KUMJ | VOL. 18 | NO. 1 | ISSUE 69 | JAN.-MARCH, 2020
An Open Label Prospective Study on Evaluation of Safety and Efficacy of Cilnidipine Over Amlodipine in Stage 1 Hypertensive Patients
Harlalka S, Roy UK, Majumdar G, Das K, Mandal P
Abstract: Background
Calcium channel blockers are considered the first line drug over renin-angiotensin-
aldosterone system inhibitor in black population and with renin-angiotensinaldosterone
system
inhibitor
in
non-black
population
with
Hypertension.
Amlodipine
has
longer
biological
half
life
and
lower
potential
to
stimulate
SNS.
But,
is
associated
with
reflex
tachycardia
and
pedal
oedema.
Cilnidipine
has
potent
inhibitory
both
on
voltage
gated
L-type
and
N-type
calcium
channels
with
better
anti-proteinuric
effect
and good tolerability. Hence, our study compared the efficacy, safety and compliance
of cilnidipine over amlodipine in Stage 1 hypertensive subjects.
Objective
To find out antihypertensive and renoprotective effect of cilnidipine.
Method
The study was open-label, single centre, prospective, parallel design, randomized
controlled was done in Outdoor Patient Department (OPD) of Medicine and
Department of Pharmacology in Burdwan Medical College and Hospital (BMCH).
Patients with stage 1 HTN received cilnidipine while the other group received
amlodipine. There were 4 follow-up visits for each participant consisting of baseline,
1 week, 6 weeks and after 12 weeks. Clinical parameters including pulse rate, blood
pressure and ankle oedema noted also laboratory investigations were done. Safety
parameters with adverse events and compliance by traditional pill count method.
Result
Blood pressure was effectively decreased by both amlodipine and cilnidipine.
Cilnidipine significantly decreased Pulse Rate while amlodipine increased it and the
difference in Pulse Rate comparing both the groups was statistically significant. None
of the ADRs were statistically significant except pedal oedema. Pedal oedema was
noted only in amlodipine arm and was statistically significant. Compliance to both
the drugs was excellent. Total cost of therapy was higher with cilnidipine.
Conclusion
Though amlodipine is preferred drug, cilnidipine should be a better alternative when
we consider subjects with sympathetic over activity, proteinuria or pedal oedema.
Keyword : Amlodipine, Cilnidipine, Efficacy, Hypertension
