9 research outputs found
Cancer-related neuropathic pain in out-patient oncology clinics: a European survey
BACKGROUND: Although pain is frequently experienced by patients with cancer, it remains under-treated. The primary aim of this study was to estimate the prevalence of cancer-related neuropathic pain (CRNP) in patients with chronic pain who attended an outpatient clinic for standard care in Europe (irrespective of the reason or stage of the cancer). The secondary aims of this study were to characterise pain and cancer in patients with CRNP (including treatment) and to evaluate the usefulness of the painDETECT (PD-Q) screening tool to help physicians identify a potential neuropathic component of cancer-related pain. METHODS: An observational, non-interventional, cross-sectional, multi-centre study of adult patients with cancer using patient and physician case report forms (CRFs). Patients with CRNP were identified by physicians’ clinical assessments after examining the completed PD-Q. RESULTS: A total of 951 patients visiting outpatient clinics across Europe were enrolled in this study between August 2010 and July 2011. Of these, 310 patients (32.60%; 95% confidence interval 29.62, 35.58) were identified as having CRNP. Twenty-nine of 39 (74.4%) physicians who completed the CRF relating to the PD-Q considered it a useful tool to help detect CRNP in daily practice and 28 of 39 (71.8%) indicated that they would use this tool in the future for most or some of their patients. Data from physicians before and after review of the completed PD-Qs showed a shift in clinical opinion (either to positive CRNP diagnosis [yes] or negative CRNP diagnosis [no]) in respect of 142 patients; about half of which (74) were categorised with an initial diagnosis of unknown. Opinions also shifted from a no to a yes diagnosis in 10 patients and from a yes to a no diagnosis in 51 patients. CONCLUSIONS: Approximately one-third of adults with cancer experiencing chronic pain attending outpatient clinics as part of routine care were considered to have CRNP in the opinion of the physicians after considering scores on the PD-Q. While physicians did not consider the PD-Q to be a useful tool for all patients, shifts in diagnosis before and after the use of this tool indicate that it may help physicians identify CRNP, especially where there is initial uncertainty
Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study.
BACKGROUND
The ongoing Pan-European Real Life (PEARL) phase 4 study is evaluating fremanezumab effectiveness and safety for the prevention of episodic and chronic migraine. This interim analysis reports primary, secondary and exploratory endpoints from when 500 participants completed at least six months of treatment.
METHODS
Adults with episodic migraine or chronic migraine maintaining daily headache diaries were enrolled upon initiation of fremanezumab. Primary endpoint: proportion of participants with ≥50% reduction in monthly migraine days during the six-month period after fremanezumab initiation. Secondary endpoints: mean change from baseline across months 1-12 in monthly migraine days, acute migraine medication use, and headache-related disability. Exploratory endpoint: mean change in headache severity from baseline across months 1-12. Safety was assessed through adverse events reported.
RESULTS
Overall, 897 participants were enrolled and 574 included in the effectiveness analyses (episodic migraine, 25.8%; chronic migraine, 74.2%). Of participants with data available, 175/313 (55.9%) achieved ≥50% monthly migraine days reduction during the six-month period post-initiation. Across months 1-12, there were sustained reductions in mean monthly migraine days, acute medication use, disability scores, and headache severity. Few adverse events were reported.
CONCLUSION
PEARL interim results support the effectiveness and safety of fremanezumab for migraine prevention in a real-world population across several European countries.Trial registration: encepp.eu: EUPAS35111
Pregabalin versus gabapentin in the management of peripheral neuropathic pain associated with post-herpetic neuralgia and diabetic neuropathy: a cost effectiveness analysis for the Greek healthcare setting
Background: The anticonvulsants pregabalin and gabapentin are both
indicated for the treatment of peripheral neuropathic pain. The decision
on which treatment provides the best alternative, should take into
account all aspects of costs and outcomes associated with the two
therapeutic options. The objective of this study was to examine the cost
- effectiveness of the two agents in the management of patients with
painful diabetic neuropathy or post - herpetic neuralgia, under the
third party payer perspective in Greece.
Methods: The analysis was based on a dynamic simulation model which
estimated and compared the costs and outcomes of pregabalin and
gabapentin in a hypothetical cohort of 1,000 patients suffering from
painful Diabetic Peripheral Neuropathy (DPN) or Post-Herpetic Neuralgia
(PHN). In the model, each patient was randomly allocated an average
pretreatment pain score, measured using an eleven-point visual analogue
scale (0 - 10) and was “run through” the model, simulating their
daily pain intensity and allowing for stochastic calculation of
outcomes, taking into account medical interventions and the
effectiveness of each treatment.
Results: Pregabalin demonstrated a reduction in days with moderate to
severe pain when compared to gabapentin. During the 12 weeks the
pregabalin arm demonstrated a 0.1178 (SE 0.0002) QALY gain, which proved
to be 0.0063 (SE 0.0003) higher than that in the gabapentin arm. The
mean medication cost per patient was higher for the pregabalin arm when
compared to the gabapentin arm (i.e. (sic)134.40) over the 12 week
treatment period. However, this higher cost was partially offset by the
reduced direct medical costs (i.e. the cost of specialist visits, the
cost of diagnostic tests and the other applied interventions). Comparing
costs with respective outcomes, the ICERs for pregabalin versus
gabapentin were (sic)13 (95%CI: 8 - 18) per additional day with no or
mild pain and (sic)19,320 (95%CI: 11,743 - 26,755) per QALY gained.
