Obesity, Overweight, Weight Loss
Conditions
Keywords
Lorcaserin, Belviq
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.
Interventions
DRUGLorcaserin
Treatment initiation with Lorcaserin
Sponsors
Eisai Inc.
Scripps Whittier Diabetes Institute
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Use - in weeks | Up to 1 year of medication use | Average duration of treatment with Lorcaserin |
| Weight change - in pounds | Up to 1 year of medication use | Change in weight with Lorcaserin treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Up to 1 year of medication use | Assessment of change in both systolic and diastolic blood pressure (mmHg) |
| Change in liver enzymes | Up to 1 year of medication use | Assessment of change in lab values for AST and ALT |
| Change in glucose values | Up to 1 year of medication use | Assessment of change in lab values for fasting glucose and hemoglobin A1c |
| Change in lipid levels | Up to 1 year of medication use | Assessment of change in lab values for total cholesterol, LDL, HDL and Triglycerides |
| Change in heart rate | Up to 1 year of medication use | Assessment of change heart rate (bpm) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reasons for Discontinuation | Up to 1 year of medication use | Reasons for discontinuing treatment with Lorcaserin - as obtained by annotation in patient's medical record from overseeing physician. |
| Changes in Healthcare Utilization | Up to 1 year of medication use | Assessment of changes in healthcare utilization including all Scripps outpatient medical visits, visits to the ER and/or Urgent care, and inpatient hospitalizations. All of the above are assessed via the Scripps network EMR and only include visits made to a Scripps facility. Reason for visit and level of visit billed reviewed via EMR using billing and diagnosis codes. |
Countries
United States
Outcome results
None listed