Adverse Reaction |
25 mg (n=312) |
50 mg (n=511) |
100 mg (n=506) |
Placebo (n=607) |
---|---|---|---|---|
Headache |
16% |
21% |
28% |
7% |
Flushing |
10% |
19% |
18% |
2% |
Dyspepsia |
3% |
9% |
17% |
2% |
Abnormal vision |
1% |
2% |
11% |
1% |
Nasal congestion |
4% |
4% |
9% |
2% |
Back pain |
3% |
4% |
4% |
2% |
Myalgia |
2% |
2% |
4% |
1% |
Nausea |
2% |
3% |
3% |
1% |
Dizziness |
3% |
4% |
3% |
2% |
Rash |
1% |
2% |
3% |
1% |
Adverse Reaction |
Sildenafil tablets |
PLACEBO |
---|---|---|
|
N=734 |
N=725 |
Headache |
16% |
4% |
Flushing |
10% |
1% |
Dyspepsia |
7% |
2% |
Nasal Congestion |
4% |
2% |
Abnormal Vision |
3% |
0% |
Back pain |
2% |
2% |
Dizziness |
2% |
1% |
Rash |
2% |
1% |
Placebo-subtracted mean maximum decrease in systolic blood pressure (mm Hg) |
Sildenafil tablets 25 mg |
Supine |
7.4 (-0.9, 15.7) |
Standing |
6.0 (-0.8, 12.8) |
Placebo-subtracted mean maximum decrease in systolic blood pressure (mm Hg) |
Sildenafil tablets 50 mg (95% CI) |
Supine |
9.08 (5.48, 12.68) |
Standing |
11.62 (7.34, 15.90) |
Placebo-subtracted mean maximum decrease in systolic blood pressure (mm Hg) |
Sildenafil tablets 100 mg |
Supine |
7.9 (4.6, 11.1) |
Standing |
4.3 (-1.8, 10.3) |
Means ± SD |
At rest |
After 4 minutes of exercise |
||||||
|
N |
Baseline (B2) |
n |
Sildenafil (D1) |
n |
Baseline |
n |
Sildenafil |
PAOP (mmHg) |
8 |
8.1 ± 5.1 |
8 |
6.5 ± 4.3 |
8 |
36.0 ± 13.7 |
8 |
27.8 ± 15.3 |
Mean PAP (mmHg) |
8 |
16.7 ± 4 |
8 |
12.1 ± 3.9 |
8 |
39.4 ± 12.9 |
8 |
31.7 ± 13.2 |
Mean RAP (mmHg) |
7 |
5.7 ± 3.7 |
8 |
4.1 ± 3.7 |
- |
- |
- |
- |
Systolic SAP (mmHg) |
8 |
150.4 ± 12.4 |
8 |
140.6 ± 16.5 |
8 |
199.5 ± 37.4 |
8 |
187.8 ± 30.0 |
Diastolic SAP (mmHg) |
8 |
73.6 ± 7.8 |
8 |
65.9 ± 10 |
8 |
84.6 ± 9.7 |
8 |
79.5 ± 9.4 |
Cardiac output (L/min) |
8 |
5.6 ± 0.9 |
8 |
5.2 ± 1.1 |
8 |
11.5 ± 2.4 |
8 |
10.2 ± 3.5 |
Heart rate (bpm) |
8 |
67 ± 11.1 |
8 |
66.9 ± 12 |
8 |
101.9 ± 11.6 |
8 |
99.0 ± 20.4 |
|
|
100mg | |
Obverse | AC338 | AC339 | AC340 |
Reverse | Plain | Plain | Plain |
Bottle of 30 | NDC 76282-643-30 | NDC 76282-644-30 | NDC 76282-645-30 |
Bottle of 100 | NA | NDC 76282-644-01 | NDC 76282-645-01 |
Count |
|
|
2 | 71610-679-02 | 71610-675-02 |
3 | - | 71610-675-33 |
4 | 71610-679-04 | 71610-675-04 |
6 | 71610-679-06 | 71610-675-06 |
9 | - | 71610-675-03 |
12 | - | 71610-675-12 |
18 | - | 71610-675-52 |