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Comparative efficacy and safety of aliskiren and irbesartan in patients with hypertension and metabolic syndrome

Journal of Human Hypertension volume 25, pages 186–195 (2011)Cite this article

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Abstract

Metabolic syndrome, a cluster of risk factors that increase the risk of cardiovascular morbidity and mortality, is common in patients with hypertension. Chronic renin–angiotensin–aldosterone system (RAAS) activation, shown by elevated plasma renin activity (PRA), is implicated in many of the features of metabolic syndrome. The direct renin inhibitor aliskiren may be of benefit in this patient group as aliskiren targets the RAAS at the rate-limiting step. In this double-blind study, 141 patients with hypertension (mean baseline BP 155/93 mm Hg) and metabolic syndrome (modified National Cholesterol Education Program ATP III criteria) were randomized to aliskiren 300 mg or irbesartan 300 mg once daily. Patients treated with aliskiren 300 mg had their mean sitting blood pressure (BP) lowered by 13.8/7.1 mm Hg after 12 weeks, significantly greater (P⩽0.001) than the 5.8/2.8 mm Hg reduction observed in patients treated with irbesartan 300 mg. A significantly greater proportion of patients treated with aliskiren achieved BP control to <135/85 mm Hg (29.2 vs 16.7% with irbesartan; P=0.019). Aliskiren treatment led to a 60% decrease in PRA from baseline, whereas irbesartan increased PRA by 99% (both P<0.001). Aliskiren and irbesartan had similar effects on glucose and lipid profiles and on a panel of biomarkers of inflammation and cardiovascular risk. Both aliskiren and irbesartan were well tolerated. Collectively, these results suggest that aliskiren 300 mg may offer treatment benefits compared with irbesartan 300 mg for BP reduction in patients with hypertension and metabolic syndrome.

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Acknowledgements

WK, MB, IR, MF, C-MY and WPD participated in the design of the original study and approval of the final protocol. All authors were involved in the collection, analysis and interpretation of the data, and in the writing of the article, and approved the final version. The authors take full responsibility for the content of the paper but thank Dr Richard White (Oxford PharmaGenesis Ltd) for medical writing support, editorial assistance, and collation and incorporation of comments from all authors. This work was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. A full list of investigators can be found in the Appendix.

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Authors and Affiliations

  1. Klinik II und Poliklinik für Innere Medizin, Zentrum für Molekulare Medizin der Universität zu Köln, Cologne, Germany

    W Krone

  2. Centre for Clinical Studies, GWT-TUD GmbH, Dresden, Germany

    M Hanefeld

  3. Facharzt für Allgemeinmedizin, Marl, Germany

    H-F Meyer

  4. Facharzt für Allgemeinmedizin, Deggingen, Germany

    T Jung

  5. Novartis Institutes for Biomedical Research, Basel, Switzerland

    M Bartlett & I Rajman

  6. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

    C-M Yeh & M F Prescott

  7. Novartis Institutes for Biomedical Research Inc., Cambridge, MA, USA

    W P Dole

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Correspondence to W Krone.

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Competing interests

WK has received honoraria from MSD Sharp & Dohme, Takeda, Sanofi, Daiichi Sankyo, and has an advisory board relationship with MSD Sharp & Dohme and a research grant from Bayer Healthcare. MB and IR (Novartis Institutes for Biomedical Research, Basel, Switzerland), C-MY and MFP (Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) and WPD (Novartis Institutes for Biomedical Research Inc., Cambridge, MA, USA) are employees of Novartis and are therefore eligible for Novartis stock and stock options. MH, H-FM and TJ declare no conflicts of interest.

Appendix

Appendix

List of investigators

Mathias Böhme (Dresden), Gerald Eckhardt (Leipzig), Andreas Haack (Schauenburg), Markolf Hanefeld (Dresden), Uwe Jorns (Trossingen), Thomas Jung (Deggingen), Michael Klamm (Neuhofen), Wilhelm Krone (Köln), Peter Krupp (Bad Zwischenahn), Anja Leker (Greven), Marco Loddo (Rastede), Marion Mielke (Berlin), Hans-Friedrich Meyer (Marl), Ingomar FK Naudts (Rodgau), Gerhard Neumann (Delitzsch), Ulrich Poser (Leipzig), Matthias Remppis (Weissenhorn), Andreas Schreckenberg (Weyhe), Bastian Steinberg (Hamburg), Joachim Weimer (Reinfeld), Bernhard Winkelmann (Frankfurt-Sachsenhausen), Hans-Hermann Zimny (Bad Pyrmont), Angelika Zscherpe (Leipzig).

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Krone, W., Hanefeld, M., Meyer, HF. et al. Comparative efficacy and safety of aliskiren and irbesartan in patients with hypertension and metabolic syndrome. J Hum Hypertens 25, 186–195 (2011). https://doi.org/10.1038/jhh.2010.38

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