Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan

Huh, Ki Young; Lee, Sang Won; Lee, Si Beum; Kim, Young Ho; Jang, In Jin; Lee, Seung Hwan

doi:10.1002/cpdd.926

Cited by 4 publications

(2 citation statements)

References 27 publications

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“…Another possible explanation is due to drug–drug interactions. Pharmacokinetic analysis of the three drugs showed a 16–26% increase in telmisartan concentrations in healthy volunteers [ 27 , 28 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Coadministered Ezetimibe–Rosuvastatin plus Telmisartan in South Korean Patients with Dyslipidemia and Hypertension: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase III Trial

Song

Kim

Lee

et al. 2023

JCM

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Background: The introduction of a fixed-dose combination (FDC) is expected to improve treatment compliance. Methods: There were 181 subjects who were randomized to three groups: ezetimibe–rosuvastatin 10/20 mg + telmisartan 80 mg, ezetimibe–rosuvastatin 10/20 mg, and telmisartan 80 mg. The primary outcomes were change in mean sitting systolic blood pressure (MSSBP) and percentage change in low-density-lipoprotein cholesterol (LDL-C) compared to baseline at week 8. Results: The least-square mean (SE) in MSSBP changes between the ezetimibe–rosuvastatin 10/20 mg + telmisartan 80 mg group and the ezetimibe–rosuvastatin 10/20 mg group were −25.81 (2.34) mmHg and −7.66 (2.45) mmHg. There was a significant difference between the two groups (−18.15 (2.83) mmHg, 95% CI −23.75 to −12.56, p < 0.0001). Changes in least-square mean (SE) in LDL-C between the ezetimibe–rosuvastatin 10/20 mg + telmisartan 80 mg group and the telmisartan 80 mg group were −63.82 (2.87)% and −2.48 (3.12)%. A significant difference was observed between the two groups (−61.34 (3.33)%, 95% CI −67.91 to −54.78, p < 0.0001). No serious adverse events were observed. Conclusions: Ezetimibe–rosuvastatin plus telmisartan treatment is effective and safe when compared to either ezetimibe–rosuvastatin or telmisartan.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Coadministered Ezetimibe–Rosuvastatin plus Telmisartan in South Korean Patients with Dyslipidemia and Hypertension: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase III Trial

Song

Kim

Lee

et al. 2023

JCM

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“…7 A bioequivalence (BE) study of EZE/rosuvastatin fixed-dose tablets in healthy Japanese subjects revealed that there was no clinically relevant effect of food on EZE and EZEG exposure. 11 In addition, the coadministration of EZE and telmisartan has been suggested to inhibit UGT1A3, increase the peak drug concentration (C max ) at steady state 12,13 of EZE, and decrease the C max at steady state 12 of total EZE.…”

mentioning

confidence: 99%

Bioequivalence Study of Ezetimibe Tablets After a Single Oral Dose of 10 mg in Healthy Japanese Subjects Under Fasting Conditions

Wada

Sasagane

Kagatani

et al. 2023

Clinical Pharm in Drug Dev

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This study compared the pharmacokinetic and safety profiles between a new generic and a branded reference product of 10‐mg ezetimibe (EZE) tablets in 24 healthy Japanese male volunteers under fasting conditions, obtaining sufficient evidence for the marketing approval of the new generic product. The bioequivalence study was conducted with an open‐label, 2 × 2, single‐dose, crossover design in which the test and reference products were administered to volunteers after fasting for ≥10 hours. Blood samples were collected 24 times before to 72 hours after the administration of the investigational drug. We evaluated the peak drug concentration and the area under the plasma concentration–time curve up to the last measured concentration of EZE, EZEG, and total EZE (EZE + ezetimibe glucuronide [EZEG]). The 90% confidence intervals of the geometric mean ratios for peak drug concentration and area under the plasma concentration–time curve up to the last measured concentration of the test and reference products fell within the bioequivalence limits of 0.80 to 1.25 for EZE, EZEG, and total EZE. The test and reference products were well tolerated, and no adverse events occurred during the study. The test product was bioequivalent to the reference product.

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Preparation of thioamides from alkyl bromides, nitriles, and hydrogen sulfide through a thio-Ritter-type reaction

Tang

Xiang²,

Rui

et al. 2022

Chem. Commun.

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Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan

Cited by 4 publications

References 27 publications

Efficacy and Safety of Coadministered Ezetimibe–Rosuvastatin plus Telmisartan in South Korean Patients with Dyslipidemia and Hypertension: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase III Trial

Efficacy and Safety of Coadministered Ezetimibe–Rosuvastatin plus Telmisartan in South Korean Patients with Dyslipidemia and Hypertension: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase III Trial

Bioequivalence Study of Ezetimibe Tablets After a Single Oral Dose of 10 mg in Healthy Japanese Subjects Under Fasting Conditions

Preparation of thioamides from alkyl bromides, nitriles, and hydrogen sulfide through a thio-Ritter-type reaction

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