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Original Article
Abstract
Editorial Viewpoint
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
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,
39
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
40
900
768
(24.9%)
662
(21.4%)
700
600
500
Female
Male
Male
132
(4.3%)
89
(2.9%)
17
(0.6%)
Female
Male
56-65
Female
56-65
Female
Male
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
800
56-65
Above normal
209.5
(1926)
211.3
(2989)
187.7
(994)
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
Triglycerides (mg/dl)
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)
-
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
Classification /
generic name
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)
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 (-)
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)
41
42
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
600
46-55
56-65
>100
70-100
LDL-C levels (mg/dl)
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%)
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
Results
Patient Characteristics
561
(24%)
600
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
Fig. 5: Age and gender-wise distribution of patients in different dose levels of atorvastatin
44
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
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)
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)
-
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
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)
46
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
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