Approval Probability
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Label indication VYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). FDA label
Also known as Vytorin, MK0653A
ezetimibe simvastatin · 7 trials · 7 indications
Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of \<2mmol/l in fasting LDL-C at study end.
Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke
| Arm | Type | Description |
|---|---|---|
| Ezetimibe/simvastatin | EXPERIMENTAL | - |
| Doubling statin dose | ACTIVE_COMPARATOR | - |
| Rosuvastatin | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | Arm 1: Drug |
| 2 | ACTIVE_COMPARATOR | Arm 2: Active comparator |
| 3 | ACTIVE_COMPARATOR | Arm 3: Active comparator |
| 4 | OTHER | Arm 4: drug + comparator + Placebo |
| 5 | OTHER | Arm 5: drug + comparator + Placebo |
| EZ/Simva 10/40 mg | EXPERIMENTAL | Ezetimibe 10 mg + Simvastatin 40 mg |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ezetimibe (+) simvastatin | DRUG | ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks. |
| simvastatin 40 mg or atorvastatin 20 mg | DRUG | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. |
| Rosuvastatin | DRUG | rosuvastatin 10 mg tablets, taken once daily for six weeks. |
| atorvastatin 10 mg or simvastatin 20 mg | DRUG | All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization. |
| Comparator: atorvastatin | DRUG | atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally |
| Comparator: rosuvastatin | DRUG | rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally. |
| Comparator : rosuvastatin calcium | DRUG | rosuvastatin 10mg. The treatment duration will be 6 weeks. |
| Comparator: Placebo (unspecified) | DRUG | rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks. |
| Comparator: atorvastatin calcium | DRUG | Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. |
| Comparator: Placebo | DRUG | matching Placebo |
Inclusion Criteria: * Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimi...
Ezetimibe simvastatin is a small molecule combination therapy developed by Organon & Co. (OGN) for cardiovascular conditions including hypercholesterolemia, hyperlipidemia, aortic stenosis, and cardiovascular disorder. It is in Phase 3 development and has been studied in completed clinical trials.
Ezetimibe simvastatin is used for hypercholesterolemia, hyperlipidemia, aortic stenosis, and cardiovascular disorder. It is a combination product in Phase 3 development by Organon & Co. (OGN), studied in patients with high cholesterol and cardiovascular risk.
Ezetimibe simvastatin targets NPC1L1 as an inhibitor. NPC1L1 is involved in cholesterol absorption, and inhibiting this target is the mechanism of action for the ezetimibe component. The simvastatin component is a statin, and the combination is designed to address lipid levels.
Ezetimibe simvastatin is developed by Organon & Co., which trades under the ticker OGN. Organon is the company responsible for the clinical development of this combination therapy.
Ezetimibe simvastatin is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The development program includes completed Phase 3 trials, and no active trials are currently listed.
Ezetimibe simvastatin has been studied in completed Phase 3 trials including NCT00862251, NCT00651560, NCT00479713, and NCT00462748. These trials enrolled a total of 2,547 participants and evaluated the combination in cardiovascular disorder, diabetes mellitus, hyperlipidemia, and hypercholesterolemia.