| Autor: |
Weidler, Donald, Jallad, Nader S., Curry, Charles, Ferdinand, Keith, Jain, Adesh K., Schnaper, Harold W., Toth, Phillip D., Codispoti, Joseph, Stokes, Arthur, McNally, Charles |
| Zdroj: |
Journal of Clinical Pharmacology; Jan1995, Vol. 35 Issue 1, p45-51, 7p |
| Abstrakt: |
A low dose (1.25 mg) of indapamide (Lozol®, Rhône-Poulenc Rorer Pharmaceuticals, Collegeville, PA) was evaluated in 222 elderly patients (≥50 years) with mild to moderate essential hypertension in a multicenter, randomized, double-blind, parallel-group clinical trial. A 4-week single-blind placebo washout period was followed by an 8-week double-blind treatment period. Patients were randomized to receive indapamide 1.25 mg/day or to receive placebo. The primary efficacy variable was the mean change in sitting diastolic blood pressure from baseline to week 8. Eighty-one patients in the indapamide group (73%) and 87 patients in the placebo group (78%) completed the 8 weeks of double-blind therapy. Therapy with 1.25 mg of indapamide produced greater reductions compared with placebo in sitting diastolic blood pressure after 8 weeks of therapy, with statistical significance (P ≤ 0.0015) seen after only 2 weeks of therapy and continuing throughout the 8 weeks. All secondary efficacy measures (sitting systolic blood pressure, standing systolic and diastolic blood pressures, and ≥ 10 mm Hg decrease or final value of ≤ 90 mm Hg in sitting diastolic blood pressure) also showed superior (P ≤ 0.0014) improvement in the indapamide group compared with placebo after 8 weeks of double-blind treatment. During the 8-week double-blind treatment period, incidence rates for all adverse events and for drug-related adverse events were similar between the two treatment groups. Among patients who received indapamide, the only drug-related adverse events that occurred with an incidence of ≥ 2% were headache (4%), dizziness (4%), asthenia (2%), pain (2%), abnormal vision (2%), and impotence (2%). Similar incidence rates for these adverse events were seen in the placebo group. Among indapamide patients, mean changes in potassium (-0.27 mEq/L), uric acid (0.76 mg/dL), and BUN (1.42 mg/dL) were noted but not clinically significant. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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