38

Journal of The Association of Physicians of India Vol. 64 April 2016

Original Article

DemographIc Assessment and EValuation of

DEgree of Lipid Control in High Risk Indian
DySlipidemia PatiEnts (DIVERSE Study)
Naresh Malhotra1, MK Keshan2, Avinash Agarwal3, R Anil Kumar4, Abhijit Trailokya5,
Kalpesh Dalvi 6, Suhas Talele7

Abstract

Editorial Viewpoint

Background: Cardiovascular diseases (CVDs) are the major cause of

morbidity and mortality in both developed and developing countries.
Many clinical trials have demonstrated that low-density lipoprotein
cholesterol (LDL-C) lowering, reduces the incidence of coronary and
cerebrovascular events across a broad spectrum of patients at risk.
Guidelines for the management of patients at risk have been established in
Europe and North America. The guidelines have advocated progressively
lower LDL-C targets and more aggressive use of statin therapy. In Indian
patients, comprehensive data on dyslipidemia management and its
treatment outcomes are inadequate. There is lack of information on
existing treatment patterns, the patients profile being treated, and
factors that determine treatment success or failure in achieving desired
goals.

High risk dyslipidemic

patients need intensive
lipid lowering therapy.

Purpose: The present study was planned to determine the lipid control
status in high-risk dyslipidemic patients treated with lipid-lowering
therapy in India.
Methods: This cross-sectional, non-interventional, single visit program
was conducted across 483 sites in India where male and female patients
with high-risk dyslipidemia aged 18 to 65 years who had visited for a
routine health check-up to their respective physician at hospital or a
healthcare center. Percentage of high-risk dyslipidemic patients achieving
adequate LDL-C level (< 70 mg/dL) on lipid-lowering therapy and the
association of lipid parameters with patient characteristics, comorbid
conditions, and lipid lowering drugs were analysed.
Results: 3089 patients were enrolled in the study; of which 64% were
males. LDL-C data was available for 95.2% of the patients; only 7.7%
of these patients achieved LDL-C levels < 70 mg/dL on lipid-lowering
therapy, which may be due to inability to follow therapeutic plans, poor
compliance, or inadequate counselling by physician. The physicians lack
of awareness about recent treatment guidelines also might contribute
to patients poor adherence, not explaining adequately the benefit and
risks of a medication, not giving consideration to the patients life style

M o s t o f t h e h i g h r i s k
dyslipidemic Indian
patients are on suboptimal
dosage of statin.
Aggressive counselling
a n d
i n t e n s i v e
management are required
for appropriate lipid
management.

Introduction

ardiovascular diseases
(CVDs) are the major cause
of morbidity and mortality in
both developed and developing
countries. Dyslipidemia has been
identified as an independent risk
f a c t o r f o r t h e d e ve l o p m e n t o f
CVD. It may occur due to elevated
production or low clearance of
lipoproteins, apolipoproteins
defects or enzyme deficiencies,
or due to environmental factors
(such as saturated fat diet or
sedentary lifestyle), diseases (such
as diabetes, hypothyroidism, liver
disease), and medications (such as
thiazide diuretics, progestins, or
anabolic steroids).1 As per European
Society of Cardiology (ESC) and the
European Atherosclerosis Society

Aditya Hospital, Ahmedabad, Gujarat; 2MK Keshan Clinic, Guwahati, Assam; 3Agarwal Poly Clinic, Jaipur, Rajasthan; 4Vismaya Diabetes Care Centre, Bangalore, Karnataka;
Chief Manager Cardiology, 6Medical Adviser, 7Manager-Clinical Research, Abbott Healthcare Private Limited, Mumbai, Maharashtra
Received: 09.11.2015; Accepted: 02.03.2016
1
5

Journal of The Association of Physicians of India Vol. 64 April 2016

and the cost of medication. Statin was the most commonly used antidyslipidemic drug across population. The higher proportion of patients
had the comorbid condition of CVD and diabetes mellitus across all
dyslipidemic patients.
Conclusion: As per the European Society of Cardiology guidelines the
ideal LDL-C levels in high risk dyslipidemic patients should be less than
70 mg/dL. In the present study, 7.7% of the patients achieved LDL-C levels
< 70 mg/dL on lipid lowering therapy which is very less. Most of high risk
dyslipidemic patients in India are on suboptimal dosage of statin. So more
aggressive and high dosage statin therapy may be required to achieve
target LDLC levels in high risk Indian dyslipidemic patients.
Guidelines (EAS), a high-risk
dyslipidemic patient is defined as
a person with known CVD, and
type 2 or type 1 diabetes mellitus
(DM) with microalbuminuria and
chronic kidney disease (CKD).
Pa t i e n t s i n h i g h - r i s k c a t e g o r y
have CVD or DM plus one or more
coronary heart disease risk factors
in addition to dyslipidemia. 2 There
exist an independent and strongly
p o s i t i ve r e l a t i o n s h i p b e t we e n
dyslipidemia and risk of CV death.3
Every individuals LDL-C treatment
goal is determined by his or her
absolute CVD risk. Elevated LDL-C
level suggests a higher risk of CVD,
hypertension, DM and obesity. 4,5
Dietary improvements (saturated
fat <7% of calories, cholesterol
<200 mg/day; soluble fiber 10-25
g/day and plant stanols/sterols 2g/
day) and lifestyle changes (weight
reduction and increased physical
activity) constitute the therapeutic
options to enhance LDL lowering. 6
In cases where these efforts fail
to achieve the target LDL-C goal,
the patients are treated by lipidlowering therapy with/without
lifestyle modification.7 Many
clinical trials have demonstrated
t h a t L D L - C l o we r i n g , r e d u c e s
th e i n c i de n c e of c oronary an d
cerebrovascular events across a
broad spectrum of patients at risk.
Statins have been recommended
as the first-line treatment and
considered as the most effective
p h a r m a c o t h e r a p y f o r e l e va t e d
LDL-C; their use has been associated
with significant improvement in
CVD outcomes. In cases where
the target goal is not achieved,

