|
The only additional adverse events reported in CAPRICORN in >3% of the patients and more commonly on carvedilol were dyspnea, anemia, and lung edema. The following adverse events were reported with a frequency of >1% but 3% and more frequently with COREG: flu syndrome, cerebrovascular accident, peripheral vascular disorder, hypotonia, depression, gastrointestinal pain, arthritis and gout . The overall rates of discontinuations due to adverse events were similar in both groups of patients. In this database, the only cause of discontinuation >1%, and occurring more often on carvedilol was hypotension (1.5% on carvedilol, 0.2% on placebo). Hypertension: Text Continues Below
COREG has been evaluated for safety in hypertension in more than 2,193 patients in US clinical trials and in 2,976 patients in international clinical trials. Approximately 36% of the total treated population received COREG for at least 6 months. In general, COREG was well tolerated at doses up to 50 mg daily. Most adverse events reported during COREG therapy were of mild to moderate severity. In US controlled clinical trials directly comparing COREG monotherapy in doses up to 50 mg (n = 1,142) to placebo (n = 462), 4.9% of COREG patients discontinued for adverse events vs. 5.2% of placebo patients. Although there was no overall difference in discontinuation rates, discontinuations were more common in the carvedilol group for postural hypotension (1% vs. 0). The overall incidence of adverse events in US placebo-controlled trials was found to increase with increasing dose of COREG. For individual adverse events this could only be distinguished for dizziness, which increased in frequency from 2% to 5% as total daily dose increased from 6.25 mg to 50 mg. Table 3 shows adverse events in US placebo-controlled clinical trials for hypertension that occurred with an incidence of > 1% regardless of causality, and that were more frequent in drug-treated patients than placebo-treated patients.
Table 3. Adverse Events in US Placebo-Controlled Hypertension Trials Incidence 1%,
Regardless of Causality Adverse Reactions Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
