Dustri Online Services

Search Results

Books: 0	Journals: 1	Articles: 4

Original

Association of gynecomastia with antidiabetic medications in older adults: Data mining from different national pharmacovigilance databases 

Katsuhiro Ohyama, Hiroyuki Tanaka, Junichiro Shindo, Manami Shibayama, Maya Iwata, and Yusuke Hori

Price
42.00 $

Add to Cart

Price

42.00 $

Volume 60 (2022) p. 24 - 31

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 60 – No. 1/2022 (24-31)

Association of gynecomastia with antidiabetic medications in older adults: Data mining from different national pharmacovigilance databases 

Katsuhiro Ohyama¹, Hiroyuki Tanaka², Junichiro Shindo¹, Manami Shibayama¹, Maya Iwata¹, and Yusuke Hori¹

¹Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, and ²Department of Practical Pharmacy, Faculty of Pharmaceutical Sciences, Toho University, Chiba, Japan
Objective: Gynecomastia is a benign proliferation of the glandular breast tissue in men and is generally caused by a decrease in androgen and an increase in estrogen. Diabetes has been reported to be a risk factor for lowering androgen levels. Moreover, lowered androgen levels are more common in older men. In the present study, we aimed to evaluate the signals for gynecomastia in older men on antidiabetic medications.
Materials and methods: A disproportionality analysis was performed to detect the signals for antidiabetic drug-associated gynecomastia in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER), using the reporting odds ratio (ROR) and information component (IC).
Results: Among 8 classes of medications for diabetes, a signal was detected only for dipeptidyl peptidase-4 (DPP-4) inhibitors (ROR: 1.90, 95% confidence interval (CI): 1.27 – 2.83; IC: 0.84, 95% CI: 0.26 – 1.42) in the FAERS. Regarding individual drugs, ROR and IC signals were detected for sitagliptin (ROR: 2.37, 95% CI: 1.48 – 3.79; IC: 1.12, 95% CI: 0.44 – 1.79) and vildagliptin (ROR: 3.34, 95% CI: 1.39 – 8.08; IC: 1.26, 95% CI: 0.07 – 2.44) in the FAERS and only for sitagliptin (ROR: 4.84, 95% CI: 1.92 – 12.2; IC: 1.48, 95% CI: 0.24 – 2.73) in the JADER.
Conclusion: This study showed an association between DPP-4 inhibitor use and gynecomastia in older men with diabetes. Further pharmacoepidemiological studies are warranted to verify this finding.Correspondence to:
 Katsuhiro Ohyama, PhD
 Center for Experiential Pharmacy Practice
School of Pharmacy
Tokyo University of Pharmacy and Life Sciences
1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan
Email: [email protected]

Original

Inverse association between DPP-4 inhibitor use and fracture in older adults: A disproportionality analysis of the FAERS and JADER 

Katsuhiro Ohyama, Takumi Okamoto, and Yusuke Hori

Price
42.00 $

Add to Cart

Price

42.00 $

Volume 61 (2023) p. 16 - 23

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 61 – No. 1/2023 (16-23)

Inverse association between DPP-4 inhibitor use and fracture in older adults: A disproportionality analysis of the FAERS and JADER 

Katsuhiro Ohyama, Takumi Okamoto, and Yusuke Hori

Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan
Objective: Fractures are significantly associated with increased morbidity and mortality in older individuals; additionally, patients with diabetes mellitus are highly prone to fractures. The aim of the present study was to examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitor use and the risk of fracture in older patients by analyzing data obtained from spontaneous adverse event reporting databases from the United States and Japan.
Materials and methods: Data on older patients registered in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2013 to the end of 2019 and data registered in the Japanese Adverse Drug Event Report database (JADER) from April 2004 to December 2019 were used. Reporting odds ratio (ROR) and information component (IC) values were used for disproportionality analysis.
Results: Significant inverse associations between DPP-4 inhibitor use and fracture were found for DPP-4 inhibitors as a whole (ROR = 0.80; 95% CI = 0.73 – 0.88; IC = –0.31, 95% CI = –0.46 to –0.17); linagliptin (ROR = 0.74; 95% CI = 0.59 – 0.94; IC = –0.42, 95% CI = –0.75 to –0.08); and sitagliptin (ROR = 0.77; 95% CI = 0.68 – 0.88; IC = –0.36, 95% CI = –0.55 to –0.17) in the analyses of FAERS data. Similarly, significant inverse associations were also found for DPP-4 inhibitors as whole (ROR = 0.71; 95% CI = 0.59 to 0.86; IC = –0.46, 95% CI = –0.74 to –0.18); sitagliptin (ROR = 0.70; 95% CI = 0.52 – 0.95; IC = –0.49, 95% CI = –0.93 to -0.05); and vildagliptin (ROR = 0.54; 95% CI = 0.35 – 0.83; IC = –0.85, 95% CI = –1.49 to –0.22) in the analyses of JADER data.
Conclusion: Our analysis of adverse event databases using different algorithms revealed that DPP-4 inhibitor use was inversely associated with fracture in older patients.Correspondence to:
Katsuhiro Ohyama, PhD
Center for Experiential Pharmacy Practice
School of Pharmacy
Tokyo University of Pharmacy and Life Sciences
1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan
Email: [email protected]

