Symptoms
Daily symptoms of patients showed a trend towards a higher
number of patients with no or mild symptoms following
NVA237 treatment compared with symptoms resulting from
placebo administration on most treatment days.
NVA237 was found to be superior to the placebo in
decreasing leg discomfort on Day 21 and exertional dyspnea
on Days 1 and 21 at isotime. On Day 21, the leg discomfort
Borg score was significantly reduced in patients receiving
NVA237 compared with those receiving the placebo
(P , 0.05; Figure 4). A numerical trend in favor of NVA237
on Day 1 was also observed for leg discomfort. On Day 21,
Modified Borg Dyspnea Score improved by 20% with
NVA237 treatment versus placebo treatment (treatment difference:
−1.16; P , 0.05; Figure 5); on Day 1, the treatment
difference was −0.92 (P , 0.05).
On Day 21, the focal score for TDI was higher in
NVA237- (2.78) versus placebo-treated patients (0.49), with
a treatment difference of 2.29, which exceeded the 1-point
treatment difference considered as clinically important.22
The number of puffs of rescue medication per day was lower
in patients receiving NVA237, with 14 NVA237-treated
patients (14.1%) taking no rescue medication compared with
9 (9.4%) placebo recipients. The total number of rescue mediations
taken between Days 1 and 21 was lower in patients
receiving NVA237 (LSM 42.0) than in those receiving the
placebo (49.8), with an LSM difference of −7.8.