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HEARTSTYLES: PROFILES IN HYPERTENSION STUDY SUPPORTS NEW APPROACH TO CONTROLLING HYPERTENSION

-- Study Reveals Four Distinct Patient Profiles With Medication Side Effects Cited As Universal Concern --

EAST HANOVER, NJ -- February 18, 1998 -- The Heartstyles: Profiles in Hypertension study, the first-ever study examining the attitudes and behaviors of people with high blood pressure, revealed that hypertensive patients can fall into one of four distinct profiles: the Actively Attentives, the Nonchalant Newcomers, the Honestly Overwhelmed and the Mainly Meds. These profiles provide physicians with powerful insights for new, individualized approaches to treatment and arm patients with a new awareness of the issues that impact their ability to successfully control their hypertension. The study, conducted in collaboration with leading hypertension experts, was commissioned by Novartis Pharmaceuticals Corporation. "The Heartstyles(tm) profiles enable physicians to quickly identify distinct patient types in order to counsel more effectively and efficiently," said Michael Weber, M.D., Professor of Medicine, State University of New York Health Sciences Center and Chairman, Department of Medicine, Brookdale Hospital Medical Center. "In addition, by recognizing what profile they fit into, patients can work with their doctors to individualize and improve their treatment plans. The application of Heartstyles in our practices may reduce the health risks and financial burden of hypertension."

Despite the availability of numerous medications and 25 years of public education, control of hypertension remains a major problem, as discussed in a recent National Institutes of Health publication called the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VI). According to the JNC VI report, nearly 50 percent of America's 50 million patients with hypertension remain untreated and a startling 73 percent of all hypertensives (or 36.5 million people) do not have their blood pressure under control. Moreover, blood pressure control has decreased in most recent years, resulting in higher rates of increase of heart failure and kidney failure and the slowing of the rate of reduction in stroke. These disturbing statistics underscore the importance of the Heartstyles study, which was designed to identify the physician and patient barriers to controlling high blood pressure and generate innovative approaches to treatment.

"We are still falling far short when it comes to controlling a medical condition with very severe consequences. This is largely because adherence to therapy is still a major problem. It's time for us to be more aggressive in counseling patients. In addition, we must ensure that our patients don't suffer from the adverse effects often associated with many antihypertensive treatments which may inhibit their compliance," said Henry R. Black, M.D., Chairman, Department of Preventive Medicine and Professor, Internal Medicine, Rush-Presbyterian St. Luke's Medical Center.

Side Effects: A Universal Concern Although the four profiles that emerged from Heartstyles reveal a pronounced diversity in health behaviors and attitudes among people with hypertension, the common denominator among all profiles is a significant concern regarding side effects of their medications. In fact, according to the survey, side effects are the single most common reason for switching high blood pressure medication. The JNC VI report found that poor adherence to antihypertensive therapy remains a major therapeutic challenge contributing to the lack of adequate control in more than two-thirds of patients with hypertension. The guidelines urge physicians to anticipate adverse effects and adjust therapy to prevent side effects.

"Side effects are still all too common with high blood pressure medications and we cannot ignore their impact on patient compliance," commented Dr. Black. "New classes of drugs, such as angiotensin II receptor blockers (ARBs), were developed to address the issue of side effects and are an important option for patients and physicians."

Heartstyles(tm) Profiles Heartstyles surveyed 727 patients with hypertension in the United States. Four distinct profiles emerged from an analysis of the study data based on medical, behavioral, psychological and social criteria. Each of the segments represents one of four patient types and together present a comprehensive picture of the total hypertensive population. Following is an overview of each of the profiles and treatment suggestions from the Heartstyles Advisory Board:

-- Actively Attentives represent 39 percent of the survey population. They strive to do everything right in their approach to caring for themselves and their condition. Actively Attentives are the least likely to suffer side effects from their current medication, which may result in their being more compliant; 28 percent of Actively Attentives say they have experienced side effects from their current medication.

