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<p>Sibutramine, usually available as sibutramine hydrochloride monohydrate, is an orally administered agent for the treatment of obesity, as an appetite suppressant. Sibutramine HCl is a neurotransmitter reuptake inhibitor that reduces the reuptake of serotonin (by 53%), norepinephrine (by 54%), and dopamine (by 16%), thereby increasing the levels of these substances in synaptic clefts and helping enhance satiety; the serotonergic action, in particular, is thought to influence appetite. Older anorectic agents such as amphetamine and fenfluramine force the release of these neurotransmitters rather than affecting their reuptake.</p>
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<p>Cardiac valve dysfunction and primary pulmonary hypertension have been associated with the use of centrally acting appetite suppressants. Sibutramine does not promote the release of serotonin (5-hydroxytryptamine, 5-HT) from nerve terminals as do the appetite suppressants that were associated with these adverse events most commonly. A comparison of echocardiograms performed on patients after 0.5 to 16 months (mean 7.6 months) of treatment with 15 mg per day of sibutramine (132 patients) or placebo (77 patients) showed no difference in the incidence of valvular heart disease between the two groups. A second study in 25 patients comparing echocardiograms administered at baseline with those administered after 3 months of treatment with 5 to 30 mg per day of sibutramine detected no cases of valvular heart disease.</p>
<p>In two 12-month studies of sibutramine in obese subjects, maximum weight loss was achieved by 6 months and statistically significant weight loss was maintained over 12 months. Among patients receiving 15 mg per day of sibutramine in clinical weight-loss trials, more than 50% lost ³ 5% of their baseline body weight and about 25% lost ³ 10% of their baseline body weight. However, some weight was regained after discontinuation of sibutramine.</p>
<p><strong>Sibutramine HCl</strong> is indicated for the management of obesity, including weight loss and maintenance of weight loss, in patients on a reduced-calorie diet. Sibutramine should be used only in obese patients with an initial body mass index ³ 30 kg of body weight per square meter of height (kg/m 2) or with an initial body mass index ³ 27 kg/m 2 in the presence of other risk factors, such as hypertension, diabetes, or dyslipidemia. Safety and efficacy of sibutramine use for more than 1 year have not been evaluated in controlled trials.</p>
<p>This medicine contains the active ingredient sibutramine hydrochloride monohydrate, which is a type of anti-obesity medicine. In Europe the drug name is Reductil, in US is called Meridia. Recently it is classified as a Schedule IV controlled substance in the United States.</p>
<p>It is in a class of medications called appetite suppressants. It works by acting on appetite control centers in the brain to decrease appetite. No metter on brand name, Sibutramine HCl comes as a capsule to take by mouth.</p>
<p>You will probably lose weight soon after you begin taking sibutramine and following your diet and exercise program. Be sure to monitor your weight, and call your doctor if you do not lose at least 4 pounds during your first 4 weeks of therapy. Your doctor may wish to change your dose of sibutramine.</p>
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<p>People can rely on prescription pills, which are specifically designed to treat their obesity problems. Among these prescription slimming pills, Sibutramine is quite noteworthy, as it works to both manage weight and control obesity. Sibutramine acts as a slimming pill as well as a diet pill.</p>
<p>Abbott Laboratories manufactures Sibutramine slimming pills. These diet pills are available in licensed pharmacies in many countries of the world including the European Union. These slimming pills are also available on prescription in the UK.</p>
<h3>Medical tests on Sibutramine and its success rates</h3>
<p>Some medical tests, which were conducted to test the effectiveness of Sibutramine, have confirmed its usefulness in controlling obesity. Read about one of the medical tests of Sibutramine.</p>
<p>· The first phase of Sibutramine test was conducted on patients who were split into two groups and given Sibutramine and placebo respectively. These patients were closely monitored for a period of 12 months. The results of this trial showed that patients who took Sibutramine experienced weight loss of 5.2kg compared to 0.5kg weight loss by those who took placebo</p>
<p>· The second phase was conducted on patients who had already lost about 2 percent of their initial body weight after 4 weeks of treatment. One group was continued with Sibutramine and the other was given placebo for another 48 weeks. The results showed that the Sibutramine group showed about 4 percent decrease in weight loss compared to the other group on placebo, which showed 0.2 percent weight gain</p>
<p>· The final phase was conducted on patients who showed about 5 percent of weight loss after continuous treatment of Sibutramine for six months. The results showed that these patients maintained lost weight. They did not regain the weight as compared to those who took placebo and showed weight gain</p>
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<p>The regular dosages of Sibutramine help increase the amount of these two neurotransmitters and they act freely in the brain. Consequently, the users may have feelings of fullness even if they eat less food.</p>
