Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study.

Abstract

OBJECTIVE:

To determine the incidence of adverse drug reactions (ADRs) associated with ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus.

RESEARCH DESIGN AND METHODS:

We report interim results of a postmarketing surveillance survey. Japanese physicians recorded ADRs in elderly patients (≥ 65 years old) who were first prescribed with ipragliflozin within 3 months of its launch (April 2014).

MAIN OUTCOME MEASURES:

Incidence of ADRs within 1 year of starting treatment with ipragliflozin.

RESULTS:

898 ADRs occurred in 721/7,170 patients (10.06%). Skin complication-, volume depletion-, genital infection-, polyuria/pollakiuria-, urinary tract infection-, and hypoglycemia-related ADRs occurred in 2.23%, 1.90%, 1.45%, 1.32%, 0.77%, and 0.32%, respectively. ADRs were classified as serious in 44 (0.61%) patients. Half of the ADRs occurred within 30 days of starting treatment. There were no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis. Most (92.1%) of the ADRs resolved or improved. Glycated hemoglobin, fasting blood glucose, body weight, and systolic blood pressure decreased by 0.6% (baseline 7.8%), 22.7 mg/dL (baseline 163.0 mg/dL), 2.3 kg (baseline 67.4 kg), and 3.1 mmHg (baseline 133.2 mmHg), respectively, from baseline to treatment discontinuation/last visit.

CONCLUSIONS:

Ipragliflozin is well tolerated and reduced surrogate endpoints in elderly Japanese patients with type 2 diabetes mellitus. Clinicaltrials.gov identifier: NCT02297620.

• Authors: Yasuo Terauchi, Koutaro Yokote, Ichiro Nakamura, Haruko Sugamori
• Journal: Expert opinion on pharmacotherapy (Expert Opin Pharmacother) Vol. 17 Issue 4 Pg. 463-71 ( 2016) ISSN: 1744-7666 [Electronic] England
• PMID: 26800061 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• Glucosides
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Thiophenes
• ipragliflozin

Topics

• Aged
• Blood Glucose (analysis)
• Blood Pressure (drug effects)
• Body Weight (drug effects)
• Diabetes Mellitus, Type 2 (drug therapy)
• Glucosides (adverse effects)
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemia (chemically induced, epidemiology)
• Hypoglycemic Agents (adverse effects)
• Incidence
• Product Surveillance, Postmarketing
• Surveys and Questionnaires
• Thiophenes (adverse effects)