Blood pressure reduction and tolerability of felodipine ER in older and younger hypertensive patients

OBJECTIVE: To evaluate and compare blood pressure reduction and tolerability of felodipine ER (extended-release), in younger and older patients. DESIGN: A multicenter, double-blind, placebo-controlled, parallel group study. SETTING: Nineteen study sites; approximately half of the sites were at academic medical centers and half were in private primary care practices. Patients were non-hospitalized and free-living. PATIENTS: There were 243 younger (less than or equal to 61 years) and older (greater than or equal to 64 years) patients, age range 26 to 83, with sitting diastolic blood pressure (SDBP) of 95-115 mm Hg (higher stage 1 to lower stage 3) on placebo. Patients volunteered for the study. INTERVENTIONS: After a 2 to 4 week, single-blind, placebo baseline period, patients with SDBP of 95-115 mm Hg were randomized to treatment with felodipine ER 2.5 mg qd or placebo at a ratio of 3:1, felodipine:placebo. The dose of felodipine ER was increased to 5 mg qd after 3 weeks and to 10 mg qd after 6 weeks if the SDBP was greater than 90 mm Hg. MEASUREMENTS: The main outcome measure was change in SDBP. Secondary Outcome measures were change in sitting systolic blood pressure (SSBP) and percent of responders, defined as SDBP less than 90 mm Hg or a greater than or equal to 10 mm Hg reduction. Other measurements included heart rate, weight, routine laboratory values, and self-reported adverse events. RESULTS: By Week 9, felodipine ER reduced blood pressure in the older subjects (n = 77) by 13/12 mm Hg; in the younger patients, (n = 102), the reduction was 12/8 mm Hg. All reductions were significantly different from placebo (P less than or equal to .003). The reduction in diastolic, but not systolic, blood pressure was significantly greater in the older than in the younger patients (P = .004 and P = .188, respectively). The percentage of patients reporting a clinical adverse experience was similar for felodipine ER and placebo treatment groups. The incidence of side effects was similar between old and young patients. Discontinuation occurred in 9% of the felodipine-treated patients and 19% of the placebo-treated patients. Older patients required lower doses of felodipine ER to achieve equivalent blood pressure control. CONCLUSIONS: Felodipine ER is effective in lowering blood pressure and is well tolerated in both young and old people.