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This Site Is Intended For US Healthcare Professionals Only

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What Roszet can give you

LDL-C reductions for Roszet are calculated as 64%, 66% and 72% for the 10 mg/10 mg, 20 mg/10 mg and 40 mg/10 mg doses respectively based on the LDL-C reductions of rosuvastatin and ezetimibe.
LDL-C reductions for placebo arms were 7% vs. rosuvastatin and 4% vs. ezetimibe in the respective studies.
- Rosuvastatin 5mg showed a LDL-C reduction of 45%.
- Ezetimibe LDL-C reductions were generally consistent across all statins in baseline therapy.

In a multicenter, double-blind, placebo-controlled, dose-ranging study1, in patients with hyperlipidemia, rosuvastatin given as a single daily dose for 6 weeks significantly reduced Total-C, LDL-C, non HDL-C, and ApoB, across the dose range.

In an 8-week, double-blind study2 in patients with primary hypercholesterolemia, known coronary heart disease, or multiple cardiovascular risk factors, adding ezetimibe to ongoing statin therapy provided an additional 25% mean LDL-C reduction from treated baseline (post statin treatment) vs. 4% when adding placebo across the statins studied (p<0.001). LDL-C reductions attributable to ezetimibe were generally consistent across all statins studied.


*Roszet LDL-C reductions calculated from baseline. 64% reduction indicates final LDL-C is at 36% of the original baseline level i.e. (1-52%)*(1-25%) = 36%

  1. Roszet (rosuvastatin and ezetimibe) Prescribing Information; Morristown, NJ; Althera Pharmaceuticals
  2. Gagne C, Bays HE, Weiss SR, et al. Efficacy and Safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am J Cardiol. 2002;90:1084-1091.

In the Gravity Study, comparator arms were simvastatin + ezetimibe 40mg/10 mg and 80mg/10mg which reduced LDL-C by 55% and 57% respectively.

* Patients were treated on statin monotherapy for first 6 weeks before 6 weeks of combination therapy

In the GRAVITY study3, 833 patients aged ≥ 18 years with hypercholesterolemia and history of CV risk were randomized to rosuvastatin 10 or 20 mg with ezetimibe 10 mg vs. simvastatin 40 or 80 mg with ezetimibe 10 mg for 12-weeks with patients being on mono-therapy statin for the first 6-weeks. Primary end-point was % LDL-C change which was 64% for rosuvastatin/ezetimibe 20 mg/10 mg dose (p<0.001 vs sim/eze 40/10 mg and sim/eze 80/10 mg) and 60% for the 10 mg/10 mg dose (p = 0.002 vs sim/eze 40/10 mg). Percent LDL-C change for simvastatin/ ezetimibe 80/10 mg was 57% and was 55% for the 40/10 mg dose. Secondary variables included % patients achieving LDL-C < 100 mg/dL or < 70 mg/dL.

In the Explorer Study, comparator arm was rosuvastatin 40mg which reduced LDL-C by 57%.

In the Explorer study4, 469 patients aged ≥ 18 years with hypercholesterolemia and a history of CV risk were randomized on rosuvastatin + ezetimibe 40 mg/10 mg vs. rosuvastatin 40 mg for a total of 6-weeks. Primary end-point was the percentage of patients achieving the LDL cholesterol goal <100 mg/dL at week 6. Significantly more patients (94%, p <0.001) achieved the primary endpoint with rosuvastatin/ ezetimibe 40 mg/10 mg than with rosuvastatin alone (79%). More patients achieved the optional goal of <70 mg/dL with rosuvastatin/ezetimibe 40 mg/10 mg (80%, p<0.001) than with rosuvastatin 40 mg (35%). On the secondary variable of % LDL-C change, patients on rosuvastatin/ezetimibe 40 mg/10 mg achieved significantly greater reductions (70%, p<0.001) than with rosuvastatin 40 mg (57%).

  1. Ballantyne CM, et al. Efficacy, safety and effect on biomarkers related to cholesterol and lipoprotein metabolism of rosuvastatin 10 or 20 mg plus ezetimibe 10 mg vs. simvastatin 40 or 80 mg plus ezetimibe 10 mg in high-risk patients: Results of the GRAVITY randomized study. Atherosclerosis 2014;232:86-93.
  2. Ballantyne CM, et al. Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol 2007; 99: 673-80.

