Relationships Among Adverse Events, Disease Characteristics, and Demographics in Treatment of Postherpetic Neuralgia With Gastroretentive Gabapentin

Abstract In the present study, we investigated disease characteristics and clinical outcome in young patients (< 40 years) with World Health Organization (WHO)–defined essential thrombocythemia (ET) compared with early/prefibrotic primary myelofibrosis (PMF) with presenting thrombocythemia. We recruited 213 young patients (median age, 33.6 years), ncluding 178 patients (84%) with WHO-defined ET and 35 patients (16%) showing early PMF. Median follow-up time was 7.5 years. A trend for more overall thrombotic complications, particularly arterial, was seen in early PMF compared with ET. Progression to overt myelofibrosis was 3% in ET and 9% in early PMF, but no transformation into acute leukemia was observed. Combining all adverse events (thrombosis, bleeding, and myelofibrosis), the rate was significantly different (1.29% vs 3.43% of patients/year, P = .01) in WHO-ET and early PMF, respectively. In multivariate analysis, early PMF and the JAK2V617F mutation emerged as independent factors predicting cumulative adverse events.

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Gabapentin: a pooled analysis of adverse events from three clinical trials in patients with postherpetic neuralgia

The American Journal of Geriatric Pharmacotherapy ◽

10.1016/j.amjopharm.2004.09.004 ◽

2004 ◽

Vol 2 (3) ◽

pp. 157-162 ◽

Cited By ~ 29

Author(s):

Bruce Parsons ◽

Leslie Tive ◽

Sue Huang

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Postherpetic Neuralgia ◽

Pooled Analysis

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Efficacy and Safety of Moxibustion for Postherpetic Neuralgia: A Systematic Review and Meta-Analysis

Frontiers in Neurology ◽

10.3389/fneur.2021.676525 ◽

2021 ◽

Vol 12 ◽

Author(s):

Qiqi Wu ◽

Hantong Hu ◽

Dexiong Han ◽

Hong Gao

Keyword(s):

Systematic Review ◽

Herbal Medicine ◽

Adverse Events ◽

Postherpetic Neuralgia ◽

Outcome Measure ◽

Meta Analysis ◽

Current Evidence ◽

Cochrane Library ◽

Efficacy Rate ◽

Efficacy And Safety

Background: Postherpetic neuralgia (PHN) is one of the most common complications of herpes zoster (HZ), and there is still a lack of effective therapies. An increasing number of studies have found that compared to traditional therapy, moxibustion treatment is beneficial for the treatment of PHN, although current evidence remains inconclusive. This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy and safety of moxibustion for PHN.Methods: We conducted a broad literature review of a range of databases from inception to December 2020, including the Cochrane Library, PubMed, EMBASE, Web of Science, Clinical Trails, China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), China Biomedical Network Information, and Wanfang databases. We included RCTs that compared moxibustion to pharmacological therapies, herbal medicine, or no treatment for treating PHN. The main outcome measure was efficacy rate and Visual Analog Scale (VAS); the secondary outcome measure was adverse events. Data accumulation and synthesis included meta-analysis, publication bias, sensitivity analysis, risk-of-bias assessment, and adverse events.Results: We included 13 RCTs involving 798 patients. Compared with the controls (pharmacological therapies, herbal medicine, or no treatment), moxibustion achieved a significantly higher efficacy rate (odds ratio [OR]: 3.65; 95% [confidence interval]: [2.32, 5.72]; P < 0.00001). Subgroup analysis of the distinct moxibustion modalities showed that both Zhuang medicine medicated thread and thunder-fire moxibustions obtained higher clinical efficacy than the control group. Compared with the controls, moxibustion resulted in significantly lower scores on the VAS (Weighted Mean Difference (MD) = −1.79; 95% CI: [−2.26, −1.33]; P < 0.00001). However, there was no significant difference in terms of safety between moxibustion and the controls (OR = 0.33; 95% CI [0.06, 1.77]; P = 0.19).Conclusion: Due to the lack of methodological quality as well as the significant heterogeneity of the included studies, it remains difficult to draw a firm conclusion on the efficacy and safety of moxibustion for the treatment of PHN. Future high-quality studies are urgently needed.

