For starters, let us emphasize that a decision as to whether you should take Acomplia / Zimulti (rimonabant) -- or any prescription medication -- is one you absolutely should make in consultation with your doctor.
But there is some information already available -- from both the European Medicines Agency (EMEA) and from Acomplia's developer, Sanofi-Aventis -- about whom this medication is intended for, and how it should not be used.
Sanofi has flatly stated that the use of Acomplia by mildly overweight individuals who are "seeking to achieve weight loss for cosmetic reasons is not appropriate." Nor is it currently approved anywhere for such weight-loss use.
The European Commission -- on the advice of the EMEA -- approved Acomplia for treatment of obese patients (Body Mass Index of 30 or greater) or overweight patients (BMI greater than 27) with risk factors such as Type 2 diabetes or dyslipidaemia (low good cholesterol, high bad cholesterol and high triglycerides).
What is the profile of this type of patient? Sanofi has helpfully provided the media with photos and patient profiles of what it views as two typical prospects for Acomplia treatment.
Sanofi's male prospect is a 55-year-old man with a BMI of 32, a waist circumference of 42.1 inches, an HDL (good) cholesterol level of 38, an LDL (bad) cholesterol level of 95, a triglyceride level of 215, a fasting glucose level of 98, blood pressure of 124 over 78, and currently is taking a statin drug and an antihypertensive. This man (as you will note in the chart below) has several cardiometabolic risk factors related to heart disease.
Sanofi's female prospect is a 44-year-old woman with a BMI of 27, a waist circumference of 39.4 inches, an HDL (good) cholesterol level of 43, an LDL (bad) cholesterol level of 159, a triglyceride level of 178, a fasting glucose level of 153, blood pressure of 122 over 80, and currently is taking a statin drug, an oral anti-diabetic drug and an antihypertensive. This woman (as you will note in the chart) has several cardiometabolic risk factors linked to Type 2 diabetes.
The above prototypes of a candidate for treatment with Acomplia, like about one-quarter of the world's adult population, have three or more of the following risk factors, which researchers say appear to predispose people to Type 2 diabetes and heart disease.
Cardiometabolic Risk Factors Linked to Type 2 Diabetes and Heart Disease |
| Risk Factor |
Increased Risk Range |
| Body Mass Index (BMI) |
BMI greater than or equal to 30; BMI greater than 27 with other risk factors. |
| Low Good Cholesterol (HDL) |
In men, less than 40; in women, less than 50. |
| High Bad Cholesterol (LDL) |
More than 100 with prior or current heart disease of diabetes; more than 130 with two or more risk factors; more than 160 with one or zero risk factors. |
| High Triglycerides |
More than 150. |
| Excess Fat (high waist circumference) |
In men more than 40 inches; in women, more than 35 inches. |
| High Blood Sugar |
Fasting glucose of more than 100. |
| High Blood Pressure |
More than 140/90; more than 130/80 if a diabetic. |
In clinical trials, Acomplia was shown to improve a wide variety of these cardiometabolic risk factors as well as promote weight loss. And researchers reported that approximately half of the observed improvement in good cholesterol, triglycerides and glucose levels was beyond what they believed could be attributed to weight-loss alone.
Thus, patients who have a BMI of 30 or greater, or a BMI of 27 or greater accompanied by other risk factors on this chart, are considered candidates for use of Acomplia together with a medically supervised program of diet and exercise.
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