Conclusions: Neuropathic pain carries a great disease burden for
patients and society and, is also, associated with a significant
economic burden. The treatment of pain associated with DPN and PHN with
pregabalin is a cost-effective intervention for the social security in
Greece compared to gabapentin. Thus, these findings need to be taken
into consideration in the decision - making process when considering
which therapy to use for the treatment of neuropathic pain
PEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine
Lay abstract: Fremanezumab is an injectable biologicmedication that
targets calcitonin gene-related peptide, a substance released in the
nerves and blood vessels during a migraine attack that plays a role in
migraine pain. Fremanezumab is approved in Europe for preventing
migraine in adults who experience >= 4 migraine days/month. The
Pan-European Real Life (PEARL) study is a 24-month long study that will
observe patients with migraine who are starting treatment with
fremanezumab in a clinical practice setting under the care of their
treating physician. The major goals of the study are to evaluate the
effectiveness of fremanezumab for reducing days with migraine attacks in
a month, disability associated with migraine and use of acute headache
medications to treat migraine, including in patients switching from
other biologic migraine therapies in the same drug class. The extent to
which patients follow their recommended treatment schedule per their
providers' instructions and whether patients discontinue treatment will
also be evaluated. The PEARL study will include >1000 patients in 100
centers across 11 European countries. The study will provide important
information on effectiveness for patients with migraine receiving
fremanezumab in the normal course of their treatment, as well as on
patients' use of fremanezumab according to their prescribing physicians'
recommendations
A Dutch cost-effectiveness analysis of fremanezumab versus best supportive care in patients with chronic migraine and inadequate response to prior preventive therapy
Abstract Background Chronic migraine (CM) is the most severe and burdensome subtype of migraine. Fremanezumab is a monoclonal antibody that targets the calcitonin gene-related peptide pathway as a migraine preventive therapy. This study aimed to conduct a cost-effectiveness analysis of fremanezumab from a societal perspective in the Netherlands, using a Markov cohort simulation model. Methods The base-case cost-effectiveness analysis adhered to the Netherlands Authority guidelines. Fremanezumab was compared with best supportive care (BSC; acute migraine treatment only) in patients with CM and an inadequate response to topiramate or valproate and onabotulinumtoxinA (Dutch patient group [DPG]). A supportive analysis was conducted in the broader group of CM patients with prior inadequate response to 2–4 different classes of migraine preventive treatments. One-way sensitivity, probabilistic sensitivity, and scenario analyses were conducted. Results Over a lifetime horizon, fremanezumab is cost saving compared with BSC in the DPG (saving of €2514 per patient) and led to an increase of 1.45 quality-adjusted life-years (QALYs). In the broader supportive analysis, fremanezumab was cost effective compared with BSC, with an incremental cost-effectiveness ratio of €2547/QALY gained. Fremanezumab remained cost effective in all sensitivity and scenario analyses. Conclusion In comparison to BSC, fremanezumab is cost saving in the DPG and cost effective in the broader population
sj-pdf-1-cep-10.1177_03331024231214987 - Supplemental material for Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study
Supplemental material, sj-pdf-1-cep-10.1177_03331024231214987 for Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study by Messoud Ashina, Dimos D. Mitsikostas, Faisal Mohammad Amin, Pinar Kokturk, Christoph J. Schankin, Gurdal Sahin, Patricia Pozo-Rosich, Paul J. Dorman, Tomáš Nežádal, Anne Christine Poole, Isabel Pavão Martins, Marja-Liisa Sumelahti, Verena Ramirez Campos, Andrew H. Ahn, Leonidas Lyras and Cristina Tassorelli in Cephalalgia</p
An open-label, add-on study of pregabalin in patients with partial seizures: A multicenter trial in Greece
Introduction: Pregabalin efficacy and safety as an adjunctive treatment for partial seizures was evaluated using an open-label, flexible-dose. Study design: In 98 adults with refractory partial epilepsy taking 1-3 anti-epileptic drugs with >= 2 seizures during an 8-week baseline period. Methods: Pregabalin was increased to 3 per 28 days, respectively. The 50% and 75% responder rates were 41.94% (95% CI: 31.91-51.96) and 30.11% (95% CI: 20.78-39.43), respectively. Nineteen percent of subjects were seizure-free throughout the last 12 weeks. Pregabalin administration resulted in a significant reduction in anxiety (mean reduction in Hospital Anxiety and Depression Scale scores of 1.68 units, 95% CI: -2.60 to -0.76). Most patients were much improved or very much improved on Patient Global Impression of Change (53.8%) and Clinical Global Impression of Change (53.8%). The most frequently self-reported adverse events (AEs) were mild or moderate somnolence (20.4%) and dizziness (5.1%) with a low AE discontinuation rate (5.1%). Conclusions: The efficacy and side-effect profile of pregabalin were similar to previous pregabalin double-blind, controlled studies. Additionally, pregabalin, as an add-on treatment for partial epilepsy, exhibits significant anti-anxiety properties. (C) 2011 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved