Journal: Drug Invention Today

Article Id: JPRS-P col-00004245
Title: Acute adverse effect profile of zoledronic acid in cancer patients
Category: Pharmaceutics
Section: Research Article
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    Aim: This study aims to determine the adverse effect profile of intravenous (IV) zoledronic acid in cancer patients with skeletal metastasis. Materials and Methods: A prospective longitudinal study was conducted at a cancer specialty hospital and research center, Bengaluru, for a period of 6 months. A total of 80 subjects receiving the first dose of zoledronic acid 4 mg 3 weekly regimens were enrolled and followed up. However, there were seven dropouts. Primary end point was to determine the difference in proportions of developing renal toxicity using relative risk (RR). Secondary end point was to compare baseline with post-treatment serum calcium values using paired t-test analysis. Suspected acute-phase reactions (APRs) were subjected to causality (WHO scale) and severity (Hartwig and Siegel scale) assessment. Results: Significant elevation in serum creatinine indicates higher risk of renal toxicity (RR = 1.625) at 95% confidence interval (CI) (1.134–2.330). Statistically significant decrease in serum calcium was determined in the patients treated with IV zoledronic acid (P = 0.00) at 95% CI indicating the therapeutic efficacy. Thirty-one patients experienced adverse drug reactions with probable causal relationship, the commonly reported APRs being flu-like symptoms (48.8%). Severity of the suspected APRs was mild to moderate. Hence, discontinuation of zoledronic acid was not needed. Conclusion: A single dose 4 mg IV infusion of zoledronic acid is effective and safe in patients with skeletal metastasis. Due to its effectiveness in increasing bone mineral density, it can be the drug of choice in preventing fractures, osteoporosis, and hematological malignancy including lymphoma and multiple myeloma other than breast cancer with skeletal metastasis.

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    Author(s) Name:

    Gayatri Jayakumar, Samuel Gideon George, K. V. Varun, Sheetal Maria Jimmy*

    Affiliation(s) Name:

    Department of Pharmacy Practice, Krupanidhi College of Pharmacy, Bengaluru, Karnataka, India

    *Corresponding author: Sheetal Maria Jimmy, Department of Pharmacy Practice, Krupanidhi College of Pharmacy, Bengaluru, Karnataka, India.

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    Author:

    Gayatri Jayakumar, Samuel Gideon George, K. V. Varun, Sheetal Maria Jimmy*

    Title:Acute adverse effect profile of zoledronic acid in cancer patients
    Journal:Drug Invention Today
    Vol(issue):12 (October)
    Year:2019
    Page No: (2365-2370)
  • Experimental Methods Keywords

    Methodology:Acute adverse effect, Acute-phase reaction, Bone mass density, Flu-like symptoms, Skeletal metastasis, Zoledronic acid
    Research Materials:Zoledronic acid

Keywords

Acute-phase reaction Bone mass density Flu-like symptoms Skeletal metastasis Zoledronic acid

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