Clinical review report : Ertugliflozin (Steglatro) (Merck Canada Inc.) : indication : type 2 diabetes mellitus / Canadian Agency for Drugs and Technologies in Health.

Format:

Book

Author/Creator:

Canadian Agency for Drugs and Technologies in Health, author, issuing body.

Series:

Common drug review clinical review report.

Common drug review clinical review report

Language:

English

Subjects (All):

Outcome assessment (Medical care).

Physical Description:

1 online resource.

Edition:

Final edition.

Place of Publication:

Ottawa, ON : CADTH, 2019.

Summary:

Diabetes mellitus is a metabolic disease that is characterized by persistent elevations in blood glucose (hyperglycemia). This persistent elevated blood glucose causes damage to blood vessels on a microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular (peripheral artery disease, cardiovascular [CV] disease) level. Diabetes is one of the most common chronic diseases in Canada. Diabetes Canada estimated that there were 3.4 million people (9.3% of the population) with diabetes in 2015, and by 2025 this number will have increased to five million people (12.1%). The objective was to perform a systematic review of the beneficial and harmful effects of ertugliflozin (ERT) 5 mg and 15 mg tablets to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance (as monotherapy); or in combination with metformin, or metformin and sitagliptin, when these therapies, along with diet and exercise, do not provide adequate glycemic control. This review was conducted in tandem with an evaluation of the ERT/metformin fixed-dose combination product, Segluromet.

Contents:

Abbreviations

Executive Summary

Introduction

Results and Interpretation

Conclusions

Disease Prevalence and Incidence

Standards of Therapy

Drug

Objectives and Methods

Objectives

Methods

Results

Findings from the Literature

Included Studies

Exposure to Study Treatments

Critical Appraisal

Efficacy

Harms

Discussion

Summary of Available Evidence

Interpretation of Results

Appendix 1. Patient Input Summary

Appendix 2. Literature Search Strategy

Appendix 3. Excluded Studies

Appendix 4. Detailed Outcome Data

Appendix 5. Summary of Extension Studies

Appendix 6. Summary of Indirect Comparisons

References.

Notes:

Description based on publisher supplied metadata and other sources.