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Center for Drug and Alcohol Programs,
Medical University of South Carolina, Charleston,
South Carolina 29425, USA.
Blood pressure and headache
frequency were evaluated in normotensive male and
female cocaine-dependent patients (N=43) participating
in a placebo-controlled, double-blind trial of Amlodipine
for the treatment of cocaine dependence. Amlodipine
produced a significant reduction in both systolic
(p=0.04) and diastolic (p=0.01) blood pressures without
producing dizziness or faintness. Placebo subjects
had about three times the frequency of headaches compared
to the Amlodipine-treated subjects (p=0.004). The
high frequency of headaches reported by cocaine-dependent
individuals was significantly reduced by Amlodipine
and may reflect improved cerebrovascular tone.
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University of Florida College
of Medicine, Gainesville, Florida 32610, USA.
The efficacy and safety of nisoldipine-extended
release (ER) and Amlodipine were compared in a 6-week
multicenter, randomized, double-blind, double-dummy,
parallel group, titration-to-effect trial in patients
with stage 1 to 2 systemic hypertension (90 to 109
mm Hg diastolic blood pressure [BP]) and chronic stable
angina pectoris. After a 3-week placebo run-in period,
patients (n = 120) were randomly assigned to active
treatment with either nisoldipine-ER (20 to 40 mg)
or Amlodipine (5 to 10 mg) once daily, titrated as
necessary after 2 weeks to achieve diastolic BP <90
mm Hg. After 6 weeks, the mean reduction in systolic/diastolic
BP from baseline was 15/13 mm Hg with nisoldipine-ER
and 13/11 mm Hg with Amlodipine (p = NS/p = NS). Both
drugs resulted in similar BP responder rates (diastolic
BP <90 mm Hg in 87% of patients who received nisoldipine-ER
and 78% of patients on Amlodipine, p = NS) and anti-ischemic
responder rates (increasing exercise time >20%
in 20% and 27%, respectively [p = NS], and increasing
exercise time >60 seconds in 32% and 29% of patients,
respectively [p = NS]. Also, after 6 weeks of active
therapy, there was a similar mean increase in total
exercise duration (23 seconds in the nisoldipine-ER
group and 21 seconds in the Amlodipine group, p =
NS). Neither drug increased heart rate and both decreased
frequency of anginal episodes. Adverse events were
infrequent, and typically were vasodilator-related
effects (including headache and peripheral edema)
that occurred with somewhat higher incidence in the
nisoldipine-ER group. Thus, nisoldipine-ER and Amlodipine
provided comparable antihypertensive and anti-ischemic
efficacy, and both were generally well tolerated.
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Hopital Cardiologique, CHRU de
Lille, 2 avenue Oscar Lambret, 59037 Lille, France.
A 90-day, multicenter, randomized,
double-blind, parallel-group study was conducted to
compare the efficacy of Amlodipine (once a day) with
nicardipine (two to three times a day), in the treatment
of isolated systolic hypertension (ISH) in the elderly.
Patients (n = 133) aged > or = 60 years, with ISH
were randomized to receive either Amlodipine 5 mg/day,
or nicardipine 60 mg/day (titrated if necessary to
10 mg/day and 100 mg/day, respectively) for 90 days.
Efficacy was assessed by measuring office blood pressure
(BP), and 24-h ambulatory blood pressure monitoring
(ABPM). The two treatments substantially and comparably
reduced office systolic blood pressure (SBP) and pulse
pressure (PP), and also produced a slight decrease
in diastolic blood pressure (DBP). Amlodipine reduced
SBP, as assessed by ABPM, to a significantly greater
extent than nicardipine. Both treatments were well-tolerated.
The sustained effect of Amlodipine, compared with
nicardipine, was reflected in its significantly greater
antihypertensive activity, particularly during the
nocturnal period, as assessed by ABPM. The study demonstrates
that once a day dose of Amlodipine is an effective
antihypertensive treatment for elderly ISH patients.
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