The Durable Safety and Effectiveness of Lixisenatide in Japanese People with Type 2 Diabetes: The Post-Marketing Surveillance PRANDIAL Study

Abstract

Introduction Real-world evidence on lixisenatide in Japanese people with type 2 diabetes (T2D) is lacking. Therefore, the 3-year post-marketing PRANDIAL study was conducted to evaluate the safety (primary objective) and effectiveness (secondary objective) of lixisenatide in Japanese people with T2D during routine clinical practice. Methods This prospective, observational, multicenter, open-label study was conducted in Japanese individuals with T2D who initiated lixisenatide treatment between March 2014 and June 2017. Using electronic case report forms, investigators collected baseline demographic and clinical information and data on medications, safety and effectiveness up to 3 years after initiation of lixisenatide. Results Overall, 3046 participants were analyzed; their mean ± standard deviation (SD) age was 58.9 ± 13.1 years, and 53.7% were male. Mean ± SD duration of T2D was 12.8 ± 8.6 years, and baseline glycated hemoglobin (HbA1c) was 8.7% ± 1.7%. Most participants (93.9%) were receiving concomitant antidiabetic medications when they initiated lixisenatide. Median (range) lixisenatide treatment duration was 382 (1–1096) days. Adverse drug reactions (ADRs) were reported in 604 participants (19.8%) and serious ADRs in 22 (0.7%). The most common ADR was nausea (9.0%). Of ADRs of special interest, hypoglycemia occurred in 2.9% of participants, injection site reactions in 0.9%, and hypoglycemic unconsciousness in 0.03%. Baseline characteristics associated with an increased risk of ADRs ( p < 0.05) were history of treatment for cardiovascular disease, hepatic dysfunction, and other complications. Effectiveness was analyzed in 2675 participants; HbA1c, fasting plasma glucose, postprandial glucose, and body weight all decreased significantly at last observation (all p < 0.0001 vs. baseline). Conclusions Lixisenatide was well tolerated, with no unexpected ADRs or new safety signals identified, and showed effective glycemic control and weight reduction up to 3 years, supporting the use of lixisenatide as a safe and effective treatment option for T2D in routine clinical practice in Japan. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02121-5.

Simultaneous Versus Sequential Initiation of Lixisenatide and Basal Insulin for Type 2 Diabetes: Subgroup Analysis of a Japanese Post-Marketing Surveillance Study of Lixisenatide (PRANDIAL)

“…S2 in the Supplementary Material). This report includes fewer participants than were included in the overall analysis of the PMS [ 22 ] because data extraction for the current analysis was conducted prior to collection of electronic case report forms from all eligible participants. The overall effectiveness analysis set included 2679 participants.…”

“…All data were collected anonymously to protect personal information; the study sponsor had no access to individual participant medical records. Full details of the parent study design have been described previously [ 22 ].…”

“…Compared with placebo, add-on lixisenatide consistently improved glycemic control, with a pronounced postprandial effect, in the predominantly Caucasian T2D populations of the GetGoal-L and GetGoal-Duo 1 trials [ 18 , 19 ], and the overall mixed Asian population and Japanese subpopulation of the GetGoal-L-Asia trial [ 20 , 21 ]. Lixisenatide is a safe and effective option for the treatment of T2D in Japanese people in routine clinical practice according to results of a 3-year post-marketing surveillance (PMS) study [ 22 ].…”