rosuvastatin/telmisartan / Generic mfg. - LARVOL DELTA

Dual-Targeted Therapy in Cardiometabolic Risk: A Meta-Analysis of Telmisartan-Based Combinations for Hypertension and Dyslipidemia. (PubMed, Clin Cardiol) - "Telmisartan + amlodipine demonstrates superior antihypertensive efficacy, while telmisartan + rosuvastatin more effectively lowers LDL-C. Safety profiles are comparable. Findings support the selection of a regimen based on individualized therapeutic goals."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Pharmacokinetic comparison of a fixed-dose combination of telmisartan/rosuvastatin/ezetimibe/amlodipine 80/20/10/5 mg and a loose-dose combination of ezetimibe/rosuvastatin 10/20 mg and telmisartan/amlodipine 80/5 mg in healthy male subjects. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Both the FDC and LDC treatments were well tolerated and determined to be safe. The FDC and LDC treatments with telmisartan, rosuvastatin, ezetimibe, and amlodipine showed pharmacokinetic bioequivalence, indicating that the FDC of telmisartan/rosuvastatin/ezetimibe/amlodipine 80/20/10/5 mg can be used as an alternative to the LDC treatment."

Journal • PK/PD data • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Pharmacokinetic Interactions Between the Fixed-Dose Combination of Ezetimibe/Rosuvastatin 10/20 Mg and the Fixed-Dose Combination of Telmisartan/Amlodipine 80/5 Mg in Healthy Subjects. (PubMed, Drug Des Devel Ther) - "The development of a fixed-dose combination (FDC) containing ezetimibe, rosuvastatin, telmisartan, and amlodipine aims to enhance patient adherence and persistence, but the potential interactions among the four medications have not been studied. Both combination therapy and monotherapy were well tolerated by the subjects. The coadministration of ezetimibe/rosuvastatin 10/20 mg and ezetimibe/rosuvastatin 10/20 mg was well tolerated in healthy subjects, and the PK interaction between those two FDCs was not clinically significant."

Journal • PK/PD data • Cardiovascular • Dyslipidemia • Hypertension

Development of a highly sensitive and green first-derivative synchronous fluorescence spectroscopic method for the simultaneous quantification of telmisartan and rosuvastatin: Greenness metric assessment and application to a pharmacokinetic study in rats. (PubMed, Spectrochim Acta A Mol Biomol Spectrosc) - "Moreover, the described method was assessed in terms of sensitivity and environmental sustainability against three previously documented methods. The comparison effectively underscores the supremacy of the proposed technique over the documented techniques."

Journal • PK/PD data • Preclinical • Cardiovascular • Dyslipidemia • Hypertension

Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension: A Multicenter Randomized Clinical Trial. (PubMed, Curr Ther Res Clin Exp) - P4 | "They were randomly assigned to 2 fixed-dose combination therapy groups, telmisartan 40 mg/amlodipine 5 mg/rosuvastatin 10 mg (TEL/ALD/RSV) or amlodipine 5 mg/atorvastatin 10 mg (ALD/ATV) after washout/run-in period...2024; XX:XXX-XXX). ClinicalTrials.gov identifier: NCT03860220."

Clinical • Journal • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders • Respiratory Syncytial Virus Infections

Efficacy and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe in patients with dyslipidemia and hypertension: A randomized, double-blind, multicenter, therapeutic confirmatory, phase III clinical trial. (PubMed, J Clin Hypertens (Greenwich)) - "No serious adverse events occurred, and no statistically significant differences in the incidence of overall AEs and adverse drug reactions occurred among the three groups. TRE therapy significantly decreased msSBP and LDL-C compared to RE or T therapy with comparable safety and tolerability profiles."

Clinical • Combination therapy • Journal • P3 data • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

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. (PubMed, J Clin Med) - "Ezetimibe-rosuvastatin plus telmisartan treatment is effective and safe when compared to either ezetimibe-rosuvastatin or telmisartan."

Clinical • Journal • P3 data • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

Investigation of the impact of rosuvastatin and telmisartan in doxorubicin-induced acute cardiotoxicity. (PubMed, Biomed Pharmacother) - "This is manifested by the significant improvement in the biomarker levels and the associated histological damage. This study points out the beneficial use of both rosuvastatin and telmisartan alone or in combination as a clinical option for decreasing the acute toxicity of Dox on cardiomyocytes."

Journal • Cardiovascular • Oncology • IL17A • TNNI3

RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination. (PubMed, Folia Med (Plovdiv)) - "Dyslipidemia-hypertension proves to be a major risk factor for cardiovascular diseases. In order to achieve better adherence and cost-effectiveness than free equivalent combination therapies, a fixed-dose combination therapy with telmisartan (TEL), rosuvastatin calcium (ROS) and amlodipine besylate (AML) is required in this type of patients."

Journal • Acute Myelogenous Leukemia • Cardiovascular • Cerebral Hemorrhage • Dyslipidemia • Hypertension • Metabolic Disorders

Central blood pressure lowering effect of telmisartan-rosuvastatin single-pill combination in hypertensive patients combined with dyslipidemia: A pilot study. (PubMed, J Clin Hypertens (Greenwich)) - "Telmisartan/rosuvastatin SPC therapy was more effective in lowering central BP compared with the telmisartan monotherapy. The results of this study showed benefit of additive statin therapy in hypertensive patients combined with dyslipidemia."