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Lidocaine 700 mg medicated plaster for postherpetic neuralgia: real-world data from the German Pain e-Registry

Pain Management ◽

10.2217/pmt-2021-0022 ◽

2021 ◽

Author(s):

Michael A Überall ◽

Mariëlle Eerdekens ◽

Els Hollanders ◽

Irmgard Bösl ◽

Ingo Sabatschus

Keyword(s):

Quality Of Life ◽

Adverse Events ◽

Medical Care ◽

Real World ◽

Postherpetic Neuralgia ◽

First Line ◽

Real World Data ◽

World Data ◽

Routine Medical Care

Aim: To provide real-world evidence for the effectiveness and tolerability of lidocaine 700 mg medicated plaster (LMP) compared with oral systemic first-line medications (OSM) in postherpetic neuralgia treatment. Patients & methods: Retrospective cohort study in patients refractory to at least one recommended OSM (single drug or a combination of drugs) using anonymized routine medical care data from the German Pain e-Registry. A matched pair approach using propensity score matching was employed. Results: A total of 1711 data sets of postherpetic neuralgia patients were identified per treatment group. The majority (>60%) had experienced pain for more than a year and reported a high burden of pain and reduced quality of life. Six months of LMP treatment provided significantly greater pain reductions, improvements in pain-related impairments and quality of life than OSM treatment (p < 0.001 for all parameters). Drug-related adverse events and treatment discontinuation due to drug-related adverse events also occurred less frequently under LMP treatment (p < 0.001). Conclusion: These real-world data confirm the effectiveness and good tolerability of LMP under routine medical care. The treatment was significantly more effective when compared with first-line oral systemic medications.

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Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord InjuryRelated Neuropathic Pain

January 2018 - Pain Physician ◽

10.36076/ppj.2017.1.e53 ◽

2017 ◽

Vol 1 (21;1) ◽

pp. E53-E63 ◽

Cited By ~ 7

Author(s):

Stephan A. Schug

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Neuropathic Pain ◽

Adverse Events ◽

Postherpetic Neuralgia ◽

Therapeutic Response ◽

Controlled Trials ◽

Cord Injury ◽

Concomitant Medications ◽

Sleep Interference

Background: Patients with neuropathic pain (NeP) often receive combination therapy with multiple agents in the hopes of improving both pain and any comorbidities that may be present. While pregabalin is often recommended as a first-line treatment of NeP, few studies have examined the effects of concomitant medications on the efficacy of pregabalin. Objective: To examine the effects of concomitant medications on the efficacy and safety of pregabalin for the treatment of NeP. Study Design: Data were derived from 7 randomized placebo-controlled trials of pregabalin (150, 300, 600, and flexible 150 – 600 mg/d) for the treatment of postherpetic neuralgia (PHN) and 2 randomized placebo-controlled trials for the treatment of NeP due to spinal cord injury (SCINeP). On each day, patients rated the severity of their pain and pain-related sleep interference (PRSI) over the previous 24 hours on a scale from 0 to 10, with higher scores indicating greater severity. Patients were also continually monitored for the occurrence of adverse events. Setting: A pooled retrospective analyses of data from randomized clinical trials. Methods: Changes from baseline in mean weekly pain and PRSI scores were compared between patients who received concomitant NeP medications and patients who did not receive concomitant NeP medications. Results of these comparisons are presented separately for the PHN (through 4, 8, and 12 weeks) and SCI-NeP (through 12 weeks) cohorts. Common adverse events are also presented for each treatment group. Results: Pregabalin significantly improved both pain and PRSI scores relative to placebo at most dose levels and time points examined. Notably, little difference was observed in the extent of therapeutic response to pregabalin between patients who received concomitant NeP medications and patients who did not receive concomitant NeP medications. Additionally, the profile of treatment-emergent adverse events appeared to be largely unaffected by the use of concomitant NeP medications in the pooled patient population. Limitations: Our analysis is limited in that the original trials of pregabalin were not powered to examine the effects of concomitant NeP medications. Conclusions: The data presented here demonstrate that therapeutic response to pregabalin and the occurrence of adverse events in patients with NeP are generally unaffected by the concurrent use of other NeP medications. Trial Registration numbers: NCT00159666; NCT00301223; NCT00407745 Key words: Pregabalin, neuropathic pain, pain-related sleep interference, concomitant medications, postherpetic neuralgia, spinal cord injury, efficacy, safety

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Continuous infusion of apomorphine in a series of thirty patients with parkinson's disease

NATIONAL JOURNAL OF NEUROLOGY ◽

10.28942/nnj.v1i3.181 ◽

2019 ◽

pp. 43-47 ◽

Cited By ~ 1

Author(s):

