Table 3.
Summary of responder analysis in patients with hypertension (n = 23) and hyperglycemia (n = 25) at last observation.
| Low-dose group | High-dose group | |||
|---|---|---|---|---|
| Responder, n/N (%) | 95% CI | Responder, n/N (%) | 95% CI | |
| Hypertension a | 5/12 (41.7) | 15.17, 72.33 | 7/11 (63.6) | 30.79, 89.07 |
| Hyperglycemia b | 2/13 (15.4) | 1.92, 45.45 | 6/12 (50.0) | 21.09, 78.91 |
CIs: 95% binomial exact two-sided confidence interval (Clopper-Pearson).
Two patients in the hyperglycemia responder analysis were excluded because they had no postbaseline efficacy data collected while on study drug.
Response defined as a ≥5 mmHg decrease in mean systolic or diastolic BP from baseline without the use of additional antihypertensive medication or an increase in dosage of a concurrent antihypertensive medication.
Achieving any of the ad-hoc hyperglycemia response criteria with no increase in HbA1c. Patients who achieve the response criteria but whose HbA1c increases cannot be considered overall responders. Ad-hoc response criteria: a ≥0.5% decrease in HbA1c, normalization (<140 mg/dL [<7.8 mmol/L]) or ≥50-mg/dL (2.8 mmol/L) decrease in 2-h glucose value on oGTT, or decrease in daily insulin (≥25%) or sulfonylurea dose (≥50%).
CI, confidence interval.