Belviq Tablet® Post Marketing Surveillance Protocol
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Lorcaserin(Belviq) is a selective 5-hydroxytryptamine receptor agonist, witch is used long term for weight loss in those who are obese. Lorcaserin was approved in 2015 the Republic of Korea for weigh loss in those who are obese. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of lorcaserin for weigh loss in real-world practice.
Incidence of adverse event after this drug administration in general medical [ Time Frame: 12 weeks ]
Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.
Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
Secondary Outcome Measures :
The change from baseline to week 12 in the Body Mass Index(BMI) [ Time Frame: 12 weeks ]
BMI is measured before administration of the drug and within 12 weeks after administration.
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Layout table for eligibility information
Ages Eligible for Study:
19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
residents of Korea, in real-world practice
Subjects who use the drug as an adjuvant therapy of diet therapy and kinesitherapy for weight control are selected.
Obese patients whose body mass index (BMI) is ≧30 kg/m2.
Overweight patients whose body mass index(BMI) is ≧27 kg/m2 and who have other risk factors(e.g. hypertension, dyslipidemia, type II diabetes mellitus)
Patients with a hypersensitivity reaction to the drug or the ingredient of the drug
Female patients of childbearing potential and pregnant or lactating women