Detection of therapeutic cascades associated with gabapentinoids and benzodiazepines in adults over 65 years old in Spain using BIFAP through prescription sequence symmetry analysis (GABALOOP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000241
• EU PAS number:
  EUPAS1000000241
• Study ID:
  1000000241
• Official title and acronym:
  Detection of therapeutic cascades associated with gabapentinoids and benzodiazepines in adults over 65 years old in Spain using BIFAP through prescription sequence symmetry analysis (GABALOOP)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Introduction: Increasing awareness of certain therapeutic cascades among healthcare professionals through evidence derived from research is crucial for their prevention. Benzodiazepines and gabapentinoids may be related to two of these cascades, and their prescription is on the rise. ; ; Objective: The main objective is to estimate the rates of sequential drug prescription combinations in the Spanish population aged over 65 with polypharmacy, compared to the rest of the population. Secondary objectives include studying individual factors associated with these combinations. ; ; Material and Methods: The study design is longitudinal and retrospective, using Symmetrical Sequential Prescription Analysis (SSPA). Data from the BIFAP database, which includes primary care information in Spain, will be utilized. ; ; Variables: Prescription times of the drugs considered exposure and event, as well as clinical and sociodemographic variables related to that prescription, will be collected. ; ; Statistical Analysis: The main characteristics of patients with cascades will be described. Sequence ratios will be calculated to identify asymmetry in prescriptions. A multilevel model will be adjusted to analyze individual factors associated with therapeutic cascades. ; ; Discussion: Trends in prescriptions over time and the variety of indications for the studied drugs may limit some of the results. In summary, the protocol focuses on investigating the prevalence and factors associated with therapeutic cascades and polypharmacy in older adults in Spain, using BIFAP data and a symmetrical sequential prescription analysis approach.
• Study status:
  Planned

Research institution and networks

Institutions

Gerencia Asistencial de Atención Primaria

Universidad Rey Juan Carlos (URJC)

Spain

Networks

Las Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS)

RICAPP

Study timelines

Date when funding contract was signed

Planned: 30/04/2023

Actual: 30/08/2023

Study start date

Planned: 30/11/2023

Date of final study report

Planned: 31/12/2025

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable