Farmacia.2013 Jul-Aug;61(4):713-724

The efficiency of metoprolol tartrate in the treatment of pure arterial hypertension at patients with coronary artery disease and the risk factors associated

DANIEL LAURENTIU COZLEA1, DAN MIRCEA FĂRCAŞ1*, CAMIL VARI2, ARTHUR-ATILLA KERESZTESI3, RAMONA ŢIFREA1 , LAURENTIU COZLEA1, GRIGORE DOGARU4

1 Clinica Medicala III, University of Medicine and Pharmacy of Târgu-Mureş, Romania

2 Discipline of Pharmacology, University of Medicine and Pharmacy of Târgu-Mureş, Romania

3 Institute of Legal Medicine, Târgu Mureş University of Medicine and Pharmacy, Romania

4 Department of Nephrology, University of Medicine and Pharmacy of Târgu-Mureş, Romania

*corresponding author: danmircearo@gmail.com

 

Abstract:

The aim of the present study was to evaluate the efficiency of metoprolol tartrate of various concentrations in the treatment of patients with diverse forms of hypertension – pure, with comorbidities and/or complications (coronary artery disease, heart failure), in the absence of contraindications for the use of betablockers. The study was performed at the Medical Clinic Nr. 3 – Cardiology of Târgu Mureș, between June 1st 2009 – September 1st 2010, involving a group of 200 patients, 128 men and 72 women, with an average age of 51.7 ± 7.2 years (32-77 years), diagnosed with hypertension (HT), without prior antihypertensive medication – 116 patients, or with a history of hypertension (1-15 years at the moment of diagnosis) and various ambulatory therapeutic schemes of questionable efficiency – 84 patients, in which the ambulatory treatment could not lower blood pressure values below 150/90 mmHg. Based on our results we consider that the administration of metoprolol tartrate in various concentrations is indicated in all hypertensive patients, in the absence of contraindications for the use of betablockers. Our study concluded that monotherapy is efficient mainly in young patients and patients with recently diagnosed HT with or without treatment, provided the treatment is maximum 4-5 years old, and the patient has not been given betablockers before. Older patients, with comorbidities or HT related complications need an association of drugs in 80% of cases, excluding the medication used in the treatment of comorbidities or complications. As far as the cost-efficiency ratio is concerned, the examined drug deserves a maximum number of points in both regards.

Full text

 

Supplement:

Betablockers are still amongst the most important pharmaceutical agents to initiate or continue an antihypertensive treatment. Betablockers provide cardiovascular protection on multiple levels, reduce blood pressure values similar to other classes of antihypertensive drugs, and have a proven therapeutic role in heart failure.

As far as metoprolol is concerned, it was the first selective antagonist of the beta-1-adrenergic receptors of the heart. It was demonstrated that if it is administered in the first 24 hours following a myocardial infarction, it reduces mortality, the risk of reinfarction and the appearance of residual angina in the post-infarction period.

Our objectives were to evaluate the efficiency of metoprolol tartrate of various concentrations in the treatment of patients with diverse forms of hypertension.

We selected the patients using the following criterias:

  • Patient diagnosed with essential arterial hypertension without causes of secondary arterial hypertension
  • Inefficient or inexistent ambulatory or hospital antihypertensive treatment
  • Absence of treatment with Metoprolol tartrate or inefficient treatment with other betablockers
  • Absence of contraindications for the use of betablockers
  • Cooperative patients who are actively participating in the study.

The total number of patients included in our study was 197, divided in 4 groups:

  • Group 1 – 50 patients with pure arterial hypertension;
  • Group 2 – 49 patients with HT and type 2 diabetes, controlled with oral antidiabetic medication;
  • Group 3 – 50 patients with HT and coronary heart disease (CHD);
  • Group 4 – 48 patients with HT and various stages of heart failure.

The entire group was monitored with ambulatory blood pressure monitoring (ABPM)  before starting the study, and average blood pressure values over 24 hours were taken into consideration. Also, blood pressure values reported at the end of the study were average values obtained through 24 hour ABPM.

Each of the 197 patients was submited to the following protocol protocol

I.       Initial evaluation (upon inclusion into the study)

*     Demographic data

*     Anamnestic data

*     Physical examination

*     Paraclinic explorations

*     Questionnaire regarding the quality of life

II.      Visit 1 (at 2 weeks)

III.     Visit 2 (at 2 months)

IV.     Visit 3 (at 4 months)

V.      Visit 4 (at 8 months)

VI.     Visit 5, final (at 12 months)

*     Final therapeutic scheme

*     Questionnaire regarding the quality of life

*     End Point tolerance to medication

 

Biological modifications at the beginning and at the end of study

Gr. 1 (50 pt)

Gr. 2 (49 pt)

Gr. 3 (50 pt)

Gr. 4 (48 pt)

Initial vs. Final serum cholesterol (mmol/l)

5,6 ± 1,7 vs. 5,5 ± 1,4

5,9 ± 1,6 vs. 5,4 ± 1,8

6,1 ± 2,1 vs. 6,0 ± 1,9

5,5 ± 1,3 vs. 5,2 ± 1,3

p value for serum cholesterol

0.0786

0.1513

0.0837

0.1218

Initial vs. Final triglycerids (mmol/l)

