In the RIO study programme, the efficacy of rimonabant was examined. The next step is to assess the use of rimonabant, its safety and effectiveness in daily practice. In daily practice people also have other diseases, may use other medication and may be less compliant to use rimonabant than in the studies performed in research centres. All these factors could influence the use and effect of rimonabant on cardiometabolic risk reduction and therefore need to be assessed.
More information can be found below:
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Qureshi AI, Fareed M, Sure K, Kirmani JF, Divani AA. The relative impact of inadequate primary and secondary prevention on cardiovasculair mortality in the United States. Stroke 2004;35:2346-2350.
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Approved by the Medical Ethics Board Maastricht University Hospital/Maastricht University (AZM/UM) on the 30th August 2006 (ref: MEC 06-3-050).
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Patient at cardiometabolic risk
Participants in the different study groups receive no medication, rimonabant or placebo plus three life style counselling sessions.
Primary outcome measure
Main study parameters/endpoints: Primary outcomes will be measured after three, six, and 12 months, and include waist circumference, plasma glucose, HbA1C and the use of rimonabant.
Secondary outcome measures
Secondary outcomes will be measured during the visits and at follow-up including lipid profile, body weight, blood pressure, smoking, Quality Adjusted Life Years (QALYs) and costs.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
We aim to include people who fulfil at least the following inclusion criteria:
1. Informed consent must be obtained in writing for all subjects at enrolment into the study
2. Male or female 18 to 75 years of age
3. Willingness and ability to comply with the study protocol (including the lifestyle counselling)
4. Waist circumference more than 88 cm in women and more than 102 cm in men
5. Diabetes mellitus type two or an impaired fasting blood glucose more than 6.1 mmol/l in venous plasma
Target number of participants
Participant exclusion criteria
Participants are excluded from participation in the study if:
1. Pregnant or breast-feeding women, or women planning to become pregnant
2. Previous use of rimonabant
3. History of surgical procedures for weight loss (e.g., stomach stapling, bypass)
4. Morbid obese patients (Body Mass Index [BMI] more than 40 kg/m^2), history of bulimia or anorexia nervosa
5. Presence of any clinically significant endocrine disease
6. Severe renal dysfunction (creatinine clearance more than 30 ml/min) or nephrotic syndrome
7. Known chronic hepatitis or clinically significant hepatic disease
8. Significant haematology abnormalities (haemoglobin less than 100 g/L and/or neutrophils less than 1.5 G/L and/or platelets less than 100 G/L)
9. Cardiac status New York Heart Association (NYHA) III or IV or Electrocardiogram (ECG) within six months showing acute changes
10. Any current malignancy or any cancer with the past five years (except adequately treated basal cell skin cancer or cervical carcinoma in situ)
11. History of seizure disorder
12. Acute psychiatric disorders or prolonged use within the last three months of neuroleptics
13. History of severe depression that could be defined as depression which necessitated the patient to be hospitalised, or patients with two or more recurrent episodes of depression or a history of suicide attempt and/or prolonged use (more than one week) within the last three months use of antidepressants (including bupropion)
14. History of alcohol or other substance abuse, use of hashish or marijuana use
15. Use of any investigational treatment (drug or device) within 30 days prior to screening
16. Prolonged use (more than one week) within the last three months of systemic corticosteroids
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Maastricht (UM)
This trial is initiated by the principal investigator C.P. van Schayck and in part financed by the Care and Public Health Research Institute and Sanofi-Aventis (The Netherlands).
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22389428
Boesten JE, Kaper J, Stoffers HE, Kroon AA, van Schayck OC, Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE)., Fam Pract, 2012, 29, 5, 521-527, doi: 10.1093/fampra/cms013.