Actively Attentives may benefit most from a treatment plan that includes brief check-ups to ensure that their blood pressure remains under control. Physicians might want to reinforce the impact a healthy lifestyle and adherence to their treatment has had on controlling their blood pressure. Although they are unlikely to need additional counseling, Actively Attentives would benefit from positive feedback and encouragement to continue their healthy behaviors.

-- Nonchalant Newcomers represent 23 percent of the survey population. They seem to suffer from a lack of understanding about their high blood pressure condition, and therefore are not as likely to be attentive to their health and treatment. Thirty-six percent of Nonchalant Newcomers taking medication for their hypertension say they have experienced side effects.

Nonchalant Newcomers may lead an unhealthy lifestyle and be non-compliant simply because they are not educated about their condition. Their physicians might want to emphasize the asymptomatic nature of hypertension, the risks associated with untreated hypertension and the benefits of complying with therapy. Nonchalant Newcomers are likely to benefit from frequent visits to their physicians which include more time for counseling and discussions about the importance of lifestyle changes, especially quitting smoking.

-- The Honestly Overwhelmed comprise 22 percent of the survey population. They seem to lack confidence that they have the ability to change their health behaviors and are generally negligent about taking proper care of themselves. They have difficulty following their antihypertensive treatment regimens and have switched medications more than any other group. 36 percent of the Honestly Overwhelmed say they have experienced side effects from their current medication.

The Honestly Overwhelmed may benefit greatly from a treatment plan that is simple and incorporates counseling sessions to address the issues behind their self-defeating behaviors. Emphasis might be placed on the overall cardiovascular risks associated with untreated hypertension, the benefits of therapy and the value of lifestyle modifications, such as weight loss and exercise. It is possible that the Honestly Overwhelmed may be suffering from depression and an assessment should be made.

-- Mainly Meds represent 16 percent of the hypertensive population sampled and rely mainly on medication, rather than lifestyle changes, to control their high blood pressure; 30 percent of Mainly Meds currently on medication say they have experienced side effects.

Mainly Meds may benefit most from a treatment plan that includes counseling, reinforcing the value of antihypertensive therapy, while emphasizing the crucial role a healthy lifestyle plays in high blood pressure control. Although side effects are a concern among all profiles, it may be particularly important with Mainly Meds to carefully monitor the incidence of side effects with their medications; if they neglect to take their treatments and are not living a healthy lifestyle, they are completely unprotected from the risks associated with hypertension.

Treating Hypertension Traditionally, hypertension has been treated with medications such as beta blockers and diuretics, which are effective in lowering blood pressure but have been associated with disturbing side effects such as fatigue, depression, impotence and metabolic disturbances. More recently, ACE inhibitors and calcium antagonists have become established options for the treatment of hypertension. These drugs were expected to reduce the side effects experienced with older medications, yet still are associated with adverse effects. Side effects associated with ACE inhibitors include dry cough. Side effects associated with calcium antagonists include edema (swelling) and constipation.

The newest class of antihypertensive treatment, ARBs offer efficacy comparable to the leading antihypertensive therapies and excellent tolerability with an overall incidence of side effects comparable to placebo. For example, Diovan(tm) (valsartan) 80 mg, developed and marketed by Novartis, has been shown in controlled clinical trials 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 side effects comparable to placebo.

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Diovan should be discontinued as soon as possible. Diovan is contraindicated in patients who are hypersensitive to any component of this product. In clinical trials, there were no significant differences between adverse events in Diovan patients vs. placebo patients. Adverse events occurring more frequently with Diovan than placebo included viral infection (3% vs. 2%), fatigue (2% vs. 1%) and abdominal pain (2% vs. 1%). The most common adverse events seen with Diovan were headache and dizziness. Diovan(tm) is a trademark of Novartis.

For a complete copy of the Heartstyles report or full Diovan prescribing information, contact Anna Frable, Novartis Pharmaceuticals Corporation, 59 Route 10, East Hanover, NJ 07936, (973) 781-5388.

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