meridia

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Diabetes Forecast, June 1998 v51 n6 p33(2)
New anti-obesity drug comes to market. (sibutramine hydrochloride monohydrate, Meridia) Debbie Fentress.
Full Text: COPYRIGHT 1998 American Diabetes Association

Nothing grabs your attention quite like hunger. It can make you feel tired, grouchy, and just plain miserable. And as anyone who has ever tried to lose weight can tell you, it's hard to stay focused on lifestyle changes and motivated to exercise when all you can think about is food.

That's the problem that Knoll Pharmaceutical Company says its new anti-obesity drug, sibutramine hydrochloride monohydrate (Meridia), is designed to help solve.

"Meridia helps patients comply better with an improved lifestyle," said Linda Mayer, director of communications at Knoll. "One patient I spoke with said it felt like she had eaten a bag of popcorn, so she wasn't so hungry that all she could do was focus on food."

Meridia, which received Food and Drug Administration approval in November 1997, has been available since February. It is used in conjunction with a reduced-calorie diet for obesity management, including both weight loss and maintenance of weight loss.

How Does It Work?

Meridia doesn't work like older weight management drugs, such as Redux and fen/phen, and therefore does not carry the same serious health risks that led to those drugs being pulled from the market late last year, Mayer said.

In the brain, chemicals known as neurotransmitters control various body functions. Serotonin is the neurotransmitter that regulates appetite. Earlier weight management drugs were serotonin-releasing agents, Mayer explained. These drugs increased serotonin levels (and thus caused a loss of appetite) by entering the cells where serotonin is stored and forcing the chemical out. Meridia, on the other hand, belongs to a drug class called "neurotransmitter reuptake inhibitors." It works outside the cells, slowing down the time it takes for naturally released serotonin to be reabsorbed, and thus prolonging the full, satisfied feeling patients have after eating a meal.

Although Meridia is the first neurotransmitter reuptake inhibitor to be used for weight management, drugs in this class have been used for years in other areas, most notably as anti-depressants, such as fluoxetine (Prozac).

Targeting The Seriously Obese

Meridia isn't for everyone who thinks they'd like to lose a few pounds.

"This is serious medicine, and it is only for certain people," Mayer said. "In the past, there has been too much emphasis on cosmetic use of obesity drugs. We're focusing on the health benefits. It is not about how you look but instead about how your health will improve if you lose weight."

Meridia is recommended for overweight people who have a body mass index (BMI) of at least 30 or for overweight individuals with a BMI of at least 27 if they have other risk factors, such as high blood pressure, diabetes, or high cholesterol.

BMI is a measurement based on height and weight as they relate to body fat. It can be used to determine how much risk people have of developing certain health problems because of their weight. Someone with a BMI of 27 is approximately 20 percent overweight. The higher the BMI, the greater the risk a person has to develop additional health problems. Your doctor can calculate your BMI to help determine whether Meridia might be an option for you.

Meridia is taken once a day without regard to meals. It is available in doses of 5, 10, or 15 mg, so that doctors can tailor therapy to their patients' needs. The recommended starting dose of Meridia is 10 mg.

But Is It Safe?

"Every drug has benefits and side effects, and there needs to be a balance between the two," Mayer said. "Knoll is urging a cautious approach."

The most common side effects associated with Meridia are minor and include dry mouth, headache, constipation, and insomnia. However, Mayer said, you should not take Meridia if you have uncontrolled or poorly controlled high blood pressure, because Meridia substantially increases blood pressure in some patients. People with well-controlled high blood pressure may use Meridia, Mayer said.

"The FDA and Knoll are encouraging doctors to monitor blood pressure regularly," she said. If the drug does cause an increase in blood pressure, the problem can be caught early and remedied either by lowering the dose or stopping the medication.

In addition to people with uncontrolled high blood pressure, Knoll's World Wide Web site for Meridia states that the drug should not be used by patients who:

* take drugs called monoamine oxidase inhibitors (MAOIs), which are used for depression, Parkinson's disease, and other disorders. This is very important because serious, sometimes even fatal, reactions can occur if Meridia is taken at the same time MAOIs are taken.

* take other weight-loss medicines that act on the brain, such as phentermine. This includes prescription drugs, over-the-counter medications, and herbal products.