Original

Aplastic anemia associated with osimertinib: Analysis of the FDA adverse event reporting system 

Katsuhiro Ohyama, Seiichiro Katagiri, Satoshi Takahashi, Hideaki Ayuhara, Hironori Takeuchi, Daigo Akahane, Akihiko Gotoh, and Yusuke Hori

Price
42.00 $

Add to Cart

Price

42.00 $

Volume 63 (2025) p. 30 - 37

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 63 – No. 1/2025 (30-37)

Aplastic anemia associated with osimertinib: Analysis of the FDA adverse event reporting system 

Katsuhiro Ohyama¹, Seiichiro Katagiri², Satoshi Takahashi³, Hideaki Ayuhara⁴, Hironori Takeuchi⁴, Daigo Akahane², Akihiko Gotoh², and Yusuke Hori¹

¹Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Hachioji, ²Department of Hematology, ³Department of Thoracic Surgery, and ⁴Hospital Pharmacy, Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan
Objective: Aplastic anemia (AA) is a life-threatening disease, and drug-induced AA is rare. Recently, studies on cases that possibly developed AA following osimertinib treatment have been conducted. This study evaluated the association of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), including osimertinib, with AA and characterized such registered patients using a large spontaneous adverse event reporting database.
Materials and methods: Data from the Food and Drug Administration’s Adverse Event Reporting System spanning from the first quarter of 2015 to the second quarter of 2023 were used. Disproportionality analyses with reporting odds ratio (ROR) and information component (IC) were performed for signal detection. Furthermore, we described a case series of patients who experienced AA during osimertinib treatment.
Results: A signal was detected with osimertinib (ROR: 4.16, 95% confidence interval (CI): 2.54 – 6.80; IC: 1.80, 95% CI: 1.10 – 2.51); however, no signals were detected with other EGFR-TKIs. 16 individuals treated with osimertinib had AA, of whom 14 (87.5%) were registered as suspected drugs. The median age of these individuals was 70.5 years (interquartile range (IQR), 64.8 – 78.3 years), with varying time to onset (IQR, 4 – 210 days) and outcomes, including 3 (18.8%) deaths.
Conclusion: Our analyses generated a safety signal for the association between osimertinib and AA. Further studies are required to understand and confirm the role of osimertinib administration in the development of AA.Correspondence to:
Katsuhiro Ohyama, PhD
Center for Experiential Pharmacy Practice
School of Pharmacy
Tokyo University of Pharmacy and Life Sciences
1432-1 Horinouchi, Hachioji,
Tokyo 192-0392, Japan
Email: [email protected]

Original

Association between incretin-related drugs and fractures in patients treated with pioglitazone: A pharmacovigilance study using the FDA Adverse Event Reporting System 

Katsuhiro Ohyama, Nonoka Abe, Takumi Okamoto, and Yusuke Hori

Price
42.00 $

Add to Cart

Price

42.00 $

Volume 64 (2026) p. 1 - 8

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 64 – No. 1/2026 (1-8)

Association between incretin-related drugs and fractures in patients treated with pioglitazone: A pharmacovigilance study using the FDA Adverse Event Reporting System 

Katsuhiro Ohyama, Nonoka Abe, Takumi Okamoto, and Yusuke Hori

Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan
Objective: Diabetes mellitus (DM) causes various long-term complications and has, e.g., a direct negative effect on bone metabolism. Pioglitazone, which is used to treat DM, increases the risk of fractures. Reduced bone metabolism in patients with DM substantially impairs their quality of life. Therefore, this study aimed to determine the association of fractures with incretin-related drugs, dipeptidyl peptidase-4 inhibitors (DPP-4Is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs), in patients treated with pioglitazone using a pharmacovigilance database.
Materials and methods: Data from the U.S. Food and Drug Administration Adverse Event Reporting System from the first quarter of 2013 to the end of 2019 were analyzed. The reporting odds ratio and information component values were used to evaluate the positive and inverse associations between the abovementioned drugs and fractures.
Results: Inverse associations were observed between incretin-related drugs and fractures in patients treated with DPP-4Is (sitagliptin) and GLP-1RAs (dulaglutide, exenatide, and liraglutide). A subgroup analysis revealed inverse associations between fractures and GLP-1RAs (exenatide and liraglutide) in patients treated with pioglitazone.
Conclusion: Our results suggest that incretin-related drugs, especially GLP-1RAs, reduce the risk of fractures in patients treated with diabetes medications such as pioglitazone.Correspondence to:
Katsuhiro Ohyama, PhD
Center for Experiential Pharmacy Practice
School of Pharmacy
Tokyo University of Pharmacy and Life Sciences
1432-1 Horinouchi, Hachioji
Tokyo 192-0392, Japan
Email: [email protected]

Shopping Overview

Shopping Overview
Type	Qtty	Discount	VAT	Price
Your basket is empty

View Cart

Search Results

Shopping Overview

Send us an E-Mail