ezetimibe/rosuvastatin (NVP-1205) / NVP Healthcare - LARVOL DELTA

Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan (clinicaltrials.gov) - P3; N=180; Completed; Sponsor: Addpharma Inc.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2019 ➔ Aug 2020; Trial primary completion date: Dec 2019 ➔ Aug 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Dyslipidemia • Hypertension • Metabolic Disorders

Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia (clinicaltrials.gov) - P4; N=200; Recruiting; Sponsor: Yonsei University; Not yet recruiting ➔ Recruiting; Initiation date: Jul 2020 ➔ Jan 2021

Clinical • Combination therapy • Enrollment open • Monotherapy • Trial initiation date • Cardiovascular • Dyslipidemia

REMBRANDT: Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia (clinicaltrials.gov) - P4; N=240; Recruiting; Sponsor: Seoul National University Hospital

Clinical • New P4 trial • Diabetes • Dyslipidemia • Endocrine Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus • APOA1 • APOB

ROZEL: A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy (clinicaltrials.gov) - P3; N=296; Recruiting; Sponsor: Sanofi; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dyslipidemia • 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

ROZEL: A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy (clinicaltrials.gov) - P3; N=296; Not yet recruiting; Sponsor: Sanofi

Clinical • New P3 trial • Dyslipidemia • Metabolic Disorders

High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes (clinicaltrials.gov) - P4; N=140; Recruiting; Sponsor: Yuhan Corporation; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Oct 2020 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus • APOA1 • APOB

MIRA: Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM (clinicaltrials.gov) - P4; N=236; Completed; Sponsor: Yuhan Corporation; Recruiting ➔ Completed

Clinical • Combination therapy • Monotherapy • Trial completion • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus • APOA1 • APOB • CRP

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

Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine (clinicaltrials.gov) - P3; N=131; Active, not recruiting; Sponsor: Addpharma Inc.; Not yet recruiting ➔ Active, not recruiting; Trial completion date: May 2020 ➔ Jan 2021; Trial primary completion date: May 2020 ➔ Jan 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Dyslipidemia • Hypertension • Metabolic Disorders

A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia (clinicaltrials.gov) - P3; N=145; Completed; Sponsor: Hanmi Pharmaceutical Company Limited; Recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Hypertension • Metabolic Disorders

Low dose of ROSuvastatin in combination with EZEtimibe effectively and permanently reduce low density lipoprotein cholesterol concentration independently of timing of administration (ROSEZE): A randomized, crossover study - preliminary results. (PubMed, Cardiol J) - "Fixed-dose combination of rosuvastatin and ezetimibe significantly and permanently decreases LDL-C regardless of the timing of drug administration."

Journal • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Metabolic Disorders

Efficacy of combination therapy with ezetimibe and statins versus a double dose of statin monotherapy in participants with hypercholesterolemia: a meta-analysis of literature. (PubMed, Lipids Health Dis) - "The addition of ezetimibe to statin appears to be more effective on reducing LDL-C and TC concentrations than doubling the statin dose. Moreover, the ability to reduce cholesterol levels of combinations therapy with ezetimibe and different statins or to participants from different geographic location may vary, based on this meta-analysis, while more samples are needed to verify."

Combination therapy • Journal • Monotherapy • Retrospective data • Dyslipidemia • Metabolic Disorders

Low-density lipoprotein cholesterol reduction and target achievement after switching from statin monotherapy to statin/ezetimibe combination therapy: Real-world evidence. (PubMed, J Clin Pharm Ther) - "The present study provides real-world evidence of the LDL-C reduction benefits associated with statin/ezetimibe combinations in the clinical practice setting. The results also demonstrate that if statin monotherapy does not effectively help patients reach their target LDL-C goals, changing to a statin/ezetimibe combination prescription may show enhanced LDL-C-lowering effects and improve the likelihood of achieving LDL-C targets, in real practice."

Clinical • Combination therapy • HEOR • Journal • Monotherapy • Real-World Evidence • Dyslipidemia

Efficacy and Tolerability of a Fixed-Dose Combination of Rosuvastatin and Ezetimibe Compared with a Fixed-Dose Combination of Simvastatin and Ezetimibe in Brazilian Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized Trial. (PubMed, Curr Ther Res Clin Exp) - P3 | "Rosuvastatin and ezetimibe fixed dose combination in both 10 mg/10 mg and 20 mg/10 mg doses, respectively, provided significantly lower levels of LDL-C compared with simvastatin and ezetimibe in doses of 20 mg/10 mg and 40 mg/10 mg, respectively. The fixed-dose combinations were both effective and well tolerated in this Brazilian study population. ClinicalTrials.gov identifier: NCT01420549. (Curr Ther Res Clin Exp. 2020; 81:XXX-XXX)."

