ADVERSE REACTIONS
In multiple-dose US and foreign controlled studies, 667 patients received
CARDENE SR. In these studies adverse events were elicited by non-directed
and in some cases directed questioning; adverse events were
generally not serious and about 9% of patients withdrew prematurely
from the studies because of them.
Hypertension
The incidence rates of adverse events in hypertensive patients were
derived from placebo-controlled clinical trials. Following are the rates
of adverse events for CARDENE SR (n=322) and placebo (n=140),
respectively, that occurred in 0.6% of patients or more on CARDENE
SR. These represent events considered probably drug related by the
investigator. Where the frequency of adverse events for CARDENE SR
and placebo is similar, causal relationship is uncertain. The only dose-related
effect was pedal edema.
Percentage of Patients With Probably Drug Related Adverse Events in Placebo-Controlled Studies
| Adverse Event |
CARDENE SR (n=322)
|
Placebo (n=140)
|
| Headache |
6.2 |
7.1 |
| Pedal Edema |
5.9 |
1.4 |
| Vasodilatation |
4.7 |
1.4 |
| Palpitation |
2.8 |
1.4 |
| Nausea |
1.9 |
0.7 |
| Dizziness |
1.6 |
0.7 |
| Asthenia |
0.9 |
0.7 |
| Postural Hypotension |
0.9 |
0 |
| Increased UrinaryFrequency |
0.6 |
0 |
| Pain |
0.6 |
0 |
| Rash |
0.6 |
0 |
| Sweating Increased |
0.6 |
0 |
| Vomiting |
0.6 |
0 |
Incidence (%) of Discontinuations Due to Any Adverse Event in Placebo-Controlled Studies
| Adverse Event |
CARDENE SR (n=322)
|
Placebo (n=140)
|
| Headache |
2.5 |
1.4 |
| Palpitation |
2.2 |
0.7 |
| Dizziness |
1.9 |
0.7 |
| Asthenia |
1.9 |
0 |
| Pedal Edema |
1.2 |
0 |
| Nausea |
1.2 |
0 |
| Rash |
0.9 |
0.7 |
| Diarrhea |
0.9 |
0 |
| Tachycardia |
0.9 |
0 |
| Blurred Vision |
0.6 |
0 |
| Chest Pain |
0.6 |
0 |
| Face Edema |
0.6 |
0 |
| Myocardial Infarct |
0.6 |
0 |
| Vasodilatation |
0.6 |
0 |
| Vomiting |
0.6 |
0 |
Uncontrolled experience in over 300 patients with hypertension treated
for up to 27.5 months with CARDENE SR has shown no unexpected
adverse events or increase in incidence of adverse events compared to
the controlled clinical trials.
Rare Events
The following rare adverse events have been reported in clinical trials or
the literature:
infection, allergic reaction
Body as a Whole:
hypotension, atypical chest pain, peripheral vascular
disorder, ventricular extrasystoles, ventricular tachycardia, angina
pectoris
Cardiovascular:
sore throat, abnormal liver chemistries
Digestive:
arthralgia
Musculoskeletal:
hot flashes, vertigo, hyperkinesia, impotence, depression,
confusion, anxiety
Nervous:
rhinitis, sinusitis
Respiratory:
tinnitus, abnormal vision, blurred vision
Special Senses:
Angina
Data are available from only 91 patients with chronic stable angina
pectoris who received CARDENE SR 30 to 60 mg administered twice
daily in open-label clinical trials. Fifty-eight of these patients were
treated for at least 30 days. The four most frequently reported adverse
events thought by the investigators to be probably related to the use
of CARDENE SR were vasodilatation (5.5%), pedal edema (4.4%),
asthenia (4.4%), and dizziness (3.3%).
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