the LDL-lowering therapies are

intensified by either increasing
the dose or by combination with
other lipid lowering therapies (e.g.
Fibrates, bile acid sequestrants,
ezetimibe, nicotinic acid etc)
along with diet optimization and
aggressive physical activity. The
major reasons for patients not
able to achieve LDL-C goal may
be due to their inability to follow
their therapeutic plan, poor or low
treatment adherence/compliance,
not able to tolerate prescribed dose
of medication, or genetic causes. In
addition, physicians do not have
enough time for extensive patient
counselling or schedule a training
session to explain the role of
treatment compliance, lifestyle, and
diet in achieving the LDL-C goals.
If the LDL-C goal is not attained by
standard lipid-lowering therapy,
consideration should be given to
seeking consultation from a lipid
specialist. 6 In addition to LDL-C,
some guidelines also highlight high
density lipoprotein cholesterol
(HDL-C)/total cholesterol (TC) and
non-HDL-C as secondary goals
of the therapy as their abnormal
levels are associated with increased
chronic heart disease risk.
Reference guidelines
(American Association of Clinical
Endocrinologists; ESC/EAS) for the
management of patients at risk have
been established in Europe and
North America. These guidelines
h a ve a d v o c a t e d p r o g r e s s i ve l y
lower LDL-C targets and more
aggressive use of statin therapy.
In Indian patients, comprehensive

39

data on dyslipidemia management

and its treatment outcomes are
inadequate. There is lack of
information on existing treatment
patterns, the patients profile
being treated, and factors that
determine treatment success
or failure in achieving desired
goals. In addition, there is poor
awareness of treatment strategies
in physicians with respect to
treatment of high risk dyslipidemic
patients in India. The therapeutic
goals for patients with very high
cardiovascular risk include LDL-C
levels less than 70 mg/dL or at
least a 50% relative reduction in
LDL-C when target level cannot
be achieved. 8 However, despite
guideline recommendations, there
is a growing evidence of suboptimal
use of lipid-lowering treatment. 9
T h e f a i l u r e t o a c h i e ve L D L - C
goal is most commonly attributed
to patient non-compliance with
Table 1: Patient characteristics
Category
Gender, n (%)1
Female, age groups
18-25
26-35
36-45
46-55
56-65
Male, age groups
18-25
26-35
36-45
46-55
56-65
Life style
Non-sedentary
Sedentary
Diet
Non-vegetarian
Vegetarian
Age (years)
Height (cm)
Weight (kg)
Body mass index (kg/m2)
Waist circumference (cm)
Laboratory test
HbA1c (%)
FPG (mg/dL)
PPG (mg/dL)

No. of pts.
(N = 3089)
1116 (36.1)
2 (0.2)
26 (2.3)
202 (18.1)
380 (34.1)
506 (45.3)
1973 (63.9)
3 (0.2)
36 (1.8)
269 (13.6)
758 (38.4)
907 (45.1)
1411 (45.7)
1677 (54.3)
1455 (47.1)
1634 (52.9)
53.57.7
163.98.5
72.89.6
27.24.0
92.98.9
7.41.73
126.035.4
186.562.6

Values as: No. of patients (%), mean SD

40

Journal of The Association of Physicians of India Vol. 64 April 2016

900

768
(24.9%)
662
(21.4%)

700
600
500

36-45 46-55 46-55

Normal

18-25 26-35 26-35

36-45 36-45 46-55

Female

Male

Male

132
(4.3%)

89
(2.9%)

17
(0.6%)
Female

Male

56-65

Female

56-65

Female

Male

26-35 26-35 36-45

18
2
2
(0.1%) (0.6%) (0.1%)
Female

18-25

123
(4%)

Female

Female

34
8
3
(1.1%)
(0.1%) (0.3%)

Male

100

139
(4.5%)

76
(2.5%)

Female

200

Male

300

306
(9.9%)

239
(7.7%)

46-55 56-65

Male

250
(8.1%)

Female

400

Male

No. of subjects (percentage)

800

56-65

Above normal

Waist circumference (cm)

Fig. 1: Age and gender-wise distribution of waist circumference

250
214.5
(1063)

209.5
(1926)

211.3
(2989)
187.7
(994)

Mean (No. of subjects)

200

132.9
(1098)

150

128
(1981)

185.5
(1867)

186.3
(2861)

Male

Overall

129.7
(3079)

100

50

43.8
(984)

44.5
(1860)

44.3
(2844)
1.7
(1033)

Female

Male

Overall Female

HDL-C (mg/dl)

