Lacidipine and Blood Pressure Variability in Diabetic Hypertensive Patients
Key result
Lacidipine significantly reduced 24-hour blood pressure and blood pressure variability (up to -24.0%), and increased baroreflex sensitivity (8.7 vs 7.7 ms/mm Hg, P<0.01) compared to placebo.
Why the study?
Does lacidipine reduce blood pressure variability and improve baroreflex sensitivity in mildly to moderately hypertensive patients with type II diabetes mellitus?
Population
n=10 mildly to moderately hypertensive patients with type II diabetes mellitus, aged 18 to 65 years
Comparison
Lacidipine 4 mg once daily for 4 weeks vs Placebo for 4 weeks
Design
RCT, double-blind
Follow-up
4 weeks per treatment period
Authors
Discussion
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Implication
Lacidipine effects on BP variability and baroreflex in diabetic hypertension need confirmation; leaves open larger RCTs before practice change.
Key Points
- To evaluate the effects of the long-acting calcium antagonist lacidipine on 24-hour mean blood pressure, blood pressure variability, and baroreflex sensitivity in patients with hypertension and type II diabetes.
- Conducted a double-blind crossover trial in 10 mildly to moderately hypertensive patients with type II diabetes mellitus aged 18 to 65 years.
- Administered once-daily lacidipine (4 mg) or placebo for 4 weeks each following a 3-week placebo run-in phase.
- Assessed continuous 24-hour beat-to-beat noninvasive ambulatory blood pressure using a Portapres device, quantifying blood pressure variability and baroreflex sensitivity in time and frequency domains.
- Lacidipine significantly lowered 24-hour, daytime, and nighttime systolic and diastolic blood pressure compared with placebo (P<0.05) with no significant alteration in heart rate.
- Lacidipine reduced blood pressure standard deviation across 24 hours (-19.6%), daytime (-14.4%), and nighttime (-24.0%) (all P<0.05), alongside reductions in variation coefficients.
- Baroreflex sensitivity improved significantly with lacidipine versus placebo, increasing the 24-hour average sequence slope from 7.7±1.7 to 8.7±1.8 ms/mm Hg (P<0.01) and the 0.1 Hz alpha coefficient from 5.7±1.5 to 6.4±1.3 ms/mm Hg (P<0.01).
Study Design
Type
RCT (n=10)
Blinding
Double-blind
Randomization
Crossover
Structured PICO
Does lacidipine reduce blood pressure variability and improve baroreflex sensitivity in mildly to moderately hypertensive patients with type II diabetes mellitus?
P
Population
10 mildly to moderately hypertensive patients with type II diabetes mellitus, aged 18 to 65 years, evaluated in a 4-week crossover study.
I
Intervention
Lacidipine 4 mg once daily for 4 weeks
C
Comparator
Placebo for 4 weeks (double-blind crossover design)
O
Outcome
24-hour average blood pressure, blood pressure variability, and baroreflex sensitivitysurrogate
Main Result
p-value: p=<0.05
In diabetic hypertensive patients, lacidipine effectively reduces 24-hour blood pressure means and variability while improving baroreflex sensitivity.
Cite This Study
Frattola et al. (2000) conducted an RCT in Mildly to moderately hypertensive patients with type II diabetes mellitus (n=10). Lacidipine vs. Placebo was evaluated on 24-hour average blood pressure, blood pressure variability, and baroreflex sensitivity (p=<0.05). Lacidipine significantly reduced 24-hour blood pressure and blood pressure variability (up to -24.0%), and increased baroreflex sensitivity (8.7 vs 7.7 ms/mm Hg, P<0.01) compared to placebo.