ZETIA SUMMARY
ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols.
ZETIA is indicated for the following:
Primary Hypercholesterolemia
Monotherapy
ZETIA, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.
Combination therapy with HMG-CoA reductase inhibitors
ZETIA, administered in combination with an HMG-CoA reductase inhibitor, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and Apo B in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.
Homozygous Familial Hypercholesterolemia (HoFH)
The combination of ZETIA and atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Homozygous Sitosterolemia
ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
Therapy with lipid-altering agents should be a component of multiple risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used in addition to an appropriate diet (including restriction of saturated fat and cholesterol) and when the response to diet and other non-pharmacological measures has been inadequate.
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NEWS HIGHLIGHTSMedia Articles Related to Zetia (Ezetimibe)
Doctors gird for patient anxiety over Zetia data (Reuters)
Source: Y! Health Anxiety News [2009.11.16]
Reuters - The good news for Merck & Co's Zetia cholesterol fighter is that doctors do not seem unduly concerned about its latest setback in a clinical trial. The bad news is they think patient anxiety will cause its sales to drop anyway.
Study Raises New Questions About Cholesterol Drug Zetia (HealthDay)
Source: Y! Health Cholesterol News [2009.11.16]
HealthDay - SUNDAY, Nov. 15 (HealthDay News) -- A new study raises more
questions about ezetimibe (Zetia), a drug used by millions of Americans in
tandem with statins to lower LDL, or "bad," cholesterol.
New Study Raises New Questions About Cholesterol Drug Zetia (HealthDay)
Source: Y! Health Cholesterol News [2009.11.16]
HealthDay - SUNDAY, Nov. 15 (HealthDay News) -- A new study raises more
questions about ezetimibe (Zetia), a drug used by millions of Americans in
tandem with statins to lower LDL, or "bad," cholesterol.
New Study Raises New Questions About Cholesterol Drug Zetia
Source: MedicineNet ezetimibe Specialty [2009.11.16]
Title: New Study Raises New Questions About Cholesterol Drug Zetia
Category: Health News
Created: 11/16/2009 12:10:00 AM
Last Editorial Review: 11/16/2009
More doubts over Merck anti-cholesterol drug: study (AFP)
Source: Y! Health Cholesterol News [2009.11.16]
AFP - A new study has cast fresh doubt on the effectiveness of Zetia, a cholesterol drug produced by US pharmaceuticals giant Merck.
Published Studies Related to Zetia (Ezetimibe)
Flow-mediated dilation in patients with coronary artery disease is enhanced by high dose atorvastatin compared to combined low dose atorvastatin and ezetimibe: results of the CEZAR study. [2009.07]
CONCLUSIONS: The present findings clearly suggest that in the presence of comparable LDL-lowering effects of both treatment forms, LDL-cholesterol independent effects of high dose atorvastatin therapy account for the improvement of endothelium-dependent vasodilation in patients with stable CAD.
Lipid-altering efficacy and safety of ezetimibe/simvastatin versus atorvastatin in patients with hypercholesterolemia and the metabolic syndrome (from the VYMET study). [2009.06.15]
Patients with the metabolic syndrome are at an increased risk of cardiovascular disease and might require intensive lipid therapy... In conclusion, ezetimibe/simvastatin was more likely to result in lipid treatment end points than atorvastatin and was generally well tolerated at the doses compared in our patients.
Effect on serum lipid levels of switching dose of ezetimibe from 10 to 5 mg. [2009.06.01]
Although during its initial development, lower doses of ezetimibe reduced low-density lipoprotein (LDL) significantly, ezetimibe is available only in 10-mg form. Compliant patients receiving ezetimibe 10 mg were randomized in a blinded fashion to continue therapy with ezetimibe 10 mg or to convert to a split-tablet 5-mg dose...
Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. [2009.04]
AIMS: To evaluate the efficacy of switching from a previous statin monotherapy to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg vs. rosuvastatin (ROSUVA) 10 mg... CONCLUSION: EZE/SIMVA 10/20 mg produced greater improvements in LDL-C, total cholesterol, non-HDL-C and apoB with a similar safety profile as for ROSUVA 10 mg.
The efficacy and tolerability of ezetimibe in cardiac transplant recipients taking cyclosporin. [2009.03.15]
BACKGROUND: Despite statin treatment, hyperlipidemia remains problematic after cardiac transplantation and is associated with the development of cardiac allograft vasculopathy. The cholesterol absorption inhibitor ezetimibe may offer a viable option for add on therapy; however, questions have been raised regarding the safety of this during concomitant cyclosporin treatment... CONCLUSION: We conclude that ezetimibe is both efficacious and tolerable in cardiac transplant recipients taking cyclosporin. It can be safely considered as add on therapy in patients taking statins (or as monotherapy) to further reduce low-density lipoprotein levels, which may in turn reduce the risk of cardiac allograft vasculopathy.
Clinical Trials Related to Zetia (Ezetimibe)
Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects [Completed]
Pharmacokinetic Drug Interaction Between Ezetimibe and Sirolimus After Single Dose Administration in Healthy Subjects [Completed]
Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED) [Completed]
This is a multicenter, randomized, double blind; active-controlled parallel groups study
enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe,
simvastatin, or the combination once daily for 8 weeks to determine the effect on
LDL-cholesterol.
Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)(COMPLETED) [Completed]
The purpose of this study is to obtain data of the coadministration of ezetimibe and
rosuvastatin to support the concomitant use of these two drugs in patients requiring
additional cholesterol-lowering management. Treatment is administered for 14 days.
Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED) [Completed]
This study was designed to evaluate the pharmacokinetic interaction and safety of
coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male
subjects or adult male subjects having no obvious disease other than high cholesterol
levels.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Zetia has an overall score of 9. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Zetia review by 60 year old male patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | high cholestrol |
| Dosage & duration: | | 10mg/day taken ongoing for the period of ongoing |
| Other conditions: | | knee osteoartritis |
| Other drugs taken: | | glucosamine, multivitamins | | |
Reported Results |
| Benefits: | | My target was to have the a cholestrol reduction from 240 to under 200. I did not want want to take statins because I am not comfortable with drugs that inhibit normal metabolic processes. Evolution is parsimonius, and inhibition of any enzyme is likely to be reflected as an adverse effect in a seemingly unrelated area. Also, I did not want to take red yeast rice, which basically is a non-phrmaceutical grade of a statin. I liked the physical mode of action of Zetia. Within 6 months of starting treatment, my total cholesterol was down from to 200 and my HDL went up from 45 to 58. |
| Side effects: | | I did not experience any perceptible side effects. |
| Comments: | | See treatment benefits above. I take my daily dose of Zetia shortly after having my breakfast. |
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Page last updated: 2009-11-16
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