Safety Profiles of Vitamin D Receptor Agonists
Author Information
Author(s): Gáll Zsolt, Kolcsar Melinda, Barbieri Maria Antonietta, Irrera Natasha, Convertino Irma
Primary Institution: George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Romania
Hypothesis
This study aimed to analyze the safety profiles of VDR agonists using the EudraVigilance database, focusing on adverse drug reactions (ADRs) reported between 1 January 2004 and 23 June 2024.
Conclusion
The safety profiles of VDR agonists differ significantly between compounds, with active derivatives requiring close monitoring for serious complications.
Supporting Evidence
- 5,369,581 reports were analyzed in the EudraVigilance system.
- 17,947 reports (0.33%) involving 80,050 ADRs were linked to VDR agonists.
- Serious ADRs were more prevalent with paricalcitol, alfacalcidol, and calcitriol than with cholecalciferol.
- Hypercalcemia was a hallmark ADR for all VDR agonists.
- Logistic regression highlighted dehydration, overdose, and concomitant administration of calcium salts as major predictors of hypercalcemia.
Takeaway
This study looked at how safe different vitamin D medications are by checking reports of side effects. Some types of these medications can cause more serious problems than others.
Methodology
Data for ten VDR agonists were collected from the EudraVigilance database and analyzed to identify specific safety signals and risk factors for ADRs using multiple logistic regression.
Potential Biases
The study may be affected by reporting bias, underreporting, and missing data.
Limitations
The EudraVigilance database only includes cases in which ADRs occurred, and the reliability of data may be affected by reporting bias and underreporting.
Participant Demographics
The majority of reports were from males (70.26%) and the age group of 18–64 years (32.47%).
Statistical Information
P-Value
p<0.0001
Confidence Interval
95%CI = 3332 to 9641
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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