The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity (Primavera)

All-Russia Non-interventional Program of Reduxine Safety Monitoring for Weight Reduction in Patients With Alimentary Obesity in the Routine Clinical Practice

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.

Study Overview

• Status: Completed
• Conditions: Alimentary Obesity

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.

• Study Type: Observational
• Enrollment (Actual): 98774

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow region
    • Moscow, Moscow region, Russian Federation, 299090
      • Promomed Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Promomed, LLC
• Investigators: Study Chair: Ivan I Dedov, academician, FEDERAL STATE BUDGETARY INSTITUTION "ENDOCRINOLOGY RESEARCH CENTRE" MINISTRY OF HEALTH OF RUSSIA

Publications and helpful links

General Publications

• 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

Helpful Links

• Obesity and metabolism is peer-reviewed medical journal that publishes articles on the problems of obesity, metabolic disorders, and endocrine diseases

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (Estimated): January 23, 2013

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: PROMOMED-PRIMAVERA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. published data
   Information comments: 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