Clinical • Journal • Dyslipidemia • Metabolic Disorders

[VIRTUAL] Higher responsiveness to rosuvastatin in polygenic versus monogenic hypercholesterolaemia: a propensity score analysis (ESC 2020) - "The type of hypercholesterolemia (polygenic or monogenic) and following variables: age, gender, LDL-baseline, statin intolerance, ezetimibe use, rosuvastatin dose, diabetes and cardiovascular disease (CVD), were examined to minimize the bias of this observational study. Our findings indicate an essentially higher responsiveness to rosuvastatin in patients with a polygenic cause, as compared to those carrying monogenic mutations."

Cardiovascular • Dyslipidemia • Hypertension • APOB

The bioequivalence and effect of food on the pharmacokinetics of a fixed-dose combination tablet containing rosuvastatin and ezetimibe in healthy Japanese subjects. (PubMed, Clin Transl Sci) - "Following single oral administration of individual ROS tablets under the same conditions, the magnitude of decrease in ROS exposure was comparable to that seen with FDC, suggesting that the effect of food on ROS exposure was similar between the FDC tablet and co-administration of individual EZE and ROS tablets. The FDC EZE/ROS5 was generally well tolerated in healthy Japanese subjects under fasted and fed conditions."

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

ROSUZET-AMI: Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI (clinicaltrials.gov) - P4; N=3548; Not yet recruiting; Sponsor: Kiyuk Chang, MD,PhD

Clinical • New P4 trial • Cardiovascular • Myocardial Infarction

Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-Lowering Efficacy. (PubMed, Clin Ther) - P3 | "Ezetimibe combined with low- or intermediate-intensity statin therapy has lipid-lowering efficacy comparable to or better than that of high-intensity rosuvastatin monotherapy. The results of the present study indicate that the combination treatment with ezetimibe is advantageous in that it permits dose reduction of rosuvastatin without compromising the lipid-lowering efficacy of rosuvastatin. ClinicalTrials.gov identifier: NCT02205606."

Clinical • Journal • Dyslipidemia • Metabolic Disorders

Rosuvastatin/Ezetimibe: A Review in Hypercholesterolemia. (PubMed, Am J Cardiovasc Drugs) - "Rosuvastatin/ezetimibe did not significantly differ from rosuvastatin monotherapy with respect to incidences of treatment-related or serious adverse events in these short-term trials and displayed a similar safety profile to simvastatin/ezetimibe. While additional cardiovascular outcomes data and head-to-head comparisons with atorvastatin/ezetimibe would be of interest, rosuvastatin/ezetimibe is a potent and generally well-tolerated drug combination that extends the range of options available for the pharmacological management of primary hypercholesterolemia in adults."

Journal • Review • Cardiovascular • Dyslipidemia • Metabolic Disorders

Time-trend analysis of medicine sales and shortages during COVID-19 outbreak: Data from community pharmacies. (PubMed, Res Social Adm Pharm) - "Pharmacies can provide timely and real-world data regarding sales and shortages. The adopted measures to guarantee the continuous supply of the medicine market seem to have worked. The long-term impacts of this pandemic are unknown and should continue to be closely monitored."

Journal • Infectious Disease • Novel Coronavirus Disease

One year follow-up of patients with reduced left ventricular ejection fraction (LVEF) on lipoprotein apheresis. (PubMed, Atheroscler Suppl) - "Our findings indicate that regular long-term LP-apheresis treatment apparently increases LVEF, independently on current statin treatment. This implies a role of lowering of atherogenic lipoproteins as underlying mechanism. A prospective study should clarify the relative extent of LVEF improvement induced by LP-apheresis."

Clinical • Journal • Dyslipidemia • Metabolic Disorders

[VIRTUAL] Avoiding the Heartache: A Case of Familial Hypercholesterolemia (ENDO-I 2020) - "At time of initial evaluation, the patient had low-density lipid (LDL) level of 180 mg/dL despite therapy with rosuvastatin, ezetimibe, and niacin...We proceeded with aggressive lipid-lowering therapy with rosuvastatin 40mg daily and alirocumab 300mg monthly. He was also started on aspirin and beta-blocker given coronary artery disease...Without aggressive lipid-lowering therapy, the lifespan of FH patients can be significantly shortened. Therefore, identifying FH patients is imperative to prevent cardiovascular disease in these patients and their afflicted family members."

Clinical • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Endocrine Disorders • Gene Therapies • Genetic Disorders • Ischemic stroke • Metabolic Disorders • Myocardial Infarction • Obesity • Ophthalmology • Pediatrics • Reperfusion Injury

An overview of rosuvastatin/ezetimibe association for the treatment of hypercholesterolemia and mixed dyslipidemia. (PubMed, Expert Opin Pharmacother) - "Ezetimibe augments rosuvastatin triglyceride-lowering and anti-inflammatory effects, as well. Taking into account its excellent safety profile and lack of clinically relevant drug-drug interactions, the rosuvastatin/ezetimibe association is a valuable alternative to statin dose uptitration."

Journal • Dyslipidemia • Immunology • Metabolic Disorders

Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia (clinicaltrials.gov) - P4; N=200; Not yet recruiting; Sponsor: Yonsei University

Clinical • Combination therapy • Monotherapy • New P4 trial • Cardiovascular • Dyslipidemia