of pioglitazone on glycemic control and atherogenic dyslipidemia in patients with type 2 diabetes mellitus. Rosenstock J, Einhorn D, Hershon K, Glazer NB, Yu S. Efficacy and safety of pioglitazone in type 2 diabetes: a randomised, placebo-controlled study in patients receiving stable insulin therapy. Metabolic efficacy and safety of once-daily pioglitazone monotherapy in patients with type 2 diabetes: a double-blind, placebo-controlled study. Thiazolidinediones Page 98 of 193 Final Report Update 1 Drug Effectiveness Review Project 97. Smith SR, De Jonge L, Volaufova J, Li Y, Xie H, Bray GA. Effect of pioglitazone on body composition and energy expenditure: a randomized controlled trial. The effect of pioglitazone on peroxisome proliferator-activated receptor-gamma target genes related to lipid storage in vivo. Pioglitazone with sulfonylurea: glycemic and lipid effects in Taiwanese type 2 diabetic patients. An increase in insulin sensitivity and basal beta- cell function in diabetic subjects treated with pioglitazone in a placebo-controlled randomized study. Honisett SY, Stojanovska L, Sudhir K, Kingwell BA, Dawood T, Komesaroff PA. Rosiglitazone lowers blood pressure and increases arterial compliance in postmenopausal women with type 2 diabetes. Raskin P, Rappaport EB, Cole ST, Yan Y, Patwardhan R, Freed MI. Rosiglitazone short- term monotherapy lowers fasting and post-prandial glucose in patients with type II diabetes. Peroxisome proliferator-activated receptor-gamma agonist rosiglitazone reduces clinical inflammatory responses in type 2 diabetes with coronary artery disease after coronary angioplasty. Rosiglitazone taken once daily provides effective glycaemic control in patients with Type 2 diabetes mellitus. Glycemic control with glyburide/metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: a randomized, double-blind trial. Rosiglitazone improves myocardial glucose uptake in patients with type 2 diabetes and coronary artery disease: a 16-week randomized, double-blind, placebo-controlled study. Negro R, Mangieri T, Dazzi D, Pezzarossa A, Hassan H. Rosiglitazone effects on blood pressure and metabolic parameters in nondipper diabetic patients. Effect of rosiglitazone on restenosis after coronary stenting in patients with type 2 diabetes. Pioneer study: PPARgamma activation results in overall improvement of clinical and metabolic markers associated with insulin resistance independent of long-term glucose control. Effect of early addition of rosiglitazone to sulphonylurea therapy in older type 2 diabetes patients (>60 years): the Rosiglitazone Early vs. Thiazolidinediones Page 99 of 193 Final Report Update 1 Drug Effectiveness Review Project 111. Impact of rosiglitazone on beta-cell function, insulin resistance, and adiponectin concentrations: results from a double-blind oral combination study with glimepiride. Effects of rosiglitazone maleate when added to a sulfonylurea regimen in patients with type 2 diabetes mellitus and mild to moderate renal impairment: a post hoc analysis. Rosiglitazone in Type 2 diabetes mellitus: an evaluation in British Indo-Asian patients. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. Gomez-Perez FJ, Fanghanel-Salmon G, Antonio Barbosa J, et al. Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes. Rosiglitazone but not metformin enhances insulin- and exercise-stimulated skeletal muscle glucose uptake in patients with newly diagnosed type 2 diabetes. Effects of metformin and rosiglitazone monotherapy on insulin-mediated hepatic glucose uptake and their relation to visceral fat in type 2 diabetes. Addition of rosiglitazone to metformin is most effective in obese, insulin-resistant patients with type 2 diabetes. Predictive clinical parameters for therapeutic efficacy of rosiglitazone in Korean type 2 diabetes mellitus. Lebovitz HE, Dole JF, Patwardhan R, Rappaport EB, Freed MI, Rosiglitazone Clinical Trials Study Group.

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