Retrospectiv Clinical Trial on Treatment with Fenofibrat – “ Lipanthil” in
Dyslipidemia of Coronary Disease Patients
Alexandra Crişu Bota*, I. Maniţiu*, Liliana Coldea*, M. Crişu**
* “Victor Papilian “ Faculty of Medicine Lucian Blaga” University of Sibiu
** The Clinic of Cardiology , the Clinic County Hospital from Sibiu
ABSTRACT
The aim of the study was to estimate/consider the effect of fenofibrat –„Lipanthyl” treatment, (daily dose 200
mg) on 52 dislipidemic patients suffering of coronary artery disease – myocardial infarction, with or without diabetes
mellitus. The investigationwas carried out between 2002–2003, on patients with myocardial infarction which were
divided into groups of age, sex, urban or rural environment, presence of diabetes mellitus, of dislipidemia and other risk
factors such as obesity, stress, sedentariness. The study used the HER of the clinical hospital and data were analysed with
SPSS.The obtained results indicate the favourable effect of fenofibrat–„Lipanthyl” for these patients. It equilibrates the
lipid risk factors: both through producing the diminution of T cholesterol and triglycerides and increasing of the HDL–C–
group in hypercholesterolemia as well as in mixed dislipidemia. The fenofibrat treatment lowers the cardiovascular risk
at the patients with decreased HDL–C and at the diabetic and nondiabetic coronary disease patients.
INTRODUCTION
Dyslipidemia represents one of the most frequent metabolism disorders met in the case of diabetes
mellitus. Dyslipidemia refers to both quantitative and qualitative modifications of lipids and blood
lipoproteins.
The first are characterized particular by atherosclerotic dyslipidemia:
- the increase of LDL
- the increase of triglycerides
- the decrease of HDL
The qualitative modifications refers to :
- postprandial hyperlipidemia
- the increase of LDL of type B
- the increase of LDL glycosylated and oxidated
The cardiovascular risk due to the dyslipidemia in the diabetes mellitus is greater than to the
general population.
THE AIM
The study was retrospectively done on 52 coronary patients (34 males and 18 females), the
average age 63,98 years old (between 40 and 85 years old). From this group 21 patients were suffering of
diabetes mellitus and 17 patients with arterial hypertension.
The parameters taken into account were: sex, age, urban or rural environment; the level of
cholesterol, of triglycerides, of HDL; the level of inflammatory tests (ESR- erythrocyte sedimentation rate,
fibrinogen and RCP- reactive C protein); the presence of diabetes mellitus and other risk factors such as:
arterial hypertension, obesity, stress and sedentariness.
RESULTS AND METHODS
The Electronic Health Record System of the cardiology clinic was used in order to extract the
selection of the cases that entered in the study.
The data analysis was realized with the SPSS program.
The study was retrospectively done on 52 coronary patients (34 males and 18 women), the average
of age of 63,98 years old (between 40 and 85 years old). From this group, 21 patients were suffering of
diabetes mellitus and 17 patients with arterial hypertension.
The parameters taken into account were: sex, age, urban and rural environment; the level of
1
cholesterol, of triglycerides, of HDL; the level of inflammatory tests (ESR erythrocyte sedimentation rate,
fibrinogen and RCP- reactive C protein); the presence of diabetes mellitus and other risk factors such as
arterial hypertension, obesity, stress and sedentariness.
RESULTS AND DISCUSSIONS
From the 52 patients, 65% were males and 35% females – table no. 1. One observed an increased
prevalence of the coronary disease at males – figure no. 1
Table no. 1 Distribution on sexes
Sex
Male
Female
No. of cases
34
18
Percentage
65%
35%
35%
Male
Fem ale
65%
Figure no. 1 Distribution on sexes
Table no. 2 Distribution depending on urbane or rural environment
Environment
No. of cases
Percentage
Urbane
42
81%
Rural
10
19%
19%
Urban
Rural
81%
Figure no. 2 Distribution depending on urbane or rural environment
More than 60%of the patients studied were over 60 years old – table no. 3, figure no. 3.