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<p>The common side effects of Sibutramine are headache, increased sweating, increased heart rate, dry mouth, insomnia, nausea, anxiety, depression, and menstrual cycle disorder in women. It also results in increase in blood pressure levels in some users. These side effects are generally mild. However, you should keep your doctor informed about their occurrence.</p>
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<p><strong>Sibutramine, usually available as sibutramine hydrochloride monohydrate, is an orally administered agent for the treatment of obesity, as an appetite suppressant.</strong></p>
<p><strong>Patients taking sibutramine may achieve a 5-10% reduction from their baseline weight. Additionally, sibutramine-assisted weight loss has been accompanied by improvement in blood lipids (e.g, cholesterol). Sibutramine was approved by the FDA in 1997.</strong></p>
<p>Sibutramine is used in combination with a reduced calorie diet and exercise to help people who are overweight lose weight and maintain their weight loss. Sibutramine is in a class of medications called appetite suppressants. It works by acting on appetite control centers in the brain to decrease appetite.</p>
<p>Sibutramine is a neurotransmitter reuptake inhibitor that reduces the reuptake of serotonin (by 53%), norepinephrine (by 54%), and dopamine (by 16%), thereby increasing the levels of these substances in synaptic clefts and helping enhance satiety; the serotonergic action, in particular, is thought to influence appetite. Older anorectic agents such as amphetamine and fenfluramine force the release of these neurotransmitters rather than affecting their reuptake.</p>
<p>Despite having a mechanism of action similar to tricyclic antidepressants, sibutramine has failed to demonstrate antidepressant properties in animal studies. It was approved by the U.S. Food and Drug Administration (FDA) in November 1997 for the treatment of obesity.</p>
<h3><strong>Dosage of Sibutramine</strong></h3>
<p><strong> </strong> Sibutramine is taken once daily, generally in the morning. Therapy usually is started with one 10mg tablet per day. The dose may be increased to 15mg by the physician after several weeks to achieve the desired effect. Doses of up to 60mg have been studied. Sibutramine may be taken with or without food.</p>
<p>Sibutramine comes as a capsule to take by mouth. It is usually taken with or without food once a day. To help you remember to take sibutramine, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sibutramine exactly as directed. Sibutramine can be habit forming. Do not take more or less of it or take it more often or for a longer time than prescribed by your doctor.</p>
<p>Your doctor may start you on a low dose of sibutramine and increase your dose, after you have been taking sibutramine for at least 4 weeks. Your doctor may decrease your dose if you experience certain side effects while you are taking your starting dose.</p>
<p>You will probably lose weight soon after you begin taking sibutramine and following your diet and exercise program. Be sure to monitor your weight, and call your doctor if you do not lose at least 4 pounds (1.8 kilograms) during your first 4 weeks of therapy. Your doctor may wish to change your dose of sibutramine.</p>
<p>You may not continue to lose weight after your first 6 months of treatment. However, you should continue to take sibutramine even if you have stopped losing weight. If you stop taking sibutramine, you may gain weight. Do not stop taking sibutramine without talking to your doctor.</p>
<h3>Sibutramine Contraindications</h3>
<p>Sibutramine is contraindicated in patients with:</p>
<p>* Psychiatric conditions as bulimia nervosa, anorexia nervosa, serious depression or preexisting mania<br />
* Patients with a history of or a predisposition to drug or alcohol abuse<br />
* Hypersensitivity to the drug<br />
* Patients below 18 years of age<br />
* Concomitant treatment with a MAO inhibitor, antidepressant or other centrally active drugs, particularly other anoretics<br />
* History of peripheral arterial disease<br />
* Hypertension that is not sufficiently controlled (e.g., &gt; 145/90 mmHg), caution in controlled hypertension<br />
* Existing pulmonary hypertension<br />
* Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, previous myocardial infarction<br />
* Stroke or transient ischemic attack (TIA)<br />
* Hyperthyroidism (overactive thyroid gland)<br />
* Closed angle glaucoma<br />
* Seizure disorders<br />
* Enlargement of the prostate gland with urinary retention (relative C.I.)<br />
* Pheochromocytoma<br />
* Pregnant and lactating women (relative C.I.)</p>
<h3>Sibutramine side effects</h3>
<p>In general, sibutramine is well-tolerated. The most common side effects have been constipation, inability to sleep, headache, and dry mouth. Other side effects include abdominal pain, acne, rash, chest pain, anxiety, joint pain, back pain, excitation, depression, sweating, dizziness, drowsiness, changes in taste, irregular or painful menstrual periods, flu-like syndrome, increased cough, muscle pain, nausea, vomiting, neck pain, nervousness, palpitations, tingling of the extremities, sore throat, and sinus congestion.<br />
Abnormal liver tests have been reported in 1 in 60 persons who receive sibutramine.<br />
