scholarly journals Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Vladimir Skljarevski ◽  
Elijah P. Frakes ◽  
Doron Sagman ◽  
Sarah Lipsius ◽  
Alexandra N. Heinloth ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Brief Pain Inventory ◽  
Primary Outcome Measure ◽  
Pain Severity ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Once Daily

We summarize efficacy and safety findings from 4 double-blind, placebo-controlled, 12-week studies and 1 open-label, uncontrolled, 34-week maintenance-of-effect (MOE) study that examine duloxetine 40 and 60 mg once daily (QD) in patients with diabetic peripheral neuropathic pain (DPNP). In all placebo-controlled studies, duloxetine showed significantly (P≤.01) greater reduction in pain severity (weekly mean of 24-hour average pain severity ratings, primary outcome measure) compared with placebo. In all placebo-controlled studies, duloxetine showed significantly (P≤.05) greater improvement on brief pain inventory-Interference ratings. Patient global impression of improvement ratings were superior to placebo (P≤.01) for duloxetine patients in all placebo-controlled studies. Response rates (based on 30% pain reduction) ranged from 57% to 68% for duloxetine and from 35% to 47% for placebo and were statistically significantly different (P≤.01) between treatment groups in 3 out of 4 studies. The open-label study showed maintenance of analgesic effect of duloxetine in DPNP. In the duloxetine groups, 4.3% to 14.9% of patients discontinued because of adverse events (placebo groups: 2.6% to 7.4%). Most commonly reported treatment-emergent adverse events were nausea, somnolence, and headache. Duloxetine 40 and 60 mg QD was efficacious and well tolerated in the management of DPNP.

scholarly journals An Assessment of Clinically Important Differences on the Worst Pain Severity Item of the Modified Brief Pain Inventory in Patients with Diabetic Peripheral Neuropathic Pain

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
James Marcus ◽  
Kathryn Lasch ◽  
Yin Wan ◽  
Mei Yang ◽  
Ching Hsu ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Rating Scale ◽  
Roc Curves ◽  
Brief Pain Inventory ◽  
Pain Severity ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Intensity Rating ◽  
Global Impression Of Change ◽  
Post Hoc

Objectives. Using patient global impression of change (PGIC) as an anchor, an approximately 30% reduction on an 11-point numeric pain intensity rating scale (PI-NRS) is considered a clinically important difference (CID) in pain. Our objective was to define the CID for another pain measure, the worst pain severity (WPS) item of the modified Brief Pain Inventory (m-BPI). Methods. In this post hoc analysis of a double-blind, placebo-controlled, phase 2 study, 452 randomized patients with diabetic peripheral neuropathic pain (DPNP) were followed over 5 weeks, with m-BPI data collected weekly and PGIC at treatment conclusion. Receiver operating characteristic (ROC) curves (via logistic regression) were used to determine the changes in the m-BPI-WPS score that best predicted ordinal clinical improvement thresholds (i.e., “minimally improved” or better) on the PGIC. Results. Similar to the PI-NRS, a change of −3 (raw) or −33.3% from the baseline on the m-BPI-WPS optimized prediction for the “much improved” or better PGIC threshold and represents a CID. There was a high correspondence between observed and predicted PGIC categories at each PGIC threshold (ROC AUCs were 0.78–0.82). Conclusions. Worst pain on the m-BPI may be used to assess clinically important improvements in DPNP studies. Findings require validation in larger studies.

scholarly journals Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in Peripheral Neuropathic Pain: Multi-Center, Randomized, and Semi-Double Blind Controlled Study

2017 ◽  
Vol 2 (20;2) ◽  
pp. 27-35
Author(s):  
PyungBok Lee
Keyword(s):  
Neuropathic Pain ◽  
Peripheral Neuropathy ◽  
College Teaching ◽  
Small Sample ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
High Concentration ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Topical Capsaicin

Background: Topical capsaicin therapy may be of benefit in providing pain relief in patients with peripheral neuropathy. Objectives: To investigate the efficacy and safety of 0.625% (50 µg/cm2 ) and 1.25% (100 µg/cm2 ) capsaicin patches (CPs) compared to conventional 0.075% capsaicin cream or placebo patches in patients suffering from peripheral neuropathy. Study Design: Early Phase II, multi-center, randomized, semi-double-blind, and placebocontrolled clinical trial. Setting: Two medical college teaching hospitals. Methods: Sixty patients were randomized to the 0.625% CP, 1.25% CP, placebo-controlled patch, or 0.075% capsaicin cream. The primary efficacy endpoint was the mean difference in the change of daily numerical rating scale (NRS) pain score. Secondary endpoints included values for the Daily Sleep Interference Scale, the percentage of patients achieving a ≥ 30% or ≥ 50% reduction in pain, and data for Global Impression Change (GIC) and EQ-5D. Results: Patients treated with the 0.625% CP and 0.075% capsaicin cream showed statistically significant improvements in pain after 6-weeks of test drug application. Daily sleep disorder scores were improved only for those patients applying the 0.075% capsaicin cream. For patient-derived GIC scores, the majority (11 of 12) of patients in the 0.625% CP group reported that their pain was improved. For the safety evaluation, 2 severe adverse events were reported for the 0.075% capsaicin cream group only. Repetitive patch application was related to minor skin problems such as a burning sensation, erythema, pruritus, and vesicles in 28 patients (46.67%). Limitations: The small sample size and relatively high dropout rates. Conclusion: Our data indicate that the 0.625% CP may prove to be an effective and safe alternative with which to treat patients with peripheral neuropathy and could replace the high concentration (8%) CP. Further studies are now needed to definitively establish efficacy. Key words: Capsaicin, patch, CP, topical capsaicin, neuropathic pain, peripheral neuropathic pain, PNP, high concentration CP

