Efficacy and Safety of Deracoxib for the Control of Postoperative Pain and Inflammation Associated with Dental Surgery in Dogs

The efficacy and safety of deracoxib administered at 1-2 mg/kg/day for 3 days was assessed for the control of postoperative pain and inflammation associated with dental surgery in dogs. Client-owned dogs scheduled for dental extractions were premedicated with butorphanol and randomly assigned to receive either deracoxib (n=31) or placebo (n=31) preoperatively and again once daily for 2 additional days. Dogs were evaluated prior to and after surgery using a modified Glasgow Composite Pain Scale (mGCPS). Dogs could be rescued at any time if they scored ≥4 on the mGCPS or in cases of obvious discomfort. Rescued dogs were considered treatment failures for determining treatment response and were removed from the study. Of the 62 dogs enrolled, 57 were usable for the efficacy analyses and all were assessed for safety. Four of 27 deracoxib-treated dogs (14.8%) were rescued compared to 20 of 30 placebo dogs (66.7%) (P=0.0006). Deracoxib-treated dogs also had numerically lower mGCPS scores. Eight of 31 deracoxib dogs (26%) had adverse events reported compared to 6 of 31 placebo dogs (19%). Results indicate perioperative administration of deracoxib to dogs at 1-2 mg/kg/day for 3 days significantly improves analgesia after dental surgery.

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Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor–Positive, Node-Positive Early Breast Cancer: Final Results of the Randomized Phase III Femara Versus Anastrozole Clinical Evaluation (FACE) Trial

Journal of Clinical Oncology ◽

10.1200/jco.2016.69.2871 ◽

2017 ◽

Vol 35 (10) ◽

pp. 1041-1048 ◽

Cited By ~ 34

Author(s):

Ian Smith ◽

Denise Yardley ◽

Howard A. Burris ◽

Richard De Boer ◽

Dino Amadori ◽

...

Keyword(s):

Breast Cancer ◽

Overall Survival ◽

Adverse Events ◽

Early Breast Cancer ◽

Clinical Evaluation ◽

Hormone Receptor ◽

Hazard Ratio ◽

Efficacy And Safety ◽

Node Positive ◽

To Receive

Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR) –positive and node-positive early breast cancer (eBC). Methods Postmenopausal women with HR-positive and node-positive eBC were randomly assigned to receive adjuvant therapy with either letrozole (2.5 mg) or anastrozole (1 mg) once per day for 5 years or until recurrence of disease. Patients were stratified on the basis of the number of lymph nodes and human epidermal growth factor receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709 DFS events (letrozole, 341 [16.5%]; anastrozole, 368 [17.7%]). The 5-year estimated DFS rate was 84.9% for letrozole versus 82.9% for anastrozole arm (hazard ratio, 0.93; 95% CI, 0.80 to 1.07; P = .3150). Exploratory analysis showed similar DFS with letrozole and anastrozole in all evaluated subgroups. The 5-year estimated overall survival rate was 89.9% for letrozole versus 89.2% for anastrozole arm (hazard ratio, 0.98; 95% CI, 0.82 to 1.17; P = .7916). Most common grade 3 to 4 adverse events (> 5% of patients) reported for letrozole versus anastrozole were arthralgia (3.9% v 3.3%, and 48.2% v 47.9% for all adverse events), hypertension (1.2% v 1.0%), hot flushes (0.8% v 0.4%), myalgia (0.8% v 0.7%), dyspnea (0.8% v 0.5%), and depression (0.8% v 0.6%). Conclusion Letrozole did not demonstrate significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR-positive, node-positive eBC.

