New Data Confirm That Diovan(R) And Valsartan-Based Combinations Offer Patients Sustained, 24-hr BP-lowering Efficacy

Main Category: Hypertension
Article Date: 15 Jun 2009 - 3:00 PDT

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Data presented at the 19th Scientific Meeting of the European Society of Hypertension (ESH) confirm that Diovan® (valsartan) and valsartan-based combinations deliver sustained, 24-hr blood pressure (BP)-lowering efficacy2-6.

Studies have suggested that the relative risks of acute myocardial infarction, stroke and sudden cardiac death are 40%, 49% and 29% higher, respectively, when the period between 6 a.m. and noon is compared to the rest of the day1. Increases in heart rate and BP are known to occur as a person awakens from sleep; the renin-angiotensin system (RAS) is also activated, possibly contributing to the morning BP rise1.

"Blood pressure evaluation over 24 hours, as measured by ambulatory blood pressure monitoring, is an accurate and important way to assess the effectiveness of an antihypertensive therapy," said Professor Rainer Düsing, Department of Cardiovascular Medicine, University of Bonn, Germany. "If we can reduce and control blood pressure, and minimize the early-morning blood pressure surge in patients at high cardiovascular risk, we may have a better chance of improving patient outcomes."

Results from five separate studies presented at ESH (EVALUATE2, VITAE3, EXPERT4, VALOROUS5 and 'Study 2302'6) confirm that Diovan®, Co-Diovan® (valsartan/hydrochlorothiazide [HCT]), Exforge® (valsartan/amlodipine) and Exforge HCT® (valsartan/amlodipine/HCT) effectively reduce BP over the full 24-hour period. In addition, valsartan-based triple therapy was associated with greater reductions in ambulatory BP throughout the 24-hour period, when compared to respective dual combinations6. Exforge HCT was approved in the United States in April 2009 by the US Food and Drug Administration (FDA) for second-line treatment of hypertension7, and is currently undergoing regulatory review in the European Union.

Study Highlights:

- Results from the EVALUATE2 study, involving 482 patients with Stage 2 hypertension (JNC 7), demonstrated that Co-Diovan provided significantly greater reductions at the end of the study in both daytime and night-time mean ambulatory BP (ABP) than the combination of amlodipine/HCT (p≤0.05). In addition, significantly more patients achieved ABP goal (<130/80 mmHg) in the Co-Diovan group (p=0.02).

- In an ABPM sub-analysis of the VITAE3 study presented at ESH, involving 111 pre-diabetic, obese patients with high BP, valsartan/HCT provided more effective and consistent 24-hour systolic BP control than amlodipine/HCT (p<0.05).

- Presented for the first time at ESH, the ExPERT4 study, involving 479 patients with essential hypertension, demonstrated that once-daily Exforge achieved consistently effective 24-hour BP reductions in patients uncontrolled on amlodipine 5 mg (SBP/DBP >125/80 mmHg over 30-hour ABPM reading), whether it was administered in the morning or in the evening (-11.5 ± 10 and -10.2 ± 9 mmHg, respectively; both p<0.001).

- The VALOROUS5 study, involving 1,093 patients with high BP, evaluated the 24-hour BP-lowering efficacy of Diovan 320 mg taken either in the morning or evening, compared to a 40 mg morning dose of the ACE-inhibitor lisinopril. The study demonstrated that once-daily dosing of Diovan was better tolerated than lisinopril, and showed similar efficacy over 24 hours.

- A sub-analysis of the pivotal Exforge HCT 2302 study6, involving 283 patients with moderate-to-severe high BP, showed that triple therapy produced significantly greater reductions in both mean systolic and diastolic 24-hour ABP (p<0.0001 for all) and also in daytime and night-time ABP (p<0.003 for all) compared to each dual therapy combination. Furthermore, greater reductions in ABP were observed with triple therapy compared to the dual therapies for every hourly mean over the 24-hour period.

"With its proven 24-hour blood pressure-lowering efficacy, we have even more evidence to support valsartan's continued use worldwide as the foundation therapy for high blood pressure," said Ameet Nathwani, Global Head of Development, CVM Franchise at Novartis Pharma AG. "In addition, Novartis' proven and trusted valsartan-based single-pill combinations offer patients the convenience of a lower pill burden. With the recent approval of Exforge HCT in the US, Novartis now offers physicians a unique portfolio of treatment options that maximize the chance of patients being able to experience success in meeting blood pressure goals."

The core of the Novartis portfolio is its cardiovascular medications for the treatment of high BP and diabetes. These include Diovan® (valsartan), the number one selling antihypertensive worldwide7; Exforge® (valsartan and amlodipine), a single pill combining two leading medicines for high BP, and Rasilez® (aliskiren), the first and only approved direct renin inhibitor. For treatment of type 2 diabetes, this includes Galvus® (vildagliptin, a novel DPP-4 inhibitor) and Eucreas® (vildagliptin and metformin).

References

1. White WB. Importance of blood pressure control over a 24-hour period. J Manag Care Pharm 2007;13(8 Suppl B):34-9.

2. Black HR, et al. Comparison of 24-hour ambulatory blood pressure response with combination of valsartan/hydrochlorothiazide and amlodipine/hydrochlorothiazide in patients with stage 2 hypertension. 19th Scientific Meeting of the European Society of Hypertension, June 14, 2009; Abstract No. 1168. Updated information presented at meeting.

3. Raij L, et al. Combination of valsartan/hydrochlorothiazide provides improved 24-hour blood pressure response compared with amlodipine/hydrochlorothiazide in prediabetic, obese, hypertensive patients. 19th Scientific Meeting of the European Society of Hypertension, June 14, 2009; Abstract No. 1170. Updated information presented at meeting.

4. Asmar R, et al. Efficacy on blood pressure control, in essential hypertensive patients uncontrolled with amlodipine 5 mg of an amlodipine / valsartan combination: ExPERT Study. 19th Scientific Meeting of the European Society of Hypertension, June 13, 2009; Abstract No. 714.

5. Palatini P, et al. The 24 hour blood pressure lowering efficacy of morning versus evening administration of valsartan compared to lisinopril based therapy in patients with hypertension. 19th Scientific Meeting of the European Society of Hypertension, June 14, 2009; Abstract No. 907. Updated information presented at meeting.

6. Lacourciere Y, et al. Twenty-four hour ambulatory BP control of therapy with amlodipine/valsartan/HCTZ triple combination compared to dual therapy in patients with moderate to severe hypertension. 19th Scientific Meeting of the European Society of Hypertension, June 14, 2009; Abstract No. 1412. Updated information presented at meeting.

7. IMS MIDAS sales data, May 2009.

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Novartis