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Renin Inhibitors: A Novel Approach to Hypertension
Decision Resources, Inc., June 2006, Pages: 17


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Hypertension, or high blood pressure, is a significant health concern worldwide. It is a major risk factor for cardiovascular disease, and poorly controlled hypertension can damage target organs, eventually resulting in heart failure, end-stage kidney disease, retinopathy, stroke, and vascular dementia.
The hypertension therapy market is also one of the largest markets in the world for prescription drugs. In this report, we examine a new class of antihypertensive drug, renin inhibitors. The first of these agents, aliskiren (Novartis/Speedel’s Rasilez), is preregistered in the United States. If approved, it will be the first of a new class of antihypertensive drug to enter the market in more than a decade.

Business Implications

- The hypertension market is large and mature; it comprises several drug classes, most of which are available in generic form, that compete for market share. Existing treatments for hypertension are considered safe and efficacious, but a significant portion of the patient population still has difficulty controlling their blood pressure (BP).

- Renin inhibitors, which block the initial, rate-limiting step of the renin-angiotensinaldosterone system (RAAS), are a novel approach to hypertension treatment. The first agent in this class, aliskiren (Speedel/Novartis’s Rasilez), is in preregistration. If approved, renin inhibitors will be the first novel drug class for hypertension treatment in more than a decade. Clinical trials have shown that aliskiren’s efficacy in lowering BP is equal to that of many existing treatments. Aliskiren may also have potential as a combination therapy, enabling greater blockage of the RAAS and improved efficacy.

- In addition, trials have shown that aliskiren does not elevate plasma renin activity, a benefit that suggests the drug may be less likely than existing treatments to cause end-organ damage. We anticipate that physicians will initially prescribe renin inhibitors as an alternative treatment as they attempt to find a drug or drug combination that will be well tolerated and enable patients to reach goal BPs.

- Adoption will likely increase as more data emerge about renin inhibitors’ side-effect profile and effect on end-organ damage. Because most rennin inhibitors, other than aliskiren, are still in early-stage development, aliskiren will enjoy a significant competitive advantage for several years as the only agent available.


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