ge; 5% of Victoza-treated patients or ≥5% of glimepiride-treated patients: 52-week monotherapy trial
|
Preferred Term |
(%) |
(%) |
|
Nausea |
28.4 |
8.5 |
|
Diarrhea |
17.1 |
8.9 |
|
Vomiting |
10.9 |
3.6 |
|
Constipation |
9.9 |
4.8 |
|
Upper Respiratory Tract Infection |
9.5 |
5.6 |
|
Influenza |
7.4 |
3.6 |
|
Urinary Tract Infection |
6.0 |
4.0 |
|
Dizziness |
5.8 |
5.2 |
|
Sinusitis |
5.6 |
6.0 |
|
Nasopharyngitis |
5.2 |
5.2 |
|
Back Pain |
5.0 |
4.4 |
|
Hypertension |
3.0 |
6.0 |
Table 2 Adverse events reported in ≥ 5% of Victoza-treated patients and occurring more frequently with Victoza compared to placebo: 26-week combination therapy trials
|
Add-on to Metformin Trial |
|
|
All Victoza + Metformin
N=724 |
Placebo + Metformin
N=121 |
Glimepiride + Metformin
N=242 |
|
Adverse Event Term |
(%) |
(%) |
(%) |
|
Nausea |
15.2 |
4.1 |
3.3 |
|
Diarrhea |
10.9 |
4.1 |
3.7 |
|
Headache |
9.0 |
6.6 |
9.5 |
|
Vomiting |
6.5 |
0.8 |
0.4 |
|
Add-on to Glimepiride Trial |
|
|
All Victoza + Glimepiride
N=695 |
Placebo + Glimepiride
N=114 |
Rosiglitazone + Glimepiride
N=231 |
|
Adverse Event Term |
(%) |
(%) |
(%) |
|
Nausea |
7.5 |
1.8 |
2.6 |
|
Diarrhea |
7.2 |
1.8 |
2.2 |
|
Constipation |
5.3 |
0.9 |
1.7 |
|
Dyspepsia |
5.2 |
0.9 |
2.6 |
|
Add-on to Metformin + Glimepiride |
|
|
Victoza 1.8 + Metformin + Glimepiride
N=230 |
Placebo + Metformin + Glimepiride
N=114 |
Glargine + Metformin + Glimepiride
N=232 |
|
Adverse Event Term |
(%) |
(%) |
(%) |
|
Nausea |
13.9 |
3.5 |
1.3 |
|
Diarrhea |
10.0 |
5.3 |
1.3 |
|
Headache |
9.6 |
7.9 |
5.6 |
|
Dyspepsia |
6.5 |
0.9 |
1.7 |
|
Vomiting |
6.5 |
3.5 |
0.4 |
|
Add-on to Metformin + Rosiglitazone |
|
|
|
All Victoza + Metformin + Rosiglitazone
N=355 |
Placebo + Metformin + Glimepiride
N=175 |
|
