Advice
Results tables
Results tables
Table 6 Mier et al. 2000
|
Glycopyrronium |
Placebo |
Analysis |
|
|
n a |
27 |
27 |
|
|
Primary outcome |
|||
|
Mean change in mTDS score from baseline to mean maximum (best) score |
From 7.52 at baseline to 1.85 |
From 7.44 to 6.33 |
p<0.001 |
|
Selected secondary outcomes |
|||
|
Mean mTDS score at lowest dose level to highest dose level |
1st dose level: 6.0 2nd dose level: 4.5 3rd dose level: 3.6 4th dose level: 2.6 After 4 weeks at highest dose level: 2.3 |
Data not reported |
Not reported |
|
% of patients with improvement in mTDS score of ≥4 points |
1st dose level: 12% 2nd dose level: 38% 3rd dose level: 54% 4th dose level: 81% |
Data not reported |
Not reported |
|
Safety and tolerability outcomes |
|||
|
n b |
39 |
39 |
|
|
Patients reporting any adverse effect |
25/36 (69%) |
5/30 (17%) |
Not reported |
|
Patients discontinued due to adverse effectsc |
7/39 (18%) |
1/39 (3%) |
|
|
Behavioural changesd |
9/39 (23%) |
1/39 (3%) |
|
|
Constipation |
7/39 (18%) |
0/39 (0%) |
|
|
Excessive oral dryness |
7/39 (18%) |
0/39 (0%) |
|
|
Urinary retention |
5/39 (13%) |
0/39 (0%) |
|
|
a Efficacy population: only the participants who completed the study were included in the efficacy analysis. No explanation or justification of this is provided by the authors. b Safety population for the individual adverse effects appears to include all randomised participants. For 'any adverse effect' this appears to be reported for only 36/39 patients in glycopyrronium group and 30/39 in the placebo group. The reason for this is not discussed in the paper. c Of the 7 participants who stopped treatment in the glycopyrronium bromide group due to adverse events, 4 stopped before the end of the first week. d Includes drowsiness, restlessness, hyperactivity, short attention span, frustration, irritability, mood changes, temper outbursts, explosive behaviour, excessive sensitivity, seriousness, sadness, frequent crying episodes, fearfulness. |
|||
|
Abbreviations: mTDS, modified Teacher's Drooling Score. |
|||
Table 7 Zeller et al 2012a
|
Glycopyrronium |
Placebo |
Analysis |
|
|
n a |
19 |
17 |
|
|
Primary outcome |
|||
|
Responder rate (% of patients with improvement in mTDS score of ≥3 points) |
Week 2: 52.6% (10/19) |
Week 2: 0% (0/17) |
Week 2: p=0.0007 |
|
Week 4: 57.9% (11/19) |
Week 4: 17.6% (3/17) |
Week 4: p value not reported |
|
|
Week 6: 68.4% (13/19) |
Week 6: 11.8% (2/17) |
Week 6: p value not reported |
|
|
Week 8: 73.7% (14/19) |
Week 8: 17.6% (3/17) |
Week 8: p=0.0011 |
|
|
Selected secondary outcomes |
|||
|
Mean improvement in mTDS score at 8 weeks (95% CI) |
3.94 (2.97 to 4.91) |
0.71 (−0.43 to 1.84) |
p<0.0001 |
|
Proportion of investigators who considered treatment worthwhileb |
84.2% |
41.2% |
p=0.0140 |
|
Proportion of parents/carers who considered treatment worthwhileb |
100% |
56.3% |
p=0.0017 |
|
Safety and tolerability outcomes |
|||
|
n c |
20 |
18 |
|
|
Patients discontinued due to adverse events |
1/20 (5%) |
1/18 (6%) |
Not reported |
|
Patients reporting a severe adverse event |
4/20 (69%) |
0/18 (0%) |
|
|
Patients reporting any adverse event |
20/20 (23%) |
15/18 (83%) |
|
|
Patients reporting an adverse event considered to be treatment-related |
15/20 (75%) |
7/18 (39%) |
|
|
Dry mouth |
8/20 (40%) |
2/18 (11%) |
|
|
Constipation |
6/20 (30%) |
4/18 (22%) |
|
|
Vomiting |
6/20 (30%) |
2/18 (11%) |
|
|
Nasal congestion |
6/20 (30%) |
1/18 (5%) |
|
|
Flushing |
5/20 (25%) |
3/18 (17%) |
|
|
AE: urinary retention |
3/20 (15%) |
0/18 (0%) |
|
|
a Efficacy population: modified ITT set, defined as all randomised participants who were within the age range of the amended protocol and received at least one dose of study medication. b Assessment performed at week 8 or at the last visit. c Safety population: all randomised participants who received at least one dose of study medication. |
|||
|
Abbreviations: 95% CI, 95% confidence interval; AE, adverse effect; ITT, intention to treat; mTDS, modified Teacher's Drooling Score. |
|||