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Mutagenic assessment of olmesartan cilexetil by bacterial mutation assay

Ji Won Kim1, Ilyoung Ahn2, Sung Ha Ryu3

  • 1Department of Pharmacology, CKD Research Institute, Yongin, Korea.

Toxicological Research
|January 4, 2014
PubMed

Insights

Olmesartan cilexetil, an antihypertensive drug, was evaluated for mutagenicity. The drug demonstrated no mutagenic potential in bacterial reverse mutation tests using Salmonella typhimurium and Escherichia coli.

Area of Science:

  • Pharmacology
  • Toxicology
  • Genetics

Background:

  • Hypertension is a prevalent health issue linked to cardiovascular and renal complications.
  • Olmesartan cilexetil is an angiotensin II receptor antagonist used for hypertension treatment.

Purpose of the Study:

  • To assess the mutagenicity of olmesartan cilexetil.
  • Evaluate potential DNA damage induced by the drug.

Main Methods:

  • Bacterial reverse mutation assay (Ames test).
  • Utilized Salmonella typhimurium strains (TA100, TA1535, TA98, TA1537) and Escherichia coli (WP2 uvrA).
  • Tested olmesartan cilexetil at concentrations ranging from 0 to 5000 μg/plate, with and without metabolic activation (S9 mix).

Main Results:

  • Olmesartan cilexetil tested negative for mutagenicity in all bacterial strains.
  • No reverse mutations were observed in Salmonella typhimurium or Escherichia coli.
  • Results were consistent with and without the presence of a metabolic activation system.

Conclusions:

  • Olmesartan cilexetil does not induce bacterial reverse mutations.
  • The drug is non-mutagenic in the bacterial reverse mutation test.
  • Supports the safety profile of olmesartan cilexetil regarding genotoxicity.
Keywords:
Angiotension II receptor antagonistHypertensionMutagenicityOlmesartan cilexetil

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