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A post marketing surveillance study to evaluate the efficacy and safety of fixed dose Amlodipine - Losartan potassium for the treatment of hypertension in the Philippines.


Cristy Mendoza,
Lucky Cuenza

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Publication Information

Publication Type
Publication Sub Type
Clinical trials/Clinical investigations (RCT
Philippine Journal of Internal Medicine
Publication Date
January-March 2016


BACKGROUND: This open label post marketing study was conducted to determine the efficacy and safety of a fixed dose combination of amlodipine - losartan in the treatment of hypertension in Filipino patients.

METHODS: Eight hundred eighteen (818) male and female ambulatory patients aged 18-70 years with mild to moderate hypertension who were initially not responding to monotherapy were enrolled. Patients were prescribed (amlodipine 5mg - losartan potassium 50mg) as therapy. The primary end point was the change from baseline to sixth week in in both systolic and diastolic blood pressure. Details of any adverse event reported or noted during the treatment with the combination were recorded.

RESULTS: There were 680 patients eligible for efficacy analysis. Mean age of patients was 53.36 ±11.3 years. One hundred twenty eight (15.6%) had dyslipidemia, 139 (16.9) had diabetes, while 7.7% had previously diagnosed cardiovascular disease. At baseline, patients had a mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 159 ± 18.3 mmHg and 96 ± 10.8 mmHg respectively. There was a statistically significant (P < 0.001) mean reduction of 30.87 ± 16.98 mmHg in SBP and 15.10 ± 10.68 mmHg in DBP at the end of follow up. By the 6th week 79.6% of patients achieved adequate SBP control of sat the while 76.6% had optimal diastolic BP. The differences in blood pressure were all statistically significant even when accounting for other comorbidities. Adverse events were noted in 2.9% with headache and peripheral edema being the most common side effects reported.

CONCLUSION: The results demonstrate that a fixed dose combination of amlodipine - losartan provides an effective and generally well-tolerated treatment option for hypertension in Filipino patients especially those with multiple cardiovascular risk factors who are unresponsive to monotherapy.

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