Trends in Insulin Therapy—A1C and Age at the Time of Insulin Initiation in the Real-World Setting

ObjectivesRecent results from ‘ORAL Surveillance’ trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting.MethodsWe created two cohorts of patients with RA initiating treatment with tofacitinib or tumour necrosis factor inhibitors (TNFI) using deidentified data from Optum Clinformatics (2012–2020), IBM MarketScan (2012–2018) and Medicare (parts A, B and D, 2012–2017) claims databases: (1) A ‘real-world evidence (RWE) cohort’ consisting of routine care patients and (2) A ‘randomised controlled trial (RCT)-duplicate cohort’ mimicking inclusion and exclusion criteria of the ORAL surveillance trial to calibrate results against the trial findings. Cox proportional hazards models with propensity score fine stratification weighting were used to estimate HR and 95% CIs for composite outcome of myocardial infarction and stroke and accounting for 76 potential confounders. Database-specific effect estimates were pooled using fixed effects models with inverse-variance weighting.ResultsIn the RWE cohort, 102 263 patients were identified of whom 12 852 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) comparing tofacitinib with TNFI was 1.01 (0.83 to 1.23) in RWE cohort and 1.24 (0.90 to 1.69) in RCT-duplicate cohort which aligned closely with ORAL-surveillance results (HR: 1.33, 95% CI 0.91 to 1.94).ConclusionsWe did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib in patients with RA treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, although statistically non-significant, in patients with RA with cardiovascular risk factors.Trial registration numberNCT04772248.

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Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1933 ◽

2020 ◽

Vol 109 (1) ◽

pp. 25-28 ◽

Cited By ~ 1

Author(s):

Kimberly Maxfield ◽

Lauren Milligan ◽

Lingshan Wang ◽

Daniel Gonzalez ◽

Bernadette Johnson‐Williams ◽

...

Keyword(s):

Real World ◽

Drug Dosing ◽

The Real ◽

Real World Setting

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EP1.12-06 New Treatment Option for ES-SCLC: Patient Characteristics and Use of an Atezolizumab Regimen in the Real-World Setting

Journal of Thoracic Oncology ◽

10.1016/j.jtho.2019.08.2251 ◽

2019 ◽

Vol 14 (10) ◽

pp. S1018-S1019 ◽

Cited By ~ 1

Author(s):

S. Mccune ◽

T. Ton ◽

S. Whipple ◽

R. Induru ◽

L. Horn ◽

...

Keyword(s):

Treatment Option ◽

Real World ◽

Patient Characteristics ◽

The Real ◽

Real World Setting ◽

New Treatment ◽

Sclc Patient

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Nocturnal Glycemic Control with New Insulin Glargine 300 U/mL

Advances in Medicine ◽

10.1155/2019/8587265 ◽

2019 ◽

Vol 2019 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Neng Chun Yu

Keyword(s):

Blood Glucose ◽

Insulin Glargine ◽

Insulin Therapy ◽

Real World ◽

Statistical Significance ◽

Treatment Phase ◽

Glycemic Variability ◽

The Real ◽

Nocturnal Hypoglycemia ◽

Glucose Levels

Insulin glargine 300 U/mL (Gla-300) is a new generation basal insulin product that has been demonstrated to have more stable pharmacokinetic and pharmacodynamic characteristics than insulin glargine 100 U/mL (Gla-100). To evaluate the real-world benefits of Gla-300 in reducing nocturnal fluctuations in blood glucose levels and nocturnal hypoglycemia, 10 Taiwanese patients using Gla-100 for insulin therapy were switched to Gla-300 and continuous glucose monitoring (CGM) was applied at nighttime to monitor changes to nocturnal glycemic variability parameters. Glycemic variability parameters measured to assess between- and within-night glycemic variability included mean 6-hour nocturnal (00:00–6:00 AM) glucose levels, standard deviation (SD), and coefficient of variance (CV) of mean nocturnal glucose levels and mean glucose excursion (MAGE). In this study, Gla-300 demonstrated comparable glycemic efficacy to Gla-100 and the potential to further reduce nocturnal hypoglycemia risk. Overall, nocturnal glycemic variability parameters measured during the Gla-300 treatment period were numerically smaller than those measured during the Gla-100 treatment phase although statistical significance was not reached. In terms of within-night glucose management, SD and CV values of mean nocturnal glucose levels were found to be statistically lower during the Gla-300 treatment phase than the Gla-100 treatment phase on nights individuals displayed normal blood glucose level readings at the beginning of the night. In summary, this study represents the first of its kind from Taiwan to evaluate the real-world clinical benefits of switching Taiwanese diabetes patients from Gla-100 to Gla-300 insulin therapy in reducing nighttime glucose variability by means of CGM.

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