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Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations: Final Original Report [Internet]

Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations: Final Original Report [Internet]

Drug Class Reviews - Oregon Health & Science University

Version: February 2011

Summary

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. Here we summarize some of the main comparative findings for the most commonly reported outcomes and the related strength of evidence (SOE). A more detailed summary of findings is presented in Table 71.

Results

Literature searches through July 28, 2010 for the current report identified 1987 unduplicated citations. We received dossiers from 6 pharmaceutical manufacturers: Takeda Pharmaceuticals, GlaxoSmithKline, Bristol-Meyers Squibb, Amylin Pharmaceuticals, Novo Nordisk, and Merck. Twenty-two additional references were identified through hand searches of systematic reviews and other sources, and 11 additional articles were identified from the dossiers, 4 from the pioglitazone (Actos®) dossier (Takeda Pharmaceuticals), 1 from the exenatide (Byetta®) dossier , 1 from the liraglutide (Victoza®) dossier (Novo Nordisk), 4 from the sitagliptin dossier (Merck), and 1 from the saxagliptin (Onglyza®) dossier (Bristol-Meyers Squibb). We also retrieved 240 excluded references from the reference database of the Fixed Dose Combination Drug Products for the Treatment of Type 2 Diabetes and Hyperlipidemia DERP report in order to review these publications using new inclusion criteria. From all of these sources, we had a total of 2260 references. In addition to these, we carried forward 209 of the included studies from 3 previous DERP reports: Newer Drugs for the Treatment of Diabetes Mellitus, Fixed Dose Combination Drug Products for the Treatment of Type 2 Diabetes and Hyperlipidemia, and the Drug Class Review on Thiazolidinediones.

Introduction

Diabetes mellitus (diabetes) is a chronic and insidious disease affecting more than 23 million Americans, about 8% of the population. Of those diagnosed, 90% to 95% have type 2 diabetes, while 5% to 10% have type 1 diabetes. Type 1 diabetes is characterized by autoimmune destruction of beta cells of the pancreas resulting in absolute insulin deficiency. Type 2 diabetes encompasses a heterogeneous group of disorders characterized by slow progressive loss of beta cell function and mass leading to variable degrees of insulin resistance, impaired insulin secretion, and increased hepatic glucose production. Higher glucagon levels relative to insulin also plays a significant role in the pathogenesis and management of type 2 diabetes.

Methods

All citations were reviewed for inclusion using the criteria described in Table 2. Studies meeting these criteria and comparing at least one of the drugs of interest with an eligible comparator were included. Eligible drugs and comparators are listed in Table 3.

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