Related Experiment Video
Updated: Oct 25, 2025
A Semi-Automated and Reproducible Biological-Based Method to Quantify Calcium Deposition In Vitro
Published on: June 2, 2022
Cinacalcet and gastrointestinal bleeding risk in patients receiving hemodialysis
Jiannong Liu1, Haifeng Guo1, Tzu-Chieh Lin2
1Chronic Disease Research Group, Hennepin Healthcare Research Institute, Minneapolis, Minnesota, USA.
Insights
Cinacalcet, a common treatment for secondary hyperparathyroidism in dialysis patients, does not appear to increase the risk of gastrointestinal bleeding. This study found no significant association between cinacalcet use and GI bleeding events requiring hospitalization or death.
Area of Science:
- Nephrology
- Clinical Pharmacology
Background:
- Secondary hyperparathyroidism (SHPT) is a frequent complication in patients undergoing hemodialysis.
- Calcimimetic agents, such as cinacalcet, are widely used to manage SHPT in this population.
Purpose of the Study:
- To investigate the potential association between cinacalcet use and the risk of gastrointestinal (GI) bleeding in a large cohort of hemodialysis patients.
- To evaluate if cinacalcet exposure correlates with GI bleeding events leading to hospitalization or death.
Main Methods:
- A nested case-control study was conducted using a linked database of clinical records and medical claims from hemodialysis patients (2007-2010).
- Patients with SHPT (parathyroid hormone >300 pg/mL) and Medicare coverage were included. Cases were defined by GI bleeding events (fatal or non-fatal hospitalization), matched with up to four controls.
- Exposure to cinacalcet was assessed based on any use, current use, past use, cumulative exposure days, and dosage, analyzed using conditional logistic models.
Main Results:
- The study included 48,437 patients, with 2,570 experiencing GI bleeding events. After matching, 2,465 cases and 9,500 controls were analyzed.
- Cinacalcet exposure was present in 17.2% of cases and 15.8% of controls; current use was 11.1% in both groups.
- Adjusted odds ratios for GI bleeding were 1.04 (any use), 0.97 (current use), and 1.22 (past use), indicating no statistically significant increased risk.
Conclusions:
- The findings suggest that cinacalcet use in hemodialysis patients with SHPT is not associated with an elevated risk of gastrointestinal bleeding.
- This study provides reassurance regarding the safety profile of cinacalcet concerning GI bleeding in this vulnerable patient population.
Purpose:
Secondary hyperparathyroidism (SHPT) is common among dialysis patients, and calcimimetics are a mainstay of treatment. This study assessed whether cinacalcet use is associated with gastrointestinal bleeding in a large hemodialysis cohort.
Methods:
A linked database of clinical records and medical claims for patients receiving hemodialysis in a large dialysis organization, 2007-2010, was used. A nested case-control study was performed among patients aged ≥18 years who had received hemodialysis for ≥90 days, had Medicare Parts A, B, and D coverage for ≥1 year, and had clinical evidence of SHPT (parathyroid hormone >300 pg/mL). Cases were those who experienced death or hospitalization caused by gastrointestinal bleeding. Each case was matched to up to four controls. Exposure was measured by any cinacalcet use, current use, past use, cumulative exposure days, and cumulative dosage. Conditional logistic models were used to assess the association.
Results:
Of 48 437 patients included, 2570 experienced gastrointestinal bleeding events (2498 non-fatal, 72 fatal), and 2465 (2397 non-fatal, 68 fatal) were matched to 9500 controls; 17.2% of cases and 15.8% of controls had cinacalcet exposure and 11.1% of both cases and controls had current use. The adjusted odds ratios (95% CI) of gastrointestinal bleeding for any use, current use, and past use of cinacalcet were 1.04 (0.91-1.19), 0.97 (0.83-1.13), and 1.22 (0.99-1.50), respectively, with no use as the reference.
Conclusion:
The results do not suggest an elevated risk of gastrointestinal bleeding resulting in hospitalization or death for hemodialysis patients exposed to cinacalcet.
Related Concept Videos
01:24Hemodialysis II: Procedure and Complications
01:28Cardiac Catheterization I: Pre-Procedure Overview
01:30Acute Kidney Injury IV: Diagnostic Studies and Prevention
01:11Renal Failure: Dose Adjustments
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
01:25Peritoneal Dialysis II: Peritoneal Dialysis Systems and Complications
01:24Chronic Kidney Disease II: Clinical Manifestations