Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study.

Abstract

OBJECTIVE:

To investigate the real-world safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (T2DM).

RESEARCH DESIGN AND METHODS:

Japanese patients (≥65 years old) who were first prescribed ipragliflozin within 3 months after its launch in April 2014 were registered in this post-marketing surveillance (PMS). Final data collection was in July 2015. Survey items included demographics, treatments, adverse drug reactions (ADRs), vital signs, and laboratory variables.

RESULTS:

The PMS included 8505 patients (4181 males/4324 females). The mean age and diabetes duration were 72.3 years and 10.6 years, respectively. In 84.3% of patients, ipragliflozin was prescribed at 50 mg/day, which was continued unchanged. Overall, 16.91% of patients experienced 1880 ADRs, and 165 ADRs were classified as serious in 127 patients (1.49%). ADRs of special interest included skin complications, volume depletion, polyuria/pollakiuria, genital infection, urinary tract infection, renal disorders, hypoglycemia, cerebrovascular disease, cardiovascular disease, malignant tumor, fracture, and ketone body-related events.

CONCLUSIONS:

This 1-year PMS revealed probable ADRs in elderly Japanese patients with T2DM prescribed ipragliflozin in real-world settings, with no new safety concerns. The risk factors for ADRs varied but could be rationalized. The results should help physicians to identify possible treatment-emergent ADRs in ipragliflozin-treated patients.

• Authors: Koutaro Yokote, Yasuo Terauchi, Ichiro Nakamura, Haruko Sugamori
• Journal: Expert opinion on pharmacotherapy (Expert Opin Pharmacother) Vol. 17 Issue 15 Pg. 1995-2003 (Oct 2016) ISSN: 1744-7666 [Electronic] England
• PMID: 27477242 (Publication Type: Journal Article)

Chemical References

• Blood Glucose
• Glucosides
• Hypoglycemic Agents
• Thiophenes
• ipragliflozin

Topics

• Aged
• Aged, 80 and over
• Blood Glucose (analysis)
• Diabetes Mellitus, Type 2 (drug therapy)
• Female
• Glucosides (therapeutic use)
• Humans
• Hypoglycemia (chemically induced)
• Hypoglycemic Agents (therapeutic use)
• Male
• Product Surveillance, Postmarketing
• Risk Factors
• Surveys and Questionnaires
• Thiophenes (therapeutic use)