Blood pressure response in 24 hours in patients with high blood pressure treated with two nifedipine formulations once a day.
A double-blind, comparative and prospective study with nifedipine once a day was undertaken, in patients with mild and moderate high blood pressure. Blood pressure was measured by mercury sphygmomanometer in two positions: resting and sitting at 3, 6 and 12 weeks of treatment and by ambulatory blood pressure monitoring (ABPM) over 24 h; both were carried out before and after the treatment and the uniformity in the pressure levels were obtained by means of the Smoothness Index. Fifty-four patients were included in the trial, 28 in the microgranules group and 26 in the osmotic pump group. These groups were similar at the baseline in age, gender, weight, height, diastolic and systolic blood pressure. The nifedipine microgranules group had a heart rate higher than the nifedipine osmotic pump group at baseline (X(M) = 75.58 vs. X(B) = 70.75). Blood pressure decreased significantly during the first 3 weeks; 85% in the microgranules group and 75% in the osmotic pump group reached a blood pressure < or =140/90 mm Hg at the end of the study. Three patients in the microgranules group and two in the osmotic pump group required an additional antihypertensive drug. In both groups, the average blood pressure over 24 h was lowered without differences between groups. A decrease was induced in the heart rate in both groups which reached a marginal statistical significance in the microgranules nifedipine group. No changes were induced in the laboratory tests; two patients in the microgranules (8%) nifedipine group and five in the nifedipine osmotic pump group, adverse effects were observed, of which only one in each group required stopping the treatment.
Rodríguez-Roa
E
E
Hospital José Ignacio Baldó, Caracas, Venezuela.
Octavio
A
A
Mayorca
E
E
Castro
P
P
Miranda
R
R
Valecillo
E
E
González
M
M
D000328:Adult; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects*; D001795:Blood Pressure Determination / Q000379:methods; D004311:Double-Blind Method; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D009543:Nifedipine