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Glargine-300: An updated literature review on randomized controlled trials and real-world studies.

ABSTRACT: Despite the availability of a variety of insulins, rates of insulinisation and the acceptance of insulin therapy is suboptimal in real-world clinical settings. Patient and physician concerns with hypoglycaemia and weight gain are the two key issues that serve to impede appropriate insulinisation in patients with diabetes. Recently introduced second-generation basal insulin analogues [for e.g., insulin glargine 300 U/mL (Gla-300) and insulin degludec] are designed to have improved pharmacokinetic profiles with an intention to deliver steady insulin levels over a longer period. Several randomised controlled and real-world studies have proven the resultant advantages of second-generations insulin analogues in lowering intra-individual variability in plasma insulin levels, flexibility in dosing, a sustained glucose-lowering effect, and decreasing the risk of hypoglycaemia. Gla-300 is one of the newer second-generation basal insulin analogues to have been approved for both type 1 and 2 diabetes. In this article, we review the currently available clinical and real-world data of Gla-300.

SUBMITTER: Ghosh S

PROVIDER: S-EPMC7156297 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Glargine-300: An updated literature review on randomized controlled trials and real-world studies.

Ghosh Sujoy S Ghosh Romik R

World journal of diabetes 20200401 4

Despite the availability of a variety of insulins, rates of insulinisation and the acceptance of insulin therapy is suboptimal in real-world clinical settings. Patient and physician concerns with hypoglycaemia and weight gain are the two key issues that serve to impede appropriate insulinisation in patients with diabetes. Recently introduced second-generation basal insulin analogues [for <i>e.g</i>., insulin glargine 300 U/mL (Gla-300) and insulin degludec] are designed to have improved pharmaco ...[more]

PMID: 32313609

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Project description:Rapid and robust strategies to evaluate the efficacy and effectiveness of novel and existing pharmacotherapeutic interventions (repurposed treatments) in future pandemics are required. Observational "real-world studies" (RWS) can report more quickly than randomized controlled trials (RCTs) and would have value were they to yield reliable results. Both RCTs and RWS were deployed during the coronavirus disease 2019 (COVID-19) pandemic. Comparing results between them offers a unique opportunity to determine the potential value and contribution of each. A learning review of these parallel evidence channels in COVID-19, based on quantitative modeling, can help improve speed and reliability in the evaluation of repurposed therapeutics in a future pandemic. Analysis of all-cause mortality data from 249 observational RWS and RCTs across eight treatment regimens for COVID-19 showed that RWS yield more heterogeneous results, and generally overestimate the effect size subsequently seen in RCTs. This is explained in part by a few study factors: the presence of RWS that are imbalanced for age, gender, and disease severity, and those reporting mortality at 2 weeks or less. Smaller studies of either type contributed negligibly. Analysis of evidence generated sequentially during the pandemic indicated that larger RCTs drive our ability to make conclusive decisions regarding clinical benefit of each treatment, with limited inference drawn from RWS. These results suggest that when evaluating therapies in future pandemics, (1) large RCTs, especially platform studies, be deployed early; (2) any RWS should be large and should have adequate matching of known confounders and long follow-up; (3) reporting standards and data standards for primary endpoints, explanatory factors, and key subgroups should be improved; in addition, (4) appropriate incentives should be in place to enable access to patient-level data; and (5) an overall aggregate view of all available results should be available at any given time.

Project description:Tumor necrosis factor (TNF) inhibitors are widely used biologics for the treatment of several chronic inflammatory diseases. The launch of anti-TNF biosimilars has introduced the possibility of non-medical switching between originator biologics and their biosimilars. However, the potential clinical and patient-reported consequences of non-medical switching remain largely unknown, as much of the evidence comes from poorly or uncontrolled real-world evidence (RWE) studies that often have an element of bias and nonstandardized outcome measures. To appropriately evaluate the safety, efficacy, and immunogenicity of non-medical switching from an originator to its biosimilar, we propose that seven key study design elements should be considered when assessing the existing evidence: studies should be (1) randomized and double-blind, (2) adequately controlled, and (3) adequately powered; include (4) multiple switching, (5) an assessment of immunogenicity, and (6) adequate follow-up duration; and (7) report individual patient-level outcomes. This systematic review assessed the robustness and consistency of the current non-medical switching evidence, with a focus on TNF inhibitors. A comprehensive literature search (January 2012-February 2018) identified 98 publications corresponding to 91 studies (17 randomized controlled trials and 74 RWE studies) describing non-medical switching from a TNF inhibitor originator to its biosimilar. When assessing the totality of this evidence, none of the non-medical switching studies conducted to date were found to use all seven of the key design elements, and the absence of these elements dilutes the robustness of the data. Furthermore, discontinuation rates varied widely among studies (0-87%), suggesting heterogeneity and inconclusiveness of the current efficacy, safety, and immunogenicity evidence, particularly at an individual patient level. Therefore, patients should not be indiscriminately switched from an originator TNF inhibitor to its biosimilar for non-medical reasons. Switching decisions should remain between the treating physicians and their patients and be made on a case-by-case basis, relying upon robust scientific evidence.FundingAbbVie.Plain Language Summary: Plain language summary available for this article.

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Glargine-300: An updated literature review on randomized controlled trials and real-world studies.

Publications

Glargine-300: An updated literature review on randomized controlled trials and real-world studies.

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