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Comparison of the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma

Nepalese Journal of Ophthalmology ◽

10.3126/nepjoph.v5i1.7831 ◽

2013 ◽

Vol 5 (1) ◽

pp. 75-80 ◽

Cited By ~ 5

Author(s):

Ashish Chander ◽

H Kapoor ◽

S Thomas

Keyword(s):

Intraocular Pressure ◽

Side Effect ◽

Primary Open Angle Glaucoma ◽

Open Angle Glaucoma ◽

Open Angle ◽

Efficacy And Safety ◽

Once Daily ◽

The Mean ◽

To Receive

Purpose: To compare the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma (POAG). Subjects and methods: Patients with POAG were randomized to receive either bimatoprost or travoprost once daily. Detailed ocular examination was done and intraocular pressure (IOP) was measured at 9.00 am, 1.00 pm and 4.00 pm at the baseline and at 1, 2, 4, 6 and 12 weeks of therapy. Results: A total of 31 patients were analysed. The patients were randomly divided into two groups (Bimatoprost group = 16; Travoprost group = 15). Both the groups had a statistically significant reduction from the baseline IOP at all follow up visits at 9.00 am, 1.00 pm and 4.00 pm. The mean IOP decreased from a baseline of 25 ± 2.32 mm Hg to 15.93 ± 1.79 mm Hg after 12 weeks in the bimatoprost group (p < 0.001), and from 24.2 ± 1.60 mm Hg to 16.53 ± 1.56 mm Hg in the travoprost group (p < 0.001). A better mean reduction of IOP was obtained with bimatoprost than with travoprost at the end of the study at 12 weeks (p = 0.03). Mild ocular redness was the commonest side effect in both the groups but was not significant in either group. Conclusion: Both drugs lowered IOP effectively but bimatoprost showed a greater reduction in the mean IOP than did travoprost at 12 weeks and both are safe for ocular use. Nepal J Ophthalmol 2013; 5(9):75-80 DOI: http://dx.doi.org/10.3126/nepjoph.v5i1.7831

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The efficacy and safety of tacrolimus suppositories in patients with localized ulcerative colitis

10.21203/rs.3.rs-50065/v1 ◽

2020 ◽

Author(s):

Shizuma Omote ◽

Tatsuya Toyokawa ◽

Ryohei Sumii ◽

Akira Nakanishi ◽

Yuka Kadowaki ◽

...

Keyword(s):

Ulcerative Colitis ◽

Adverse Events ◽

Blood Concentration ◽

Efficacy And Safety ◽

Monitoring Methods ◽

Once Daily ◽

Mayo Score ◽

Amino Salicylic Acid ◽

One Year ◽

Dose Change

Abstract Background Tacrolimus is a calcineurin inhibitor used for the treatment of 5-Amino-salicylic acid (5-ASA) and systematic corticosteroid refractory ulcerative colitis. However, systemic administration of tacrolimus could lead to many adverse events. Therefore, we used tacrolimus suppositories as a local therapeutic agent and examined its efficacy and safety with strict blood concentration monitoring. Methods Sixteen patients with ulcerative colitis were administered a 0.5-mg tacrolimus suppository once daily. In cases with an insufficient clinical effect, additional amounts, at an increment of 0.5 mg of tacrolimus, were administered. The blood concentration was measured two weeks after the start of treatment or any dose change and every four weeks thereafter. Results The partial Mayo score was 5.31 before the start of treatment, and it decreased significantly after 2 (2.56, P = 0.001), 4 (1.53, P < 0.001), and 8 (1.47, P = < 0.001) weeks of treatment. The median duration of tacrolimus treatment was 24 (range 2–96) weeks, and 6 patients were treated continuously for more than one year after the pMayo score improved. No exacerbation of adverse events during the treatment regimen was observed. The effects and safety of tacrolimus suppositories were verified with strict blood concentration monitoring. Conclusions Our findings suggest that the application of tacrolimus suppositories is safe and effective in the treatment of patients with ulcerative colitis.

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OP33 Oral ritlecitinib and brepocitinib in patients with Moderate to Severe Active Ulcerative Colitis: Data from the VIBRATO umbrella study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab075.032 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S030-S031

Author(s):

W Sandborn ◽

S Danese ◽

J Leszczyszyn ◽

J Romatowski ◽

E Altintas ◽

...