Clinical • Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Hypertension • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease

Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension (clinicaltrials.gov) - P4; N=80; Completed; Sponsor: Yuhan Corporation; Recruiting ➔ Completed; N=158 ➔ 80

Enrollment change • Trial completion • Dyslipidemia • Hypertension • Metabolic Disorders

Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan. (PubMed, Clin Pharmacol Drug Dev) - "The C (GMR, 1.16; 90%CI, 1.01-1.32) and AUC (GMR, 1.26; 90%CI, 1.17-1.37) of telmisartan were slightly increased. Considering the therapeutic range of the components, the interaction would have limited clinical impact."

Journal • PK/PD data • Dyslipidemia • Hypertension • Metabolic Disorders

Pharmacokinetic Interaction Between Telmisartan and Rosuvastatin/Ezetimibe After Multiple Oral Administration in Healthy Subjects. (PubMed, Adv Ther) - P1 | "The coadministration of multiple doses of telmisartan and rosuvastatin/ezetimibe led to a mild increase in systemic exposure with respect to telmisartan and rosuvastatin and a nonsignificant change in exposure to total ezetimibe and ezetimibe, which was not considered clinically significant without safety concerns. Furthermore, for the generalizability of the clinical effects, a large-scaled clinical study might be required in patients with hypertension and dyslipidemia."

Clinical • Journal • PK/PD data • Dyslipidemia • Hypertension • Metabolic Disorders

HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria (clinicaltrials.gov) - P4; N=374; Recruiting; Sponsor: Yuhan Corporation; Trial completion date: Aug 2021 ➔ Dec 2021; Trial primary completion date: Aug 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease • CCL2

To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia (clinicaltrials.gov) - P3; N=156; Recruiting; Sponsor: Hanlim Pharm. Co., Ltd.

Clinical • New P3 trial • Dyslipidemia • Hypertension • Metabolic Disorders

Efficacy and safety of co-administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia. (PubMed, J Clin Hypertens (Greenwich)) - P3 | "Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688."

Clinical • Journal • Cardiovascular • CNS Disorders • Dyslipidemia • Hypertension • Metabolic Disorders

Telmisartan and Rosuvastatin Synergistically Ameliorate Dementia and Cognitive Impairment in Older Hypertensive Patients With Apolipoprotein E Genotype. (PubMed, Front Aging Neurosci) - "Clinical Trial Registration: www.ClinicalTrials.gov, ChiCTR.org.cn, identifier ChiCTR-IOR-17013557. Registered on April 12, 2017 - Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=23121."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia • Hypertension • APOE

Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension (clinicaltrials.gov) - P4; N=158; Recruiting; Sponsor: Yuhan Corporation; Trial completion date: Dec 2020 ➔ Aug 2020; Trial primary completion date: Dec 2020 ➔ Aug 2020

Clinical • Monotherapy • Trial completion date • Trial primary completion date • Dyslipidemia • Hypertension

Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study. (PubMed, Clin Ther) - P3 | "Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316."

Clinical • Journal • P3 data

Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension (clinicaltrials.gov) - P4; N=158; Recruiting; Sponsor: Yuhan Corporation; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Monotherapy • Trial completion date • Trial primary completion date

Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial. (PubMed, Clin Ther) - P3; "Fixed-dose combinations of telmisartan, amlodipine, and rosuvastatin decreased BP and LDL-C in patients with hypertension and dyslipidemia. The safety and tolerability profiles of fixed-dose telmisartan, amlodipine, and rosuvastatin combination therapy were comparable with those of telmisartan plus amlodipine or telmisartan plus rosuvastatin. ClinicalTrials.gov identifier: NCT03088254."

Clinical • Journal

HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria (clinicaltrials.gov) - P4; N=374; Recruiting; Sponsor: Yuhan Corporation; Trial completion date: Aug 2020 ➔ Aug 2021; Trial primary completion date: Aug 2019 ➔ Aug 2020

Clinical • Trial completion date • Trial primary completion date

High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension (clinicaltrials.gov) - P4; N=100; Completed; Sponsor: Yuhan Corporation; Recruiting ➔ Completed

Trial completion

Relative Activity Factor (RAF)-based Scaling of Uptake Clearance Mediated by Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 in Human Hepatocytes. (PubMed, Mol Pharm) - "Fourteen OATP1B substrate drugs selected (atorvastatin, bosentan, cerivastatin, fexofenadine, fluvastatin, glibenclamide, irbesartan, nateglinide, pitavastatin, pravastatin, rosuvastatin, telmisartan, torasemide, and valsartan) showed temperature-dependent uptake in human hepatocytes. RAF-based net CL was mainly accounted for by OATP1B1 (72.3% - 99.7%), and fell within the 3-fold of PS observed in human hepatocytes in 11 out of 13 compounds (excluding telmisartan). This study demonstrated that the RAF approach provides a quantitative index of OATP1B1- and OATP1B3-mediated PS in human hepatocytes, which will facilitate the optimization of the pharmacokinetic properties of OATP1B substrates at nonclinical stages of drug development."

Journal

Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-Arm, Double-blind, Placebo-controlled, Phase III Study. (PubMed, Clin Ther) - P3; "Treatment with an FDC drug containing telmisartan and rosuvastatin showed similar efficacy in lowering blood pressure and LDL-C levels compared with that of each single drug. ClinicalTrials.gov identifier: NCT01914432."

Clinical • Combination therapy • Journal • P3 data