In the GRAVITY study3, 833 patients aged ≥ 18 years with hypercholesterolemia and history of CV risk were randomized to rosuvastatin 10 or 20 mg with ezetimibe 10 mg vs. simvastatin 40 or 80 mg and ezetimibe 10 mg or 12-weeks with patients being on mono-therapy statin for the first 6-weeks. Primary end-point was % LDL-C change. Secondary endpoints included % patients achieving LDL-C < 100 mg/dL and achieving LDL-C < 70 mg/dL. Percent of patients achieving a goal < 100 mg/dL was 93% on rosuvastatin/ezetimibe 10 mg/10 mg dose (p=0.03 vs sim/eze 40/10 mg (87%)) and was 96% on the 20 mg/10 mg dose (p = 0.001 vs sim/eze 40/10 mg and p = 0.007 vs sim/eze 80/10 mg (89%)). Percent of patients achieving a goal < 70 mg/dL was 67% on rosuvastatin/ezetimibe 10 mg/10 mg dose and was 77% on the 20 mg/10 mg dose (p < 0.001 vs sim/eze 40/10 mg (55%) and p < 0.001 vs sim/eze 80/10 mg (68%)).

In the Explorer study4, 469 patients aged ≥ 18 years with hypercholesterolemia and a history of CV risk were randomized on rosuvastatin + ezetimibe 40 mg/10 mg vs. rosuvastatin 40mg for a total of 6-weeks. Primary end-point was the percentage of patients achieving the LDL cholesterol goal <100 mg/dL at week 6. Significantly more patients (94%, p <0.001) achieved the primary endpoint with rosuvastatin/ ezetimibe 40 mg/10 mg than with rosuvastatin alone (79%). More patients achieved the optional goal of <70 mg/dL with rosuvastatin/ezetimibe 40 mg/10 mg (80%, p<0.001) than with rosuvastatin 40 mg (35%). Secondary variable was % LDL-C change.

  1. Ballantyne CM, et al. Efficacy, safety and effect on biomarkers related to cholesterol and lipoprotein metabolism of rosuvastatin 10 or 20 mg plus ezetimibe 10 mg vs. simvastatin 40 or 80 mg plus ezetimibe 10 mg in high-risk patients: Results of the GRAVITY randomized study. Atherosclerosis 2014;232:86-93.
  2. Ballantyne CM, et al. Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol 2007; 99: 673-80.

In ACTE clinical trial5, addition of ezetimibe 10 mg to rosuvastatin 5 mg and 10 mg was compared to doubling the rosuvastatin dose (to 10 mg and 20 mg respectively) in 440 patients at moderately high/high risk of CHD over 6 weeks. The primary efficacy end point was the percentage of change from baseline in LDL-C evaluated in the overall population (pooled across doses). Pooled across doses, rosuvastatin (5 mg or 10 mg) plus ezetimibe (10 mg) demonstrated incremental LDL-C reduction of 21% compared to rosuvastatin up-titration (to 10 mg or 20 mg) of 5.7% (p < 0.001). For Stratum II that included patients who received rosuvastatin + ezetimibe 10 mg + 10 mg dose, the incremental LDL-C reduction was 23.7% compared to 6.3% for dose up-titration to rosuvastatin 20 mg (p < 0.001)

  1. Bays HE, et al. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol 2011;108:523-30.

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Important Safety Information

Indications and Usage
ROSZET is indicated in adults:
  • As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
  • Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Important Safety Information
Contraindications: ROSZET is contraindicated in patients with active liver disease or decompensated cirrhosis, and hypersensitivity to any component of this product.
Myopathy and Rhabdomyolysis: ROSZET may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase [CK] above ten times the upper limit of normal) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin.
Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs including other lipid-lowering therapies, and higher ROSZET dosage; Asian patients on ROSZET may be at higher risk for myopathy. The myopathy risk is greater in patients taking ROSZET 40 mg/10 mg daily compared with lower ROSZET dosages.
The concomitant use of ROSZET with cyclosporine or gemfibrozil is not recommended. ROSZET dosage modifications are recommended for patients taking certain anti-viral medications, darolutamide, and regorafenib. Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis.
Discontinue ROSZET if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Muscle symptoms and CK increases may resolve if ROSZET is discontinued. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Immune-Mediated Necrotizing Myopathy: There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Treatment with immunosuppressive agents may be required. Consider risk of IMNM carefully prior to initiation of a different statin. If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM.
Hepatic Dysfunction: Increases in serum transaminases have occurred with rosuvastatin. Consider liver enzyme testing before ROSZET initiation and thereafter, when clinically indicated. There have been rare post marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue ROSZET.
Proteinuria and Hematuria: Dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin treated patients. These findings were more frequent in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, consider a dose reduction for patients on ROSZET therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
HbA1c and Fasting Serum Glucose: Increases in HbA1c and fasting serum glucose levels have been reported with statins, including rosuvastatin. Based on clinical trial data with rosuvastatin, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus.
Adverse Reactions: Most frequent adverse reactions (incidence >2% and greater than placebo) for rosuvastatin in clinical trials are: headache, nausea, myalgia, asthenia, dizziness, asthenia, constipation, and abdominal pain. Other adverse reactions reported in clinical studies were hypersensitivity (including rash, pruritus, urticaria, and angioedema), and pancreatitis. For ezetimibe co-administered with a statin most frequent adverse reactions (incidence >2% and greater than statin alone) are nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue. For ezetimibe monotherapy most frequent adverse reactions (incidence >2% and greater than placebo) are upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue and influenza.
There have been rare post marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use, including ROSZET. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation.
Drug Interactions:
Gemfibrozil or Cyclosporin: Avoid concomitant use with ROSZET.
Antivirals: Avoid concomitant use or adjust dose of ROSZET.
Darolutamide: Do not exceed ROSZET 5 mg/10 mg once daily.
Regorafenib: Do not exceed ROSZET 10 mg/10 mg once daily.
Fenofibrates, Niacin, Colchicine: Consider risks and benefits of concomitant use with ROSZET.
Warfarin: Obtain INR before ROSZET initiation and monitor INR during ROSZET initiation or dosage adjustment.