Keyword(s):

Ulcerative Colitis ◽

Rectal Bleeding ◽

Active Ulcerative Colitis ◽

Efficacy And Safety ◽

Dose Response Relationship ◽

Once Daily ◽

Mayo Score ◽

Adult Participants ◽

Respective Treatment ◽

To Receive

Abstract Background The efficacy and safety of oral ritlecitinib (JAK3/TEC inhibitor) and brepocitinib (TYK2/JAK1 inhibitor) were assessed in a 32-week Phase 2b induction-maintenance umbrella study (VIBRATO) in participants with moderate to severe active ulcerative colitis who had inadequate or loss of response, or intolerance to corticosteroids, immunosuppressants, or biologic therapies. We report efficacy and safety results from the 8-week induction period of the VIBRATO study. Methods Adult participants with Total Mayo Score ≥6 and centrally-read Mayo endoscopic subscore ≥1 were randomised to receive oral ritlecitinib 20, 70, or 200 mg; brepocitinib 10, 30, or 60 mg; or placebo once-daily (QD) for 8 weeks. Participants then continued in their respective treatment cohorts to receive ritlecitinib 50 mg or brepocitinib 30 mg QD for 24 weeks. The proportions of patients who achieved remission (Total Mayo Score ≤2; no individual subscore >1; rectal bleeding subscore 0), modified remission (Modified Mayo Score: Total Mayo without Physician’s Global Assessment; stool frequency subscore ≤1; rectal bleeding subscore 0; endoscopic subscore ≤1), or endoscopic improvement (Mayo endoscopic subscore ≤1) were analysed. Results 319 participants were randomised: baseline mean (standard deviation [SD]) age 40.3 (13.8) years; mean (SD) Total Mayo Score 9.0 (1.5); and median (range) disease duration 4.8 (0.24, 36.5) years. Ritlecitinib and brepocitinib were generally safe and well tolerated. At Week 8, a dose–response relationship was observed across all efficacy endpoints for ritlecitinib and brepocitinib. The proportions of participants achieving remission were significantly higher (P<0.05) with ritlecitinib 70 and 200 mg and brepocitinib 30 and 60 mg vs placebo (Figure 1). The proportions of participants achieving endoscopic improvement and modified remission were significantly higher in all ritlecitinib and brepocitinib groups vs placebo (Figures 2 and 3). Conclusion Ritlecitinib 70 and 200 mg QD and brepocitinib 30 and 60 mg QD demonstrated significant improvement in remission, modified remission, and endoscopic improvement in participants with moderate to severe active ulcerative colitis.

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Effect of Eltrombopag on Platelet Response and Safety Results in Chinese Adults with Chronic ITP-Primary Result of a Phase III Study

Blood ◽

10.1182/blood.v124.21.1464.1464 ◽

2014 ◽

Vol 124 (21) ◽

pp. 1464-1464 ◽

Cited By ~ 3

Author(s):

Renchi Yang ◽

Ming Hou ◽

Junmin Li ◽

Jie Jin ◽

Meijuan Huang ◽

...

Keyword(s):

