A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Corvert Side Effects, and Drug Interactions - Ibutilide
Corvert Side Effects, and Drug Interactions - Ibutilide
SIDE EFFECTS
CORVERT Injection was generally well tolerated in clinical
trials. Of the 586 patients with atrial
fibrillation or
atrial flutter
who received CORVERT in phase
II/III studies, 149 (25%) reported medical
events related to the cardiovascular system, including sustained
polymorphic ventricular
tachycardia (1.7%) and nonsustained polymorphic
ventricular tachycardia
(2.7%).
Other clinically important adverse’events with an uncertain relationship
to CORVERT include the following (0.2% represents one patient):
sustained monomorphic ventricular
tachycardia (0.2%),
nonsustained monomorphic
ventricular tachycardia (4.9%), AV block
(1.5%), bundle branch
block (1.9%), ventricular
extrasystoles (5.1%), supraventricular
extrasystoles (0.9%), hypotension/ postural hypotension
(2.0%), bradycardia/sinus bradycardia
(1.2%), nodal arrhythmia (0.7%), congestive heart
failure (0.5%), tachycardia/sinus
tachycardia/supraventricular tachycardia (2.7%), idioventricular
rhythm (0.2%), syncope
(0.3%), and renal failure
(0.3%). The incidence
of these events, except for syncope, was greater in the group
treated with CORVERT than in the placebo
group.
Another adverse reaction
that may be associated with the administration of CORVERT was nausea,
which occurred with a frequency
greater than 1% more in ibutilide-treated patients than those treated
with placebo.
The medical events
reported for more than 1% of the placebo- and ibutilide- treated
patients are shown in the following Table.
|
Treatment-Emergent Medical Events With
Frequency of More Than 1% and Higher
Than That of Placebo
|
Event |
Placebo
N= 127
|
All Ibutilide
N= 586
|
|
Patients
|
Patients
|
|
n
|
%
|
n
|
%
|
| CARDIOVASCULAR
|
|
|
|
|
| Ventricular extrasystoles |
1
|
0.8
|
30
|
5.1
|
| Nonsustained monomorphic
VT |
1
|
0.8
|
29
|
4.9
|
| Nonsustained polymorphic
VT |
—
|
—
|
16
|
2.7
|
| Hypotension |
2
|
1.6
|
12
|
2.0
|
| Bundle branch block
|
—
|
—
|
11
|
1.9
|
| Sustained polymorphic
VT |
—
|
—
|
10
|
1.7
|
| AV block
|
1
|
0.8
|
9
|
1.5
|
| Hypertension |
—
|
—
|
7
|
1.2
|
| QT segment prolonged
|
—
|
—
|
7
|
1.2
|
| Bradycardia |
1
|
0.8
|
7
|
1.2
|
| Palpitation |
1
|
0.8
|
6
|
1
|
| Tachycardia |
1
|
0.8
|
16
|
2.7
|
| GASTROINTESTINAL |
|
|
|
|
| Nausea |
1
|
0.8
|
11
|
1.9
|
| CENTRAL NERVOUS SYSTEM |
|
|
|
|
| Headache |
4
|
3.1
|
21
|
3.6
|
DRUG INTERACTIONS
No specific pharmacokinetic
or other formal drug interaction
studies were conducted.
top
