Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review
Purpose: Type 2 diabetes mellitus (T2DM) is a multifactorial disease characterized by insulin resistance. As time progresses, monotherapy often does not provide effective glycemic control, generating the need for an add-on therapy. Hence, multiple oral hypoglycemic agents formulated as a single-dose...
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doaj-45983e718a694577b35e495452930cbe2020-11-24T22:54:35ZengElsevierCurrent Therapeutic Research0011-393X1879-03132017-01-0184C4910.1016/j.curtheres.2017.01.005Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated ReviewThangavel Mahalingam Vijayakumar, M.Pharm, PhDJayasutha Jayram, M.PharmVishnu Meghana Cheekireddy, Pharm.DDasari Himaja, Pharm.DYalamanchili Dharma Teja, Pharm.DDamodharan Narayanasamy, M.Pharm, PhDPurpose: Type 2 diabetes mellitus (T2DM) is a multifactorial disease characterized by insulin resistance. As time progresses, monotherapy often does not provide effective glycemic control, generating the need for an add-on therapy. Hence, multiple oral hypoglycemic agents formulated as a single-dose form called fixed-dose combinations (FDCs) play an essential role in glycemic control. The purpose of this systematic review is to appraise the recently published evidence on the safety, efficacy, and bioavailability of FDCs. Methods: A comprehensive literature search of PUBMED, Scopus, ScienceDirect.com, ProQuest, SpringerLink, clintrials.gov, Embase, and EBSCO using the key words FDCs, combination therapy, T2DM management, and add-on therapy was conducted. Studies on the safety profile/tolerability, efficacy, and bioavailability of various FDCs of oral hypoglycemic agents were preferred. Findings: The systematic review of all the publications suggests that FDCs of oral hypoglycemic agents (OHAs) significantly reduce HbA1c and fasting plasma glucose values, thereby efficiently reducing hyperglycemia in patients in whom monotherapy fails. FDCs are the bioequivalent of the concomitant drugs administered as individual components. Improved adherence to FDCs and the absence of serious adverse drug reactions compared with dual therapy play an important role in decreasing the incidence of hyperglycemia in patients with T2DM. Implications: From this updated review, it was found that metformin was the most widely used component of FDCs with other OHAs. Studies on the safety and efficacy of newly approved OHAs such as sodium glucose cotransporter inhibitors were limited. An increasing number of randomized trials on the safety and efficacy of newly emerging FDCs suggests that they would be better treatment options for T2DM patients.http://www.sciencedirect.com/science/article/pii/S0011393X16300996bioavailabilityfixed-dose combinationsglycemic controlhyperglycemiamonotherapy |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Thangavel Mahalingam Vijayakumar, M.Pharm, PhD Jayasutha Jayram, M.Pharm Vishnu Meghana Cheekireddy, Pharm.D Dasari Himaja, Pharm.D Yalamanchili Dharma Teja, Pharm.D Damodharan Narayanasamy, M.Pharm, PhD |
spellingShingle |
Thangavel Mahalingam Vijayakumar, M.Pharm, PhD Jayasutha Jayram, M.Pharm Vishnu Meghana Cheekireddy, Pharm.D Dasari Himaja, Pharm.D Yalamanchili Dharma Teja, Pharm.D Damodharan Narayanasamy, M.Pharm, PhD Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review Current Therapeutic Research bioavailability fixed-dose combinations glycemic control hyperglycemia monotherapy |
author_facet |
Thangavel Mahalingam Vijayakumar, M.Pharm, PhD Jayasutha Jayram, M.Pharm Vishnu Meghana Cheekireddy, Pharm.D Dasari Himaja, Pharm.D Yalamanchili Dharma Teja, Pharm.D Damodharan Narayanasamy, M.Pharm, PhD |
author_sort |
Thangavel Mahalingam Vijayakumar, M.Pharm, PhD |
title |
Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review |
title_short |
Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review |
title_full |
Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review |
title_fullStr |
Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review |
title_full_unstemmed |
Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review |
title_sort |
safety, efficacy, and bioavailability of fixed-dose combinations in type 2 diabetes mellitus: a systematic updated review |
publisher |
Elsevier |
series |
Current Therapeutic Research |
issn |
0011-393X 1879-0313 |
publishDate |
2017-01-01 |
description |
Purpose: Type 2 diabetes mellitus (T2DM) is a multifactorial disease characterized by insulin resistance. As time progresses, monotherapy often does not provide effective glycemic control, generating the need for an add-on therapy. Hence, multiple oral hypoglycemic agents formulated as a single-dose form called fixed-dose combinations (FDCs) play an essential role in glycemic control. The purpose of this systematic review is to appraise the recently published evidence on the safety, efficacy, and bioavailability of FDCs.
Methods: A comprehensive literature search of PUBMED, Scopus, ScienceDirect.com, ProQuest, SpringerLink, clintrials.gov, Embase, and EBSCO using the key words FDCs, combination therapy, T2DM management, and add-on therapy was conducted. Studies on the safety profile/tolerability, efficacy, and bioavailability of various FDCs of oral hypoglycemic agents were preferred.
Findings: The systematic review of all the publications suggests that FDCs of oral hypoglycemic agents (OHAs) significantly reduce HbA1c and fasting plasma glucose values, thereby efficiently reducing hyperglycemia in patients in whom monotherapy fails. FDCs are the bioequivalent of the concomitant drugs administered as individual components. Improved adherence to FDCs and the absence of serious adverse drug reactions compared with dual therapy play an important role in decreasing the incidence of hyperglycemia in patients with T2DM.
Implications: From this updated review, it was found that metformin was the most widely used component of FDCs with other OHAs. Studies on the safety and efficacy of newly approved OHAs such as sodium glucose cotransporter inhibitors were limited. An increasing number of randomized trials on the safety and efficacy of newly emerging FDCs suggests that they would be better treatment options for T2DM patients. |
topic |
bioavailability fixed-dose combinations glycemic control hyperglycemia monotherapy |
url |
http://www.sciencedirect.com/science/article/pii/S0011393X16300996 |
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