EXTENSION OF META-ANALYSIS IN COMPARING OF FIMASARTAN WITH LOSARTAN IN BLOOD PRESSURE LOWERING EFFECT
Author(s)
Na Y, Lee EKSookmyung Women's University, Seoul, South Korea
OBJECTIVES: A new drug fimasartan had been developed and currently approved in Korea for treating essential hypertension. This study aimed to identify whether main results of direct comparative study maintains consistency with those of extension of meta-analysis in the blood pressure lowering effect of fimasartan with losartan. METHODS: Systematic reviews of literatures of clinical trials including fimasartan or losartan were conducted. The blood pressure change from baseline were used as an effectiveness measure and was pooled in RevMan 4.0. For direct comparison, the head-to-head randomized controlled trial (RCT) of fimasartan and losartan was used. For indirect comparison, it followed to method of adjusted indirect comparison (Bucher 1997) using common comparator and used ITC (Indirect Treatment Comparison) program (CADTH). In addition, Bayesian mixed treatment comparison (MTC) was performed on which combines whole pairwise comparison studies together by WinBugs program. After that, the results were compared with that of a direct comparison. RESULTS: In regard to direct comparison, there is the only head-to-head trial (Phase III) report of comparing fimasartan with losartan, which had conducted locally. For indirect comparison, the search identified one report of the trial of comparing fimasartan with placebo (Phase IIb), and the 6 of articles of comparing losartan with placebo were selected and measured estimates were pooled. The change in reduction in diastolic blood pressure of losartan and fimasartan versus placebo was -2.7 mmHg as direct estimate retrieved from RCT, and -3.315 mmHg as combined estimate through MTC analysis, respectively. In SBP reduction, it was -4.3 mmHg and -3.995 mmHg respectively. CONCLUSIONS: This study found that estimates obtained from indirect comparison were similar with those of direct. The results from the two comparison methods both indicated consistently that the antihypertensive effect of fimasartan is better than losartan.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PCV112
Topic
Methodological & Statistical Research
Topic Subcategory
Confounding, Selection Bias Correction, Causal Inference
Disease
Cardiovascular Disorders