Male

Overall Female

LDL-C (mg/dl)

1.7
(1857)

1.7
(2890)

Male

Overall Female

TC/LDL ratio

Male

Overall Female

Total cholesterol (mg/dl)

Triglycerides (mg/dl)

Lipid prole prameters

Fig. 2: Gender-wise mean values of lipid profile parameters

drug treatment regimen and poor

physician adherence to treatment
guidelines. 10 Other reasons for
poor achievement of LDL-C goal
include insufficient dosing, failure
to adequately up titrate the dose,
not switching to a more potent drug
when essential, and lack of follow-up
after initiation of treatment. In
Indian patients, comprehensive
data on dyslipidemia management

and its treatment outcomes are

inadequate. There is lack of
information on existing treatment
patterns, the patients profile being
treated, and factors that determine
treatment success or failure in
achieving desired LDL-C goals.
H e n c e , t h e p r e s e n t s t u d y wa s
designed to determine the lipid
control in high-risk dyslipidemic

Indian patients treated with lipidlowering therapy.

Methods
This cross-sectional, noninterventional, single visit study
was conducted between January
2014 to September 2014 at 483 sites
all-over India. Patients diagnosed
for high-risk dyslipidemia aged

n (%)

1 (100.0)

507 (18.7)
453 (19.4)
2 (11.1)
1 (50.0)
50 (14.9)
1 (33.3)
1 (33.3)

9 (29.0)
7 (28.0)
2 (33.3)
27 (8.1)
27 (8.3)
1 (20.0)
1 (20.0)

1 (100.0)

1 (100.0)

1 (50.0)
-

1 (50.0)
-

1861 (68.5) 972 (35.8) 1171 (43.1) 232 (8.5)

1626 (69.5) 840 (35.9) 1023 (43.8) 183 (7.8)
16 (88.9)
9 (50.0)
1 (5.6)
3 (16.7)
18 (100.0)
9 (50.0)
3 (16.7)
1 (50.0)
1 (50.0)
1 (50.0)
198 (58.9) 121 (36.0) 136 (40.5) 43 (12.8)
2 (66.7)
1 (33.3)
1 (33.3)
1 (33.3)
1 (33.3)
1 (33.3)
-

14 (4.2)
13 (4.0)
1 (10.0)
-

HDL-C (mg/dL)
<40
40-59
60
1 (100.0)
-

19 (61.3) 16 (51.6)
8 (25.8)
18 (72.0) 14 (56.0)
5 (20.0)
1 (16.7)
2 (33.3)
3 (50.0)
284 (85.0) 128 (38.3) 164 (49.1)
277 (85.5) 125 (38.6) 161 (49.7)
7 (70.0)
3 (30.0)
3 (30.0)
4 (80.0)
1 (20.0)
4 (80.0)
1 (20.0)
-

1 (100.0)

LDL-C (mg/dL)
<70
70-100
>100
1 (100.0)

Ezetimibe w/
1 (0.03)
Fibrates w/ Statins
Atorvastatin, Ezetimibe,
1 (0.03)
Fenofibrate
Fibrates
31 (1.00)
2 (6.5)
Clofibrate
25 (0.8)
Fenofibrate
6 (0.2)
2 (33.3)
Fibrates w/ Statins
334 (10.8) 11 (3.3)
Atorvastatin, Fenofibrate 324 (10.5) 11 (3.4)
Fenofibrate, Rosuvastatin 10 (0.3)
Nicotinic acid w/ Statins
5 (0.2)
Atorvastatin,
5 (0.2)
Nicotinic acid
Statins
2715 (87.9) 213 (7.8)
Atorvastatin
2338 (75.7) 143 (6.1)
Fluvastatin
18 (0.6)
Lovastatin
18 (0.6)
Pitavastatin
2 (0.1)
Rosuvastatin
336 (10.9) 70 (20.8)
Simvastatin
3 (0.1)
Statins w/
3 (0.1)
other combinations
Acetylsalicylic acid,
2 (0.1)
Atorvastatin
Acetylsalicylic acid,
1 (0.03)
Atorvastatin,
Atorvastatin calcium

No. of patients (%); $Mean SD

Classification /
generic name

Table 2: Association of lipid lowering drugs with lipid parameters

19 (61.3)
18 (72.0)
1 (16.7)
54 (16.2)
51 (15.7)
3 (30.0)
1 (20.0)
1 (20.0)

1 (100.0)
6 (19.4)
2 (8.0)
4 (66.7)
219 (65.6)
216 (66.7)
3 (30.0)
-

1 (100.0)

1 (50.0)

752 (27.7) 959 (35.3) 676 (24.9)

639 (27.3) 838 (35.8) 582 (24.9)
1 (5.6)
5 (27.8)
8 (44.4)
3 (16.7)
7 (38.9)
2 (11.1)
1 (50.0)
109 (32.4) 106 (31.5) 84 (25.0)
2 (66.7)
2 (66.7)

1 (3.2)
1 (4.0)
29 (8.7)
28 (8.6)
1 (10.0)
1 (20.0)
1 (20.0)

