Meridia (Sibutramine) Provides Effective Weight Control, Improve Heart Health

MOUNT OLIVE, NJ -- November 2, 2000 --

Research presented this week at the annual meeting of the North American Association for the Study of Obesity (NAASO) highlighted the positive impact Meridia® (sibutramine hydrochloride monohydrate) C-IV capsules may have on coronary heart disease risk and overall weight loss.

The studies, two of more than 12 research efforts presented at the meeting held in Long Beach, California, suggest the added benefits Meridia therapy may offer obese people working to control their weight. Meridia has been shown to help people control their eating habits and is effective when used in conjunction with a reduced-calorie diet and a regular routine of physical activity. More than two million people have taken the medication since its launch in 1998.

Heart disease, one of the leading causes of death in the United States and around the world, is closely linked with obesity and weight gain. Excess weight has been shown to negatively effect lipids -- or cholesterol levels -- causing HDL ("good") cholesterol to fall and LDL ("bad") cholesterol to rise. Researchers, lead by Gareth Williams, M.D. at the University Hospital Aintree in the United Kingdom, reviewed the cases of more than 700 people taking Meridia. The team not only saw significant weight loss but also meaningful improvements in the patients' cholesterol levels. Of patients treated with 15 mg of Meridia, one-third lost at least 10 percent of their body weight and saw a 15 percent increase in the levels of their "good" HDL cholesterol. Only three percent of patients taking placebo saw similar results.

"Our researchers reviewed the experience of 700 people in six, 12-month placebo-controlled studies," said Dr. Williams, leader of the study. "The news from our analysis is good: any weight loss helps improve cholesterol levels, but treatment with Meridia leads to greater weight loss and much increased HDL or "good" cholesterol levels. Since high levels of HDL cholesterol appear to protect against a heart attack, patients who successfully lost 10 percent or more of their weight with Meridia may also lower their risk for coronary heart disease."

Researchers from Baylor College of Medicine presented NAASO attendees new and definitive data on the impact a personalized weight-management patient support program can have on overall weight-management success. Their findings, drawn from the experience of more than 1500 people who enrolled in the Point of Change® weight-management program, an individually tailored program available to Meridia patients, showed that people participating in the program were more likely to achieve early weight loss and complete the four-month course of therapy.

"Intuitively, we all know that individualized patient support programs help people trying to gain control of their weight," said John Foreyt, Ph.D., lead investigator of the study. "We are delighted our study empirically confirms that belief. Without a doubt, individuals who receive ongoing and tailored support from a program like Point of Change via mailings, phone calls and/or the Internet stay motivated, lose weight, and continue on a course of therapy for a longer period of time."

Sixty-one percent of patients enrolled in Point of Change lost four pounds or more during the first four weeks of therapy compared with less than 50 percent of those who did not enroll. A four-pound, first-month weight loss is predictive of future success with Meridia. Point of Change enrollees were more likely to stay on therapy and saw greater total weight loss at the end of the four-month period (12.8 pounds vs. 10.9 pounds).

"With one out of every two Americans either overweight or obese, obesity is a condition that is threatening the health of nearly 100 million people," said Timothy Seaton, M.D., Senior Medical Director at Knoll Pharmaceutical Company. "Meridia has become a valuable option for people and doctors managing obesity, and the therapy continues to be studied in leading research institutions around the world. We are encouraged with the data presented here at NAASO and believe these studies underscore the significant role Meridia can play in the management of obesity."

Clinical trials have established the safety and effectiveness of Meridia for people who have at least 30 pounds to lose. A new research effort, undertaken by Sally Butler, a preventive health researcher and licensed social worker, and her colleagues at Kaiser Permanente of Colorado, is designed to evaluate something different: the effectiveness of Meridia in the naturalistic environment of a weight-management program, including the impact Meridia can have in changing psychosocial characteristics, such as depression and overall quality of life. The launch of this study, The Long-Term Obesity Sibutramine Effectiveness (L.O.S.E.) Weight Study, was reported at NAASO. More than 580 people are enrolled in the trial. Researchers will evaluate study participants at six and 12 months, noting differences in productivity, quality of life and depression measures. Further results are expected in 2001.

Knoll Pharmaceutical Company is the maker of Meridia, an FDA-approved oral medication used for the medical management of obesity, including weight loss and the maintenance of weight loss. Meridia is recommended for people who have 30 pounds or more to lose depending on height. In the majority of patients, Meridia has been shown to reduce weight by five to 10 percent. By sustaining this weight loss, patients can reduce obesity-related risks, including diabetes and hypertension.

Patients being treated with Meridia should see their doctor as directed for regular follow-up visits, during which the doctor can follow their body weight and carefully monitor their overall health, including regular monitoring of blood pressure and pulse rate.

As with all medications, Meridia may not be for everyone. Meridia is well tolerated, and most side effects are mild and temporary, and include dry mouth, headache, insomnia and constipation. Meridia substantially increases blood pressure in some people and for this reason regular blood pressure monitoring is required when taking Meridia. These blood pressure increases generally occur early in treatment and the prescribing physician may decide to decrease the dose of Meridia or discontinue the medication.

You cannot take Meridia if you are taking prescription medicines called monoamine oxidase inhibitors (MAOIs), which are sometimes used to treat depression or Parkinson's disease. Meridia should not be taken if you are taking other weight-loss medications that act on the brain. This includes both prescriptions and over-the-counter medications and herbal products. Meridia should not be used by pregnant women or nursing mothers.

In clinical trials, the number of patients who discontinued Meridia use because of hypertension was less than one-half of one percent and was comparable to placebo. Meridia should be given with caution to those patients with a history of hypertension and should not be given to patients with uncontrolled or poorly controlled hypertension.

As a centrally acting prescription anti-obesity medication, Meridia is classified as a schedule IV drug.