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Drug Class Review: Newer Drugs for the Treatment of Diabetes Mellitus: Final Report [Internet]

Drug Class Review: Newer Drugs for the Treatment of Diabetes Mellitus: Final Report [Internet]

Drug Class Reviews - Oregon Health & Science University

Version: August 2008

Results

We identified 134 citations from our literature search (Figure 1). Six randomized controlled trials (with 1 companion paper) and 4 pooled analyses fulfilled inclusion criteria. No comparative cohort or case-control studies reporting long-term benefits or harms were identified. Details of included studies are found in Evidence Tables 1– and quality assessment in Evidence Table 4. Trials excluded upon review of the full text are listed in Appendix D. In the FDA Medical and Statistical Reviews, 6 relevant trials were identified, of which 4 were published and already included in our review. The remaining two trials could not be found in the published literature. No good quality systematic reviews of pramlintide were identified for inclusion.

Introduction

Diabetes mellitus (diabetes) is a chronic and insidious disease affecting more than 20 million Americans, approximately 7% of the population. Of those diagnosed, 90–95% have type 2 diabetes, while 5–10% 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. Among the counterregulatory hormones, higher glucagon levels relative to insulin also plays a significant role in the pathogenesis and management of type 2 diabetes, making optimal control difficult to maintain.

Evidence Tables

Baseline characteristics of trials and studies of newer drugs for the treatment of diabetes mellitus

Methods

To identify relevant citations we searched Ovid MEDLINE®, Ovid MEDLINE® IN-Process (1950 to April Week 3, 2008), Cochrane Database of Systematic Reviews®, Cochrane Central Register of Controlled Trials®, and the Database of Abstracts of Reviews of Effects (3rd quarter 2007) using search terms for included drugs, indications, and study designs. Electronic database searches were supplemented by hand searches of reference lists of included studies and reviews. In addition, we searched the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research, the Canadian Agency for Drugs and Technologies in Health, and the National Institute for Health and Clinical Excellence web sites for medical or statistical reviews and technology assessments. Finally, we searched dossiers of published and unpublished studies submitted by pharmaceutical companies. (See Appendix A for complete search strategies.) All citations were imported into an electronic database (Endnote® v.9.0).

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