<150
-

TGs (mg/dL)
150-199
200-499
1 (100.0)
-

3 (0.1)
3 (0.1)
-

5 (1.5)
5 (1.5)
-

500
-

8 (25.8)
7 (28.0)
1 (16.7)
78 (23.4)
76 (23.5)
2 (20.0)
-

7 (22.6)
7 (28.0)
169 (50.6)
167 (51.5)
2 (20.0)
2 (40.0)
2 (40.0)

1.89 (0.6)
1.77 (0.4)
2.49 (0.9)
1.77 (0.5)
1.77 (0.5)
1.70 (0.2)
1.37 (0.2)
1.37 (0.2)

1.12 (-)

1.12 (-)

TC/LDL
ratio$

1 (100.0)

1 (50.0)

2.14 (-)

1.43 (-)

1132 (41.7) 669 (24.6) 708 (26.1) 1.72 (0.6)

959 (41.0) 590 (25.2) 602 (25.7) 1.71 (0.6)
2 (11.1)
9 (50.0)
7 (38.9) 1.50 (0.3)
9 (50.0)
4 (22.2)
5 (27.8) 1.47 (0.2)
1 (50.0)
1 (50.0) 2.14 (1.4)
159 (47.3) 65 (19.3) 93 (27.7) 1.82 (0.7)
2 (66.7)
1 (33.3)
1.64 (0.4)
1 (33.3)
1 (33.3) 1.79 (0.5)

15 (48.4)
11 (44.0)
4 (66.7)
65 (19.5)
62 (19.1)
3 (30.0)
3 (60.0)
3 (60.0)

1 (100.0)

Total cholesterol (mg/dL)

<200
200-239
240
1 (100.0)
-

Journal of The Association of Physicians of India Vol. 64 April 2016

41

18 to 65 years and prescribed

lipid-lowering therapy for at
least 3 months with no dose
adjustments for at least 6 weeks
prior to study enrollment were
enrolled in the study. Patients
who did not have their recent
lipid profile (within 15 days)
a n d / o r we r e n o t w i l l i n g t o
provide lipid profile; pregnant
or lactating; or were currently
participating in other trial
or had participated in any of
the clinical trial in the past 3
months were excluded from the
study. The primary objective
of the study was to determine
the lipid control in high-risk
dyslipidaemic Indian patients
t r e a t e d w i t h l i p i d - l o we r i n g
therapy. The secondary
objectives of the study were to
understand the demographic
profile, treatment modalities,
co-morbidities, and to identify
potential determinants in
achieving defined LDL-C levels
in patients with high-risk
dyslipidemia. The protocol was
approved by the independent/
institutional ethics committee.
The study was conducted in
accordance with the Declaration
of Helsinki and International
Conference on Harmonization
of Good Clinical Practice
guidelines with Cardiologists/
Consulting Physicians with
e x t e n s i ve e x p e r i e n c e i n t h e
management of dyslipidemia.

For each patient, the

investigator recorded the
following information in
web based case report form:
patients demographics
(age, gender, height, weight,
body mass index, and waist
circumference), lifestyle
(sedentary and non-sedentary),
dietary patterns (vegetarian and
non-vegetarian), risk categories
(CVD, cerebrovascular disease,
CKD, and DM), medical history,
lipid profile (LDL-C, HDL-C,
triglycerides [TGs], TC, and
TC/LDL ratio), lipid lowering
therapy (statins, fibrate, nicotinic

42

Journal of The Association of Physicians of India Vol. 64 April 2016

654
(30.1%)

700
530
(24.4%)

500
361
(16.6%)

400
286
(13.2%)

300

26-35

36-45

46-55

56-65

18-25

26-35

<70

36-45

46-55

56-65

18-25

26-35

36-45

Male

Female

Male

Female

Male

Female

Male

Female

Male

Female

18
16
1
1
(0.8%) (0.7%)
(0%) (0%)

Male

Female

Male

Female

Male

Female

Male

Female

Male

Female

Male

Female

Male

Female

Male

Female

79
(14.5%)

70
57
59
36 (12.8%) 44
31 (26.1%) 39 (25.2%)
15
16
11 (6.6%)
(8.1%)
7
(17.3%)
2
4
2
1
(13.7%)
(0.9%) (3.1%) (6.6%) (7.1%)
(0.2%) (0.4%) (0.7%) (2%)

Male

100

165
138 (7.6%)
(6.4%)

158
(29%)

140
(25.7%)

200

Female

No. of subjects (percentage)

600

46-55

56-65

>100

70-100
LDL-C levels (mg/dl)

Fig. 3: Age and gender-wise distribution of LDL-C levels

2338
(75.7%)

No. of subjects (percentage)

2500
2000
1500
1000
500
0

25
(0.8%)

6
(0.2%)

Clo

Feno

336
(10.9%)

18
(0.6%)

18
(0.6%)

2
(0.1%)

Fluv

Lova

Pit

Ator

Fib

Rosu

3
(0.1%)
Sim

1
(0%)

Ator, Eze, Ator,

Feno
Feno

Eze w/
Fib w/
Stat

Stat

324
(10.5%)

10
(0.3%)

5
(0.2%)

2
(0.1%)

1
(0%)

Feno,
Rosu

Ator, Nic

Acet,
Ator

Acet,
Ator,
Ator C

Fib w/ Stat

Nic w/
Stat

Stat w/ other

Medication for dyslipidemia

Fig. 4: Medication for dyslipidemia

acid, ezetimibe, and combination

therapy), vital parameters (systolic
and diastolic blood pressure),
laboratory investigations (fasting
plasma glucose [FPG], postprandial
glucose [PPG] levels, and glycated
hemoglobin [HbA1c]), and
concomitant medications.
Study Endpoint

