Meridia (Sibutramine Hydrochloride) - Summary

MERIDIA SUMMARY

MERIDIA® (sibutramine hydrochloride monohydrate) is an orally administered agent for the treatment of obesity.

MERIDIA is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. MERIDIA is recommended for obese patients with an initial body mass index >/=30 kg/m², or >/=27 kg/m² in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).

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NEWS HIGHLIGHTS

Published Studies Related to Meridia (Sibutramine)

Effects of CYP3A5, CYP2C19, and CYP2B6 on the clinical efficacy and adverse outcomes of sibutramine therapy: a crucial role for the CYP2B6*6 allele. [2014]
clinical outcomes of sibutramine administration... CONCLUSION: The CYP2B6*6 allele influences the extent of weight reduction and

Systematic review of the clinical efficacy of sibutramine and orlistat in weigth loss, quality of life and its adverse effects in obese adolescents. [2011.06]
INTRODUCTION: The prevalence of obesity, a serious public health problem, is increasing among teenagers and thus also increases cardiovascular morbidity and mortality in adulthood. OBJECTIVE: To provide a systematic review of the best evidence about the effect of sibutramine and orlistat in weight loss, quality of life and its adverse effects in adolescents diagnosed with obesity... CONCLUSIONS: Sibutramine and orlistat in combination with a hypocaloric diet and changes in lifestyle in obese adolescents achieve a short-term loss of weight greater than that achieved through the dietary-behavioral therapy alone.

Effects of combination of sibutramine and L-carnitine compared with sibutramine monotherapy on inflammatory parameters in diabetic patients. [2011.03]
The aim of the study was to evaluate the effects of 12-month treatment with sibutramine plus L-carnitine compared with sibutramine alone on body weight, glycemic control, insulin resistance, and inflammatory state in type 2 diabetes mellitus patients... Sibutramine plus L-carnitine gave a better and faster improvement of all the analyzed parameters compared with sibutramine alone without giving any severe adverse effect.

Distinct modulatory effects of satiety and sibutramine on brain responses to food images in humans: a double dissociation across hypothalamus, amygdala, and ventral striatum. [2010.10.27]
We used functional magnetic resonance imaging to explore brain responses to food images in overweight humans, examining independently the impact of a prescan meal ("satiety") and the anti-obesity drug sibutramine, a serotonin and noradrenaline reuptake inhibitor... Furthermore, they support a regionally specific effect on brain function through which sibutramine exerts its clinical effect.

Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. [2010.09.02]
BACKGROUND: The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established... CONCLUSIONS: Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.)

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Clinical Trials Related to Meridia (Sibutramine)

Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes [Completed]
Control of food intake, size and frequency of meals are critical to the development of obesity. The stomach signals feelings of fullness after a meal and therefore plays a role in control of calorie intake. It is unclear whether the approved appetite reducing drug sibutramine changes the function of the stomach. Differences in the way individuals respond to treatment with the appetite suppressant sibutramine may also explain why some people lose weight while others do not. In a previous study of 48 overweight or obese participants, we preliminarily observed that variation in the gene for the promoter of the serotonin transporter protein was significantly associated with degree of weight loss. This new single center clinical study aims to evaluate the effects of the FDA-approved appetite suppressing medication, sibutramine (MERIDIA)on weight loss and stomach emptying in patients who are overweight or obese. The effect of individual differences in inherited genes that modify serrotonin and noradrenergic receptors on weight reduction with sibutramine will be tested.

Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects [Completed]

A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients [Completed]
The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients [Active, not recruiting]
The aim of this study is to evaluate the effect of sibutramine and metformin combination therapy in comparison with sibutramine or metformin monotherapy over weight, adiposity, glucose metabolism and inflammatory state in obese patients.

Studying the Effects of Sibutramine on Eating Behavior [Terminated]

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Reports of Suspected Meridia (Sibutramine) Side Effects

Aphasia (2),  Hemiparesis (2),  Cerebrovascular Accident (2),  Disability (2),  Drug Ineffective (1),  Foetal Exposure During Pregnancy (1),  Impaired Work Ability (1),  Pain (1),  Paralysis (1),  Pulmonary Embolism (1), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Meridia review by 21 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Overeating, weight gain
Dosage & duration:		15mg taken once daily (best in the morning) for the period of 7 months
Other conditions:		Insomnia, dry mouth, mild headaches
Other drugs taken:		None
		Reported Results
Benefits:		I lost 90 pounds in 6 months. The key was drinking water all throughout the day. I ate 1 meal a day before 6pm & snacked on fruit (applesauce, fruit cups, canned fruit,etc.) all through the day (instead of fast food, icecream, chips or any other food that is unhealthy). I saw no results in the first month, but once 30 days had passed, I started to lose 1 lb. a day & sometimes 1 1'2 lb. a day. Even after getting off of Meridia, I still continued to lose weight 2 months later. Product was VERY expensive but worth it! The more weight you have to lose the more you WILL lose!
Side effects:		Insomnia sometimes. My bedtime(before Meridia) was around 10pm but once I began taking the medicine, I couldn't sleep sometimes until 12am or 1am, but even with lack of sleep, I never felt fatigued like I thought I would. Every once in a while, mild headaches & dry mouth. But nothing too major or life-threatening.
Comments:		Lost 91 lbs. in 6-7 months. Kept the weight off even to this day (4 years later) b/c the Meridia taught me the key to weight loss: Less calorie intake. And since the Meridia trained my body to get full quicker, I was able to still eat & crave less even after getting off of the medication.

Meridia review by 26 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Over eating, reduce wieght gain
Dosage & duration:		10mg taken once daily for the period of 3 months
Other conditions:		high cholesterol, hypoglycemia
Other drugs taken:		pantoprazole
		Reported Results
Benefits:		Decreased meal size, felt more satisfied when I ate and felt fuller quicker. Didn't get hunger urges as often and started to loose weight as decreased my calorie intake
Side effects:		Insomnia, headaches, nausea, increased heart rate
Comments:		Reductil gave me a motivational start to healthy eating and decreasing my portion sizes. Because of low sugar levels I always feel hungry and it gave me some relief as I didnt get hungry as often and when I ate, I couldnt eat as much, but I felt satisfied. I felt that the effects of the drug started to ware off after a few months but now I dont take it anymore as I have lost about 5 kilos and want to continue to lose another 5 through healthy controlled eating and exercise. I feel I can control my eating a bit better and realised that the overeating was creating the roller coaster ride, so I think the drug helped me mentally with portion control and now I tell myself as I have created the habbit with better eating habbits.

Meridia review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		weight loss
Dosage & duration:		10 mg a day taken daily for the period of 2 mos
Other conditions:		heartburn
Other drugs taken:		prilosec
		Reported Results
Benefits:		Definitely lifted mood. Helped me feel full and able to turn down unhealthy snacks. Helped me eat reasonable portions.
Side effects:		Occasional headache. Mild occasional insomnia
Comments:		Taken once a day it acts as a mood lifter and helps you feel full with less food. It helped me take off a few pounds. However, it is only a tool and patient has to be diligent about monitoring hunger and deciding to limit portions. It's easy to "eat around" the drug and overeat. For short term weight loss or to help lose 10 -15 lbs it is great. VERY expensive...$125 for one months supply.