A Drug Utilisation Study of Qsiva for Weight Management: A Postmarketing Cohort Database Study in Denmark, Finland, Norway, and Sweden

Study identification

• EU PAS number:
  EUPAS1000000883
• Study ID:
  1000000883
• Official title and acronym:
  A Drug Utilisation Study of Qsiva for Weight Management: A Postmarketing Cohort Database Study in Denmark, Finland, Norway, and Sweden
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  Qsiva® (Vivus, B.V.) is a fixed-dose combination of phentermine hydrochloride and topiramate. According to the summary of product characteristics (SmPC), Qsiva, as an adjunct to a reduced-calorie diet and physical activity, is indicated for weight management in adult patients with an initial body mass index (BMI) of ≥30 kg/m2 (obese) or ≥27 kg/m2 (overweight) with weight-related comorbidities such as hypertension, type 2 diabetes, or dyslipidaemia. Qsiva was first approved for use in the Nordic countries in 2021 and later received approval from other European countries through de-centralised procedures. Qsiva is also approved for use in the United States and the Republic of Korea (as Qsymia®). Warnings and precautions are included for the use of Qsiva in patients with cardiovascular disease and patients with psychiatric disorders, including mood disturbances and suicidal ideation. This drug utilisation study aims at describing important characteristics of the patient population initiating the use of Qsiva in Denmark, Finland, Norway, and Sweden and demonstrating that the patient characteristics are consistent with the labelled indication for Qsiva.
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned:15/09/2023

Actual:15/09/2023

Study start date

Planned:17/11/2025

Actual:17/11/2025

Data analysis start date

Planned:23/03/2026

Date of final study report

Planned:30/09/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

The study is funded by VIVUS LLC.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

Protocol identification number: OB-907