Novartis Pharmaceuticals Corporation
Barri Winiarski: (212) 229-8411; [email protected]
Chandler Chicco Agency
EMBARGOED FOR RELEASE
FRIDAY, MAY 19 AT 10 A.M. EASTERN TIME
Abstract # A-36
Patients Experienced Improved Quality of Life and Efficacious Blood Pressure Control When Switched to Diovan from Other Antihypertensive Drugs
New York -May 19- Results of a new study presented today at the 15th Scientific Meeting of the American Society for Hypertension found that hypertensive patients who switched to the angiotensin II receptor blocker (ARB) Diovan(r) (valsartan) or Diovan HCT(tm) (valsartan/hydrochlorthiazide) after becoming intolerant to commonly prescribed antihypertensive drugs experienced significantly improved quality of life while their systolic and diastolic blood pressure control was adequately maintained. Symptomatology (e.g., cough or edema) declined by as much as 89 percent in certain study patients who switched to Diovan. Based on the results of this pilot study, a larger, but similarly designed study involving more than 8,000 patients called QoLITY is currently underway to further investigate this encouraging finding.
The Symptomatology and Quality of Life Assessment of Hypertension Patients Following Changes in Treatment Regimen was an open-label observational study that measured changes in the quality of life of high blood pressure patients who discontinued antihypertensive therapy because of tolerability problems. There were 307 patients recruited by 192 participating primary care physicians from three states. A majority of patients were taking angiotensin-converting-enzyme inhibitors (ACE-Is) (93 patients) or calcium channel blockers (CCBs) (64 patients) before they switched to Diovan or Diovan HCT. Other study patients previously took beta blockers (11 patients), ARBs (7 patients), or fixed dose or multi-drug combinations (54 patients). In the remaining 78 patients, the previous antihypertensive drug was not known. Patients were eligible if their blood pressure was <170/105 mm Hg. The study measured both symptomatology and quality of life in patients at baseline and follow up, or approximately 7 weeks after the switch to Diovan or Diovan HCT.
Significant improvements in cough, edema
Among all patients studied, the most common symptoms causing a change in antihypertensive therapy were cough (14%), fatigue (11%), edema (10%), and headache (9%). At follow up, symptomatology among all patients had significantly improved. Of 93 patients originally taking ACE-Is, for example, nearly 60 percent had reported cough (55 patients). Of these, 78 percent (43 patients) showed improvements in cough after the switch to valsartan-based therapy. Similarly, of the 64 patients who originally took CCBs, about one-third reported edema (19 patients). Of these, 89 percent (17 patients) showed improvements in edema after switching to Diovan or Diovan HCT.
In this study, quality of life also improved significantly in patients who switched to valsartan-based therapy. Investigators used the Medical Outcome Study 12-Item Short Form (MOS SF-12) to score patients' physical (PCS score) and mental (MCS score) quality of life before and after the switch. At follow up, PCS scores increased 2.5 points from 45.2 to 47.7 (p<0.001) in those who had switched to Diovan or Diovan HCT, compared to the national averages of the hypertensive general United States population (PCS 46.5). MCS scores rose 2.1 points from 48.9 to 51.0 (p<0.001).
Blood pressure control maintained
As important as findings about symptomatology and quality of life were findings demonstrating the efficacy of Diovan or Diovan HCT in blood pressure control. Diastolic and systolic blood pressure control was maintained in the 275 study patients switched to Diovan as well as the 32 patients switched to Diovan HCT. Mean follow-up blood pressure in both types of Diovan patients was 139/84 mm Hg.
Diovan is an ARB indicated for the treatment of hypertension. As with all drugs that act on the renin-angiotensin system (RAS), Diovan or Diovan HCT can cause injury and even death to the developing fetus when used in pregnancy during the second and third trimesters. When pregnancy is detected, Diovan or Diovan HCT should be discontinued as soon as possible. The most common side effects with Diovan-based therapy are headache and dizziness. Because of the hydrochlorothiazide component, Diovan HCT should not be taken by patients who have a history of reduced urine output or have had allergic reactions to drugs of the sulfonamide class.
For full prescribing information, visit the Novartis website at www.pharma.us.novartis.com or contact Anna Frable, Novartis Pharmaceuticals Corporation, 59 Route 10, East Hanover, NJ 07936, (973) 781-5388 or Barri Winiarski at Chandler Chicco Agency at (212) 229-8411.
Novartis is a member of the American Heart Association (AHA) Pharmaceutical Roundtable, a strategic coalition of leading pharmaceutical companies who support the AHA's mission by supporting its cardiovascular research and educational programs.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of the Novartis Group, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of USD 21.7 billion and invested more than USD 2.8 billion in R&D.
Headquartered in Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000.
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