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Original

Pharmacokinetics of single-dose morinidazole in patients with severe renal impairment

Hao Zhang, Lu Huang, Yuan-yuan Huang, Bin Yi, Qi Pei, Hong-yi Tan, Jie Huang, Ji-shi Liu, Hong Yuan, and Guo-ping Yang

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Volume 52 p. 159 - 165

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 2/2014 (159-165)

Pharmacokinetics of single-dose morinidazole in patients with severe renal impairment

Hao Zhang², Lu Huang¹,³, Yuan-yuan Huang¹, Bin Yi², Qi Pei¹, Hong-yi Tan¹, Jie Huang¹, Ji-shi Liu², Hong Yuan¹, and Guo-ping Yang¹

¹Center of Clinical Pharmacology, ²Department of Nephrology, the Third Xiangya Hospital, and ³College of Pharmacy, Central South University, Changsha, Hunan, China
Objective: To evaluate the pharmacokinetics of morinidazole in individuals with severe renal impairment (RI). Methods: This open-label Phase I study enrolled healthy volunteers and patients with severe RI aged 18 – 65 years. All subjects received a single infusion of sodium chloride injection with 500 mg morinidazole. Plasma and urine concentration of morinidazole and one of its metabolites (M4-1) were evaluated by using HPLC-UV and HPLC-MS/MS respectively. Pharmacokinetic parameters were calculated by Phoenix WinNonlin 6.0 software. Results: 22 individuals (healthy: n = 11, severe RI: n = 11) received morinidazole. In both groups, maximum plasma concentration of morinidazole was reached within 1 hour, while the t_max of M4-1 differed greatly. Both AUC_0–t and AUC_0–∞ of morinidazole were 1.4 times higher in patients with severe RI, while M4-1 were over 7 times higher than healthy groups. Renal excretion of unchanged morinidazole was decreased by 65% in patients with RI, and M4-1 was decreased by 72%. Apparent correlation between CL_cr and CL, AUC, t_1/2 and CL_r were seen in two groups. Conclusions: A single dose of 500 mg morinidazole is well tolerated. Changes in pharmacokinetic parameters of morinidazole and M4-1 are seen in patients with RI and may be clinically important.Correspondence to:
Prof. Guoping Yang
Center of Clinical Pharmacology, Third Xiangya Hospital
Central South University
Changsha, Hunan 410013, China
Email: [email protected]

Original

Serum osteocalcin concentration as an independent biomarker of osteoporosis in patients with chronic kidney disease 

Po-Jui Chi, Shih-Yuan Hung, Fu-Tsung Hsiao, Hung-Hsiang Liou, and Jen-Pi Tsai

Volume 98 (2022) p. 1 - 9

Abstract

Clinical Nephrology, Vol. 98 – No. 1/2022 (1-9)

Serum osteocalcin concentration as an independent biomarker of osteoporosis in patients with chronic kidney disease 

Po-Jui Chi¹#², Shih-Yuan Hung¹#², Fu-Tsung Hsiao³, Hung-Hsiang Liou⁴, and Jen-Pi Tsai⁵#⁶

