The efficacy and the safety of a fixed dose combination of amlodipine and atorvastatin in hypertensives with dyslipidaemia

N. C. Mukta, A. Prabha, S. K. Ashok, C. K. Nithyananda

Research output: Contribution to journalArticle

Abstract

Introduction: It was claimed that the amlodipine/atorvastatin combination improved the patient's achievement of national-guideline-recommended blood pressure and lipid target levels and exhibited a safety profile consistent with its parent compounds. The present study has been undertaken to evaluate the efficacy and the safety of a fixed dose combination of amlodipine with atorvastatin in the Indian population. Methods: The study was designed as a prospective, open labeled, noncomparative trial in 35 adult patients of mild to moderate essential hypertension with dyslipidaemia. The blood pressure criteria for inclusion was >140/90mmHg and less than 180/110mmHg. The dyslipidaemia criteria was LDL cholesterol>130mg/dl and triglycerides more than 150mg/dl. The patients were screened at baseline visit (Day 0) and at visit 2 (Day 4). The supine blood pressure was recorded by taking the mean of three readings. The blood pressure was measured again after a week during the placebo period (visit 3, day 10, week 1). The active medication (Combination of 5mg of amlodipine and 10mg of atorvastatin) started at visit 4 (day 17, week 2). The blood pressure was measured again during visit 5 (day 31, week 4), visit 6 (day 45, week 6) and visit 7 (day 60, week 8) by using the same instrument at all visits. Results: A total of 35 patients were included in the study, out of which 27 were males and eight were females. The average decrease of supine blood pressure from the baseline recording was 10.3± 3.62mmHg at the end of treatment, which was statistically highly significant (p=0.005). The average decrease of diastolic blood pressure was 9.51±2.13mmHg at the end of the treatment, which was also statistically highly significant (p=0.0002). A statistically significant decrease in the levels of total cholesterol and LDL cholesterol were observed during the treatment. The most common adverse events were hyponatraemia (25.93%), head ache (22.22%) and hypoglycaemia (22.22%). Conclusion: To conclude, the concomitant administration of amlodipine and atorvastatin is well tolerated and effective in reducing both blood pressure and lipid levels and in helping patients achieve their goals in cases of hypertension and dyslipidaemia.

Original languageEnglish
Pages (from-to)3144-3149
Number of pages6
JournalJournal of Clinical and Diagnostic Research
Volume4
Issue number5
Publication statusPublished - 25-11-2010
Externally publishedYes

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Blood pressure
Dyslipidemias
Blood Pressure
Safety
LDL Cholesterol
Lipids
Amlodipine
atorvastatin drug combination amlodipine
Cholesterol
Hyponatremia
Hypoglycemia
Triglycerides
Reading
Therapeutics
Head
Placebos
Guidelines
Hypertension
Pain

All Science Journal Classification (ASJC) codes

  • Clinical Biochemistry

Cite this

@article{3563d9630d1c4f7a97efd138f0b9b9a0,
title = "The efficacy and the safety of a fixed dose combination of amlodipine and atorvastatin in hypertensives with dyslipidaemia",
abstract = "Introduction: It was claimed that the amlodipine/atorvastatin combination improved the patient's achievement of national-guideline-recommended blood pressure and lipid target levels and exhibited a safety profile consistent with its parent compounds. The present study has been undertaken to evaluate the efficacy and the safety of a fixed dose combination of amlodipine with atorvastatin in the Indian population. Methods: The study was designed as a prospective, open labeled, noncomparative trial in 35 adult patients of mild to moderate essential hypertension with dyslipidaemia. The blood pressure criteria for inclusion was >140/90mmHg and less than 180/110mmHg. The dyslipidaemia criteria was LDL cholesterol>130mg/dl and triglycerides more than 150mg/dl. The patients were screened at baseline visit (Day 0) and at visit 2 (Day 4). The supine blood pressure was recorded by taking the mean of three readings. The blood pressure was measured again after a week during the placebo period (visit 3, day 10, week 1). The active medication (Combination of 5mg of amlodipine and 10mg of atorvastatin) started at visit 4 (day 17, week 2). The blood pressure was measured again during visit 5 (day 31, week 4), visit 6 (day 45, week 6) and visit 7 (day 60, week 8) by using the same instrument at all visits. Results: A total of 35 patients were included in the study, out of which 27 were males and eight were females. The average decrease of supine blood pressure from the baseline recording was 10.3± 3.62mmHg at the end of treatment, which was statistically highly significant (p=0.005). The average decrease of diastolic blood pressure was 9.51±2.13mmHg at the end of the treatment, which was also statistically highly significant (p=0.0002). A statistically significant decrease in the levels of total cholesterol and LDL cholesterol were observed during the treatment. The most common adverse events were hyponatraemia (25.93{\%}), head ache (22.22{\%}) and hypoglycaemia (22.22{\%}). Conclusion: To conclude, the concomitant administration of amlodipine and atorvastatin is well tolerated and effective in reducing both blood pressure and lipid levels and in helping patients achieve their goals in cases of hypertension and dyslipidaemia.",
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The efficacy and the safety of a fixed dose combination of amlodipine and atorvastatin in hypertensives with dyslipidaemia. / Mukta, N. C.; Prabha, A.; Ashok, S. K.; Nithyananda, C. K.

