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Real-World Data and Real-World Evidence
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Ipragliflozin, an orally active, next-generation sodium-glucose transporter 2 (SGLT2) inhibitor, was approved in Japan for treating type 2 diabetes mellitus (T2DM) among adults in 2014, either alone or in combination with one of six other types of antihyperglycemic agents (metformin, pioglitazone, a sulfonylurea, an a-glucosidase inhibitor, a dipeptidylpeptidase-4 inhibitor or nateglinide)76. SGLT2 inhibitors suppress glucose reabsorption at renal proximal tubules, thus stimulating glycosuria and leading to reductions in both fasting and postprandial blood glucose (and consequently a decrease in glycated hemoglobin [HbA1c] level), body weight and blood pressure in patients with T2DM. In addition, SGLT2 inhibitors also decrease cardiovascular risk, and improve hepatic function, and thus are recommended as the first-line oral medication for specific T2DM patients by the European Society of Cardiology and the European Association.
Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus: final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM)
Published in Expert Opinion on Pharmacotherapy, 2021
Ichiro Nakamura, Hiroshi Maegawa, Kazuyuki Tobe, Satoshi Uno
This was an observational, multicenter post-marketing surveillance study conducted in Japan over an observation period of 3 years per patient (ClinicalTrials.gov identifier: NCT02479399). Details of the study design, patient selection criteria, and methods have been described previously in a report based on analysis of data at 3 months [21]. In brief, data from Japanese patients with T2DM who were newly initiated on treatment with ipragliflozin during the registration period (17 July 2014 to 16 October 2015) were included; the cutoff date for data inclusion was 30 September 2019. Ipragliflozin 50 mg once daily was administered before or after breakfast in accordance with the approved label with dose increase or decrease permitted also according to the label at the attending physician’s discretion.
Safety and efficacy of ipragliflozin in elderly versus non-elderly Japanese patients with type 2 diabetes mellitus: a subgroup analysis of the STELLA-LONG TERM study
Published in Expert Opinion on Pharmacotherapy, 2018
Hiroshi Maegawa, Kazuyuki Tobe, Hiromi Tabuchi, Ichiro Nakamura, Satoshi Uno
The efficacy of ipragliflozin was assessed in the efficacy analysis set up to 24 months (8757 patients). HbA1c (Figure 2(a)), FPG (Figure 2(b)), and body weight (Figure 2(c)) significantly decreased from baseline to 3 and 12 months in both age categories (all P < 0.05 vs. baseline). In non-elderly and elderly patients, the mean ± SD HbA1c was 8.23 ± 3.16% and 7.78 ± 1.24% at baseline, with a mean change of −0.75% and −0.53% at 3 months and −0.84% and −0.66% at 12 months, respectively; the mean ± SD FPG was 168.6 ± 61.0 mg/dL and 165.1 ± 56.6 mg/dL at baseline, with a mean change of −30.0 mg/dL and −25.9 mg/dL at 3 months and −32.7 mg/dL and −27.0 mg/dL at 12 months, respectively; and the mean ± SD body weight was 82.15 ± 17.19 kg and 67.93 ± 12.08 kg at baseline, with a mean change of −2.22 kg and −1.96 kg at 3 months and −2.92 kg and −2.45 kg at 12 months, respectively. Changes in HbA1c, FPG, and body weight at 3 and 12 months were similar to those in elderly patients in the STELLA-ELDER study (HbA1c: 7.78 vs. 7.84% [baseline], −0.53 vs. −0.54% [3 months], −0.66 vs. −0.67% [12 months]; FPG: 165.1 vs. 164.3 mg/dL [baseline], −25.9 vs. −22.5 mg/dL [3 months], −27.0 vs. −28.1 mg/dL [12 months]; and body weight: 67.64 vs. 67.64 kg [baseline], −1.96 vs. −2.20 kg [3 months], −2.45 vs. −2.91 kg [12 months]).
Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study
Published in Expert Opinion on Pharmacotherapy, 2018
Ichiro Nakamura, Hiroshi Maegawa, Kazuyuki Tobe, Hiromi Tabuchi, Satoshi Uno
The strength of this study was that a safety analysis on ipragliflozin treatment beyond 12 months could be performed on a large sample of patients. The limitations of the study included potential bias from incorrect completion of the survey report forms and the lack of a control group for comparisons. Additionally, there are still large amounts of unlocked data for the 12-month period that were not included in the current analysis; although the data at 3, 12, and 24 months have been combined and analyzed together, data for a number of patients at the 12-month period (and beyond) are still pending analysis. Further, the number of patients analyzed at 24 months of treatment was small because few patients had received 24 months of treatment by the cutoff date for this study. Nevertheless, we believe it is important to present the currently available data in a timely manner so that clinicians are fully informed of all potential safety issues.