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A Comparison of the Tolerability of the Direct Renin Inhibitor Aliskiren and Lisinopril in Patients with Severe Hypertension

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A Comparison of the Tolerability of the Direct Renin Inhibitor Aliskiren and Lisinopril in Patients with Severe Hypertension Journal of Human Hypertension (2007) 21, 780–787 & 2007 Nature Publishing Group All rights reserved 0950-9240/07 $30.00 www.nature.com/jhh ORIGINAL ARTICLE A comparison of the tolerability of the direct renin inhibitor aliskiren and lisinopril in patients with severe hypertension RH Strasser1, JG Puig2, C Farsang3, M Croket4,JLi5 and H van Ingen4 1Technical University Dresden, Heart Center, University Hospital, Dresden, Germany; 2Department of Internal Medicine, La Paz Hospital, Madrid, Spain; 31st Department of Internal Medicine, Semmelweis University, Budapest, Hungary; 4Novartis Pharma AG, Basel, Switzerland and 5Novartis Institutes for Biomedical Research, Cambridge, MA, USA Patients with severe hypertension (4180/110 mm Hg) LIS 3.4%). The most frequently reported AEs in both require large blood pressure (BP) reductions to reach groups were headache, nasopharyngitis and dizziness. recommended treatment goals (o140/90 mm Hg) and At end point, ALI showed similar mean reductions from usually require combination therapy to do so. This baseline to LIS in msDBP (ALI À18.5 mm Hg vs LIS 8-week, multicenter, randomized, double-blind, parallel- À20.1 mm Hg; mean treatment difference 1.7 mm Hg group study compared the tolerability and antihyperten- (95% confidence interval (CI) À1.0, 4.4)) and mean sitting sive efficacy of the novel direct renin inhibitor aliskiren systolic blood pressure (ALI À20.0 mm Hg vs LIS with the angiotensin converting enzyme inhibitor À22.3 mm Hg; mean treatment difference 2.8 mm Hg lisinopril in patients with severe hypertension (mean (95% CI À1.7, 7.4)). Responder rates (msDBPo90 mm Hg sitting diastolic blood pressure (msDBP)X105 mm Hg and/or reduction from baselineX10 mm Hg) were 81.5% and o120 mm Hg). In all, 183 patients were randomized with ALI and 87.9% with LIS. Approximately half of (2:1) to aliskiren 150 mg (n ¼ 125) or lisinopril 20 mg patients required the addition of HCTZ to achieve BP (n ¼ 58) with dose titration (to aliskiren 300 mg or control (ALI 53.6%; LIS 44.8%). In conclusion, ALI alone, lisinopril 40 mg) and subsequent addition of hydrochlor- or in combination with HCTZ, exhibits similar tolerability othiazide (HCTZ) if additional BP control was required. and antihypertensive efficacy to LIS alone, or in Aliskiren-based treatment (ALI) was similar to lisinopril- combination with HCTZ, in patients with severe hyper- based treatment (LIS) with respect to the proportion of tension. patients reporting an adverse event (AE; ALI 32.8%; LIS Journal of Human Hypertension (2007) 21, 780–787; 29.3%) or discontinuing treatment due to AEs (ALI 3.2%; doi:10.1038/sj.jhh.1002220; published online 31 May 2007 Keywords: aliskiren; renin–angiotensin system; angiotensin converting enzyme inhibitor; severe hypertension; thiazide diuretic; combination therapy Introduction 3 hypertension),2,3 with a treatment target of o140/ 90 mm Hg. Due to the large BP reductions required Patients with severe hypertension are at particularly for patients with severe hypertension to reach their high cardiovascular risk due to the direct and treatment goals, combination therapy is almost independent relationship between blood pressure invariably required. (BP) and the risk of mortality due to stroke and 1 Existing antihypertensive therapies are associated ischaemic heart disease. Current treatment guide- with high rates of discontinuation, despite the lines define severe hypertension as BP4160/100 mm proven clinical benefit of reducing BP.4,5 A recent Hg (stage 2 hypertension) or 4180/110 mm Hg (grade population-based study of 4100 000 patients with hypertension found that compliance with older drug Correspondence: Professor RH Strasser, Technische Universita¨t classes, such as diuretics, b-blockers and calcium Dresden, Herzzentrum Dresden, Universita¨tsklinik, Fetscherstr. channel blockers, was as low as 36–59% after 76, 01307 Dresden, Germany. 1year.5 Compliance was better with newer treatments, E-mail: [email protected] such as angiotensin converting enzyme (ACE) Trial registry: This trial is registered at ClinicalTrials.gov with inhibitors (62%) and angiotensin receptor blockers trial identifier NCT00219050. 