* are allergic to Meridia or sibutramine

* have coronary artery disease, angina (heart-related chest pain), arrhythmias (irregular heart beats), prior heart attack, or congestive heart failure

* have severe liver or kidney disease

* have had a stroke or symptoms of a stroke

* are pregnant, planning to become pregnant, or breast-feeding

* suffer from anorexia

* take drugs for depression

* have had seizures (epilepsy or convulsions)

* have an eye disorder called narrow angle glaucoma

* are under 16 years of age

* take other drugs that regulate serotonin. Combining Meridia with other serotonin regulators can cause a rare, but serious condition called "serotonin syndrome," which requires immediate medical attention and may include symptoms such as restlessness, loss of consciousness, confusion, disorientation, anxiety, agitation, weakness, tremor, incoordination, fever, shivering, sweating, vomiting, and increased heart rate. Other serotonin regulators include many of the most widely used anti-depressants, as well as some migraine headache therapies, pain medications, the cough suppressant dextromethorphan, lithium, and the amino acid tryptophan.

While Redux and fen/phen were removed from the market for causing damage to heart valves, Meridia has not been shown to carry the same risk. Patients in two Meridia studies were examined with cardiac ultrasound testing to check heart valve structure and function. In one study, 25 patients were examined before using Meridia and again after 3 months. None had evidence of heart valve disease. In another study, patients who had received either Meridia or placebo (sugar pills) for periods of 2 weeks to 16 months were examined. Three out of 132 patients (2.3 percent) who had taken Meridia and two out of 77 patients (2.6 percent) who had taken placebo had heart valve disease.

Some weight loss drugs have been associated with pulmonary hypertension (PPH), a rare but sometimes fatal disease. No cases of PPH have been reported with Meridia, but because this disease is so rare, it is not known whether Meridia may cause PPH.

The FDA classifies Meridia and other prescription weight-loss drugs as controlled substances, but Meridia is classified as a "schedule IV" controlled substance, which indicates a low abuse potential. Knoll's product information states that research shows a low likelihood of addiction or physical dependency on the drug.

"What this classification means for patients is that there may be limitations on the number of refills they can get," Mayer said.

Long-Term Safety

Although neither the FDA nor Knoll has placed a time-limit on the safe use of Meridia, no long-term studies of the drug have been completed.

"The data we have are from trials of up to 12 months," Mayer said. "How long someone takes Meridia is really up to the doctor."

Longer-term studies are now underway as part of routine surveillance and monitoring procedures, Mayer said. However, she added, "this type of drug has been around for many years and has been used safely in millions of patients. Because it works similarly to Prozac, we do not anticipate that any serious side effects will be identified."

Encouraging Healthier Lifestyles

While Meridia may help take your mind off food, Knoll is stressing that it is not likely to be a magic bullet for weight problems.

"It is important for people to have realistic expectations," Mayer said. "Meridia should be used as part of a comprehensive lifestyle management program."

Toward that end, Knoll is offering a free weight management program called Point of Change to all of its Meridia customers. The program focuses on eating a reduced-calorie diet, increasing physical activity, setting realistic weight-management goals, and overcoming lapses or setbacks. Patients who enroll in the program will receive information about Meridia, newsletters, and personal menu plans. They will also have access to a toll-free hotline offering information about physical activity services and nutrition counseling in their area.

How Much Can You Lose?

In the Knoll clinical studies, overweight patients on Meridia and a reduced-calorie diet achieved an average 5 to 10 percent weight reduction from their initial weight at various dosage levels.

In one 12-month study, patients who took 10 mg of Meridia daily lost an average of 10 pounds, while those taking 15 mg daily lost an average of 14 pounds. The average weight loss in people on only a reduced calorie diet was 3.5 pounds.

Study participants lost most of their weight in the first 6 months and maintained statistically significant weight losses for up to a year. Meridia also had a positive effect on cholesterol levels, which tend to improve with weight loss.

Patients and health professionals who have medical questions about the appropriate use of Meridia or about weight management can call Knoll's toll-free medical information line at 1-800-526-0221. Additional information about Meridia can be found at Knoll's World Wide Web site, http://www.healthyweight.com. Meridia patients can enroll in the company's free patient support program by calling tollfree, 1-888-KNOLL-02.

Debbie Fentress is a freelance writer and editor living in Falls Church, Va.