Use in Specific Populations: Discontinue ROSZET when pregnancy is recognized as it may cause fetal harm. Breastfeeding is not recommended during treatment with ROSZET.
Please see full Prescribing Information for ROSZET
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Important Safety Information
Indications and Usage
ROSZET is indicated in adults:
  • As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
  • Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Important Safety Information
Contraindications: ROSZET is contraindicated in patients with active liver disease or decompensated cirrhosis, and hypersensitivity to any component of this product.
Myopathy and Rhabdomyolysis: ROSZET may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase [CK] above ten times the upper limit of normal) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin.
Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs including other lipid-lowering therapies, and higher ROSZET dosage; Asian patients on ROSZET may be at higher risk for myopathy. The myopathy risk is greater in patients taking ROSZET 40 mg/10 mg daily compared with lower ROSZET dosages.
The concomitant use of ROSZET with cyclosporine or gemfibrozil is not recommended. ROSZET dosage modifications are recommended for patients taking certain anti-viral medications, darolutamide, and regorafenib. Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis.
Discontinue ROSZET if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Muscle symptoms and CK increases may resolve if ROSZET is discontinued. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Immune-Mediated Necrotizing Myopathy: There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Treatment with immunosuppressive agents may be required. Consider risk of IMNM carefully prior to initiation of a different statin. If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM.
Hepatic Dysfunction: Increases in serum transaminases have occurred with rosuvastatin. Consider liver enzyme testing before ROSZET initiation and thereafter, when clinically indicated. There have been rare post marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue ROSZET.
Proteinuria and Hematuria: Dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin treated patients. These findings were more frequent in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, consider a dose reduction for patients on ROSZET therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
HbA1c and Fasting Serum Glucose: Increases in HbA1c and fasting serum glucose levels have been reported with statins, including rosuvastatin. Based on clinical trial data with rosuvastatin, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus.
Adverse Reactions: Most frequent adverse reactions (incidence >2% and greater than placebo) for rosuvastatin in clinical trials are: headache, nausea, myalgia, asthenia, dizziness, asthenia, constipation, and abdominal pain. Other adverse reactions reported in clinical studies were hypersensitivity (including rash, pruritus, urticaria, and angioedema), and pancreatitis. For ezetimibe co-administered with a statin most frequent adverse reactions (incidence >2% and greater than statin alone) are nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue. For ezetimibe monotherapy most frequent adverse reactions (incidence >2% and greater than placebo) are upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue and influenza.
There have been rare post marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use, including ROSZET. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation.
Drug Interactions:
Gemfibrozil or Cyclosporin: Avoid concomitant use with ROSZET.
Antivirals: Avoid concomitant use or adjust dose of ROSZET.
Darolutamide: Do not exceed ROSZET 5 mg/10 mg once daily.
Regorafenib: Do not exceed ROSZET 10 mg/10 mg once daily.
Fenofibrates, Niacin, Colchicine: Consider risks and benefits of concomitant use with ROSZET.
Warfarin: Obtain INR before ROSZET initiation and monitor INR during ROSZET initiation or dosage adjustment.

Use in Specific Populations: Discontinue ROSZET when pregnancy is recognized as it may cause fetal harm. Breastfeeding is not recommended during treatment with ROSZET.
Please see full Prescribing Information for ROSZET