Meridia General Remarks

Sibutramine

(Meridia in the USA, Reductil in Europe), usually as sibutramide hydrochloride monohydrate, is an orally administered agent for the treatment of obesity. It is a centrally-acting stimulant chemically related to amphetamine, methamphetamine, and phentermine (one of the drugs in the Fen-Phen combination). Sibutramine is classified as a Schedule IV controlled substance in the United States.

Pharmacokinetics
Sibutramine is well absorbed from the GI-Tract (77%), but undergoes a considerable first-pass metabolism reducing its bioavailability. The drug itself reaches its peak plasma level after 1 hour and has also a halflife of 1 hour. Sibutramine is metabolized by cytochrom-P450-isoenzyme CYP3A4 resulting in 2 active primary and secondary amines (called active metabolites 1 und 2) with halflives of 14 and 16 hours, respectively. Peak plasma concentrations of active metabolites 1 and 2 are reached after 3 to 4 hours. The following metabolic pathway mainly results in two inactive conjugated and hydroxylated metabolites (called metabolites 5 and 6). Metabolites 5 and 6 are mainly excreted in the urine.

Pharmacological Aspects
Sibutramine is a neurotransmitter reuptake inhibitor that helps control appetite by inhibiting the reuptake of serotonin (by 73%), norepinephrine (by 54%), and dopamine (by 16%); as such it is an anorectic (i.e. it decreases appetite) although it also has antidepressant properties (due to its actions upon the aforementioned neurotransmitters). It was approved by the Food and Drug Administration (FDA) in November 1997 for the treatment of obesity.

Sibutramine acts by increasing serotonin and noradrenaline levels in the brain. The serotonergic action, in particular, is thought to influence appetite.

Contraindications and Precautions
Psychiatric conditions as Bulimia nervosa, Anorexia nervosa, serious depression or preexisting mania
Patients with a history of or a predisposition to drug or alcohol abuse
Hypersensitivity to the drug
Patients below 18 yrs. of age
Concomitant treatment with MAOI
Concomitant treatment with other central active drugs, particular other anoretics
Hypertension, which is not sufficiently controlled (caution : controlled hypertension)
Existing pulmonal hypertension
Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, state after myocardial infarction
Stroke or TIA
Overfunction of the thyroid gland
Closed angle glaucoma
Seizure disorders
Enlargement of the prostate gland with urinary retention
Phaeochromocytoma
Pregnant and lactating women

Side effects
Dry mouth, increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain may frequently occur.

The following side effects are infrequent but serious and require immediate medical attention: fast/pounding/irregular heartbeat, numbness/tingling of the hands or feet, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, change in the amount or color of urine, easy or unusual bruising/bleeding, black stools, vomit that looks like coffee grounds, yellowing eyes or skin (signs of liver damage), unexplained fever, shaking, unusual sweating, chest pain, weakness on one side of the body, vision changes, trouble breathing, swelling of the arms/legs.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

Currently, no case of pulmonal hypertension has been noted. But as pulmonal hypertension is a very rare condition, its emergence under Sibutramine cannot be completely excluded.

Interactions
Sibutramine has quite a number of clinically significant interactions.

Dosage
10mg once daily (usually in the morning), if this proves insufficient the dose may be increased to 15mg daily after 4 weeks.

Additional Remarks
Studies are ongoing into reports of sudden death, heart failure, renal failure and gastrointenstinal problems. Despite petitions, the drug has not been banned by the FDA, but was part of a Senate hearing in 2005.

A large randomized-controlled study with over 9000 patients (SCOUT) is currently ongoing to examine whether or not sibutramine reduces the risk for cardiovascular complications in people at high risk for heart disease.

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