scholarly journals Correction to: Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial

2019 ◽  
Vol 18 (2) ◽  
pp. 583-583
Author(s):  
Khojasteh Joharchi ◽  
Moosareza Memari ◽  
Eznollah Azargashb ◽  
Navid Saadat
Keyword(s):  
Clinical Trial ◽  
Neuropathic Pain ◽  
Randomized Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Iranian Patients

The article Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial, written by Khojasteh Joharchi, Moosareza Memari, Eznollah Azargashb, and Navid Saadat, was originally published.

scholarly journals Efficacy, Safety, and Tolerability of Gepotidacin (GSK2140944) in the Treatment of Patients with Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections

2017 ◽  
Vol 61 (6) ◽  
Author(s):  
William O'Riordan ◽  
Courtney Tiffany ◽  
Nicole Scangarella-Oman ◽  
Caroline Perry ◽  
Mohammad Hossain ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Utility ◽  
The United States ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Open Label ◽  
Gram Positive ◽  
Double Blind ◽  
Skin Structure

ABSTRACT Gepotidacin is a novel, first-in-class, triazaacenaphthylene antibacterial agent which has in vitro activity against causative pathogens of acute bacterial skin and skin structure infections (ABSSSIs). This phase 2, randomized, 2-part, multicenter, dose-ranging, response-adaptive study with optional intravenous-oral switch evaluated the efficacy and safety of gepotidacin for the treatment of Gram-positive ABSSSIs in 122 adult patients in the United States. The study had a double-blind phase (part 1; intravenous [750 mg or 1,000 mg every 12 h {q12h}]) and an open-label phase (part 2; intravenous [750 mg q12h, 1,000 mg q12h, or 1,000 q8h]). The primary endpoint was a composite of efficacy and safety which consisted of the early cure rate and the withdrawal rate due to drug-related adverse events and utilized a clinical utility index for dose selection. At the early efficacy visit (48 to 72 h after the first dose), the 750-mg q12h and 1,000-mg q8h groups met prespecified success criteria for clinical utility in terms of efficacy and safety; however, the 1,000-mg q12h group did not meet these criteria due to observed lower efficacy rates. The most frequently reported adverse events were nausea (20%) and diarrhea (13%). These encouraging phase 2 results demonstrate the potential for gepotidacin to meet the medical need for novel antibacterial agents to treat ABSSSIs due to drug-resistant pathogens through a unique mechanism of action. (This study has been registered at ClinicalTrials.gov under registration no. NCT02045797.)

scholarly journals Progressive Response to Repeat Application of Capsaicin 179 mg (8% w/w) Cutaneous Patch in Peripheral Neuropathic Pain: Comprehensive New Analysis and Clinical Implications

Pain Medicine ◽  
2021 ◽  
Author(s):  
Rainer Freynhagen ◽  
Charles Argoff ◽  
Mariëlle Eerdekens ◽  
Sylvia Engelen ◽  
Serge Perrot
Keyword(s):  
Neuropathic Pain ◽  
Pain Intensity ◽  
Brief Pain Inventory ◽  
Initial Response ◽  
Open Label ◽  
Self Assessment ◽  
Peripheral Neuropathic Pain ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Global Impression Of Change

Abstract Objective To investigate efficacy of repeated application of capsaicin 179 mg cutaneous patch in non-responders to the first application. Design Post hoc, as-treated analysis of two prospective trials (STRIDE and PACE) with 52-week follow-up. Blinding Open-label. Setting Multicenter clinical trial. Subjects STRIDE: non-diabetic neuropathic pain; PACE: painful diabetic peripheral neuropathy. Methods Patients were divided according to number of applications needed before ≥30% response on average pain intensity (question 5 of the Brief Pain Inventory [BPI-Q5]). We assessed change from baseline in average pain intensity (BPI-Q5), mean ‘interference with sleep’ score, Patient Global Impression of Change, quality of life (QOL) using EuroQol 5-dimension, and Self-Assessment of Treatment. Results In STRIDE and PACE, respectively, n = 306/313 received capsaicin patch; n = 60/96 had a response after the first application, n = 33/68 after the second, n = 11/43 after the third. Among patients without a ≥ 30% reduction in pain intensity at 3 months, 23.3%/28.1% achieved a ≥ 30% reduction at 6 months, increasing to 33.9%/45.7% at 12 months. Similar results were obtained using a decrease of ≥ 50% as responder definition. Progressive improvements in pain intensity in slower responders reached similar levels as those in early responders at month 12 and were accompanied by improvements in sleep, QOL, and patient satisfaction. Conclusions While some patients with peripheral neuropathic pain experience rapid improvements with a single treatment of capsaicin 179 mg patch, some may require two or three treatments before an initial response is observed. Similar benefits on pain, sleep, and QOL can be achieved in early and late responders.