Products: Meridia (Medication) - Evaluation

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Prevention, May 1998 v50 n5 p38(2)
Is the new diet pill for you? (sibutramine)(Brief Article)
Full Text: COPYRIGHT 1998 Rodale Press, Inc.

What you need to know

Heard of Meridia? Sibutramine, trade name Meridia, is the new player in the diet-pill scene, but it raises the same essential questions: Will it help me? Is it safe? Should I take it? Consider these factors before you decide:

It's serious stuff. Sibutramine has been approved by the FDA for treatment of serious obesity, usually accompanied by other health problems, such as diabetes. (What's "serious"? Body Mass Index of 30 or above, or BMI of 27 with complicating factors.)

Its benefits depend upon your situation. Studies show sibutramine to help weight loss by 5% to 10%. "We're not going to see many people lose as much as they have on the average with fen-phen," says Robert H. Eckel, MD, vice chairperson of the American Heart Association's Nutrition Committee. Someone who is seriously overweight could see health benefits. But, for someone only trying to lose 10 pounds, that only means 1 extra pound dropped.

You still have to do your part. The drug's benefits were documented in people who were also dieting and exercising. "Diet and exercise should still be a major part of the equation," says Dr. Eckel.

Complications may develop. Studies have found that some people with hypertension developed even higher blood pressure while taking the drug. "If you're already hypertensive, either this drug shouldn't be used or your blood pressure should be monitored very carefully during the first few weeks," says Dr. Eckel.

Bottom line? Meridia is for folks who really need it. Check with your doctor.

Products: Meridia (Medication) - Evaluation

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Environmental Nutrition, Jan 1998 v21 n1 p3(1)
FDA clears diet drug, but safety an issue. (Food and Drug Administration)
Full Text: COPYRIGHT 1998 Environmental Nutrition, Inc.

The dust had barely settled from the sudden demise of two popular diet drugs, Redux (dexfenfluramine) and Pondimin (fenfluramine, of "fen-phen" fame), when in late November the Food and Drug Administration (FDA) approved yet another diet drug. The new prescription drug, sibutramine, will soon be sold under the brand name Meridia.

It is intended, as were the others, for the management of severe obesity--20% to 30% above a healthy weight--not for dropping a few unsightly pounds. In clinical studies, participants taking Meridia, while following a reduced-calorie diet, lost more weight than those who simply dieted. In one trial, Meridia-takers lost about 7 to 11 pounds more over a year.

But there is much to be cautious about. Like Redux and Pondimin, Meridia suppresses appetite by increasing levels of brain chemicals, including serotonin, which makes you feel full. It slows the brain's reabsorption of serotonin, so it lasts longer. But unlike its predecessors, the new drug does not cause cells to produce more serotonin, which is thought to be responsible for the heart valve damage and primary pulmonary hypertension (PPH) seen with Redux and Pondimin. Clinical trials found no PPH with Meridia and no more heart valve damage with Meridia than with a placebo. But neither did the original trials for Redux and Pondimin.

Certainly, Meridia is not off the safety hook. This time around, explicit cautions will accompany the drug to warn users it increases blood pressure and heart rate. The FDA cautions all who take the drug to have their blood pressures closely monitored. Avoiding the drug is recommended for those with uncontrolled high blood pressure, irregular heart beat, heart disease or previous stroke. Other side effects include dry mouth, headache, constipation and insomnia. Meridia can also be habit-forming.

Bottom line? Clearly, this is not a benign drug. Meridia's short-term side effects are substantial and its long-term safety is a big unknown. Learning from past mistakes seems wise. EN advises waiting until more research is done to prove Meridia can avoid the same fate as Redux and fen-phen.

Products: Meridia (Medication) - Evaluation

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HealthFacts, Feb 2004 v28 i2 p3
Two weight loss drugs--Meridia and Xenical the pros and cons of each.
Full Text: COPYRIGHT 2004 Center for Medical Consumers, Inc.

Thinking of taking a weight loss drug? Now that the popular dietary supplement ephedra has been linked to sudden cardiac death and is due to be removed from the market by the Food and Drug Administration, more people may turn to one of the two widely promoted prescription drugs for weight loss: Meridia and Xenical. Both are oral drugs that can produce modest weight loss in adults when used with a restricted calorie diet. Here are some of the pros and cons of each drug.