5 Received 31 October 2006; revised 16 March 2007; accepted 17 (ARBs; 71%). These differences are suspected to be March 2007; published online 31 May 2007 due to the poor tolerability of some of these drugs.5 Tolerability of aliskiren in patients with severe hypertension RH Strasser et al 781 Significant adverse events (AEs) associated with the study drugs; and known or suspected contra- conventional antihypertensive drug classes include indications to the study medications. fatigue or dizziness in 16% of patients receiving The study was performed in compliance with the b-blockers,6 Oedema in up to 70% of patients Guidelines for Good Clinical Practice and the receiving calcium channel blockers6,7 and a dry, Declaration of Helsinki of the World Medical non-productive cough in 5–35% of patients receiv- Association, and received approval by the appro- ing treatment with ACE inhibitors.6,8,9 However, this priate independent ethics committees. All partici- does not explain the poor compliance observed with pants gave written informed consent before any diuretics, which have few symptomatic side effects.5 study-related procedure. Inhibitors of the renin system, such as ACE inhibitors and ARBs, do not provide optimal suppression of the renin system as they stimulate a Study design reactive increase in plasma renin activity, which This was an 8-week, randomized, double-blind, may ultimately lead to elevated angiotensin II active-controlled, parallel-group study of aliskiren levels.10 Consequently, direct inhibition of renin compared with lisinopril (both with the optional (that is, targeting the renin system at its point of addition of HCTZ to achieve BP control) in adult activation) has long been proposed as the most patients with uncomplicated severe hypertension. promising means of inhibiting the renin system.11 Owing to the severity of the disease, the use of a Aliskiren will be the first in a new class of oral placebo treatment was not employed. Lisinopril was direct renin inhibitors for the treatment of hyperten- selected as an active control because it is commonly sion. Aliskiren is a highly potent inhibitor of human used to treat patients with severe hypertension. renin in vitro (IC50 ¼ 0.6 nmol/l) and in healthy The primary objective of this study was volunteers.12,13 Studies in patients with mild- to compare the tolerability of aliskiren-based treat- to-moderate hypertension (ESH-ESC grade 1 or 2, ment with treatment based on the ACE inhibitor, or JNC7 stage 1) have shown that aliskiren provides lisinopril. The BP-lowering efficacy of these two similar antihypertensive efficacy and tolerability to treatments was a secondary objective of this study. ARBs,14,15 and that addition of hydrochlorothiazide The study consisted of three periods (Figure 1). (HCTZ) to aliskiren produces significant additional Eligibility for study entry was assessed at an initial BP-lowering effects with maintained good tolerabil- study visit and eligible patients then entered a ity.16 Aliskiren alone or in combination with HCTZ washout phase (period 1) of up to 10 days, during has also been shown to provide highly effective BP which all other antihypertensive medications were lowering with excellent tolerability over X1-year withdrawn. However, due to the severity of hyper- period of treatment.17 tension, and the potential increased cardiovascular The aim of the present study was to assess the risk associated with the withdrawal of antihyper- tolerability and antihypertensive efficacy of aliskiren- tensive medication, the washout period was de- based treatment compared with treatment based on signed to minimize the length of time patients the ACE inhibitor, lisinopril, in patients with severe remained untreated. Consequently, antihypertensive hypertension. medications were withdrawn for a minimum of 3 days and all participants with an msDBPX105 mm Hg and o120 mm Hg at the end of the washout Materials and methods period proceeded immediately to the active treat- ment phase of the study (period 3). Patients with Study population msDBPX85 mm Hg and o105 mm Hg after the This study enrolled 194 patients aged X18 years washout phase entered a single-blind placebo run- with uncomplicated severe hypertension (mean in of 1–3 weeks (period 2). During this period, BP sitting diastolic blood pressure (msDBP)X105 mm Hg was monitored weekly up to a maximum of 3 weeks and o120 mm Hg) from 12 study centres in to assess eligibility for randomization (msDBPX Germany, 9 in Spain and 5 in Hungary. 105 mm Hg and o120 mm Hg). Participants who Exclusion criteria included a history or evidence failed to meet the eligibility criteria after 3 weeks of secondary hypertension; antihypertensive treat- were discontinued from the study. Any patient with ment with more than three classes of antihyperten- an msDBPX120 mm Hg and/or a mean sitting sive medication; diabetes mellitus requiring insulin systolic blood pressure (msSBP)X200 mm Hg at treatment; type II diabetes mellitus with poor any time during the washout or single-blind placebo glucose control (HbA1C48% at Visit 1); diagnosed run-in periods was immediately discontinued from heart failure; history of myocardial infarction, cor- the study. onary bypass surgery, or any percutaneous coronary In period 3, all patients who met the inclusion intervention; angina pectoris; potentially life- criteria were randomized in a 2:1 ratio to receive threatening arrhythmia or symptomatic arrhythmia aliskiren 150 mg or lisinopril 20 mg once daily. BP or other life-threatening disease; any surgical or was assessed weekly for the first 2 weeks and medical condition that might significantly alter the every 2 weeks thereafter. For patients with msDBPX absorption, distribution, metabolism or excretion of 110 mm Hg or msSBPX180 mm Hg at the end of Journal of Human Hypertension Tolerability of aliskiren in patients with severe hypertension RH Strasser et al 782 Figure 1 Study design.
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