The primary study endpoint

was to evaluate the percentage of
high-risk dyslipidemia patients
achieving adequate LDL-C level

(< 70 mg/dL) on lipid-lowering

therapy. The secondary study
e n d p o i n t wa s t o e va l u a t e t h e
association of lipid parameters with
patient characteristics, comorbid
conditions, and lipid lowering
drugs.
Statistical Analysis

As this was a non-interventional

study, no formal sample size
c a l c u l a t i o n wa s d o n e . A l l t h e
enrolled patients were analysed in
the study. The statistical analysis

was done using Statistical Analysis

System version 9.3 software. The
data was summarized descriptively.

Results
Patient Characteristics

3089 (70.4%) patients were

enrolled in the study and
constituted the analysis population.
1973 (64%) of the patients were
males while 1116 (36%) were
females. Higher proportion of
patients (46%) in males and females

Journal of The Association of Physicians of India Vol. 64 April 2016

561
(24%)

600

No. of subjects (percentage)

500

433
(18.5%)

367
(15.7%)

400
300

228
(9.8%)

184
(7.9%)

200
100
0

43

39
(1.7%)

49
(2.1%)

Female

Male

Female

Male

43-65 years

18-42 years
10

37
(1.6%)

44
(1.9%)

Female

Male

Female

18-42 years

Male

11
(0.5%)

18
(0.8%)

Female

Male

43-65 years

79
(3.4%)
2
(0.1%)
Female

18-42 years

43-65 years
40

20

Male

Male

43-65
years
80

Atorvastatin dose (mg)

Fig. 5: Age and gender-wise distribution of patients in different dose levels of atorvastatin

category were aged 56-65 years

followed by patients of age 46-55
ye a r s . S e d e n t a r y l i f e s t yl e a n d
vegetarian diet was reported in
higher proportion of females
a g e d 5 6 - 6 5 ye a r s c o m p a r e d t o
other age categories. The patients
characteristics are summarized
in Table 1. Waist circumference
above normal (pre-obese/obese)
was reported in higher proportion
of females of age category 36 to 65
years than males of the same age
category (Figure 1).
Lipid Profile

The mean value of LDL-C (130.8

41.8 mg/dL), HDL-C (44.5 22.2
mg/dL), TG (187.4 72.9 mg/dL),
TC/LDL-C ratio (1.7 0.6 mg/
d L) , a n d T C ( 2 1 2 . 2 5 4 . 8 m g /
dL) were recorded, respectively.
T h e m e a n L D L - C va l u e s we r e
comparable between males and
females. Similarly, mean HDL-C,
TG, TC/LDL-C ratio, and TC was
also comparable between males and
females (Figure 2). Overall, LDL-C
data was available for 2941 of
3089 (95.2 %) patients. Out of 2941
patients, 226 (7.7%) patients (males:
139 [61.5 %]; females: 87 [38.5 %])
achieved LDL-C levels < 70 mg/dL

on lipid-lowering therapy (Table 2).

Higher number of males aged 26-35,
46-55, and 56-65 years achieved
LDL-C < 70 mg/dL than females.
The level of LDL-C < 70 mg/dL was
comparable in males and females of
age 36-45 years. 545 of 2941 (18.5
%) patients (381 males and 164
females) achieved LDL-C levels
between 70-100 mg/dL. Higher
number of males aged 36-45, 46-55,
and 56-65 years achieved the LDL-C
level 70-100 mg/dL as compared
to females of the same age groups.
The level of LDL-C 70-100 mg/
dL was comparable in males and
females of age 18-25 and 26-35
years (Figure 3).
Percentage of Patients on Lipid
Lowering Therapy

All 3089 patients received either

statin, fibrates, statins with fibrates,
statins with nicotinic acid, or statins
with other combination as the lipid
lowering therapy. 87.9% patients
received statins; with Atorvastatin
being the most common statin used
by the patient population (86.1%)
(Figure 4).
Association of Lipid-Lowering Therapy
with Lipid Parameters

88% (2715/3089) of patients

received statins. Atorvastatin was

the most common statin used (86%)
followed by Rosuvastatin (13%),
Fluvastatin (0.7%) and Lovastatin
(0.7%). The other drugs received
by the patients includes either
fibrates (1%), fibrates with statins
(10.8%), nicotinic acid with statins
(0.2%), ezetimide with fibrates
and statins (0.03%), or statins with
other combination as the lipid
lowering therapy (0.1%) (Table
2). Overall, Atorvastatin was the
most common statin used by 86%
patients (2338/2715 patients) with
10 mg dose (43.5%, 1016/2338
patients) as the most commonly
used dose followed by 20 mg dose
(31.7%, 742/2338 patients); genderwise, higher proportion of males
than females of age category 43-65
years were on atorvastatin doses
10 to 80 mg (Figure 5). Atorvastatin
was found to be effective statin in
achieving LDL-C < 70 mg/dL (141
[4.6%] patients), LDL-C 70-100
mg/dL (453 [14.7%] patients),
HDL-C 40-59 mg/dL (1014 [32.8%]
patients), HDL 60 mg/dL (180
[5.8%] patients), TG < 150 mg/dL
(630 [20.4%] patients), TG 150-199
mg/dL (833 [27%] patients), TC <
200 mg/dL (948 [30.7%] patients),

