The Centre of Research Excellence (CRE) to Reduce Inequality in Heart Disease focuses on improving the heart health and outcomes of groups and communities i.e. Regional Australians, Indigenous Australians and International Health

VIPER-BP Study

Research Stream: Regional Australians

 

VIPER.JPG - largeThe Valsartan Intensified Primary carE Reduction of Blood Pressure Study was one of the largest contemporary studies involving more than 250 GPs and 2185 uncontrolled hypertensive patients in primary care settings across Australia.

 

Full Study Title

The Valsartan Intensified Primary carE Reduction of Blood Pressure Study: The VIPER-BP Study

 

Trial Registration

ClinicalTrials.gov Registry (NCT00902304) (http://clinicaltrials.gov)

 

Funding Source

VIPER-BP was an investigator-led study sponsored by Novartis Pharmaceuticals Ltd.

 

Rationale for the Study

This VIPER-BP study reflects the need to ‘strike’ hard and fast to reduce high levels of blood pressure and achieve targets set by our National Heart Foundation. The main objective was to find out the best way to treat high blood pressure in the community, we compared usual care management with an intensive-structured care and guided approach to reduce high levels of blood pressure. We supported GPs with practical ways to achieve this goal.

 

Study Aims

To evaluate the efficacy of an intensive blood pressure management strategy relative to usual care in a primary care setting, using a number of currently available forms of valsartan therapy (single and in combination with a thiazide diuretic or calcium channel blocker), to achieve blood pressure control at 26 weeks of active management in patients who have a sub-optimal blood pressure (with or without current antihypertensive treatment) relative to the current National Heart Foundation of Australia expert guidelines.

 

Study Design

 

Figure 1 - Study Schema

 

The VIPER-BP Study was a prospective, multi-centre, open-label randomised controlled trial involving 119 primary care clinics and 2,185 patients with sub-optimal blood pressures (according to 2008 NHFA criteria) recruited from primary care practices throughout Australia; this included more than 200 hypertensive patients living in rural/regional Australia. Figure 1 (see below) shows the key schema of the study.

 

Briefly, the VIPER-BP intervention comprised: 1) automated CV risk profiling and recommendations; 2) standardised guideline-based, step-wise pharmacological treatment (initial angiotensin receptor blocker [ARB] mono-therapy or two forms of single pill ARB combination therapy) and 3) computer assisted intensified follow-up and treatment titration to achieve individual BP target.

 

Primary Endpoint: The primary endpoint was the percent of patients randomised to the usual care treatment group versus VIPER-BP intervention treatment group who have achieved their pre-specified (individualised NHFA criteria) blood pressure target at 26 weeks.

 

Secondary Endpoints: Change in mean sitting systolic and diastolic blood pressure from baseline (visit 4) to 26 weeks (visit 9), rate of adverse events attributable to anti-hypertensive therapy and changes in anti-hypertensive therapy related to adverse events, and the proportion of ‘early responders’ who achieve individualised blood pressure control (recorded at pre-specified study visits) after one or two adjustments in anti-hypertensive therapy. During the 26 week follow-up period: changes in absolute cardiovascular risk, quality of life, depression, evidence of end-organ damage, self-care and treatment compliance. Major clinical end-points (at 26 weeks) were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure).

 

Primary Outcomes

On an intention-to-treat basis, individual target blood pressure was achieved in 358/988 (36.2%) intervention versus 138/504 (27.4%) usual care patients: RR 1.28, 95%CI 1.10-1.49, p=0.0013. Overall, 180/295 (61.0%), 153/524 (29.2%) and 25/169 (14.8%) intervention patients achieved their blood pressure target of ≤ 140/90, 130/80 and 125/75 mmHg versus 69/140 (49.3%), 60/277 (21.7%) and 9/87 (10.3%) of usual care patients. The intervention group achieved a mean blood pressure reduction of 13.2 (95% CI -12.3 to -14.2) / 7.7 (95% CI -7.1 to -8.3) mmHg versus 10.1 (95% CI -11.3 to -8.8) / 5.5 (95% CI - 4.7 to -6.2) mmHg in the usual care group (pversus272/504 (54.0%) usual care patients achieved the classical blood pressure target of ≤ 140/90 mmHg: RR 1.18, 95% CI 1.07-1.29, p

 

Study Conclusions & Translational Potential

Our data showed that a computer-assisted blood pressure management approach resulted in significantly higher control rates in a primary care setting. However, achieving currently advocated risk-based blood pressure targets remains challenging. The challenge of translating the study results into clinical practice were made easier by the size and scope of the study and the fact that it was conducted in a ‘real-world’ setting with patients who previously remained above their individual blood pressure target despite previous management and treatment.

 

Ongoing Research

This pragmatic randomised controlled study demonstrated that the composite strategy of effective pharmacotherapy plus structured/intensive BP management has the potential to dramatically improve the blood pressure profile of particularly high risk patients in the primary care setting. Overall, VIPER-BP may well prove to be the template for other pragmatic effectiveness trials that combined pharmacotherapy with structured approaches to the detection, risk profiling and management of high risk individuals requiring long-term treatment for a chronic condition.

 

Key Collaborators

  • Novartis Pharmaceuticals Australia
  • Professor Simon Stewart: Australian Catholic University, Australia 
  • Associate Professor Melinda Carrington: Australian Catholic University, Australia
  • Dr Carla H Swemmer: Novartis Pharmaceuticals Australia
  • Professor Craig Anderson:The George Institute
  • Dr Nicol P Kurstjens: Novartis Pharmaceuticals Australia
  • Associate Professor John Amerena: Deakin University
  • Professor Alex Brown: SAHMRI, South Australian Health and Medical Research Institute, Aboriginal Research Unit
  • Dr Louise M Burrell: University of Melbourne
  • Dr Ferdinandus J de Looze: University of Queensland
  • Professor Mark Harris: University of New South Wales
  • Professor Joseph Hung: University of Western Australia
  • Professor Henry Krum: Monash University
  • Professor Mark Nelson: Menzies Research Institute, Tasmania
  • Associate Professor Markus Schlaich: Baker IDI Heart & Diabetes Institute
  • Professor Nigel P Stocks: The University of Adelaide
  • Professor Garry Jennings: Baker IDI Heart & Diabetes Institute, Director

Study Publications

  1. Stewart S, Carrington MJ, Swemmer CH, Anderson C, Kurstjens NP, Amerena J, Brown AD, Burrell LM, de Looze FJ, Harris M, Hung J, Krum H, Nelson M, Schlaich M, Stocks NP, Jennings GL. Effect of intensive structured care on individual blood pressure targets in primary care: multicentre randomised controlled trial. British Medical Journal. 2012;345, e7156.
  2. Stewart S, Carrington MJ, Swemmer C, Kurstjens N, Jennings GL. Optimising management of hypertension in primary care: the Valsartan Intensified Primary Care Reduction of Blood Pressure (VIPER-BP) Study. International Journal of Cardiology. 2011;153(3):317-22.
  3. Stewart S, Carrington MJ, Swemmer C, Kurstjens N, Anderson C, Brown AD, Burrell L, Nelson M, Stocks NP, Jennings G, on behalf of the VIPER-BP Study Investigators. Determinants of achieving early blood pressure control with mono therapy in a primary care setting.  Journal of Clinical Hypertension, 15:674-680.