Table 2.
Efficacy and Safety End Points.
| End Point | Placebo (N = 110) | Isosorbide Mononitrate (N = 110) | Treatment Difference* | P Value |
|---|---|---|---|---|
| mean (95% CI) | ||||
| Efficacy | ||||
| Activity as assessed on accelerometry | ||||
| Daily arbitrary accelerometer units during 120-mg phase: primary end point | 9303 (8884–9723) | 8922 (8500–9345) | −381 (−780 to 17) | 0.06 |
| No. of hours of activity per day | 9.31 (9.05–9.56) | 9.01 (8.75–9.27) | −0.30 (−0.55 to −0.05) | 0.02 |
| Daily arbitrary accelerometer units for all treatment doses | 9623 (9271–9976) | 9185 (8822–9547) | −439 (−792 to −86) | 0.02 |
| Six-minute walk test | ||||
| Distance — m | 321 (307–336) | 322 (307–336) | 0.57 (−9.63 to 10.78) | 0.91 |
| Borg dyspnea score† | 3.97 (3.59–4.34) | 3.89 (3.52–4.26) | −0.07 (−0.50 to 0.36) | 0.74 |
| Quality of life | ||||
| Overall score on Kansas City Cardiomyopathy Questionnaire | 61.6 (58.9– 64.4) | 59.7 (57.0–62.5) | −1.91 (−4.55 to 0.74) | 0.16 |
| Total score on Minnesota Living with Heart Failure Questionnaire | 35.4 (31.6– 39.2) | 37.0 (33.3–40.6) | 1.62 (−1.98 to 5.23) | 0.37 |
| NT-proBNP — pg/ml | 497 (422– 572) | 550 (475–625) | 53 (−33 to 138) | 0.22 |
| Blood pressure — mm Hg | ||||
| Systolic | 129 (125–132) | 125 (122–128) | −3.7 (−7.2 to −0.3) | 0.04 |
| Diastolic | 70 (69–72) | 69 (67–71) | −1.6 (−3.5 to 0.3) | 0.10 |
| Mean arterial blood pressure — mm Hg | 90 (88–92) | 88 (86–90) | −2.3 (−4.4 to −0.2) | 0.03 |
| Safety | ||||
| no. of patients with event | ||||
| Any event of interest | 6 | 14 | ||
| Arrhythmia | 2 | 2 | ||
| Worsening heart failure | 1 | 5 | ||
| Stroke or transient ischemic attack | 0 | 1 | ||
| Presyncope or syncope | 3 | 6 | ||
| Worsening renal function | 0 | 0 | ||
| Serious adverse event | ||||
| Death | 0 | 0 | ||
| Other serious adverse event‡ | 1 | 2 | ||
*
The treatment difference is the value in the isosorbide mononitrate group minus the value in the placebo group.
†
The Borg dyspnea score ranges from 1 to 10, with higher scores indicating greater severity.
‡
One patient had fecaloma and urinary retention during the baseline period before starting any study drug and cellulitis while taking isosor-bide mononitrate, one patient had herpes zoster while taking isosorbide mononitrate, and one patient had an exacerbation of chronic obstructive pulmonary disease while taking placebo.