Alimentary Obesity
Conditions
Brief summary
The aim of this study is to summarize the data on efficacy and safety of Reduxine administration in the routine clinical practice according to the approved indications.
Detailed description
Secondary objectives: * to study the structure of the population of patients with the diet induced obesity with body mass index (BMI) 30 kg/m2 or diet induced obesity with BMI ≥27 kg/m2 associated with type 2 diabetes mellitus in respect of comorbidities and concomitant treatment to determine the areas for further investigations. * to introduce the elements of control of adverse cardiovascular risks into the routine clinical practice: questionnaire concerning enrollment criteria for Reduxine treatment initiation, algorithm of Reduxine administration and treatment efficacy and safety monitoring (assessment schedule). * to assess the effects of the treatment of overweight and obesity with Reduxine on patients' quality of life parameters. The Time Frame: the follow up of the study patients will be performed during six month to one year. Exception - premature discontinuation from the study. The scheduled visits of the patients to the investigational centres are: Week0 (inclusion of the patient), Week 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and Week 48.
Interventions
None listed
Sponsors
Promomed, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women of 18-65 years of age to whom, in the doctor's opinion, the on-label use of Reduxine is indicated. * Patient's desire and ability to participate in the program and fulfill the doctor's instructions designed to achieve the treatment goal and the program requirements compliance. * Signed informed consent form for participation in the program.
Exclusion criteria
\- Patients under age of 18 or older than 65; Current or the history of: * coronary artery disease (e.g. angina, myocardial infraction); * congestive heart failure; * tachycardia; * peripheral arterial occlusive disease; * arrythmia; * Uncontrolled arterial hypertension \>145/90 mm Hg; * Hypersensitivity to sibutramine or any components of Reduxine®; * Current use of monoamineoxidase inhibitors (IMAO) or their use within the last 2 weeks; * Current use of other central acting weight reducing drugs or their use within the last 2 weeks; * Use on other drugs affecting the central nervous system (e.g. antidepressants, neuroleptics); tryptophan-containing drugs indicated for sleep disturbance; * Severe eating disorder (anorexia nervosa or bulimia); * Mental disease; * Gilles de la Tourette syndrome (generalized tics); * Body mass index ≤30 kg/m2 or ≤27 kg/m2 in the presence of concomitant diseases (dyslipidemia, diabetes); * Organic cause of obesity (e.g. hypothyrosis); * Thyrotoxicosis; * Sever liver and/or kidney function abnormality; * Benign prostatic hyperplasia; * Phaeochromocytoma; * Narrowangle glaucoma; * Documented pharmacologic, drug or alcohol addiction; * Pregnancy and lactation; * Refusal to sign the informed consent form for participation in the program; * Participation in a clinical study of any new drug product within 90 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Loss After 3, 6 & 12 Month Treatment | Baseline, after 3, 6 and 12 months of treatment. | Patients were weighed at each visit, but the statistical data processing was carried out after 3, 6 and 12 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events | From the 1st day of Reduxine treatment until the end of the treatment | Percentage of participants with all adverse events since the start of the Reduxine treatment to the end of the study |
Participant flow
Pre-assignment details
98774 patients signed ICF (Informed Consent Forms), but only 93313 patients started Reduxine treatment, as soon as 5461 patients discontinued prior to the treatment start due to contraindications detected after ICF completion.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Obesity Patients 18-65 y.o. with obesity (BMI≥ 30 kg/m2) | 80,146 |
| Patients With Overweight Associated With DM2 Patients 18-65 y.o. with DM2 and overweight (BMI ≥ 27 kg/m2) | 13,167 |
| Total | 93,313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3,286 | 540 |
| Overall Study | Other different categories of not compl | 55,415 | 7,781 |
| Overall Study | Pregnancy | 28 | 0 |
Baseline characteristics
| Characteristic | Patients With Obesity | Patients With Overweight Associated With DM2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80146 Participants | 13167 Participants | 93313 Participants |
| Sex: Female, Male Female | 46617 Participants | 10836 Participants | 57453 Participants |
| Sex: Female, Male Male | 10026 Participants | 2331 Participants | 12357 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56,643 | 0 / 13,167 |
| other Total, other adverse events | 2,322 / 56,643 | 540 / 13,167 |
| serious Total, serious adverse events | 0 / 56,643 | 0 / 13,167 |
Outcome results
Primary
Body Weight Loss After 3, 6 & 12 Month Treatment
Patients were weighed at each visit, but the statistical data processing was carried out after 3, 6 and 12 months of treatment.
Time frame: Baseline, after 3, 6 and 12 months of treatment.
Population: Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obesity | Body Weight Loss After 3, 6 & 12 Month Treatment | Body weight loss after 3 month treatment | -9.5 kg | Standard Error 4.3 |
| Obesity | Body Weight Loss After 3, 6 & 12 Month Treatment | Body weight loss after 6 month treatment | -15.0 kg | Standard Error 6.2 |
| Obesity | Body Weight Loss After 3, 6 & 12 Month Treatment | Body weight loss after 12 month treatment | -20.0 kg | Standard Error 8.6 |
| Overweight & Risk Factors | Body Weight Loss After 3, 6 & 12 Month Treatment | Body weight loss after 3 month treatment | -9.0 kg | Standard Error 4.19 |
| Overweight & Risk Factors | Body Weight Loss After 3, 6 & 12 Month Treatment | Body weight loss after 6 month treatment | -14.4 kg | Standard Error 5.9 |
| Overweight & Risk Factors | Body Weight Loss After 3, 6 & 12 Month Treatment | Body weight loss after 12 month treatment | -19.2 kg | Standard Error 8.25 |
Secondary
Percentage of Participants With Adverse Events
Percentage of participants with all adverse events since the start of the Reduxine treatment to the end of the study
Time frame: From the 1st day of Reduxine treatment until the end of the treatment
Population: Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obesity | Percentage of Participants With Adverse Events | 4.1 percentage of participants |
| Overweight & Risk Factors | Percentage of Participants With Adverse Events | 4.1 percentage of participants |
p-value: <0.001t-test, 1 sided