Felodipine once daily in elderly hypertensives. Binational MC Study Group (United Kingdom and Netherlands)

In this monotherapy study, 102 elderly hypertensive patients aged 65-80 years with a diastolic blood pressure (DBP) greater than or equal to 100 mmHg were randomized to double-blind treatment with felodipine 5 mg as an extended release (ER) formulation or placebo once daily. In patients with a DBP greater than 95 mmHg after two weeks the dose was doubled. Total treatment time was four weeks. Blood pressure and heart rate were measured 24 hours after dose intake. At the end of the study, supine BPs were reduced in comparison with values at randomization by 14/13 mmHg in the felodipine group and by 4/8 mmHg in the placebo group (P = 0.005/P = 0.007, felodipine vs. placebo). The proportion of responders was also significantly greater on felodipine than on placebo, 75% and 42%, respectively (response was defined as a reduction in supine DBP to less than or equal to 95 mmHg and/or a reduction by greater than or equal to 10 mmHg). A dose increase was performed in 41% of the patients on felodipine and in 50% on placebo. The proportion of patients reporting adverse events was low and of the same magnitude in both groups.