MERIDIA (generic name: sibutramine)

Introduced in 1998

Supporting Research: Altogether 11 clinical trials have been conducted in which obese and overweight people went on a reduced calorie diet and were randomly assigned to take Meridia or a placebo. The trials lasted for 12 to 52 weeks. After one year, participants taking 10 mg a day of Meridia lost ten pounds, and those taking 15 mg of Meridia lost 14 pounds. The people solely on the reduced calorie diet lost 3 1/2 pounds. Weight was regained after Meridia was discontinued.

How it works: Meridia acts somewhat like an antidepressant. It decreases the appetite by blocking reuptake of nerve transmitters (norepinephrine, serotonin and dopamine) in brain synapses.

Downside: Meridia causes small increases blood pressure (1 to 3 mm Hg) with increases in pulse rate of four to five beats per minute. Side effects that may occur include headache, constipation, back pain, insomnia, drug mouth, nervousness and too many more to list. For a fuller description, read the drug label (see For More Information).

Caution: Use in people over age 60 requires careful consideration, as they are more likely to have high blood pressure and heart disease.

Cost: Approximately $3.83 a day, depending on where the drug is purchased.

XENICAL (orlistat) Introduced in 1999.

Supporting Research: The FDA has approved Xenical not only for weight loss but also for weight maintenance following weight loss. Altogether five clinical trials have been conducted in which 3,379 obese and overweight people went on a reduced calorie diet and were randomly assigned to take Xenical or a placebo. The amount of weight loss at one year was similar to that of Meridia. After one year of treatment, three trials looked at the percentage of people who regained weight. People who had been on the placebo regained 52% of the weight lost during the clinical trials, and people who had been on Meridia regained 26% of the weight lost while on the drug.

How it works: It works in the intestines, where it blocks some of the fat a person eats from being absorbed and digested. This undigested fat is eliminated in the person's bowel movements (BMs).

Downside: Gastrointestinal distress: The most common side effects are changes in BMs, according to the drug label, including "oily, spotting BMs, gas with discharge, urgent need to have a BM, oily or fatty stools, an oily discharge, fecal incontinence," etc. The rate of these adverse reactions rises according to increases in dietary fat intake. Xenical blocks the body's uptake of fat-soluble vitamins, making supplementation necessary.

Caution: Safety in people over the age of 60 is unknown. They were not represented in the clinical trials.

Cost: Approximately $3.56 a day, depending on where the drug is purchased.

For More Information.

Both the physician and patient labeling information can be read in the Physicians' Desk Reference, available at public libraries, and on the FDA web site (www.fda.gov), go to "drugs", "drug approval," name of drug, and click into the date in the right-hand column entitled "label posted," or call 1(888) 463-6332.

Products: Meridia (Medication) - Evaluation
Xenical (Medication) - Evaluation

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Time, Nov 29, 2004 v164 i22 p151
How Safe Are They? In a rare move, an FDA official openly attacks five drugs. Should you worry? (Your Time/Health)(Accytane, Bextra, Crestor, Meridia, Serevent) Christine Gorman.
Full Text: COPYRIGHT 2004 Time, Inc.

Byline: Christine Gorman

Ii's not often the FDA airs its dirty laundry in public, but when it does, boy, watch out! Appearing before a Senate committee last week, Dr. David Graham, an FDA safety officer, testified that there are five drugs on the market that he had serious concerns about--and then, in a rare display of FDA indiscretion, he actually named them. Other agency officials quickly took issue with the assessment, and the next day the FDA released a statement declaring that all five drugs are quite "safe and effective." But anyone on one of the medications is bound to be confused. What are the facts? Let's take the drugs one at a time.

ACCUTANE This drug works wonders for severe acne when all else fails. Doctors have long known, however, that Accutane (generic name: isotretinoin) can cause birth defects in pregnant women. Indeed, the drug comes with a black-box warning, the strongest available to the FDA, to that effect. But each year several women still become pregnant while on it.

BEXTRA Like the other COX-2 pain relievers, Pfizer's Bextra doesn't work any better than Advil but may be easier on the stomach. Reports suggest Bextra may sometimes cause blood-pressure problems; Pfizer is working with the FDA to get to the bottom of the matter.