44

Journal of The Association of Physicians of India Vol. 64 April 2016

Table 3: Association of lipid modifying therapy with patient characteristics

Classification

n (%)

Age
mean (SD)

BMI (kg/m2)
mean (SD)

Ezetimibe w/
Fibrates w/ Statins
Fibrates

1
(0.03)
31
(1.00)
334
(10.81)
5
(0.16)
2715
(87.89)
3
(0.10)

55.0
(.)
54.6
(6.77)
54.4
(7.76)
49.8
(15.06)
53.3
(7.67)
55.7
(4.04)

24.80
(.)
25.17
(3.179)
28.15
(5.421)
26.44
(3.710)
27.09
(3.827)
25.63
(1.097)

Fibrates w/ Statins
Nicotinic acid w/
Statins
Statins
Statins w/ other
combinations

and TC 200-239 mg/dL (587 [19%]

patients).
Association of Lipid Modifying Therapy
with Patient Characteristics

Gender-wise, the proportion

of males using Fibrates with or
without statins, and only statins
was higher than females (fibrates:
males, 83.9%, females, 16.1; fibrates
with statins: males, 67.7%, females,
32.3%; statins: males, 63.3%,
females, 36.7%) and the proportion
of females using nicotinic acid
with statins and statins with
other combinations was higher
than males (Nicotinic acid with
statins: males, 40%, females, 60%;
statins with other combinations:
males, 33.3%, females, 66.7%). The
higher proportion of patients using
Ezetimibe with fibrates and statins,
Fibrates with or without statins,
nicotinic acid with statins, and
statins with other combination had
a sedentary lifestyle and vegetarian
diet.
Co-morbid Conditions

The most common risk categories

were CVD (70.5%; 2177/3089) and
DM (69.7%; 2152/3089). Genderwise, males are in between age
43-65 years had a high incidence of
CVD (59.3% versus 31.8%) and DM
(56.5% versus 33.1%) than females
of same age category (Figure 6).
The most common concomitant
medication was anti-diabetic drugs
(1731 [65.4%] patients) and renin
angiotensin system inhibitors (1132
[42.8%] patients). Metformin (1066
[61.6%] patients) and Glimepiride

Gender, n (%)
Male

Female

1
(100.0)
5
(16.1)
108
(32.3)
3
(60.0)
997
(36.7)
2
(66.7)

26
(83.9)
226
(67.7)
2
(40.0)
1718
(63.3)
1
(33.3)

Lifestyle, n (%)
NonSedentary
sedentary
1
(100.0)
21
10
(67.7)
(32.3)
266
68
(79.6)
(20.4)
3
2
(60.0)
(40.0)
1383
1331
(50.9)
(49.0)
3
(100.0)

(667 [38.5%] patients) were the

most common anti-diabetic drugs.
Telmisartan (742 [65.5%] patients)
and Olmesartan (254 [22.4%]
patients) were the most common
renin-angiotensin system inhibitors
used.
Association of Comorbid Conditions
with Defined Lipid Parameters

CVD and DM were reported

as the most common comorbid
conditions in patients who achieved
the LDL-C < 70 mg/dL and LDL-C
70-100 mg/dL (Table 4).

Discussion
Dyslipidemia as a common
health problem in India. As per
ESC/EAS guideline, a patient with
high-risk dyslipidemia is defined
as the person with known CVD,
type 2 or type 1 diabetes with
microalbuminuria, CKD, or with
very high levels of individual risk
factors. Prevalence of dyslipidemia
is reported to be higher in males
compared to females in India. 11
Higher (64%) number of the
p a t i e n t s we r e m a l e s a n d a g e d
more than 46 years in our study. In
2006, Goff et al. reported that men
had 30% more likelihood to have
dyslipidemia than women with
higher proportion of dyslipidemic
patients (both genders) in the older
age groups.12 The reason for having
dyslipidemia in higher proportion
of aged population may be due
to their high sedentary activities
and lack of physical exercise,
altered dietary habits, abnormal

Diet, n (%)
Veg

Non-veg

1
(100.0)
20
(64.5)
264
(79.0)
3
(60.0)
1343
(49.5)
3
(100.0)

11
(35.5)
70
(21.0)
2
(40.0)
1372
(50.5)
-

lipid profile, etc. Hence, lifestyle

modifications or lipid-lowering
drugs help in management of
dyslipidemia patients. Both
s e d e n t a r y l i f e s t yl e a n d t r a n s unsaturated fatty acid diet lead
to an increase in body weight and
hence increases the risk for CVD
either directly or by influencing
the lipid profile. We found females
of age 46-65 years to have a more
sedentary lifestyle and a higher
waist circumference than males
along with lower proportion to
a c h i e ve a d e q u a t e l i p i d l e ve l s
(LDL-C < 70 mg/dL, LDL-C 70-100
mg/dL, HDL-C 60 mg/dL, TC <
200 mg/dL, TG < 150 mg/dL, and
TG 150-199 mg/dL); which may be
due to insufficient dosing, failure
to adequately up titrate the dose,
not switching to a more potent
drug when essential, and lack
of follow-up after initiation of
treatment.
As per ESC/EAS guideline,
treatment target for LDL-C for a
high-risk dyslipidemic patient was
< 70 mg/dL or a 50 % reduction
from baseline LDL-C. Of all the
lipid-lowering drugs, statins have
been considered as the mainstay
at lowering the LDL-C levels in
dyslipidemic patients acts by
reducing the cholesterol synthesis
i n t h e l i ve r a n d s u b s t a n t i a l l y
reducing cardiovascular-associated
morbidity and mortality. In a
Cholesterol Treatment Trialists
Collaboration (CTT) meta-analyses
of > 170000 participants in 26
randomized trials of statins, per

