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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Group - Lorcaserin Treated | The group in this study will be all patients who initiated therapy with Lorcaserin during the review period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin | Drug | Treatment initiation with Lorcaserin |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Discontinuation | Reasons for discontinuing treatment with Lorcaserin - as obtained by annotation in patient's medical record from overseeing physician. | Up to 1 year of medication use |
| Changes in Healthcare Utilization |
Inclusion Criteria:
Exclusion Criteria:
- Patient under the age of 18 at time of index date
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Study population includes 157 patients seen and evaluated in an insurance-based medical weight loss clinic in San Diego, CA. Eligible participants will include patients who are overweight or obese, and who received at least one prescription for Lorcaserin treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Ken Fujioka, MD | Scripps Clinic Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Whittier Diabetes Institute | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| 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 |
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.
| Up to 1 year of medication use |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |