The Effects of Telmisartan and Amlodipine in Treatment-Naïve and Previously Treated Hypertensive Patients: A Subanalysis from a 4 × 4 Factorial Design Study

Abstract

The subanalysis of a 4 × 4 factorial, 8-week study to evaluate the efficacy and tolerability of telmisartan (T) 40–80 mg/amlodipine (A) 5–10 mg used in treatment-naïve patients (n = 231) and patients previously treated with antihypertensive agents (n = 880). Similar blood pressure (BP) reductions were achieved with T + A, regardless of their pretreatment status. Highest reductions were achieved with T80 + A10 (treatment-naïve −26.5/−18.2 mm Hg and previously treated −25.6/−19.9 mm Hg). Most patients (treatment-naïve 72.4% and previously treated 77.6%), including those with added risk, achieved BP goal (<140/90 mm Hg) with T80 + A10. Tolerability was comparable in both groups.

Trial registration: ClinicalTrials.gov identifier: NCT00281580.

• added risk
• amlodipine
• antihypertensive
• hypertension
• telmisartan
• treatment-naïve

ACKNOWLEDGMENTS

Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Emma Fulkes, PhD, of PAREXEL during the preparation of this article.

The authors would like to thank all study personnel who participated in the study, especially the principal investigators: Argentina: H Baglivo, M Bendersky, E Kuschnir, P Rodriguez, A Villamil; Brazil: J Felicio, P Jardim, O Kohlman, D Mion Jr; Mexico: M Alpizar, R Alvarado, J Illescas, A Meaney, J Parra, R Peralta, I Rodriguez, H Sanchez, S Trevethan; South Africa: D Bernhardi, A Briel, S Chetty, E Janari, J Jurgens, C Kahanowitz, D Lakha, H Makan, I Mitha, P Nel, P Patel, Z Vawda, N Wellington; USA: J Agaiby, J Anderson, G Balaji, H Bays, N Bertini, W Bestermann Jr, K Blaze, A Borge, J Boscia III, T Brobyn, J Brodnan, V Brown, T Cavalieri, C Chappel, A Chen, D Cheung, S Christensen, S Chrysant, C Cooper, T Copeland, C De Busk, D DeSantis, B Douglas, J Ervin, P Fiacco, T Fiel, J George, L Gilderman, R Gilman, R Glover III, A Goetsch, R Graf, A Graff, M Graves, J Gutmann, C Hall, W Harper, D Henry, H Hidalgo Jr, J Holland, D Honeycutt, C Johnson, A Khan, B Khan, P Klaassen, M Kozinn, S Kreis, K Layne, J Lee, A Lewin, C-S Liang, L Ligon, T Linder, R Lipetz, TW Littlejohn III, M Lucas, R Marple, J Meli, C Mello, R Middleton, S Mion-Bet, K Mootoo, A Murray, J Naidu, P Narayan, J Navarro, J Neutel, A Niederman, R Noble, A Patron, F Phillips, W Pleskow, H Punzi, G Raad, T Raoof, P Raskin, A Razzetti, L Reed, H Resnick, J Schmidt, R Schreiman, M Seidner, K Self, G Serfer, W Shapiro, J Silverfield, S Slabic, R Sockolov, J Sparks, R Struble, C Thompson, P Toth, T Treimer, P Vrooman, D Webster, G Willis, S Willsie, D Wright, S Yates. The authors would also like to thank Karen Shannon (Trial Data Manager, Boehringer Ingelheim), Steven Koval (Trial Statistician, Boehringer Ingelheim), and Ashish Singh (Director, Boehringer Ingelheim).