New study shows Diovan controls isolated systolic hypertension in elderly patients
EAST HANOVER, N.J., May 14 2003 -- Diovan (valsartan) effectively lowers isolated systolic hypertension, (ISH), a difficult-to-treat type of high blood pressure, in 75 percent of elderly patients, according to Val-Syst, one of 25 new studies reinforcing the efficacy of Diovan presented during the American Society of Hypertension 18th Annual Meeting and Scientific Exposition in New York.
Affecting approximately two-thirds of older people who have high blood pressure, ISH is a serious form of hypertension in which the systolic blood pressure (the top number in blood pressure readings) is high (>140 mmHg) but diastolic pressure (lower number) is normal (<90 mmHg). In people age 50 or older, high systolic blood pressure (SBP) is a more important risk factor for heart failure, heart attack, stroke, and kidney failure than diastolic pressure. The risk of cardiovascular disease doubles with every 20 mmHg rise in SBP in individuals 40 to 60 years of age. In Val-Syst, mean SBP levels were reduced from 170 mmHg to 136 mmHg in study patients who took Diovan, a level in keeping with new national guidelines for SBP target goals.
"The elderly have the lowest rates of blood pressure control of any group, and the difficulty of managing high blood pressure in this population is compounded by physicians' concerns about these patients' increased sensitivity to drug side effects," said study author Ettore Malacco, MD, director of the division of internal medicine, at the University of Milan, Italy. "Val-Syst shows Diovan is a very effective high blood pressure treatment for elderly patients while causing less edema."
A comparative study, Val-Syst showed Diovan, an angiotensin II receptor blocker (ARB), was as effective as a calcium channel blocker, amlodipine, in lowering ISH in the elderly -- but much less likely to cause leg swelling (edema), a side effect associated with amlodipine. With 421 patients age 60-80 from 35 outpatient settings in Italy, Val-Syst was a multicenter, double-blind, randomized parallel group study that compared the therapeutic efficacy and tolerability of Diovan vs. amlodipine in patients with ISH.
To be eligible for the study, patients had to have SBP of 160-220 mmHg and diastolic blood pressure less than 90 mmHg. Patients were randomized to receive Diovan 80 mg or amlodipine 5 mg once-daily. After eight weeks, doses were increased in patients who required additional blood pressure control to Diovan 160 mg or amlodipine 10 mg once-daily. If, after an additional eight weeks, SBP was still not controlled to target goals, low-dose hydrochlorothiazide (a diuretic) was added in both treatment groups. By 24 weeks, mean reductions in blood pressure were -33.4/-6.0 mmHg with Diovan alone or in combination with the diuretic compared to -33.5/-6.5 mmHg with amlodipine alone or in combination with the diuretic and mean blood pressures achieved were 136.4/77.6 mmHg and 136.3/77.2 mmHg respectively. By study end, systolic blood pressure control (<140 mmHg) was observed in 74.7% of Diovan patients vs. 73.0% of amlodipine patients. While Diovan and amlodipine were equally effective in reducing systolic blood pressure, patients taking Diovan were five times less likely to suffer symptomatic leg edema (p<0.0001).
VALUE: Better blood pressure control at 30 months than any published large-scale study
An abstract from the ongoing VALUE (Valsartan Antihypertensive Long-Term Use Evaluation) trial demonstrates superb levels of total blood pressure control in its population of 15,314 high-risk high blood pressure patients. The VALUE trial compares cardiovascular outcomes in patients randomized to valsartan or amlodipine based treatment. Patients were randomized to receive either valsartan, titrated to a target dose of 160 mg once-daily, or amlodipine, titrated to a target dose of 10 mg once-daily. Patients in either group who require additional blood pressure control receive hydrochlorothiazide up to 25 mg, then other types of add-on antihypertensive therapy as necessary.
