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Sibutramine
(Brand names: Meridia in the US or Reductil in other countries)

Warning: Sibutramine ( Meridia or Reductil ) has been withdrawn from the market.
See below for more.


How it works


Sibutramine is classified as a sympathomimetic drug. When one nerve cell (also called a neuron) signals another nerve cell, it releases chemicals called neurotransmitters. There is a space these chemicals must cover called the synapse. When the first neuron is finished sending a signal to the second neuron, it must take up all the left over neurotransmitters in the synapse.

Synapse

These medicines block the nerve signals called norepinephrine, serotonin, and dopamine from being taken back up by the signaling nerves. This means that receiving nerve cells are exposed to these signals for a longer period of time.

Norepinephrine, serotonin, and dopamine are neurotransmitters used by a branch of the nervous system called the sympathetic nervous system. More stimulation by these chemicals causes a decrease in appetite. This causes people to eat less. Sibutramine (Meridia or Reductil) has a chemical structure related to amphetamine and works in a somewhat similar manner.

Pros

Studies have shown that on average, people lose weight with Meridia. Within 1 year, there may be a 9.8 lb (4.45 kg) weight loss. One study showed that sibutramine in combination with lifestyle changes caused a weight loss of 26.6 lbs compared to the drug (11 lbs) or lifestyle changes (14.8 lbs) alone.

There also appears to be a reduction in triglycerides and bad (or LDL) cholesterol. People with diabetes may see a decrease in their blood sugar (glucose) and hemoglobin A1c levels (a longer term measure of blood sugar control). Diabetics may also see an increase in their good (or HDL) cholesterol. Meridia causes weight loss in adolescents.

Cons

By 2004, in a hearing that prompted the withdraw of Vioxx, an FDA officer testified to the US Senate that sibutramine was potentially dangerous. In the fall of 2010 at the request of the FDA, Abbott Laboratories withdrew Meridia from the US market based on analysis of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study which showed a "16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo." [ref.] The European Medicines Agency (EMA) had already suspended marketing authorization for all anti-obesity medicines containing sibutramine in January of 2010

Meridia increases blood pressure by 1-3 points (mmHg) and heart rate by about 4-5 beats per minute. Diabetics need good control of their blood pressure in order to prevent kidney or other organ damage. In one study among adolescents, the dose of sibutramine had to be decreased or the drug had to be stopped because of increases in blood pressure or heart rate. The effect on increased blood pressure is most in people weighing 203 lbs or more and in people younger than 44 years old.

Before its withdraw, this drug was already to be be avoided in people with coronary heart disease (CHD or CAD), congestive heart failure (CHF), heart rhythm problems, or people who have had a stroke. There is a risk of developing something called serotonin syndrome in people who take Meridia along with a monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI), both of which are mainly antidepressants but can be use for other conditions. Erythromycin, ketoconazole, or other medicines that affect the enzyme cytochrome P450 (CYP450) can affect the body’s metabolism of sibutramine. You should discuss all of this with your doctor.

Other Comments

In nearly all studies, giving the drug was also accompanied by making a change in the person’s diet. Diet and exercise are the cornerstones of any weight loss program.


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It is important you discuss any weight loss or exercise plan with your doctor. Only you and your physician can decide what is best for you. Some people have certain conditions that prevent them from doing all exercises, and goal body weights may be different for different people. You need to discuss all these things with your physician before starting any weight loss or exercise program. In addition, the dosage of any medicine may be different if it is used for weight loss and not its FDA approved indication. You should also discuss this with your doctor.


This article was written by John Vickery, MD.

References

Ann Intern Med 2005;142:525-531
“Drug therapy of Obesity” Up To Date version 15.3
The Medical Letter on Drugs and Therapeutics 1998;40:32
The Medical Letter on Drugs and Therapeutics 2004;46:97
NEJM 2008;358:1941-50
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm228830.htm (accessed 1/11/11)
http://www.abbott.com/global/url/pressRelease/en_US/Press_Release_0908.htm
(accessed 1/11/11)

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Last updated: 1/11/11