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

Sponsor
Scripps Whittier Diabetes Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03552107
Collaborator
Eisai Inc. (Industry)
157
Enrollment
1
Location
24
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Actual Enrollment :
157 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Real World Experience With Lorcaserin for Weight Management
Actual Study Start Date :
Apr 11, 2017
Actual Primary Completion Date :
Oct 11, 2018
Actual Study Completion Date :
Apr 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Observational Group - Lorcaserin Treated

The group in this study will be all patients who initiated therapy with Lorcaserin during the review period.

Drug: Lorcaserin
Treatment initiation with Lorcaserin
Other Names:
  • Belviq

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weight change - in pounds [Up to 1 year of medication use]

      Change in weight with Lorcaserin treatment

    2. Duration of Use - in weeks [Up to 1 year of medication use]

      Average duration of treatment with Lorcaserin

    Secondary Outcome Measures

    1. Change in heart rate [Up to 1 year of medication use]

      Assessment of change heart rate (bpm)

    2. Change in blood pressure [Up to 1 year of medication use]

      Assessment of change in both systolic and diastolic blood pressure (mmHg)

    3. Change in lipid levels [Up to 1 year of medication use]

      Assessment of change in lab values for total cholesterol, LDL, HDL and Triglycerides

    4. Change in liver enzymes [Up to 1 year of medication use]

      Assessment of change in lab values for AST and ALT

    5. Change in glucose values [Up to 1 year of medication use]

      Assessment of change in lab values for fasting glucose and hemoglobin A1c

    Other Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Whittier Diabetes Institute San Diego California United States 92121

    Sponsors and Collaborators

    • Scripps Whittier Diabetes Institute
    • Eisai Inc.

    Investigators

    • Principal Investigator: Ken Fujioka, MD, Scripps Clinic Medical Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Athena Philis-Tsimikas, Corporate Vice President, Scripps Whittier Diabetes Institute
    ClinicalTrials.gov Identifier:
    NCT03552107
    Other Study ID Numbers:
    • Lorcaserin
    First Posted:
    Jun 11, 2018
    Last Update Posted:
    Oct 31, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Athena Philis-Tsimikas, Corporate Vice President, Scripps Whittier Diabetes Institute
    Lorcaserin
    Belviq
    Additional relevant MeSH terms:
    Body Weight
    Overweight
    Weight Loss

    Study Results

    No Results Posted as of Oct 31, 2019