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Ipragliflozin demonstrates efficacy among older Japanese adults with type 2 diabetes
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Older Japanese adults with type 2 diabetes prescribed to the SGLT2 inhibitor ipragliflozin experienced a decline in HbA1c and body weight over 12 months that was similar to adults younger than 65 years, although researchers observed more serious adverse drug reactions among the older population, according to findings published in Current Medical Research and Opinion.
“Since the approval of the SGLT2 inhibitor ipragliflozin [Astellas Pharma and Kotobuki Pharmaceutical] for the treatment of type 2 diabetes mellitus in Japan in 2014, two postmarketing surveillance studies of ipragliflozin have been conducted (the STELLA-ELDER and STELLA-LONG TERM studies) in Japan,” Hiroshi Maegawa, MD, PhD, deputy director of the Center for Epidemiologic Research in Asia and professor in the department of internal medicine at Shiga University of Medical Science in Shiga, Japan, and colleagues wrote. “Although the safety and effectiveness of ipragliflozin were evaluated in six pre-approval trials, a pooled analysis of these trials showed that only 32.6% of the studied population was 65 years of age. This raised concerns regarding the lack of long-term postmarketing data on the safety and effectiveness of ipragliflozin in the elderly population.”
In a subgroup analysis, Maegawa and colleagues analyzed data from adults with type 2 diabetes and 12 months of data participating in the STELLA-LONG TERM study prescribed ipragliflozin between July 2014 and October 2015, stratified by age (aged < 65 years vs. 65 years). Ipragliflozin was administered at a dose of 50 mg once daily before or after breakfast. Researchers evaluated safety based on adverse drug reactions during treatment; effectiveness was defined by changes in HbA1c and body weight between baseline and 12 months. The safety set included 11,051 patients (and the efficacy set included 8,788 patients.
Within the cohort, 28.6% of patients (n = 3,157) were aged at least 65 years. Compared with patients younger than 65 years, older patients were more likely to have a baseline HbA1c of 8% or lower (59.5% vs. 50.1%) have a lower BMI (mean, 26.8 kg/m² vs. 29.9 kg/m²) and have more comorbidities (87.3% vs. 83.2%; P < .001 for all).
Researchers found that mean HbA1c and body weight decreased from baseline to 12 months in both age groups, regardless of baseline HbA1c and body weight (P < .05 for all). In older vs. younger patients, the incidence of adverse drug reactions was similar (14.2% vs. 14.8%); however, older adults experienced more serious adverse drug reactions (1.4% vs. 0.8%; P = .002), according to researchers.
In assessing adverse events of special interest, the researchers found that incidences of hypoglycemia (P = .037), renal disorder (P = .021) and skin complications (P = .012) were higher among older vs. younger patients, whereas incidences of genital infection (P = .043), polyuria/pollakiuria (P < .001) and hepatic disorder (P = .002) were higher among younger vs. older patients. – by Regina Schaffer
Disclosures: Astellas Pharma sponsored this study. Maegawa reports he has received lecture fees, research support or grants from Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Kissei, Kowa, Kyowa Hakko Kirin, Mitsubishi Tanabe, MSD, Nippon, Ono, Otsuka, Sanofi, Sanwa Kagaku Kenkyusho, Shionogi, Taisho Toyama, Takeda and Teijin Limited. Please see the study for all other authors’ relevant financial disclosures.
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