Efficacy and tolerability of telmisartan plus amlodipine in added-risk hypertensive patients

Abstract

Objectives:

Added-risk hypertensive patients with co-morbidities such as diabetes and metabolic syndrome often require two or more antihypertensives to achieve blood pressure (BP) targets. The aim of this sub-analysis was to determine the efficacy and safety of telmisartan 40 or 80 mg plus amlodipine 5 or 10 mg in patients with hypertension, stratified according to certain criteria such as type 2 diabetes mellitus and metabolic syndrome.

Methods:

Patients were treated for 8 weeks with telmisartan 20–80 mg plus amlodipine 2.5–10 mg. This post-hoc analysis included patients treated with higher doses, and stratified according to a number of sub-populations (age, race, diabetes, obesity, metabolic syndrome, elevated baseline systolic BP (SBP), renal impairment).

Results:

Eight weeks’ treatment with telmisartan plus amlodipine combinations provided consistent reductions in mean SBP/diastolic BP (DBP) across the different sub-populations, similar to the overall population. SBP/DBP reductions ranged from −13.5 to −34.7/−12.6 to −26.1 mmHg and BP goal rates (<140/90 mmHg) ranged from 29.8–100% for the four key dose combinations of telmisartan plus amlodipine. For the highest dose combination of telmisartan 80 mg plus amlodipine 10 mg, SBP/DBP reduction ranged from −19.1 to −34.7/−16.4 to −22.8 mmHg and goal attainment rate from 66.7% to 87.0%. Across the sub-populations, high SBP and DBP response rates were seen with combination treatment (83.3–97.7% and 75.0–95.7%, respectively, with telmisartan 80 mg plus amlodipine 10 mg). The combination was safe and well tolerated across all sub-populations and the incidence of peripheral oedema with telmisartan 40–80 mg plus amlodipine 10 mg was generally lower than with A10 monotherapy.

Conclusions:

Despite small patient numbers in some sub-populations and the post-hoc nature of the analysis, this does show that the combination of telmisartan plus amlodipine provides an effective, safe and well-tolerated antihypertensive treatment for added-risk hypertensive patients.

Key words::

• Added-risk
• Amlodipine
• Hypertension
• Obesity
• Telmisartan
• Type 2 diabetes mellitus

Transparency

Declaration of funding

The study reported was funded and sponsored by a grant from Boehringer Ingelheim International GmbH. The authors received no compensation related to the development of the manuscript.

Robert M. Guthrie^a

Björn Dahlöf^b

Kenneth A. Jamerson^c

Rafael Olvera^d

Mary Seeber^e

Wille Oigman^g

Declaration of financial/other relationships

H.S. is an employee of Boehringer Ingelheim.

Acknowledgments

Writing and editorial assistance was provided by Emma Fulkes PhD of PAREXEL, which was contracted by Boehringer Ingelheim International GmbH for these services. The authors state that they meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE) and were fully responsible for all content and editorial decisions, and were involved at all stages of manuscript development.

The authors would like to thank all study personnel who participated in the study, especially the Principal Investigators: Argentina: C Majul, 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: T Littlejohn, 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, 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, D Schumacher, 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 Maureen Kobe (Trial Clinical Monitor, Boehringer Ingelheim), Karen Shannon (Trial Data Manager, Boehringer Ingelheim), Steven Koval (Trial Statistician, Boehringer Ingelheim) and Ashish Singh (Director, Boehringer Ingelheim).

Previous presentations: Some of this material has been previously presented in poster format at 19th Scientific Meeting of the European Society of Hypertension, Milan, Italy, 12–16th June 2009.