Rezzak Yılmaz ◽

Çağlar Sarılar ◽

Cenk Akbostancı

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Deep Brain Stimulation ◽

Adverse Events ◽

Medical Records ◽

Motor Fluctuations ◽

Motor Complications ◽

Subcutaneous Nodules ◽

Disease Characteristics ◽

Deep Brain

Apomorphine is a dopamine agonist primarily used for the treatment of motor fluctuations and severe dyskinesias in late – stage Parkinson’s Disease. We retrospectively studied medical records of 30 patients who were on continuous apomorphine infusion treatment. They were evaluated for their disease characteristics, satisfaction for the therapy and adverse events. Results showed that 17 patients were satisfied with the therapy. The main reason of cessation of therapy (15 patients) was subthalamic nucleus deep brain stimulation. Arrythmia and subcutaneous nodules were relatively rare (3 patients). Results were compared with similar studies. Apomorphine therapy appears as a safe option for patients with motor complications and cognitive or neuropsychiatric problems.

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Mapping PRO-CTCAE responses to clinician-graded adverse events, dose reductions, interruptions, and discontinuations in phase I cancer trials.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.2014 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 2014-2014

Author(s):

Geoffrey Alan Watson ◽

Zachary William Neil Veitch ◽

Daniel Shepshelovich ◽

Zhihui (Amy) Liu ◽

Anna Spreafico ◽

...

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Medical Records ◽

Phase 1 ◽

Patient Report Outcome ◽

Disease Characteristics ◽

Life Scale ◽

First Time ◽

The Relationship ◽

Dose Reductions

2014 Background: Typically symptomatic adverse events (sy-AEs) on clinical trials are reported by clinicians using the CTCAE. To complement clinician collected sy-AEs and understand tolerability better, the patient report outcome version of the CTCAE (PRO-CTCAE) has been developed to provide the patient (pt) perspective on severity of AEs (graded scale 0-4) and their interference in daily life (scale 0-4). The aim of this study was to correlate PRO responses with the grade (G) of AEs, dose interruptions/reductions and dose limiting toxicities (DLTs). Methods: Pts enrolled on phase 1 clinical trials at Princess Margaret were surveyed electronically on tablet using the full library of items for PRO-CTCAE. The PRO-CTCAE was administered at baseline (prior to therapy), mid-cycle 1, and mid-cycle 2. AEs on study were recorded by physicians using the CTCAE. The electronic medical records were analyzed for an association between reported sy-AEs and PRO score. Summary statistics were used to describe patient and disease characteristics, as well as the outcomes. Spearman’s method was used to correlate PRO severity and interference responses. Logistic regression was used to assess which factors were associated with CTCAE G 3-4 vs G 2 AEs. Results: We analyzed 158 pts: median age 60yrs, 77 (49%) were male; all were ECOG ≤1 and 22, 55 and 81 pts completed 1, 2 and 3 surveys, respectively. Clinician reported G2, 3 and 4 sy-AEs occurred in 81, 47 and 3 pts, respectively and all of these were related to a PRO item except 5% (4/81), 9% (4/47) and 33% (1/3), respectively because either the AE occurred after 3rd time point or patient not able to complete the PRO (encephalitis). Sy-AEs causing dose interruptions, reductions, DLTs and discontinuations occurred in 45 (28%), 12 (7.5%), 5 (3%) and 12 (7.5%) pts, respectively; with a corresponding PRO item in 40 (89%), 12 (100%), 4 (80%) and 11(92%) pts, respectively. For patients who had CTCAE G2, G3/4 AEs, interruptions and discontinuations, their severity and inference levels were positively correlated (coefficient 0.49, p < 0.001; 0.45, p < 0.001 0.59, p < 0.001, 0.86, p < 0.001). Dose interruptions (p = 0.0027) and reductions (p = 0.0061) were significantly associated with G3-4 compared to G2 AEs. Conclusions: This is the first time an association between PRO-CTCAE severity and interference; and CTCAE G2, 3, 4 AEs, dose interruptions and discontinuations has been demonstrated. Additional modelling and more patient data are being analyzed to explore the relationship.

