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

*, Mukta NC and *, Prabha A and *, Ashok SK and *, Nithyananda CK (2010) The efficacy and the safety of a fixed dose combination of amlodipine and atorvastatin in hypertensives with dyslipidaemia. Journal of Clinical and Diagnostic Research, 4 (5). pp. 3144-3149.

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Abstract

Introduction: It was claimed that the amlodipine/atorvastatin combination improved the patient’s achievement of national-guideline-recommended blood pressure and lipid targetlevels and exhibited a safety profile consistent with its parent compounds. The presentstudy has been undertaken to evaluate the efficacy and the safety of a fixed dosecombination of amlodipine with atorvastatin in the Indian population. Methods: The study was designed as a prospective, open labeled, noncomparative trial in35 adult patients of mild to moderate essential hypertension with dyslipidaemia. Theblood pressure criteria for inclusion was >140/90mmHg and less than 180/110mmHg. Thedyslipidaemia criteria was LDL cholesterol>130mg/dl and triglycerides more than150mg/dl. The patients were screened at baseline visit (Day 0) and at visit 2 (Day 4). Thesupine blood pressure was recorded by taking the mean of three readings. The bloodpressure was measured again after a week during the placebo period (visit 3, day 10, week1). 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 sameinstrument at all visits. Results: A total of 35 patients were included in the study, out of which 27 were malesand eight were females. The average decrease of supine blood pressure from thebaseline recording was 10.3+ 3.62mmHg at the end of treatment, which was statisticallyhighly significant (p=0.005). The average decrease of diastolic blood pressure was9.51+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 LDLcholesterol were observed during the treatment. The most common adverse events werehyponatraemia (25.93%), head ache (22.22%) and hypoglycaemia (22.22%). Conclusion: To conclude, the concomitant administration of amlodipine and atorvastatinis well tolerated and effective in reducing both blood pressure and lipid levels and inhelping patients achieve their goals in cases of hypertension and dyslipidaemia.

Item Type: Article
Uncontrolled Keywords: Amlodipine, atorvastatin, hypertension, dyslipidaemia.
Subjects: Medicine > KMC Mangalore > Pharmacology
Medicine > KMC Mangalore > Medicine
Depositing User: KMCMLR User
Date Deposited: 23 Sep 2011 06:18
Last Modified: 18 Oct 2011 06:04
URI: http://eprints.manipal.edu/id/eprint/1376

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