Journal of The Association of Physicians of India Vol. 64 April 2016

1290
(59.3%)

1400

1215
(56.5%)

1200
No. of subjects (percentage)

45

1000
713
(33.1%)

693
(31.8%)

800
600
400
200
0

25
13
(34.2%) (65.8%)

Female

Male

43-65

65
(3%)

Female

129
(5.9%)

Male

18-42

Female

Male

98
(4.6%)

126
(5.9%)

Female

Male

18-42

43-65

Male

43-65

DM (n=2152)

CVD (n=2177)

CBD (n=38)

Female

1
(4.8%)

12
8
(38.1%) (57.1%)

Male

Female

18-42

Male

43-65
CKD (n=21)

Risk categories

Fig. 6: Age and gender-wise distribution of co-morbid conditions

Table 4: Association of comorbid
conditions with defined lipid
parameters
Lipid
Comorbid
parameter
conditions
LDL-C (mg/dL)
< 70
CVD
DM
70-100
CVD
DM
HDL-C (mg/dL)
40-59
CVD
DM
60
CVD
DM
Triglycerides (mg/dL)
<150
CVD
DM
150-199
CVD
DM
TC (mg/dL)
200-239
CVD
DM

Number of
patients (%)
126 (55.8)
174 (77.0)
394 (72.3)
347 (63.7)
951 (70.7)
931 (69.2)
152 (61.8)
187 (76.0)
559 (71.4)
546 (69.7)
718 (69.4)
687 (66.4)
549 (72.7)
492 (65.2)

Cardiovascular disease included ischemic

heart disease, peripheral arterial disease,
hypertension and cardiovascular disease

1 mmol/L LDL-C reduction was

associated with 10 % proportional
reduction in all-cause mortality
and 20 % proportional reduction
in coronary artery disease death. 13
A meta-analysis of randomized
clinical trials have reported that
the use of Statins in patients
without CVD but with risk factors

was associated with improved

s u r v i va l a n d r e d u c t i o n i n t h e
r i s k o f C V e v e n t s . 14 H i g h e r
proportion of patients on statins
had attained LDL-C goal with
lower cardiovascular outcomes
previously. 15 In our study as well,
statin was the most commonly
used drug in the management of
dyslipidemia. Approximately 7.7%
of the patients achieved LDL-C < 70
mg/dL compared to 19% patients
with LDL-C 70-100 mg/dL. On the
contrary statin monotherapy (for >
90 days) had also achieved LDL-C
< 100 mg/dL (67% to 77%) than
LDL-C < 70 mg/dL (20% to 26%
patients) in higher proportion of
high-risk dyslipidemic patients. 16
The present study results show
that lipid management remains
unsatisfactory in high-risk
dyslipidemia patients. The reason
for low proportion of patients to
have adequate LDL-C level may
be due to their drug intolerance,
inability to follow therapeutic
plans or poor compliance. In
addition, physicians play a major
role in achieving the target LDL-C
goal in their patients by extensive
counselling to improve their
treatment adherence. However they
often, fail to titrate medications,

choose inappropriate drug with

limited effectiveness, or are unable
to address patient noncompliance.
Clinical benefit is only dependent
on the extent of LDL-C lowering
rather than on the type of statin.
The statin chosen should provide
appropriate percent reduction of
LDL-C required to reach the target
goal in a given patient. 13,17
Our study had few limitations.
It was an observational study and
did not give any information on
treatment compliance, duration of
treatment, types of sedentary and
non-sedentary activities, and type
of fats in the diet. It was a single
v i s i t n o n - i n t e r ve n t i o n a l s t u d y
which did not provide the lipid
values over time. Only high-risk
dyslipidemic patients who were
o n l i p i d l o we r i n g d r u g s we r e
selected in the study; hence the
lipid profile of patients without
lipid lowering drugs cannot be
evaluated. The data of lipid profile
was taken from patient medical
records without routine blood
sample collection or central, corelaboratory evaluation; moreover,
the study reflected a more real world practice in which patients
with high-risk dyslipidemia who
presented themselves for routine

46

Journal of The Association of Physicians of India Vol. 64 April 2016

health check-up to their treating

physician were enrolled. The
strength of our study was that it
presented a real-world Indian
data in a big cross-sectional setting.