The new data from VALUE show that by 30 months into the study, a majority (60.5%) of all study patients had achieved combined systolic/diastolic blood pressure control of <140/<90 mmHg (p<0.0001), in keeping with target goals specified by new national guidelines. The blood pressure control achieved in VALUE is better than in any previously published large-scale clinical trial, even though VALUE patients have high-risk high blood pressure.
"The level of control in VALUE is in stark contrast to the low rate of control seen in real-world practice, where blood pressure is not adequately treated in two out of three high blood pressure patients," said Stevo Julius, MD, ScD, lead investigator for VALUE and professor of internal medicine-hypertension at the University of Michigan Medical School in Ann Arbor, Michigan. "VALUE demonstrates that when explicit goals are set and a treatment algorithm is provided, physicians can achieve much better control rates."
Besides having high blood pressure, all patients in VALUE have at least one other risk factor for cardiovascular disease or death, such as high cholesterol, diabetes, coronary heart disease or history of stroke. VALUE will provide important new information about the relative efficacy of valsartan vs. amlodipine on reduction of cardiovascular outcomes with better controlled blood pressure than in other studies. The final results of VALUE are expected in 2004.
Several other new studies presented at ASH 2003 also provided new insights, including:
- Studies by Hermida et al into the effectiveness of Diovan over 24 hours in relation to patients' rest cycles and circadian patterns.
- Abstracts by Smith et al about the cost-effectiveness of Diovan for treatment of heart failure patients who are intolerant of ACE inhibitors and in high blood pressure patients with type 2 diabetes and microalbuminuria, an early sign of kidney disease.
New findings by Delgado et al about the role of systolic blood pressure in predicting death 30 days after patients experience heart attacks were also presented. This abstract is an analysis of data from the ongoing VALIANT study (VALsartan In Acute myocardial iNfarction Trial), the largest study of its kind ever conducted. With 14,703 patients, VALIANT is investigating which long-term treatment strategy is best for improving survival in patients after heart attack: Diovan, the conventional ACE inhibitor captopril, or the combination of these two drugs. The results of VALIANT are expected in late 2003.
The studies presented at ASH 2003 are part of the Diovan clinical research program, one of the world's largest and most innovative clinical trial programs with an ARB, which involves more than 45,000 patients including 8,000 patients with diabetes. Besides VALUE and VALIANT, ongoing clinical trials investigating new applications for Diovan across the cardiovascular disease continuum include NAVIGATOR (a study of 9,150 patients with impaired glucose tolerance, or pre-diabetes, at high risk for cardiovascular events), and VAL-HeFT, one of the largest studies ever completed in heart failure. Diovan was the first ARB to obtain an indication beyond hypertension in the US, and is the only drug in its class approved by the US Food and Drug Administration (FDA) for the treatment of heart failure in patients who are intolerant of ACE inhibitors. The leading ARB in the US, Diovan is the fastest growing branded antihypertensive agent in the world today. Diovan is approved for first-line treatment of high blood pressure in the US and more than 80 other countries.
All ARBs and ACE inhibitors carry a warning that the drug should not be used in pregnant women due to the risk of injury and even death to the fetus. The most common side effects with Diovan in hypertensive patients were headache and dizziness. In patients with heart failure, concomitant use of Diovan, an ACE inhibitor and a beta blocker is not recommended. In Val-HeFT, this triple combination was associated with an unfavorable heart failure outcome. Because of the risk of hypotension, caution should be observed when initiating therapy in heart failure patients. Evaluation of heart failure patients should always include assessment of renal function. The most common side effects in heart failure patients with Diovan were dizziness, hypotension and diarrhea. Care should be exercised with dosing of Diovan in patients with severe renal impairment. As a consequence of inhibiting the rennin- angiotensin system, changes in renal function may be observed in susceptible individuals (e.g., patients with renal artery stenosis and severe congestive heart failure). For full prescribing information go to "Prescribing Info/Quick Download" at www.pharma.us.novartis.com or call Kim Callahan at (862) 778-7692.
Posted: May 2003
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