Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, descriptive study that involves de-identified data consisting of weight changes, pertinent vital signs and laboratory values influenced by body weight, and healthcare utilization of patients prescribed lorcaserin at The Center for Weight Management at the Scripps Clinic in San Diego, CA.

Detailed Description
-----------------
All patients who initiated treatment with Lorcaserin during the review period will undergo chart review. The primary endpoint will be weight change in patients on Lorcaserin and average duration of Lorcaserin treatment over time (up to 1 year). Secondary endpoints will include changes in vital signs, liver function, glucose, and lipids. In addition, time on treatment, reasons for discontinuation of medication, and changes in healthcare utilization (to include inpatient and outpatient utilization) will be examined. This is a retrospective, one-arm observational study that will include chart reviews of 157 patients who have been treated in the clinic.

Official Title
-----------------
Real World Experience With Lorcaserin for Weight Management

Conditions
-----------------
Obesity, Weight Loss, Overweight

Intervention / Treatment
-----------------
* Drug: Lorcaserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received at least one prescription for Lorcaserin treatment At least 18 years of age or with guardian/parent able to consent for a minor Exclusion Criteria: - Patient under the age of 18 at time of index date

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational Group - Lorcaserin Treated<br>The group in this study will be all patients who initiated therapy with Lorcaserin during the review period. | Drug: Lorcaserin<br>* Treatment initiation with Lorcaserin<br>* Other names: Belviq;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change - in pounds | Change in weight with Lorcaserin treatment | Up to 1 year of medication use | 
| Duration of Use - in weeks | Average duration of treatment with Lorcaserin | Up to 1 year of medication use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate | Assessment of change heart rate (bpm) | Up to 1 year of medication use | 
| Change in blood pressure | Assessment of change in both systolic and diastolic blood pressure (mmHg) | Up to 1 year of medication use | 
| Change in lipid levels | Assessment of change in lab values for total cholesterol, LDL, HDL and Triglycerides | Up to 1 year of medication use | 
| Change in liver enzymes | Assessment of change in lab values for AST and ALT | Up to 1 year of medication use | 
| Change in glucose values | Assessment of change in lab values for fasting glucose and hemoglobin A1c | Up to 1 year of medication use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lorcaserin, Belviq