scholarly journals TO EVALUATE EFFICACY AND SAFETY OF RUPATADINE, BILASTINE, AND LEVOCETRIZINE IN ALLERGIC RHINITIS AT TERITARY CARE HOSPITAL, TELANGANA

2021 ◽  
pp. 140-143
Author(s):  
NAGUR SHARONE GRACE ◽  
SYED ARSHADDUDDIN AHMED ◽  
BHUVANESWARI E ◽  
SYED HAMZA QUADRI ◽  
VEENA B ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Nasal Congestion ◽  
Care Hospital ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Significant Difference ◽  
The Mean ◽  
The Government

Objective: Allergic rhinitis (AR) is a heterogeneous disorder characterized by symptoms – sneezing, itching, nasal congestion, and rhinorrhea. The aim of the study is to evaluate the efficacy and safety of rupatadine, bilastine, and levocetirizine in AR. Methods: A prospective, open-label, comparative study was conducted at the Government ENT Hospital, Hyderabad, Telangana. Ninety patients diagnosed with AR were randomized, of whom Group 1 received oral tab. bilastine 20 mg once daily, Group 2 received oral tab. levocetirizine 5 mg once daily, and Group 3 received oral tab. rupatadine with a dose of 10 mg once daily for 2 weeks. The reduction in total nasal symptom score (TNSS) and absolute eosinophil counts (AECs) was compared with baseline and at 2 weeks. Safety was assessed according to adverse events reported during the study period. An analysis of variance was used as a test of significance for the three groups. Results: Overall, 90 cases were included in the study, with 48% of males and 52% of females. All three drugs significantly reduced the TNSS and AEC after treatment compared to before treatment (p<0.05). The mean difference in TNSS and AEC showed no statistically significant difference among the three groups (TNSS: p>0.908 and AEC: p>0.967). In terms of safety, all three drugs showed nearly similar adverse events. Conclusion: In this study, after 2 weeks of follow-up, the three drugs (bilastine, levocetirizine, and rupatadine) showed significant improvement clinically, but the mean reduction in the score of symptoms and AEC was not statistically significant in the treatment of AR.

scholarly journals Randomized Double-Blind Study Comparing 3- and 6-Day Regimens of Azithromycin with a 10-Day Amoxicillin-Clavulanate Regimen for Treatment of Acute Bacterial Sinusitis

2003 ◽  
Vol 47 (9) ◽  
pp. 2770-2774 ◽  
Author(s):  
Dan C. Henry ◽  
Ernie Riffer ◽  
William N. Sokol ◽  
Naumann I. Chaudry ◽  
Robert N. Swanson
Keyword(s):  
Adverse Events ◽  
Multicenter Study ◽  
Clinical Success ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Success Rates ◽  
Double Blind ◽  
Once Daily ◽  
Acute Bacterial Sinusitis ◽  
Amoxicillin Clavulanate

ABSTRACT A randomized, double-blind, multicenter study of adults with acute bacterial sinusitis (ABS) compared the efficacy and safety of two azithromycin (AZM) regimens, 500 mg/day once daily for 3 days (AZM-3) or 6 days (AZM-6) to the efficacy and safety of an amoxicillin-clavulanate (AMC) regimen of 500-125 mg three times daily for 10 days. A total of 936 subjects with clinically and radiologically documented ABS were treated (AZM-3, 312; AZM-6, 311; AMC, 313). Clinical success rates were equivalent among per-protocol subjects at the end of therapy (AZM-3, 88.8%; AZM-6, 89.3%; AMC, 84.9%) and at the end of the study (AZM-3, 71.7%; AZM-6, 73.4%; AMC, 71.3%). Subjects treated with AMC reported a higher incidence of treatment-related adverse events (AE) (51.1%) than AZM-3 (31.1%, P < 0.001) or AZM-6 (37.6%, P < 0.001). More AMC subjects discontinued the study (n = 28) than AZM-3 (n = 7) and AZM-6 (n = 11) subjects. Diarrhea was the most frequent treatment-related AE. AZM-3 and AZM-6 were each equivalent in efficacy and better tolerated than AMC for ABS.

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