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FDA Approves New Combination Pills for Hypertension Treatment

EAST HANOVER, N.J., Aug. 4 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT(R) (valsartan and hydrochlorothiazide) and Exforge(R) (amlodipine and valsartan), as initial or 'first-line' therapies in patients likely to need multiple drugs to achieve their blood pressure goals.

The FDA approval of Diovan HCT and Exforge for first-line use reinforces current US guideline recommendations to start appropriate patients on combination therapy. Research suggests that up to 80% of patients may need multiple medications to help them reach blood pressure goals.

"These approvals provide flexibility and confidence to physicians to use well-proven and well-accepted therapies as first-line treatment," said Kenneth Jamerson, MD, Professor of Medicine, Department of Cardiovascular Medicine, University of Michigan Healthcare System. "Patients may also benefit by getting their blood pressure effectively and quickly under control with a single pill and fewer co-pays."

With the approvals, healthcare professionals will have simplified treatment strategies to help control high blood pressure with Diovan HCT and Exforge. In patients who are likely to need multiple drugs to achieve blood pressure goals, using single-pill combination medications first-line will help eliminate the added steps of starting on a single medication, increasing the dose and then adding on another medication.

The multiple steps often used in clinical practice may delay the time it takes to reach blood pressure goals, which may create patient frustration and a sense of failure. In addition, the first-line use of single-pill combination medications in patients who are likely to need multiple treatments to reach goal may reduce their pill burden and co-pays.

High blood pressure affects approximately 73 million adult Americans, and one in four adults worldwide. It is one of the most important, but treatable, risk factors for cardiovascular disease -- the world's leading cause of death.

While it is easy to measure and can be successfully managed, nearly 40% of people treated for high blood pressure do not have the condition under control, underscoring the critical need for more effective treatment regimens. If left untreated, patients with high blood pressure are at risk of cardiovascular events, such as stroke, heart attack and heart failure, as well as kidney failure and eye problems. Diovan HCT and Exforge are approved to treat high blood pressure and are not approved to treat or prevent stroke, heart attack, heart failure, kidney failure or eye problems.

"We are very pleased that the FDA recognizes the therapeutic value and the need of some patients to start therapy with a single-pill combination," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "These approvals demonstrate our confidence in combination medications for this therapeutic category, while reinforcing the Novartis commitment to provide physicians with well-researched and effective treatments for high blood pressure."

Diovan HCT combines in one tablet Diovan (valsartan), the world's number one selling branded high blood pressure medication, and hydrochlorothiazide, a high blood pressure treatment from the diuretics drug class. Exforge is the first treatment to combine Diovan (an angiotensin receptor blocker, or ARB) and the calcium channel blocker (CCB) amlodipine besylate, two of the most commonly prescribed high blood pressure medications in their classes, into a convenient, once-daily single tablet.

The Diovan HCT and Exforge first-line approvals were based on several clinical trials in approximately 2,000 and 3,500 patients, respectively, in which both products demonstrated efficacy and tolerability in patients with mild-to-severe high blood pressure.

Source: Novartis

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