¹Division of Nephrology, Department of Medicine, E-DA Hospital, ²School of Medicine, College of Medicine, I-Shou University, Kaohsiung, ³Department of Radiology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, ⁴Division of Nephrology, Department of Medicine, Hsin-Jen Hospital, New Taipei City, ⁵Division of Nephrology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, and ⁶School of Medicine, Tzu Chi University, Hualien, Taiwan
Objectives: Osteocalcin, an osteoblast-derived hormone, is associated with the development of osteoporosis and arteriosclerosis in the general population. However, its role on the pathogenesis of osteoporosis and vascular calcification in patients with chronic kidney disease (CKD) is unclear. Here, we investigated the connection between osteocalcin, bone mineral density (BMD), and abdominal aortic calcification (AAC) in CKD patients.
Materials and methods: In total, 95 patients with stage 2 to stage 5 CKD were enrolled. Serum osteocalcin levels were measured using an electrochemiluminescence immunoassay. BMD was determined by dual-energy X-ray absorptiometry, and AAC scores were generated from lateral lumbar radiograph findings.
Results: 95 patients were assigned into normal bone density (30.5%, n = 29), osteopenia (45.3%, n = 43), and osteoporosis (24.2%, n = 23) groups. The osteoporosis group was characterized by older age, higher female-to-male ratio, phosphorous levels, calcification scores, osteocalcin levels, and intact parathyroid hormone (PTH) levels, while with lower hemoglobin levels as compared to normal and osteopenia groups. Multivariate multinominal regression analysis showed age, female sex, intact PTH, and serum osteocalcin level were independent determinants of osteoporosis severity in CKD patients. Furthermore, serum osteocalcin level is positively correlated to intact PTH in multivariate linear regression model, indicating that osteocalcin might be a bone turnover marker in patients with CKD. Multivariate stepwise linear regression analysis revealed that age, diabetes mellitus, poorer renal function, rather than osteocalcin, have independent associations with AAC score.
Conclusion: Elevated serum osteocalcin levels could be considered as a marker of osteoporosis rather than that of vascular calcification in patients with CKD.Correspondence to:
Hung-Hsiang Liou, MD
Division of Nephrology, Department of Medicine
Hsin-Jen Hospital
New Taipei City, Taiwan
or
Jen-Pi Tsai, MD, PhD
Division of Nephrology
Department of Internal Medicine
Dalin Tzu Chi Hospital
Buddhist Tzu Chi Medical Foundation
Chiayi, Taiwan
Email: [email protected]; [email protected]

Original

The guanylate cyclase stimulator vericiguat: Insights and adverse events from a FAERS-based pharmacovigilance study 

Jia Tang, Bing Lv, Jingchun Han, Kehan Li, Qianying Li, and Yuan Hu

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Volume 64 (2026) p. 144 - 153

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 64 – No. 3/2026 (144-153)

The guanylate cyclase stimulator vericiguat: Insights and adverse events from a FAERS-based pharmacovigilance study 

Jia Tang¹, Bing Lv², Jingchun Han², Kehan Li¹, Qianying Li¹, and Yuan Hu¹

¹Department of Dermatology, Suining Central Hospital, Suining, Sichuan Province, and ²Department of Emergency, The First Hospital of Jilin University, Changchun, Jilin Province, China 
Background: Since its approval by the U.S. Food and Drug Administration in January 2021, vericiguat, a novel soluble guanylate cyclase stimulator, has been increasingly utilized in the treatment of heart failure with reduced ejection fraction. However, comprehensive long-term safety data on vericiguat in large populations are lacking.
Objective: This study analyzed the adverse events reported to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to assess the safety profile of vericiguat.
Materials and methods: We selected four algorithms to evaluate the signals of adverse events related to vericiguat: Multi-item Gamma Poisson Shrinker, Bayesian Confidence Propagation Neural Network, Proportional Reporting Ratio, and Reporting Odds Ratio.
Results: We conducted a retrospective analysis of the FAERS database from January 19, 2021, to December 31, 2024, encompassing 6, 981, 085 reports. Among these, 1,863 adverse events from 886 reports were identified with vericiguat as the primary suspect. After applying all four algorithms at the preferred term level, 64 preferred terms were recognized, encompassing 853 signals. The most common adverse events, such as hypotension, dizziness, dyspepsia, and anemia, were consistent with findings of clinical trials. Additionally, we identified new adverse events, including gastrointestinal hemorrhage and renal impairment.
Conclusion: Our analysis provides a comprehensive safety assessment of vericiguat. Most of these results align with findings from previous studies. In addition, our data revealed several new adverse events. This study provides valuable insights that can inform future research and clinical practice.Correspondence to:
Yuan Hu
Master of Dermatology, Resident Physician
Department of Dermatology
Suining Central Hospital
No. 127 West Desheng Road,
Chuanshan District, Suining 629000,
Sichuan Province, China
Email: [email protected]

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