P. Greminger et al., MORNING VERSUS EVENING ADMINISTRATION OF NIFEDIPINE GASTROINTESTINAL THERAPEUTIC SYSTEM IN THE MANAGEMENT OF ESSENTIAL-HYPERTENSION, The Clinical investigator, 72(11), 1994, pp. 864-869
The nifedipine gastrointestinal therapeutic system (GITS) is a recentl
y developed controlled-release formulation for once-a-day dosing. We e
valuated the influence of morning versus evening administration of the
drug in a randomized double-blind cross-over study including 15 essen
tial hypertensives. Five patients had to be excluded from blood pressu
re analysis because of noncompliance (three cases) or intolerable side
effects (two cases). To assess the exact duration of the antihyperten
sive efficacy noninvasive automatic ambulatory blood pressure monitori
ng was performed. After a placebo period patients were given 30 mg nif
edipine GITS either at 1000 or 2200 hours. Twenty-four-hour systolic a
nd diastolic blood pressure profiles documented a sustained antihypert
ensive effect of both nifedipine regimens throughout the whole period
without affecting the circadian rhythm. Statistical analysis revealed
no significant difference between morning and evening administration.
Two patients stopped their medication because of intolerable side effe
cts (fatigue and muscle cramps, respectively). Two more eases suffered
from mild reversible headache which provoked no discontinuation of th
e drug. In conclusion our results document a sustained antihypertensiv
e efficacy of 30 mg nifedipine GITS in patients with moderate essentia
l hypertension. Time of administration has no impact on day- and night
time blood pressure control.