Abstract
Longitudinal analysis of an antihypertensive trial comparing the single pill combination of telmisartan and amlodipine with their monotreatments Nanshi Sha,1 Naitee Ting,1 Ludwin Ley,2 Helmut Schumacher2 1Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 2Boehringer-Ingelheim Pharma GmbH and Co, KG, Ingelheim, Germany Abstract: An 8-week clinical trial was designed to evaluate the efficacy of the single pill combination (SPC) of telmisartan and amlodipine in treating patients with severe hypertension. The primary endpoint was change from baseline in mean (seated trough cuff) systolic blood pressure (SBP) following 8 weeks of treatment. Secondary endpoints included changes in SBP from baseline to weeks 6, 4, 2, and 1. In order to demonstrate superiority of the SPC, statistical significance has to be achieved in comparisons with both components (telmisartan and amlodipine). In this paper, various approaches are applied to analyze this set of longitudinal data. Superiority of SPC over each component drug can be established for all time points, starting from week 1. The clinical conclusion is robust regardless of the longitudinal analysis methodologies being applied. Keywords: amlodipine, telmisartan, longitudinal data analysis, last observation carried forward, mixed model repeated measures, grouping method
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