Pharmacy & Therapeutics - March 2008 - (Page 143) Favorable tolerability profile and convenient once-daily dosing Overall low incidence of side effects1 Percentage of Adverse Events by Dose, Occurring in ≥1% of Patients Taking BYSTOLIC and More Frequently Than in Patients Taking Placebo1 Placebo (n=205) % BYSTOLIC 5 mg (n=459) % BYSTOLIC 10 mg (n=461) % BYSTOLIC 20-40 mg (n=677) % Adverse Event Headache Fatigue Dizziness Diarrhea Nausea Insomnia Chest pain Bradycardia Dyspnea Rash Peripheral edema 6 1 2 2 0 0 0 0 0 0 0 9 2 2 2 1 1 0 0 0 0 1 6 2 3 2 3 1 1 0 1 1 1 7 5 4 3 2 1 1 1 1 1 1 Pooled results from three U.S. phase III, 3-month, placebo-controlled studies of BYSTOLIC monotherapy for the treatment of mild to moderate hypertension (N=2016; n=1802). Overall low discontinuation rate2 n The discontinuation rate due to adverse events was 2.8% for BYSTOLIC vs 2.2% for placebo1 Flexible, once-daily dosing1 n Dose should be individualized to the needs of the patient; the recommended starting dose for most patients is 5 mg once daily. Dose can be increased at 2-week intervals up to 40 mg 1** Can be taken with or without food, as monotherapy or in combination with other agents1 n **Patients with severe renal impairment or moderate hepatic impairment should begin with an initial dose of 2.5 mg once daily; upward titration, if needed, should be performed cautiously. BYSTOLIC has not been studied in patients undergoing dialysis. See full Prescribing Information. References: 1. BYSTOLIC [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc.; 2007. 2. Data on file, Forest Laboratories, Inc. 3. Saunders E, Smith WB, DeSalvo KB, Sullivan WA. The efficacy and tolerability of nebivolol in hypertensive African American patients. J Clin Hypertens. 2007;9:866-875. ©2008 Forest Laboratories, Inc. 44-1012123R1 01/08
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