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Roszet adverse experiences are expected to be similar to those with co-administered rosuvastatin and ezetimibe taken separately.
Rosuvastatin
In double-blind, controlled (placebo- or active-controlled) clinical trials of rosuvastatin, 5394 patients with primary hyperlipidemia were treated for a duration of up to 12 weeks. Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo were:
Adverse Reaction | Placebo N=382 | Total Rosuvastatin 5 mg-40 mg N=744 |
Headache | 5.0% | 5.5% |
Nausea | 3.1% | 3.4% |
Myalgia | 1.3% | 2.8% |
Asthenia | 2.6% | 2.7% |
Constipation | 2.4% | 2.4% |
Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema), and pancreatitis.
Ezetimibe Combination with Statins
In 28 double-blind, controlled (placebo- or active-controlled) clinical trials, 11,308 patients with primary hyperlipidemia (48% women, 85% Caucasians, 7% Blacks, 4% Hispanics, 3% Asians) and elevated LDL-C were treated with ezetimibe concurrently with or added to ongoing statin therapy for a median treatment duration of 8 weeks. Clinical adverse reactions reported in ≥2% of patients treated with ezetimibe + statin and at an incidence greater than statin were:
Adverse Reaction | All Statins (%), n=9361 | Ezetimibe + statins (%) N=11,308 |
Nasopharyngitis | 3.3% | 3.7% |
Myalgia | 2.7% | 3.2% |
Upper respiratory tract infection | 2.8% | 2.9% |
Arthralgia | 2.4% | 2.6% |
Diarrhea | 2.2% | 2.5% |
Back pain | 2.3% | 2.4% |
Influenza | 2.1% | 2.2% |
Pain in extremity | 1.9% | 2.1% |
Fatigue | 1.6% | 2.0% |
The incidence of consecutive increased transaminases (≥3x ULN) was higher in patients receiving ezetimibe administered with statins (1.3%) than in patients treated with statins alone (0.4%). These elevations in transaminases were generally asymptomatic, not associated with cholestasis, and returned to baseline after discontinuation of therapy or with continued treatment.
Important Safety Information