Nicovas Dyslipidemia PMS Study

Confidential

Statistical Report
Sponsor
Dr Harsha K. P.
MBBS MD DNB (Pharmacology)
Senior Manager Medical services
Micro Labs Ltd.
Ph: 9844884802
Email id: kp.harsha@gmail.com

No. of pts.

13

Interventions

NICOVAS (n=13)

Duration of Treatment

8 weeks

Statistical methods:
Change from baseline calculated for all parameters at 8 weeks.
The 8 weeks value is compared to baseline value for differences by paired t test.
If p <0.05 : significant

Nicovas Dyslipidemia PMS Study

Confidential

List of Tables
Table 1: LDL Cholesterol ....................................................................................................................... 3
Table 2: Triglycerides ........................................................................................................................... 4
Table 3: Total Cholesterol ..................................................................................................................... 5
Table 4: VLDL Cholesterol .................................................................................................................... 6
Table 5: HDL Cholesterol ...................................................................................................................... 7

List of Figures
Figure 1: Mean LDL cholesterol ........................................................................................................... 3
Figure 2: Change from baseline in LDL cholesterol ............................................................................ 3
Figure 3: Mean Triglycerides cholesterol ............................................................................................ 4
Figure 4: Change from baseline in Triglycerides ................................................................................ 4
Figure 5: Mean Total cholesterol ......................................................................................................... 5
Figure 6: Change from baseline in Total cholesterol .......................................................................... 5
Figure 7: Mean VLDL cholesterol ......................................................................................................... 6
Figure 8: Change from baseline in VLDL cholesterol ......................................................................... 6
Figure 9: Mean HDL cholesterol ........................................................................................................... 7
Figure 10: Change from baseline in HDL cholesterol ......................................................................... 7

Nicovas Dyslipidemia PMS Study

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Table 1: LDL Cholesterol

Mean

SD

LDL Cholesterol
113.54
Baseline
97.08
8 Weeks
Change from baseline
-16.46
Mean Change
-14.50
% Change
-23.45
95% C.I. for Change
Paired t test (12 d.f.)
5.135
t
<0.0001
p
* Negative value suggest reduction from baseline

30.724
21.831

-9.48

Figure 1: Mean LDL cholesterol

Mean LDL Cholesterol

160
140
120
100
80
60
40
20
0

Baseline

8 Weeks

Figure 2: Change from baseline in LDL cholesterol

LDL Cholesterol
Mean Ch.

% Ch.

0
-4
-8
-12
-16
-20

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Table 2: Triglycerides
Mean

SD

Triglycerides
230.77
Baseline
166.08
8 Weeks
Change from baseline
-64.69
Mean Change
-28.03
% Change
-108.04
95% C.I. for Change
Paired t test (12 d.f.)
3.251
t
0.007
p
* Negative value suggest reduction from baseline

90.294
24.445

-21.34

Figure 3: Mean Triglycerides cholesterol

Mean Triglycerides
350
300
250
200
150
100
50
0

Baseline

8 Weeks

Figure 4: Change from baseline in Triglycerides

Triglycerides
Mean Ch.

% Ch.

0
-4
-8
-12
-16
-20

Nicovas Dyslipidemia PMS Study

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Table 3: Total Cholesterol

Mean

SD

Total Cholesterol
177.92
Baseline
163.54
8 Weeks
Change from baseline
-14.38
Mean Change
-8.08
% Change
-34.39
95% C.I. for Change
Paired t test (12 d.f.)
1.567
t
<0.0001
p
* Negative value suggest reduction from baseline

40.477
28.524

5.62

Figure 5: Mean Total cholesterol

Mean Total Cholesterol

250
200
150
100
50
0

Baseline

8 Weeks

Figure 6: Change from baseline in Total cholesterol

Total Cholesterol
Mean Ch.

% Ch.

-4

-8

-12

-16

Nicovas Dyslipidemia PMS Study

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Table 4: VLDL Cholesterol

Mean

SD

VLDL Cholesterol
45.92
Baseline
37.38
8 Weeks
Change from baseline
-8.54
Mean Change
-18.59
% Change
-13.56
95% C.I. for Change
Paired t test (12 d.f.)
3.703
t
0.003
p
* Negative value suggest reduction from baseline

17.909
16.287

3.52

Figure 7: Mean VLDL cholesterol

Mean VLDL Cholesterol

70
60
50
40
30
20
10
0

Baseline

8 Weeks

Figure 8: Change from baseline in VLDL cholesterol

VLDL Cholesterol
Mean Ch.

% Ch.

0
-4
-8
-12
-16
-20

Nicovas Dyslipidemia PMS Study

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Table 5: HDL Cholesterol

Mean

SD

HDL Cholesterol
25.77
Baseline
36.00
8 Weeks
Change from baseline
10.23
Mean Change
39.70
% Change
5.69
95% C.I. for Change
Paired t test (12 d.f.)
4.914
t
<0.0001
p
* Negative value suggest reduction from baseline

10.175
11.262

14.77

Figure 9: Mean HDL cholesterol

Mean HDL Cholesterol

50
40
30
20
10
0

Baseline

8 Weeks

Figure 10: Change from baseline in HDL cholesterol

HDL Cholesterol
50
40
30
20
10
0

Mean Ch.

% Ch.