New Drug Puts The Brakes On Hypertension
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New Drug Puts The Brakes On Hypertension

TORONTO, ON -- December 2, 1997 -- Novartis Pharmaceuticals Canada Inc. today announced it has received Canadian marketing approval for the antihypertensive drug PrDiovan(tm) (valsartan), an angiotensin II AT (1) receptor blocker -- the newest class of antihypertensive medications.

Convenient once-daily Diovan is effective in controlling high blood pressure while the incidence of adverse events is comparable to placebo across the dosage range.

"Diovan is an improvement for hypertensive patients because of the low incidence of adverse events with the convenience of a once-a-day medication," said Dr. S. George Carruthers, chair of the London Health Sciences Centre. "These attributes are critical with respect to the fact that one of the main reasons many patients discontinue hypertensive therapy is due to adverse events. I believe the AT (1) receptor blockers represent an important advance in the treatment of hypertension."

There are approximately 4.1 million Canadians between the ages of 18 and 74 with hypertension who are at increased risk for coronary heart disease and stroke. Of these, 3.4 million individuals (84 per cent of hypertensives) do not have their blood pressure controlled. Diovan represents an important new therapy choice to fill the gap in hypertension treatment. Furthermore, cardiovascular disease (CVD) mortality is still the leading cause of death in Canada with 38 per cent of mortality due to CVD. Premature mortality could be improved with better control of hypertension.

The safety and efficacy of Diovan has been demonstrated in clinical trials involving more than 4,000 patients treated for hypertension. Administration of Diovan to patients with essential hypertension resulted in a significant reduction of sitting, supine and standing systolic and diastolic blood pressure, with the antihypertensive effect persisting for 24 hours after dosing.

Controlled trials have shown Diovan 80 mg to be as effective in controlling high blood pressure as today's leading treatments for hypertension, enalapril 20 mg, lisinopril 10 mg and amlodipine 5 mg, with an overall incidence of adverse events comparable to placebo.

Furthermore, a double-blind, randomized study involving 1,369 patients measured the efficacy and safety of Diovan versus losartan in mild to moderate essential hypertension, and demonstrated that responder rates with Diovan were statistically significantly superior to losartan at the higher of two dosage levels studied for each of the two drugs. The responder rates were 62 per cent for 160 mg Diovan and 55 per cent for 100 mg losartan.

Diovan minimizes the adverse events commonly associated with established drug classes such as ACE inhibitors, calcium antagonists, beta blockers and diuretics. The overall incidence of adverse events was comparable to placebo across the Diovan dosage range (80 mg to 160 mg per day). Furthermore, the incidence of discontinuation due to an adverse event with Diovan in controlled clinical trials was comparable to that seen with placebo (3.1 per cent and 4.0 per cent respectively).

Once-daily Diovan is available by prescription in 80 mg and 160 mg capsules, offering convenience and flexibility in dosing. The recommended starting dose of Diovan is 80 mg once daily and the dosage can be increased to 160 mg once daily if additional control is required. Furthermore, an important patient benefit is the fact that both dosages of Diovan are priced the same at $1.05 CDN per day, so patients needing additional control can achieve it for the same price. The pricing structure for Diovan results in cost savings to both the patient and the healthcare system.

Diovan's dosing and price complements a recent report of the Canadian Coalition for High Blood Pressure Prevention and Control, which recommended patients be prescribed once-a-day medications which are realistically priced from the patients' perspective.

Diovan is indicated for the treatment of mild to moderate essential hypertension (i.e., high blood pressure for which a specific cause is unknown, comprising the majority of cases). Diovan should normally be used in those patients in whom treatment with diuretic or beta-blocker was found ineffective or has been associated with unacceptable adverse events. Diovan can also be tried as an initial agent in patients whom the use of diuretics and/or beta-blockers is contraindicated or in patients with medical conditions in which these drugs frequently cause serious adverse events.

Diovan has been approved for the treatment of mild to moderate essential hypertension in more than 30 countries.

More information on: Diovan, Novartis Pharmaceuticals Canada Inc.

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