1,8 ± 0,96 vs. 1,7 ± 0,9

1,8 ± 0,8 vs. 1,8 ± 0,6

1,9 ± 1,0 vs. 1,7 ± 1,1

1,6 ± 0,8 vs 1,6 ± 0,9

Initial vs. final HDL-cholesterol (mmol/l)

1,45±0,12 vs. 1,48 ± 0,13

1,37±0,2 vs. 1,43 ± 0,29

1,2 ±0,75 vs. 1,41 ± 0,66

1,3±0,14 vs. 1,33 ± 0,21

Initial vs. final LDL-cholesterol (mmol/l)

3,1 ± 0,6 vs  3 ± 0,7

3,6 ± 0,8 vs. 3,4 ± 1,2

3,4 ± 1,1 vs. 2,7 ± 0,9

3,2 ± 0,7 vs. 3,3 ± 0,8

Initial vs. Final Glycemia (mmol/l)

5,6 ± 0,9 vs. 5,4 ± 0,7

6,2  ± 2,9 vs.   6,1 ± 2,6

5,6 ± 0,8 vs. 5,8 ± 1,1

5,4 ± 0,5 vs. 5,6 ± 0,8

p value for  glycemia

0.1153

0.1313

0.0689

0.0747

HDL = high density lipoproteints; LDL = low density lipoproteins.

 

Questionnaire regarding the evolution of the quality of life and associated symptoms at the beginning and at the end of study

Gr. 1 (50 pt)

Gr. 2 (49 pt)

Gr. 3 (50 pt)

Gr. 4 (48 pt)

Initial vs. Final quality of life

22 vs. 5

27 vs. 12

19 vs. 6

43 vs. 13

Initial vs. Final working capacity

20 vs. 3

22 vs. 13

25 vs. 8

45 vs. 22

Initial vs. Final sexual activity

6 vs. 8

12 vs. 15

10 vs. 15

28 vs. 32

Initial vs. Final digestive symptoms

11 vs. 8

18 vs. 15

15 vs. 14

17 vs. 14

Initial vs. Final respiratory symptoms

6 vs. 5

5 vs. 5

9 vs. 8

24 vs. 13

Initial vs. Final neurological symptoms

26 vs. 14

28 vs. 21

17 vs. 9

42 vs. 23

 

As far as the improvement in the quality of life of patients is concerned, we observed a statistically significant improvement of symptoms (p = 0.035 for quality of life, p = 0.002 for working capacity, p = 0.413 for sexual activity, p = 0.355 for respiratory symptoms, p = 0.0017 for neurological symptoms ), the only negative aspect being the worsening of the quality of sexual activity, due to the erectile dysfunction induced by the betablocker treatment.

The evolution of blood pressure values during the study (mmHg) is presented in the table below

Gr. 1 (50 pt)

Gr. 2 (49 pt)

Gr. 3 (50 pt)

Gr. 4 (48 pt)

Initial   evaluation

SBP

178 ± 17

198 ± 12

189 ± 15

168 ± 19

DBP

105 ± 7

102 ± 13

109 ± 7

97 ± 11

Visit   I

SBP

158 ± 14

157 ± 13

165 ± 12

160 ± 17

DBP

99 ± 11

97 ± 12

100 ± 13

93 ± 10

Visit   II

SBP

151 ± 12

148 ± 12

145 ± 11

144 ± 9

DBP

93 ± 9

93 ± 11

95 ± 10

91 ± 11

Visit   III

SBP

132 ± 17

131 ± 14

140 ± 9

138 ± 8

DBP

89 ± 8

85 ± 9

90 ± 9

87 ± 10

Visit   IV

SBP

131 ± 15

128 ± 11

133 ± 13

134 ± 13

DBP

85 ± 7

84 ± 8

89 ± 8

85 ± 11

Visit   V

SBP

128 ± 12

123 ± 10

130 ± 11

131 ± 10

DBP

84 ± 9

78 ± 9

88 ± 6

77 ± 10

Final   evaluation

SBP

128 ± 12

123 ± 10

130 ± 11

131 ± 10

DBP

84 ± 9

78 ± 9

88 ± 6

77 ± 10

p value (initial vs. final)

P<0.0001

P<0.0001

P<0.0001

P<0.0001

 

Our study has reached its PRIMARY END-POINT, the blood pressure values decreased in each studied group, with a statistically significant (p < 0.0001) decrease in the entire group, and the target values specified in the guidelines were achieved.

The efficiency of the studied drug was 100% in the entire group, blood pressure values decreasing below 140/90 mmHg, the percentage of patients needing drug associations being under 50%.

Metoprolol tartrate was administered 2 time daily, in doses of 25, 50 or 100 mg.

Based on our results we consider that the administration of Metoprolol Tartrate in various concentrations is indicated in all hypertensive patients in the absence of contraindications for the use of betablockers.

Our study concluded that monotherapy is efficient mainly in young patients and patients with recently diagnosed HT with or without treatment, provided the treatment is maximum 4-5 years old, and the patient has not been given betablockers before.

Older patients, with comorbidities or HT related complications need an association of drugs in 80% of cases, excluding the medication used in the treatment of comorbidities or complications.

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