BLOOD-PRESSURE REDUCTION AND TOLERABILITY OF FELODIPINE ER IN OLDER AND YOUNGER HYPERTENSIVE PATIENTS

OBJECTIVE: To evaluate and compare blood pressure reduction and tolera bility of felodipine ER (extended-release), in younger and older patie nts. 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 primar y care practices. Patients were non-hospitalized and free-living. PATI ENTS: There were 243 younger (less than or equal to 61 years) and olde r (greater than or equal to 64 years) patients, age range 26 to 83, wi th sitting diastolic blood pressure (SDBP) of 95-115 mm Hg (higher sta ge 1 to lower stage 3) on placebo. Patients volunteered for the study. INTERVENTIONS: After a 2 to 4 week, single-blind, placebo baseline pe riod, 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 we eks and to 10 mg qd after 6 weeks if the SDBP was greater than 90 mm H g. MEASUREMENTS: The main outcome measure was change in SDBP. Secondar y Outcome measures were change in sitting systolic blood pressure (SSB P) 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 includ ed heart rate, weight, routine laboratory values, and self-reported ad verse events. RESULTS: By Week 9, felodipine ER reduced blood pressure in the older subjects (n = 77) by 13/12 mm Hg; in the younger patient s, (n = 102), the reduction was 12/8 mm Hg. All reductions were signif icantly different from placebo (P less than or equal to .003). The red uction in diastolic, but not systolic, blood pressure was significantl y greater in the older than in the younger patients (P = .004 and P = .188, respectively). The percentage of patients reporting a clinical a dverse experience was similar for felodipine ER and placebo treatment groups. The incidence of side effects was similar between old and youn g patients. Discontinuation occurred in 9% of the felodipine-treated p atients and 19% of the placebo-treated patients. Older patients requir ed lower doses of felodipine ER to achieve equivalent blood pressure c ontrol. CONCLUSIONS: Felodipine ER is effective in lowering blood pres sure and is well tolerated in both young and old people.