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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.
Secondary objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese | Patients 18-65 y.o.with alimentary obesity, BMI (Body Mass Index) ≥ 30 kg/m2) | ||
| Overweight & risk factors | Patients 18-65 y.o., overweight, BMI ≥ 27 kg/m 2 plus T2DM ( type 2 diabetes mellitus) or dyslipidemia |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, after 3, 6 and 12 months of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the 1st day of Reduxine treatment until the end of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
- Patients under age of 18 or older than 65;
Current or the history of:
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Men and women of 18-65 years old, in the random gender and demographical proportion, with the diagnosed overweight (BMI ≥ 27 and < 30) and obesity (BMI ≥ 30).
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| Name | Affiliation | Role |
|---|---|---|
| Ivan I Dedov, academician | FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF RUSSIA | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Dedov I.I., Mel'nichenko G.A., Romantsova T.I. The strategy of obesity management: the results of All-Russian observational program "Primavera". Obesity and metabolism. 2016;13(1):36-44. (In Russ.) https://doi.org/10.14341/omet2016136-44 |
| Label | URL |
|---|---|
| Obesity and metabolism is peer-reviewed medical journal that publishes articles on the problems of obesity, metabolic disorders, and endocrine diseases | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| published data | View IPD |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Obesity | Patients 18-65 y.o. with obesity (BMI≥ 30 kg/m2) |
| FG001 | Patients With Overweight Associated With DM2 | Patients 18-65 y.o. with DM2 and owerweigt (BMI ≥ 27 kg/m2) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Obesity | Patients 18-65 y.o. with obesity (BMI≥ 30 kg/m2) |
| BG001 | Patients With Overweight Associated With DM2 | Patients 18-65 y.o. with DM2 and overweight (BMI ≥ 27 kg/m2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion. | Posted | Mean | Standard Error | kg | Baseline, after 3, 6 and 12 months of treatment. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obese | Patients 18-65 y.o.with alimentary obesity, BMI (Body Mass Index) ≥ 30 kg/m2) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Ivan I . Dedov, Director of the Endocrinology Research Centre | FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION | +7 499 124 4300 | dedov@endocrincentr.ru |
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The observation program allow to implement the principles of active monitoring of the efficacy and safety of the drug in the current clinical practice and to develop a skill of reasonable prescribing. In Primavera program it was shown that the use of Reduxine® (sibutramine+ microcrystalline cellulose) leads to loss of body weight and doesn't lead to serious adverse effect |
| Other different categories of not compl |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion. | Count of Participants | Participants |
|
|
|
| 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 | Data for 69810 patients was analyzed. Data for the remaining participants was not analyzed because of the poor quality of Case Report Forms completion. | Posted | Number | percentage of participants | From the 1st day of Reduxine treatment until the end of the treatment |
|
|
|
|
| 0 |
| 56,643 |
| 0 |
| 56,643 |
| 2,322 |
| 56,643 |
| EG001 | Overweight & Risk Factors | Patients 18-65 y.o., overweight, BMI ≥ 27 kg/m 2 plus T2DM ( type 2 diabetes mellitus) or dyslipidemia | 0 | 13,167 | 0 | 13,167 | 540 | 13,167 |
| Headache | General disorders | MedDRA 10.0 | Systematic Assessment | Headache |
|
| Insomnia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | Insomnia |
|
| Hypertension/increased blood pressure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | Hypertension/increased blood pressure |
|
| tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | tachycardia |
|
| Depression | Nervous system disorders | MedDRA 10.0 | Systematic Assessment | Depression |
|
| Other Adverse Events | General disorders | MedDRA 10.0 | Systematic Assessment | Other Adverse Events |
|
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