Prescribing practice of pregabalin/gabapentin in pain therapy: an evaluation of German claim data

Abstract

ObjectivesTo analyse the prevalence and incidence of pregabalin and gabapentin (P/G) prescriptions, typical therapeutic uses of P/G with special attention to pain-related diagnoses and discontinuation rates.DesignSecondary data analysis.SettingPrimary and secondary care in Germany.ParticipantsFour million patients in the years 2009–2015 (anonymous health insurance data).InterventionNone.Primary and secondary outcome measuresP/G prescribing rates, P/G prescribing rates associated with pain therapy, analysis of pain-related diagnoses leading to new P/G prescriptions and the discontinuation rate of P/G.ResultsIn 2015, 1.6% of insured persons received P/G prescriptions. Among the patients with pain first treated with P/G, as few as 25.7% were diagnosed with a typical neuropathic pain disorder. The remaining 74.3% had either not received a diagnosis of neuropathic pain or showed a neuropathic component that was pathophysiologically conceivable but did not support the prescription of P/G. High discontinuation rates were observed (85%). Among the patients who had discontinued the drug, 61.1% did not receive follow-up prescriptions within 2 years.ConclusionThe results show that P/G is widely prescribed in cases of chronic pain irrespective of neuropathic pain diagnoses. The high discontinuation rate indicates a lack of therapeutic benefits and/or the occurrence of adverse effects.

Patterns of pregabalin initiation and discontinuation after its subsidy in Australia

“…Following the PBS subsidy of pregabalin, we observed high rates of pregabalin initiation from 2013/14 to 2016/17 with only a slight drop in 2017/18. However, consistent with other studies, 7,17,18 we observed high rates of discontinuation which have been increasing over time, suggesting suboptimal efficacy or low tolerability of pregabalin for the conditions for which it is being used. The lower discontinuation rates in people that initiated on the higher capsule strengths may indicate a better risk–benefit profile, use for different indications, or use in different populations.…”

“…Pregabalin use is on the rise globally, 2–4 with growing concerns about off‐label use and misuse 5,6 . Many people initiating pregabalin do not have a diagnosis for an approved indication and there is suspicion that pregabalin is being prescribed for non‐neuropathic pain, particularly low back pain, despite evidence that it is ineffective for this condition 2,3,7 …”

Pregabalin prescribing patterns in Australian general practice, 2012–2018: a cross-sectional study

“…(5) There are concerns it is being over-prescribed, (2,6) with several studies finding high rates of offlabel use, particularly for non-neuropathic pain conditions where evidence of benefit is unclear. (2,3,7) Pregabalin has abuse potential, and is commonly misused in people with a history of substance use disorder or psychiatric problems. (8)(9)(10) When pregabalin is taken in combination with other medicines with sedative properties, particularly opioids and benzodiazepines, it can lead to central nervous system depression, with the greatest risk observed with high doses.…”

“… 5 There are concerns it is being overprescribed, 2 , 6 with several studies finding high rates of off-label use, particularly for non-neuropathic pain conditions where evidence of benefit is unclear. 2 , 3 , 7 …”

“…(19) While we did not have information on prescribed dose, the 25mg tablet is intended for dose titration purposes, and on its own it is not considered a therapeutic dose for neuropathic pain (30). In international studies, prescribing of pregabalin for unapproved or off-label indications is common (2,7,29,31). A 2019 study of pregabalin prescribing in UK general practice found that 55% of pregabalin prescriptions were off-label, primarily for non-neuropathic pain,(2) while in a 2019 German study only 26% of people prescribed pregabalin had a neuropathic pain diagnosis.…”