Assessing the Risk of Falls and Fractures in Older Adults with Diabetic Polyneuropathy Initiated on Gabapentinoids, SNRIs, or TCAs: An Observational Study (SAFER-PDPN)

Study identification

• EU PAS number:
  EUPAS1000000419
• Study ID:
  1000000419
• Official title and acronym:
  Assessing the Risk of Falls and Fractures in Older Adults with Diabetic Polyneuropathy Initiated on Gabapentinoids, SNRIs, or TCAs: An Observational Study (SAFER-PDPN)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Switzerland
• Study description:
  Painful diabetic polyneuropathy (PDPN) affects up to a quarter of patients with diabetes and requires effective pain management. However, first-line treatments, including gabapentinoids, serotonin-noradrenaline reuptake inhibitors (SNRIs) and tricyclic antidepressants (TCAs), all carry risks, particularly in older adults. Importantly, all three drug classes increase the risk of falls, which is worrying because falls are a major cause of morbidity and mortality. To date, there is no evidence comparing the risk of falls and fall-related injuries in older people receiving first-line therapies for PDPN.; Therefore, this study aims to assess and compare the risk for falls and fractures in patients with painful diabetic neuropathy after initiation of gabapentinoids versus SNRIs or TCAs. This study will emulate a clinical trial of gabapentinoids, SNRIs and TCAs in older people with PDPN using the Danish nationwide registers. Patients are eligible if they are 65 years or older, have PDPN and are starting one of the drugs being studied. Patients are excluded if they have an alternative indication or a contraindication for one of the initiated drugs. Follow-up will be 6 months. We will mimic randomisation using propensity score weighting.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Department of Drug Design and Pharmacology, University of Copenhagen

Inselspital

Study timelines

Date when funding contract was signed

Planned:07/01/2025

Actual:07/01/2025

Study start date

Planned:05/05/2025

Actual:21/05/2025

Data analysis start date

Planned:12/05/2025

Date of final study report

Planned:31/08/2025

Sources of funding

Other public funding (e.g. hospital or university)

More details on funding

AG received a "UniBE Short Travel Grants for (Post)Docs" from the University of Bern financing the short research stay to conduct this study. The University of Bern was not involved in designing the study.

Regulatory

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