The Resource Drug class review : final original report, Newer diabetes medications, TZDs, and combinations, Dan Jonas ... [et al.] ; produced by RTI-UNC Evidence-based Practice Center ; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill ; Drug Effectiveness Review Project, Oregon Evidence-based Practice Center, (electronic book)

Drug class review : final original report, Newer diabetes medications, TZDs, and combinations, Dan Jonas ... [et al.] ; produced by RTI-UNC Evidence-based Practice Center ; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill ; Drug Effectiveness Review Project, Oregon Evidence-based Practice Center, (electronic book)

Label
Drug class review : final original report, Newer diabetes medications, TZDs, and combinations
Title
Drug class review
Title remainder
final original report
Title part
Newer diabetes medications, TZDs, and combinations
Statement of responsibility
Dan Jonas ... [et al.] ; produced by RTI-UNC Evidence-based Practice Center ; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill ; Drug Effectiveness Review Project, Oregon Evidence-based Practice Center
Title variation
Newer diabetes medications, TZDs, and combinations
Contributor
Subject
Language
  • eng
  • eng
Summary
PURPOSE: To compare the effectiveness and adverse event profiles of amylin agonists, DPP-4 inhibitors, incretin mimetics, TZDs, and certain combination products for people with type 2 diabetes and for people with type 1 diabetes for pramlintide only. DATA SOURCES: To identify published studies, we searched MEDLINE, The Cochrane Library, Embase, International Pharmaceutical Abstracts, and reference lists of included studies through July 2010. We also requested dossiers of information from pharmaceutical manufacturers. REVIEW METHODS: Study selection, data abstraction, validity assessment, grading the strength of the evidence (SOE), and data synthesis were all carried out according to standard Drug Effectiveness Review Project methods. RESULTS: Most of the evidence was limited to adult populations. Most of the included studies evaluated intermediate outcomes, such as HbA1c or weight. Very few studies reported health outcomes and few studies were longer than 6 months. For the amylin agonists, DPP-IV inhibitors, and GLP-1 agonists, we found no studies that focused on health outcomes as primary outcomes. Some studies of these drug classes reported some health outcomes such as all-cause mortality or number of people with macrovascular disease among secondary outcomes or adverse events, but overall evidence was generally insufficient to determine how medications in these classes compare with other treatments for their impact on health outcomes. For the newer diabetes drugs (pramlintide, sitagliptin, saxagliptin, exenatide, and liraglutide), all of the included medications were efficacious for reducing HbA1c compared with placebo. For reduction in HbA1c, pramlintide was similar to rapid acting insulin analog when added to insulin glargine or detemir (low SOE); sitagliptin monotherapy was less efficacious than metformin or glipizide monotherapy (low SOE); sitagliptin was not significantly different than rosiglitazone when either was added to metformin (moderate SOE); and there was no comparative evidence for saxagliptin (insufficient SOE). One head-to-head trial comparing exenatide with liraglutide reported a slightly greater reduction in HbA1c with liraglutide (between group difference 0.33%, 95% CI 0.47 to 0.18, low SOE). For reduction in HbA1c, exenatide was similar to glibenclamide (low SOE), rosiglitazone (low SOE), and insulin (with both groups also receiving oral diabetes agents, moderate SOE). Liraglutide-treated subjects had greater reductions in HbA1c than subjects treated with glargine (low SOE), rosiglitazone (low SOE), or sitagliptin (low SOE), and similar or greater reductions than those treated with glimepiride (insufficient SOE). For weight, pramlintide, exenatide, and liraglutide (doses of 1.2 or greater) appear to cause weight loss compared with placebo. Sitagliptin and saxagliptin are likely weight neutral. Most studies evaluating weight change were 6 months or less and it is uncertain whether weight loss is sustained long-term. Rates of hypoglycemia were lower with sitagliptin than with glipizide (moderate SOE), with liraglutide than exenatide (low SOE), and with liraglutide than glimepiride (high SOE). Hypoglycemia rates were similar to placebo for sitagliptin and saxagliptin (low SOE) and were similar between exenatide and insulin (moderate SOE). Rates of gastrointestinal side effects were higher with exenatide and liraglutide than with comparators. For the TZDs, the available evidence indicates that pioglitazone and rosiglitazone are not statistically significantly different in their ability to reduce HbA1c (moderate SOE). Further, there were no significant differences in ability to reduce HbA1c between either TZD and sulfonylureas or metformin (moderate to high SOE). Both TZDs increase the risk of heart failure (high SOE), edema (high SOE), and fractures in women (moderate SOE). The risk of hypoglycemia is reduced with TZDs when compared with sulfonylureas; the risk is similar to the risk with metformin (high SOE). Both TZDs cause a similar degree of weight gain to that caused by sulfonylureas (moderate SOE). Although rosiglitazone now has restricted access due to an increased risk of cardiovascular adverse events, we found no evidence of increased all-cause mortality or cardiovascular mortality with pioglitazone; some studies suggest reduced risk of all-cause and cardiovascular mortality with pioglitazone (low SOE) For the FDCPs, we found no head to head trials that compared HbA1c control between any 2 FDCPs (insufficient SOE). Therapy with Avandamet,(r) Avandaryl,(r) Actoplus Met, or dual therapy with metformin and sitagliptin produced statistically significantly greater reductions in HbA1c compared to monotherapy with any of their respective components. CONCLUSION: All of the included medications were efficacious for reducing HbA1c and none of the newer medications appear to cause weight gain. Little data was available to evaluate the long-term effectiveness of the newer medications compared with more established treatments, limiting our ability to determine how to best incorporate newer medications into clinical practice
Member of
Additional physical form
Issued also online.
Cataloging source
DNLM
Illustrations
illustrations
Index
no index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • surveys of literature
http://library.link/vocab/relatedWorkOrContributorName
  • Jonas, Dan
  • Research Triangle Institute-University of North Carolina Evidence-based Practice Center.
  • Cecil G. Sheps Center for Health Services Research.
  • Drug Effectiveness Review Project.
  • Oregon Health & Science University
  • Oregon Health & Science University.
Series statement
Drug class reviews
http://library.link/vocab/subjectName
  • Diabetes Mellitus
  • Thiazolidinediones
  • Thiazolidinediones
  • Drug Combinations
  • Treatment Outcome
  • Drug Evaluation
Label
Drug class review : final original report, Newer diabetes medications, TZDs, and combinations, Dan Jonas ... [et al.] ; produced by RTI-UNC Evidence-based Practice Center ; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill ; Drug Effectiveness Review Project, Oregon Evidence-based Practice Center, (electronic book)
Instantiates
Publication
Bibliography note
Includes bibliographical references
Control code
1563657
Dimensions
unknown
Extent
1 online resource.
Form of item
online
Specific material designation
remote
Label
Drug class review : final original report, Newer diabetes medications, TZDs, and combinations, Dan Jonas ... [et al.] ; produced by RTI-UNC Evidence-based Practice Center ; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill ; Drug Effectiveness Review Project, Oregon Evidence-based Practice Center, (electronic book)
Publication
Bibliography note
Includes bibliographical references
Control code
1563657
Dimensions
unknown
Extent
1 online resource.
Form of item
online
Specific material designation
remote

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