Depression, psychosis, mania, suicidal thoughts and suicide have been reported rarely during treatment with sibutramine; however, it has not been established that sibutramine caused these events.  If any of these events occur during treatment, sibutramine probably should be discontinued.</p>
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Sibutramine is a drug for the treatment of obesity. It is a centrally acting stimulant chemically related to amphetamines. Sibutramine is classified as a Schedule IV controlled substance in the United States. Sibutramine acts by increasing serotonin and norepinephrine levels in the brain. The serotonergic action, in particular, is thought to influence appetite.</p>
<p>Sibutramine is a neurotransmitter reuptake inhibitor that helps enhance satiety by inhibiting the reuptake of serotonin (by 53%), norepinephrine (by 54%), and dopamine (by 16%). It was approved by the U.S. Food and Drug Administration (FDA) in November 1997 for the treatment of obesity.</p>
<p>Frequently encountered side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, anorgasmia and delayed ejaculation, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.</p>
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<p>Studies are ongoing into reports of sudden death, heart failure,  renal failure and gastrointestinal problems. Despite a petition by  Ralph Nader-founded NGO Public Citizen, the FDA made no attempts to  withdraw the drug, but was part of a Senate hearing in 2005. Similarly,  Dr. David Graham, FDA &#8220;whistleblower&#8221;, testified before a Senate Finance  Committee hearing that sibutramine may be more dangerous than the  conditions it is used for.</p>
<p>A large randomized-controlled study with 10,742 patients (SCOUT)  examined whether or not sibutramine administered within a weight  management program reduces the risk for cardiovascular complications in  people at high risk for heart disease and concluded that &#8220;Six-week  treatment with sibutramine appears to be efficacious, tolerable and safe  in this high-risk population for whom sibutramine is usually  contraindicated.&#8221;</p>
<p>The FDA is reviewing preliminary data from a recent study suggesting  that patients using sibutramine have a higher number of cardiovascular  events (heart attack, stroke, resuscitated cardiac arrest, or death)  than patients using a placebo. The preliminary data shows that  cardiovascular events were reported in 11.4% of patients using  sibutramine compared to 10% of patients using a placebo. This difference  is higher than expected, suggesting that sibutramine is associated with  an increased cardiovascular risk in the study population. The analysis  of these data is ongoing and FDA is making no conclusions about the  preliminary findings at this time. These findings highlight the  importance of avoiding the use of sibutramine in patients with a history  of coronary artery disease (heart disease), congestive heart failure  (CHF), arrhythmias, or stroke, as recommended in the current sibutramine  labeling.</p>
<p>On January 21, 2010, the European Medicines Agency recommended  suspension of marketing authorizations for Sibutramine following a  six-year study which showed an increased risk of non-fatal but serious  cardiovascular events in patients with a known or high risk for  cardiovascular disease.</p>
<p>The European Medicines Agency (EMA) has recommended that all  medicines containing the drug sibutramine should no longer be prescribed  or dispensed in European Union (EU) member countries, as well as  Iceland and Norway.  Abbott is complying with the agency&#8217;s  recommendation and has suspended marketing of medicines containing  sibutramine.</p>
<p>Abbott offers sibutramine medicines under the brand name, Reductil,  in the UK.  Sibutramine is also marketed under other names by other  companies.</p>
<p>Below you will find answers to some of the most frequently asked  questions about the EMA recommendation and sibutramine.  For additional  information, we would suggest you consult your physician or contact  Abbott at the number listed below.</p>
<h4>What are the recommendations for prescribers and patients?</h4>
<p>The EMA recommends in Europe that:</p>
<ul>
<li>Doctors should stop prescribing sibutramine-containing medicines to  obese or overweight patients. They should also review the treatment of  patients currently treated with the medicine.</li>
<li>Pharmacist should no longer dispense sibutramine-containing  medicines</li>
<li>Patients who are taking a medicine containing sibutramine to help  them lose weight should make an appointment with their doctor at the  next convenient time to discuss alternative measures to lose weight.</li>
<li>Patients who wish to stop treatment before seeing their doctor can  do so at any time.</li>
<li>Patients who have any questions should speak to their doctor or  pharmacist.</li>
</ul>
<h4>What should I do if I’m currently taking sibutramine?</h4>
<ul>
<li>Please contact your doctor. See also EMA and MHRA recommendation</li>
</ul>
<h4>Why was sibutramine suspended in Europe?</h4>
<ul>
<li>The Committee for Medicinal Products for Human Use (CHMP) of the EMA  voted to recommend that suspension of marketing authorisations for all  medicines containing sibutramine in the EU, as well as Iceland and  Norway.</li>
<li>The CHMP’s recommendation was based on a review of results from the  SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which became  available in November 2009.</li>
</ul>
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