In: Journal of Clinical and Diagnostic Research, Vol. 4, No. 5, 25.11.2010, p. 3144-3149.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The efficacy and the safety of a fixed dose combination of amlodipine and atorvastatin in hypertensives with dyslipidaemia

AU - Mukta, N. C.

AU - Prabha, A.

AU - Ashok, S. K.

AU - Nithyananda, C. K.

PY - 2010/11/25

Y1 - 2010/11/25

N2 - Introduction: It was claimed that the amlodipine/atorvastatin combination improved the patient's achievement of national-guideline-recommended blood pressure and lipid target levels and exhibited a safety profile consistent with its parent compounds. The present study has been undertaken to evaluate the efficacy and the safety of a fixed dose combination of amlodipine with atorvastatin in the Indian population. Methods: The study was designed as a prospective, open labeled, noncomparative trial in 35 adult patients of mild to moderate essential hypertension with dyslipidaemia. The blood pressure criteria for inclusion was >140/90mmHg and less than 180/110mmHg. The dyslipidaemia criteria was LDL cholesterol>130mg/dl and triglycerides more than 150mg/dl. The patients were screened at baseline visit (Day 0) and at visit 2 (Day 4). The supine blood pressure was recorded by taking the mean of three readings. The blood pressure was measured again after a week during the placebo period (visit 3, day 10, week 1). The active medication (Combination of 5mg of amlodipine and 10mg of atorvastatin) started at visit 4 (day 17, week 2). The blood pressure was measured again during visit 5 (day 31, week 4), visit 6 (day 45, week 6) and visit 7 (day 60, week 8) by using the same instrument at all visits. Results: A total of 35 patients were included in the study, out of which 27 were males and eight were females. The average decrease of supine blood pressure from the baseline recording was 10.3± 3.62mmHg at the end of treatment, which was statistically highly significant (p=0.005). The average decrease of diastolic blood pressure was 9.51±2.13mmHg at the end of the treatment, which was also statistically highly significant (p=0.0002). A statistically significant decrease in the levels of total cholesterol and LDL cholesterol were observed during the treatment. The most common adverse events were hyponatraemia (25.93%), head ache (22.22%) and hypoglycaemia (22.22%). Conclusion: To conclude, the concomitant administration of amlodipine and atorvastatin is well tolerated and effective in reducing both blood pressure and lipid levels and in helping patients achieve their goals in cases of hypertension and dyslipidaemia.

AB - Introduction: It was claimed that the amlodipine/atorvastatin combination improved the patient's achievement of national-guideline-recommended blood pressure and lipid target levels and exhibited a safety profile consistent with its parent compounds. The present study has been undertaken to evaluate the efficacy and the safety of a fixed dose combination of amlodipine with atorvastatin in the Indian population. Methods: The study was designed as a prospective, open labeled, noncomparative trial in 35 adult patients of mild to moderate essential hypertension with dyslipidaemia. The blood pressure criteria for inclusion was >140/90mmHg and less than 180/110mmHg. The dyslipidaemia criteria was LDL cholesterol>130mg/dl and triglycerides more than 150mg/dl. The patients were screened at baseline visit (Day 0) and at visit 2 (Day 4). The supine blood pressure was recorded by taking the mean of three readings. The blood pressure was measured again after a week during the placebo period (visit 3, day 10, week 1). The active medication (Combination of 5mg of amlodipine and 10mg of atorvastatin) started at visit 4 (day 17, week 2). The blood pressure was measured again during visit 5 (day 31, week 4), visit 6 (day 45, week 6) and visit 7 (day 60, week 8) by using the same instrument at all visits. Results: A total of 35 patients were included in the study, out of which 27 were males and eight were females. The average decrease of supine blood pressure from the baseline recording was 10.3± 3.62mmHg at the end of treatment, which was statistically highly significant (p=0.005). The average decrease of diastolic blood pressure was 9.51±2.13mmHg at the end of the treatment, which was also statistically highly significant (p=0.0002). A statistically significant decrease in the levels of total cholesterol and LDL cholesterol were observed during the treatment. The most common adverse events were hyponatraemia (25.93%), head ache (22.22%) and hypoglycaemia (22.22%). Conclusion: To conclude, the concomitant administration of amlodipine and atorvastatin is well tolerated and effective in reducing both blood pressure and lipid levels and in helping patients achieve their goals in cases of hypertension and dyslipidaemia.

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