Table no. 3 Distribution depending on age
Age
No. of cases
40-60 years
18
Over 60 years
34
Percentage
35%
65%
2
35%
40-60 years
Over 60 years
65%
Figure no. 3 Distribution depending on age
Taking into account the myocardial infarction localization, the distribution of the patients was: 16
cases of anterior myocardial infarction, 7 cases of inferior - lateral myocardial infarction, 16 cases of inferior
myocardial infarction and 13 cases with other localization (profound septal, inferior and right ventricular,
posterior- inferior- lateral, lateral, non-Q ) table no. 4
Table no. 4 Distribution depending on myocardial infarction localization
Localization
No. of cases
Percentage
Anterior
16
31%
Inferior-lateral
7
13%
Inferior
16
31%
Other localizations
13
25%
Other localizations
Inferior
Inferior - lateral
Anterior
0
2
4
6
8
10
12
14
16
To be noticed that the most frequent localizations were those fore and inferior – figure no. 4
Figure no. 4 Distribution depending on myocardial infarction localization
The studied coronary patients had different types of dyslipidemia such as: mixed
dyslipidemia (38,46%), hypercholesterolemia (61,53%), with an average value of cholesterol of
221,15mg% (98-485mg%) and hypertriglycerides (23%) with an average value of 194,26mg% (471676mg%). Low values of HDL was present at 66% of the patients (an average value of 44,56mg%)
- figure no. 5
3
38,46%
Mixed dyslipidemia
23%
Hypertriglycerides
61,53%
Hypercholesterolemia
66%
Low HDL
0%
10%
20%
30%
40%
50%
60%
70%
Figure no.5 Distribution depending on the type of dyslipidemia
Hypercholesterolemia was present more frequently at male patients (25 cases), at female patients (7
cases), the same data were found in the mixed dyslipidemia - 12 cases at male patients and 8 cases at female
patients – table no. 5, figure no. 6
Table no.5 Distributions depending on the type of dyslipidemia and sexes
Type of Dyslipidemia
Males
Hypercholesterolemia
25
Mixed Dyslipidemia
12
Females
7
8
25
20
15
Hypercholesterolem ia
10
Mixed Dyslipidem ia
5
0
Males
Females
Figure no.6 Distribution depending on the type of dyslipidemia and sexes
From 52 patients, 21 patients were found with diabetes mellitus (47%), 6 patients with obesity
(14%), 17 patients with high blood pressure (39%)- figure no.7
14%
Obesity
39,00%
Arterial hypertension
47%
Diabetus mellitus
0%
10%
20%
30%
40%
Figure no. 7 Distribution depending on associated risk factors
4
50%
At normo-ponderal patients (88%) prevailed hypercholesterolemia, at the obese patients (12%)
prevailed mixed dyslipidemia. There were 3 cases of obese male patients and 3 cases of female patients.
From the 21 patients with diabetes mellitus, there were 14 male patients and 7 female patients.
From the diabetes mellitus patients, 6 of them had dyslipidemia. The patients with a precarious glycemic
control (57,5%) were found more frequently having mixed dyslipidemia while at those with a good and
acceptable glycemic control prevailed hypercholesterolemia.
Concerning the inflammation tests, 14 patients (30%) were found with increased values of the
ESR (erythrocyte sedimentation rate), fibrinogen and RCP (reactive C protein)- table no. 6, figure no.8
Table no.6 Distribution depending on the inflammation tests’ presence
Inflammation tests
No. of cases
Percentage
Normal
38
73%
Increased
14
27%
27%
Norm al
Increased
73%
Figure no. 8 Distribution depending on inflammation tests’ presence
In the studied group one found other associated affections such as: 8 cases of pulmonary
affections; one case of neurological, ocular and endocrine affections; 4 cases of renal affections; 2 cases of
digestive affections – table no. 7
Table no.7 Distribution depending on the associated affections
Associated Affections
Pulmonary
Neurological
Ocular
Endocrine
Renal
Digestive
No. of cases
8
1
1
1
4
2
Percentage
15%
1%
1%
1%
8%
4%
The therapy associated to Lipanthyl on the studied group was as follows: in 36 cases thrombolysis,
in 39 cases converting -enzyme -inhibitors, in 17 cases beta-blockers, in 45 cases nitrates, in 2 cases
blockers of calcium channels, in 48 cases antiaggregants and anticoagulants and in 8 cases other therapies.
– table no. 8
Table no. 8 Distribution depending on the therapy associated to Lipanthyl
Associated Therapy
Thrombolysis
Converting- enzyme- inhibitors
Beta-blockers
Nitrates
5
No. of cases
36
39
17
45
Percentage
70%
75%
33%
86%
Blockers of calcium channels
Antiaggregants and anticoagulants
Other therapies
2
48
8
4%
92%
15%
To be noticed that most of the cases benefited from thrombolythic therapy, the therapy of acute
myocardial infarction being a complex therapy in which each class of drugs brought its benefits in the
atheroma plaque’s stabilization or in influencing the other factors involved in cardiac pathology.
CONCLUSIONS
 The control and evaluation of dyslipidemia must be a major object in the medical attendance of the
persons with coronary disease.
 The most frequent dyslipidemia in the studied group was: hypercholesterolemia (61,53%) with an
average value of cholesterol of 221,15mg% (98 – 485mg%), followed by mixed dyslipidemia
(38,46%) and hypertriglycerimia (23%) with an average value of 194,26mg% (47 – 1676mg%).
 Low values of HDL were present at 66% of the patients ( an average value of 44,56mg%)
 The patients with precarious glycemic control (57,5%) were more frequently found with mixed
dyslipidemia while at those with a good and acceptable glycemic control prevailed
hypercholesterolemia.
 At normo-ponderal patients (88%) prevailed the hypercholesterolemia and at the obese patients (12%)
was more frequently found the mixed dyslipidemia.
 By treating dyslipidemias with Lipanthyl one significantly improves the level of cholesterol and
triglycerides, together with the increase of HDL at the patients with hypercholesterolemia and mixed
dyslipidemia.
 The treatment of dyslipidemias with Lipanthyl influences the morbidity and the cardiovascular
mortality at the diabetic and non-diabetic patients.
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