Table 4.
Estimated Effect of Gaboxadol on PSG and Subjective Sleep Measures in Elderly Primary Insomnia Patients: Difference (95% CI) Between Gaboxadol and Placebo in Mean Change from Baseline Score
|
Week 11 |
Week 41 |
|||
|---|---|---|---|---|
| Measure | Gaboxadol 5 mg | Gaboxadol 10 mg | Gaboxadol 5 mg | Gaboxadol 10 mg |
| PSG measures, N | 152 | 155 | 146 | 145 |
| WASO, min11 | −10.5 (−18.0,−3.1)** | −19.6 (−27.0, −12.2)*** | −3.4 (−11.1, 4.4) | −14.6 (−22.4,−6.8)*** |
| LPS, min11 | −4.4 (−9.7,0.9) | −6.6 (−11.9,−1.3)* | −3.6 (−9.7,2.6) | −0.4 (−6.5,5.8) |
| TST, min | 16.2 (8.1, 24.3)*** | 26.5 (18.4, 34.6)*** | 11.1 (1.6, 20.7)* | 17.0 (7.4, 26.5)*** |
| NAW, n | −0.2 (−1.3, 0.9) | −0.4 (−1.5, 0.7) | 0.4 (−0.7, 1.5) | −0.1 (−1.3, 1.0) |
| SWS, min | 5.3 (0.5, 10.1)*a | 10.1 (5.3, 14.8)***a | 5.2 (0.3, 10.1)* | 11.1 (6.2, 16.1)*** |
| Subjective measures, N | 138 | 139 | 127 | 135 |
| sWASO, min | −5.2 (−14.1, 3.6) | −8.6 (−17.5,0.2) | −5.4 (−14.9, 4.1) | −11.7 (−21.2, −2.3)* |
| sTSO, min | 3.0 (−5.3, 11.3) | −0.1 (−8.4, 8.2) | −1.1 (−10.7, 8.5) | 3.8 (−5.8,13.3) |
| sTST, min | −3.6 (−12.1, 5.0) | 10.1 (1.6, 18.6)* | 5.7 (−5.5, 16.9) | 15.5 (4.4, 26.6)** |
| sNAW, n | −0.2 (−0.4, 0.0) | −0.2 (−0.4, 0.0) | −0.2 (−0.5, −0.0)* | −0.2 (−0.5, −0.0)* |
| sQUAL, 0–100 VAS | 2.1 (−0.4, 4.6) | 2.8 (0.3, 5.3)* | 1.3 (−1.8, 4.3) | 2.1 (−1.0, 5.2) |
| sFRESH, 0–100 VAS | 0.5 (−2.0, 3.0) | 1.2 (−1.2, 3.7) | 0.6 (−2.4, 3.7) | 1.9 (−1.1, 5.0) |
Data shown are estimated treatment effects derived from the statistical model. The sample sizes indicate the number of patients with a measurement at the time point; all patients with any data were included in the statistical model used to provide estimated effects.
For PSG measures, data are the average of measures made over 2 nights (nights 1/2 for week 1, nights 29/30 for week 4). For subjective measures, data are the average of measurements made over 3 to 5 nights.
The primary prespecified analysis used log transformed data and was based on the geometric mean ratio between gaboxadol and placebo. The untransformed means are shown here for illustrative purposes. Statistical significance shown is for the analysis of untransformed data; this yielded identical results to the pre-specified primary analysis. The results of the pre-specified primary analysis for geometric mean ratios were as follows: WASO on nights 1/2: gaboxadol 10 mg versus placebo = 0.82 (95% CI: 0.76, 0.88), P < 0.001; gaboxadol 5 mg versus placebo = 0.89 (95% CI: 0.82, 0.95), P = 0.002. WASO on nights 29/30: gaboxadol 10 mg versus placebo = 0.86 (95% CI: 0.79, 0.93), P < 0.001; gaboxadol 5 mg versus placebo = 0.97 (95% CI: 0.90, 1.05), P = 0.447. LPS on nights 1/2: gaboxadol 10 mg versus placebo = 0.87 (95% CI: 0.76, 0.98), P = 0.028; gaboxadol 5 mg versus placebo = 0.90 (95% CI: 0.79, 1.02), P = 0.101. LPS on nights 29/30: gaboxadol 10 mg versus placebo = 0.95 (95% CI: 0.81, 1.10), P = 0.464; gaboxadol 5 mg versus placebo = 0.93 (95% CI: 0.80, 1.08) P = 0.357.
P ≤ 0.05,
P < 0.01,
P < 0.001 versus placebo. Nominal P values are provided for all measures.
Declared not significant according to the prespecified testing strategy to adjust for multiplicity.