Conclusion
As per the ESC guidelines the
ideal LDL-C levels in high risk
dyslipidemic patients should be
less than 70 mg/dL. In the present
study, only 7.7% of the patients
achieved LDL-C levels < 70 mg/
dL with lipid lowering therapy.
Despite the availability of statins,
lipid management in high-risk
patients remains unsatisfactory.
The reasons for poor achievement
of LDL-C goals may be due to
inability to follow therapeutic plans,
poor compliance, or inadequate
counselling by physician. The
p h y s i c i a n s l a c k o f a wa r e n e s s
about recent treatment guidelines
also might contribute to patients
poor adherence, not explaining
adequately the benefit and risks
of a medication, not giving
consideration to the patients life
style and the cost of medication.
Hence, a more aggressive patients
counselling and treatment is
r e q u i r e d t o a c h i e ve t h e t a r g e t
lipid goals.

Acknowledgements
The authors would like to thank
all doctors who participated in this
study. The authors would also like
to acknowledge site management
organization and medical
writing agency (Max-Neeman
International) for their efforts.
We are also like to thank Dr. Amit
Bahulayan PhD (Pharmacology)
and Dr. Jyotirmoy Paul MD
(Pharmacology) for reviewing the

manuscript.

Disclosure
This study was funded by Abbott
Healthcare Pvt Ltd. Dr. Abhijit
Trailokya, Chief Manager- Medical
Services, Dr. Kalpesh Dalvi,
Medical Advisor- Medical Services,
Mr. Suhas Talele, Manager-Clinical
Research; Medical Services all are
employees of Abbott Healthcare
Private Limited, Mulund, Mumbai.

References
1.

Kingsbury KJ, Bondy G. Understanding the

essentials of blood lipid metabolism. Prog
Cardiovasc Nurs2003; 18:13-8.

2.

Wei YQ. Treating dyslipidemia in high-risk

group patients- current management and
future approach. Singapore Fam Physician
2011; 37:18-24.

3.

Ford I, Murray H, Packard CJ, Shepherd

J, Macfarlane PW, Cobbe SM. Long-term
follow-up of the West of Scotland Coronary
Prevention Study. N Engl J Med 2007;
357:1477-86.

4.

Gaziano TA, Bitton A, Anand S, AbrahamsGessel S, Murphy A. Growing epidemic of

coronary heart disease in low- and middleincome countries. Curr Probl Cardiol 2010;
35:72-115.

5.

6.

7.

8.

Gersh BJ, Sliwa K, Mayosi BM, Yusuf S. Novel

therapeutic concepts: the epidemic of
cardiovascular disease in the developing
world: global implications. Eur Heart J 2010;
31:642-8.
ATP III At-A-Glance: Quick Desk Reference,
2001. Available from: http://www.nhlbi.
nih.gov/health-pro/guidelines/current/
cholesterol- guidelines/quick- deskreference-html
Exper t D yslipidemia Panel of the
International Atherosclerosis Society Panel
members. An International Atherosclerosis
Society Position Paper: global
recommendations for the management of
dyslipidemia--full report. J Clin Lipidol2014;
8:29-60.
Reiner Z, Catapano AL, De Backer G,
Graham I, Taskinen MR, Wiklund O, et al.
ESC/EAS guidelines for the management of

dyslipidaemias. Eur Heart J 2011; 32:17691818.

9.

Goodman SG, Langer A, Bastien NR,

McPherson R, Francis GA, Genest JJ,
et al. Prevalence of dyslipidemia in
statintreated patients in Canada: Results
of the DYSlipidemia International Study
(DYSIS). Can J Cardiol 2010; 26:e330-e335.

10. Vashitz G,Meyer J,Parmet Y,Henkin Y,Peleg

R, Gilutz H. Physician adherence to the
dyslipidemia guidelines is as challenging
an issue as patient adherence. Fam
Pract2011; 28:524-31.
11. Karnik R, Trailokya A, Dalvi K, Patel K.
Efficacy evaluation and safety assessment
of Rosuvastatin 40mg treatment in high
risk dyslipidemic patients (Earth Study).
Indian Medical Gazette 2015; 149:314-19.
12. Goff DC Jr, Bertoni AG, Kramer H, et al.
Dyslipidemia prevalence, treatment,
and control in the Multi-Ethnic Study
of Atherosclerosis (MESA): gender,
ethnicity, and coronary artery calcium.
Circulation2006; 113:647-56.
13. Cholesterol Treatment Trialists (CTT )
Collaboration. Efficacy and safety of more
intensive lowering of LDL cholesterol:
a meta-analysis of data from 170000
participants in 26 randomised trials.Lancet
2010; 376:1670-81.
14. Brugts JJ, Yetgin T, Hoeks SE, Gotto AM,
Shepherd J, Westendorp RGJ, et al. The
benefits of statins in people without
established cardiovascular disease but with
cardiovascular risk factors: meta-analysis
of randomised controlled trials. BMJ 2009;
338:b2376.
15. Raal F, Schamroth C, Blom D, Marx J, Rajput
M, Haus M ,et al. CEPHEUS SA: a South
African survey on the undertreatment of
hypercholesterolaemia. Cardiovasc J Afr
2011; 22:234-40.
16. Jones PH, Nair R, Thakker KM. Prevalence of
dyslipidemia and lipid goal attainment in
statin-treated subjects from 3 data sources:
a retrospective analysis. J Am Heart Assoc
2012; 1:e001800.
17. Catapano AL. Perspectives on low-densitylipoprotein cholesterol goal achievement.
Curr Med Res Opin 2009; 25:431-47.