Antihypertensive efficacy and tolerability of a new once-daily felodipine-metoprolol combination compared with each component alone. The Swedish/UK Study Group.
A double-blind, randomised, parallel-group study was performed to compare the efficacy and tolerability of a new extended-release tablet containing felodipine and metoprolol with each constituent agent as monotherapy. After a 4-week placebo period, 159 patients with mild-to-moderate essential hypertension were randomised to receive either the combination tablet of felodipine and metoprolol 10/100 mg, felodipine 10 mg or metoprolol 100 mg once daily if supine diastolic blood pressure was > or = 95 mmHg. After 12 weeks of active treatment, reductions in supine systolic/diastolic blood pressure 24 h after dosing were 20/14, 13/10 and 11/8 mmHg with felodipine-metoprolol, felodipine and metoprolol, respectively. The differences in blood pressure changes were 7/4 mmHg (p = 0.004/0.006) and 8/5 mmHg (p = 0.0002/< 0.0001) between the fixed combination and felodipine and metoprolol, respectively. Blood pressure response (defined as a diastolic blood pressure < or = 90 mmHg and/or a reduction > or = 10 mmHg) after 12 weeks of treatment was greater with the combination than with felodipine or metoprolol alone: 85% vs 72% (p = 0.06) and 54% (p = 0.001), respectively. Treatments were well tolerated and adverse events were as expected from previous studies with each agent and did not differ in frequency between groups. In conclusion, the extended-release tablet formulation of felodipine-metoprolol 10/100 mg produces a clinically relevant and significantly greater blood pressure reduction 24 h after dosing than either agent as monotherapy without decreasing tolerability.