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Submitted: 01 September 2007
HERDIN Record #: PCHRD083107050836

A local study on Alternative Brand's efficacy and safety in hypertensive patients (Alab study).

A Gurango,
J A. Bautista,
G Vilela,
R Rosas,
R Pesebre,
L Durante,
H Bautista,
J Yulde,
R Rangel,
G Pangwi,
W Camarao,
R Jr Abarquez,
Z Uy,
R Ramboyong

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Background: Felodipine, a dihydropyridine calcium antagonist, causes arteriolar dilatation through a selective action on smooth muscle in the resistance vessels and has been shown to be effective and well-tolerated in lowering the blood pressure in various clinical trials.

Objectives: To compare the antihypertensive effect and tolerability of a new felodipine brand with the innovator brand in Filipino patients with mild to moderate hypertension.

Methods: Multicenter, randomized, parallel-group study, patients received four weeks of treatment with a new felodipine brand (Group A) or the innovator brand (Group B). The efficacy variables were, mean BP reduction from baseline, response rate (drop of 15 mmHg in SBP AMD/OR 10 mmHg in DBF) and rate of normalized BP (BP < 140/90 mmHg) at Week 4. The frequency and nature of adverse events were assessed.

Results: One hundred seventy four (Group A 85; Group B 89) of the 207 enrolled patients in the study successfully completed the trial. Data from all subjects were analyzed by intention to treat (ITT) analysis and efficacy analysis. For the ITT analysis, the mean change in SBP on the fourth week was 20.22 mmHg and 21.35 mmHg (p-0.59) and DBP was reduced by 11.91 mmHg and 11.72 mmHg
(p = 0.11) in the new felodipine brand and the innovator brand groups respectively. The response rate was 75 percent and 78.64 percent (p = 0.53) while the normalized rate 79.81 percent and 74.76 percent (p-0.38) in groups A and B respectively. For the efficacy analysis, the mean reduction in the SBP at week 4 was 23.78 mmHg and 23.46 mmHg (p = 0.88) while the mean reduction of DBP was 14.01 and 13.02 (p=0.42) in the new felodipine brand and innovator brand groups respectively. There was an 88 percent and 85.39 percent response rate (p = 0.58) and 92.94 percent and 82.02 percent normalized rate in the new felodipine brand and innovator brand groups, respectively. The most common AEs in both groups were headache, palpitations, ankle edema, and muscle pain. The incidence of the adverse events (AEs) was not statistically different between the two groups. There were no significant clinical differences in the baseline and week 4 laboratory values.

Conclusions: Four weeks of treatment with the new felodipine brand produced significant reductions in BP in patients with mild to moderate HPN. The efficacy of this new brand is clinically and statistically similar to the innovator brand. Safety and tolerability was comparable between the two treatment groups. (Author)

Publication Type
Journal
Publication Sub Type
Others
Title
Philippine Journal of Internal Medicine
Frequency
Bimonthly
Publication Date
November-December 2006
Volume
44
Issue
6
Page(s)
329-338

Objectives

To compare the antihypertensive effect and tolerability of a new felodipine brand with the innovator brand in Filipino patients with mild to moderate hypertension.

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Philippine Council for Health Research and Development Library Abstract Print Format (Request Document)