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Table 2 Evaluation of pitting edema score (ITT analysis, N = 172)

From: Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial

Variable

Test group

Reference group

p*

N

Pitting edema score (mean ± sd)

N

Pitting edema score (mean ± sd)

 

Baseline (day 0), V1

86

00.00 ± 00.00

86

0.05 ± 00.34

na

After 30 days of therapy, V2

86

01.09 ± 02.47

86

00.97 ± 01.88

ns

After 60 days of therapy, V3

86

00.44 ± 01.36

86

00.88 ± 01.88

ns

After 90 days of therapy, V4

86

00.38 ± 01.21

86

00.73 ± 01.66

ns

After 120 days of therapy, V5

86

0.33 ± 01.00

86

00.83 ± 01.52

0.0380

p**

 

na

 

<0.0001

 
  1. ITT intention to treat, N number of patients, V1-V5 Visits 1–5, na not applicable, ns not significant
  2. Mann-Whitney test was applied; *p value, when compared between the groups; **p value, when V5 value compared with baseline value in same group; p <0.05 = statistically significant