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Combined therapy of pulsed radiofrequency and nerve block in postherpetic neuralgia patients: a randomized clinical trial

PeerJ ◽

10.7717/peerj.4852 ◽

2018 ◽

Vol 6 ◽

pp. e4852 ◽

Cited By ~ 5

Author(s):

Dan Li ◽

Guohua Sun ◽

Hanzhe Sun ◽

Yanjuan Wang ◽

Zhiping Wang ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Randomized Clinical Trial ◽

Nerve Block ◽

Postherpetic Neuralgia ◽

Therapy Group ◽

Combined Therapy ◽

Pulsed Radiofrequency ◽

Cotton Swab ◽

Vas Scores

Caused by viral infection, postherpetic neuralgia (PHN) is the most common chronic neuropathic pain. Various treatment modalities such as early use of nerve block therapy (NBT) and pulsed radiofrequency (PRF) have been studied in reducing pain, however, no consistent success was achieved in all the patients treated with single regimen. The combined therapy of PRF and NBT with different targeting mechanism are of interest and remains to be determined. Here we investigated the combined effects of pulsed radiofrequency (PRF) with nerve block therapy (NBT) in PHN patients in a prospective randomized clinical trial. Sixty PHN patients were divided into four groups (n = 15 each): the conventional puncture group (group CP), the nerve block therapy group (group NB), the PRF group (group PRF), and the combined treatment group (PRF combined with nerve block therapy (group CT). To evaluate the extent of remission of hyperalgesia, we recorded the visual analogue scale (VAS) scores during cotton swab reaction before and after treatment and in the resting and active pain states. In addition, blood samples were collected and plasma cytokine and neuropeptides such as interleukin-6 (IL-6), substance P (SP), and β-endorphin (β-EP) were measured by enzyme-linked immunosorbent assay (ELISA) at the admission (basic state), before the operation, and at 12 h postoperatively. The number of adverse events (nausea, vomiting, constipation, puncture point hemorrhage, swelling and redness) within 12 h of the treatment were also documented. Our results showed that VAS scores during cotton swab reaction decreased after treatment in all patients (p < 0.05). Compared to group CP, plasma IL-6 and SP levels decreased (p < 0.05) and β-EP levels increased (p < 0.05) in groups NB, PRF, and CT. There were no significant differences in adverse events among groups (p > 0.05). We found that PRF in combination with NBT increased β-EP levels and decreased plasma IL-6 and SP, thereby alleviating pain and hyperalgesia in PHN patients. Taken together, our data suggest combined therapy of PRF and NBT is effective and safe for PHN patients.

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Biologic therapy is associated with a mild decrease in the rate of hospitalizations in pediatric IBD

BMC Pediatrics ◽

10.1186/s12887-021-02526-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Gil Berkovitch ◽

Shlomi Cohen ◽

Ronit Lubetzky ◽

Dana Singer ◽

Anat Yerushalmy-Feler

Keyword(s):

Adverse Events ◽

Retrospective Cohort ◽

Biologic Therapy ◽

Medical Center ◽

Biologic Agents ◽

Disease Characteristics ◽

Inflammatory Bowel ◽

The Impact ◽

The Relationship ◽

Pediatric Ibd

Abstract Background The effect of biologic therapy on the incidence of inflammatory bowel disease (IBD)-related hospitalizations is controversial. The high efficacy of biologic agents is weighted against potential therapy-related adverse events, however, there are no data on the effect of biologic therapy on the indications for hospitalization in IBD. We aimed to evaluate the impact of biologic therapy on the indications and rate of hospitalization in pediatric IBD. Methods This retrospective cohort study included all children (< 18 years of age) with IBD who were hospitalized in our medical center from January 2004 to December 2019. Data on demographics, disease characteristics and course, and therapy were collected, as were the indications for and course of hospitalizations. We evaluated the relationship between therapy with biologic agents, indications and rates of hospitalization. Results Included were 218 hospitalizations of 100 children, of whom 65 (65%) had Crohn’s disease and 35 (35%) had ulcerative colitis. The indications for hospitalization were IBD exacerbations or complications in 194 (89%) and therapy-related adverse events in 24 (11%). The patients of 56 (25.7%) hospitalizations were receiving biologic therapy. In a multivariate analysis, no correlation between therapy and indication for hospitalization was found (p = 0.829). Among children under biologic therapy, a decrease in the rate of hospitalizations from 1.09 (0.11–3.33) to 0.27 (0–0.47) per year was observed for patients that were hospitalized during 2016–2019 (p = 0.043). Conclusion Biologic therapy did not influence the indication for hospitalization, but were associated with a decrease in the rate of hospitalization during 2016–2019 in pediatric IBD.

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