CRESTOR Graham cited reports that some patients on Crestor, one of the newest anticholesterol statins, have suffered kidney failure. The drug's manufacturer, AstraZeneca, says the prescription drug is safe as long as it is used properly.

MERIDIA One of the few remaining drug treatments for obesity after fen-phen and Redux were pulled from the market, Meridia has been associated with blood-pressure problems in some people. But, says the drug's maker, you have to balance that potential problem against the severe health risks of obesity.

SEREVENT Like many antiasthma drugs, Serevent can, paradoxically, trigger life-threatening spasms in the lungs. The risk from Serevent appears to be greater for African Americans, and last year the company agreed to include a black-box warning on this possible side effect.

If you're taking one of those drugs, you should definitely talk to your doctor. You might also read the package inserts that come with your prescription; you may find something your physician has overlooked. And it never hurts to ask about alternative treatments. If there are good ones, it might be prudent to switch until everything gets sorted out.

Products: Meridia (Medication) - Adverse and side effects
Serevent (Medication) - Adverse and side effects
Accutane (Medication) - Adverse and side effects
Bextra (Medication) - Adverse and side effects
Crestor (Medication) - Adverse and side effects

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Title: The efficacy and safety of sibutramine for weight loss - A systematic review
Author(s): Arterburn DE, Crane PK, Veenstra DL
Source: ARCHIVES OF INTERNAL MEDICINE 164 (9): 994-1003 MAY 10 2004
Document Type: Article
Language: English
Cited References: 61 Times Cited: 2
Abstract: Background: The primary goal of weight loss is to prevent or reduce obesity-associated morbidity and mortality by improving cardiovascular and metabolic risk factors. We conducted a systematic review to assess the efficacy and safety of sibutramine hydrochloride for weight loss.
Methods: In April 2002, we searched MEDLINE, EMBASE, the Cochrane Library, and 7 other computerized bibliographic search tools using the keywords "sibutramine," "Meridia," and "Reductil" (in all languages and all available years). The authors and the manufacturer were contacted. We reviewed randomized placebo-controlled trials of sibutramine, 10 to 20 mg/d, in obese adults. Methodological quality was assessed.

Results: A total of 29 trials had sufficient data for analysis after including unpublished data from 10 authors. The summary mean differences in weight loss, sibutramine minus placebo, for the 3-month and 1-year trials were -2.78 kg (95% confidence interval, -2.26 to -3.29 kg) and -4.45 kg (95% confidence interval, -3.62 to -5.29 kg), respectively. The 6-month trials were statistically heterogeneous, and evidence of publication bias was found. One trial found that sibutramine maintains weight loss better than placebo at 2 years. Weight loss with sibutramine was associated with modest increases in heart rate and blood pressure, small improvements in high-density lipoprotein cholesterol and triglycerides levels, and, among diabetic patients, small improvements in glycemic control. There was no direct evidence that sibutramine reduces obesity-associated morbidity or mortality.

Conclusions: Sibutramine is effective in promoting weight loss. Weight loss with sibutramine is associated with both positive and negative changes in cardiovascular and metabolic risk factors. There is insufficient evidence to accurately determine the long-term risk-benefit profile for sibutramine.

KeyWords Plus: SUFFERING ESSENTIAL OBESITY; DOUBLE-BLIND; RANDOMIZED-TRIAL; CLINICAL-TRIAL; ENERGY-EXPENDITURE; METAANALYSIS; OVERWEIGHT; MAINTENANCE; QUALITY; HEALTH
Addresses: Arterburn DE (reprint author), Vet Affairs Med Ctr, Hlth Serv Res & Dev Serv, 3200 Vine St, Cincinnati, OH 45220 USA
Puget Sound Hlth Care Syst, Dept Vet Affairs, Seattle, WA USA
Univ Washington, Sch Med, Dept Med, Seattle, WA 98195 USA
Univ Washington, Pharmaceut Outcomes Res & Policy Program, Sch Pharm, Seattle, WA 98195 USA
E-mail Addresses: david.arterburn@uc.edu
Publisher: AMER MEDICAL ASSOC, 515 N STATE ST, CHICAGO, IL 60610 USA
Subject Category: MEDICINE, GENERAL & INTERNAL
IDS Number: 818XF

ISSN: 0003-9926

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[Goes4ever]

WOW, thanks Budlite!!! lots of info there to swallow............