Platelet Count ◽

Placebo Group ◽

Adverse Events ◽

Initial Dose ◽

East Asian ◽

Chinese Adults ◽

Once Daily ◽

Platelet Counts ◽

Chronic Itp ◽

To Receive

Abstract INTRODUCTION: Eltrombopag (PROMACTA®/REVOLADE®; GlaxoSmithKline) is a non peptide, oral thrombopoietin receptor agonist which promotes the differentiation and proliferation of megakaryocytes and increases platelet counts. In previous studies, East Asians ITP subjects had an approximately 1.85 fold higher plasma eltrombopag AUC (0-τ) and 1.6 fold higher plasma eltrombopag Cmax than non-East Asian ITP subjects who were predominantly Caucasian. An initial dose of 25mg once daily has not been studied in a randomized fashion in East Asian subjects with ITP. METHODS: This is a randomized study comprising a double-blind (DB), placebo (PBO)-controlled phase, followed by an open-label (OL) phase in previously treated Chinese patients with chronic ITP who had failed ≥1 previous treatment. Subjects were stratified at baseline by use of ITP medication, splenectomy status and platelet count ≤15×109/L. In the DB phase, Chinese Adults with Chronic ITP and platelet counts <30 ×109/L received standard of care and were randomized (2:1) to receive either an initial dose of 25mg of eltrombopag or matching placebo once daily. The dose was increased every 2 weeks by 25 mg once daily increments up to a maximum of 75 mg once daily if the desired platelet response (> 50×109/L) was not achieved. The primary efficacy endpoint was the proportion of patients achieving a platelet count of ≥50×109/L and ≤250×109/L after the first 6 weeks of study treatment using a logistic regression model adjusted for stratification factors . All subjects completing the DB phase entered the OL phase where they initiated (if they were on placebo) or continued (if they were on eltrombopag) to receive eltrombopag (25, 50 or 75 mg/day) based on individual platelet counts. RESULTS: 155 subjects were randomized to receive 6 weeks of once daily eltrombopag (n=104) or matching placebo (n=51) in 2:1 ratio. Of 155 subjects randomized, 81 subjects (52.3%) were receiving concomitant ITP medication at baseline, 25 subjects (16.1%) had prior splenectomy, and 82 subjects (52.9%) had baseline platelet count ≤15×109/L. A total of 53/104 (51%) subjects on eltrombopag were receiving concomitant ITP medication at baseline vs 28/51 (54.9%) subjects on placebo. A total of 18/104 (17.3%) subjects on eltrombopag had prior splenectomy vs 7/51 (13.7%) subjects on placebo. A total of 54/104 (51.9%) subjects on eltrombopag had baseline platelet counts ≤15×109/L vs 28/51 (54.9%) subjects on placebo. The primary efficacy analysis showed that eltrombopag statistically significantly increased platelet counts in patients with chronic ITP: 57.7% (60/104) of subjects in eltrombopag group, and 6% (3/50) of subjects in placebo group achieved a platelet count of ≥50×109/L after the first 6 weeks of study treatment. (Odds ratio= 26.08, 95% CI [7.29, 93.26]; p <0.001). 63.5% (66/104) of patients in eltrombopag group and 66.7% (34/51) of patients in placebo group experienced adverse events. The most common (≥3% total incidence) adverse events are hypokalaemia [10.6% (11/104) in eltrombopag group, 15.7% (8/51) in placebo group], alanine aminotransferase increased [8.7% (9/104) in eltrombopag group, 15.7% (8/51) in placebo group], and nasopharyngitis [10.6% (11/104) in eltrombopag group, 9.8% (5/51) in placebo group]. The AEs were mostly mild to moderate. Only 4.9% (4/104) of patients on eltrombopag and 9.8% (5/51) of patients on placebo experienced serious adverse events. Additional safety and efficacy results will be presented at meeting. CONCLUSION: This is the first study to evaluate eltrombopag at an initial dose of 25mg once daily in a randomized fashion in East Asian patients with previously treated chronic ITP. Eltrombopag statistically significantly increased platelet counts in Chinese adults with chronic ITP when compared to placebo. Eltrombopag was well-tolerated and these results are consistent with the known clinical benefit: risk profile of eltrombopag in patients with chronic ITP. Eltrombopag may be a new treatment option for Chinese patients with chronic ITP. Disclosures No relevant conflicts of interest to declare.

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Extended-release tramadol (tramadol ER) in the treatment of chronic low back pain

Journal of Opioid Management ◽

10.5055/jom.2008.0013 ◽

2018 ◽

Vol 4 (2) ◽

pp. 87 ◽

Cited By ~ 42

Author(s):

Gary J. Vorsanger, PhD, MD ◽

Jim Xiang, PhD ◽

Theophilus J. Gana, MD, PhD ◽

Maria Luz G. Pascual, MD, MPH ◽

R. Rosanna B. Fleming, MS

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Relief ◽

Adverse Events ◽

Pain Intensity ◽

Chronic Low Back Pain ◽

Low Back ◽

Open Label ◽

Once Daily ◽

To Receive

Background: This study evaluated the safety and efficacy of tramadol ER 300 mg and 200 mg versus placebo once daily in the treatment of chronic low back pain, using an open-label run-in followed by, without washout, a randomized controlled study design.Methods: Adults with scores ≥40 on a pain intensity visual analog scale (VAS; 0 = no pain; 100 = extreme pain) received open-label tramadol ER, initiated at 100 mg once daily and titrated to 300 mg once daily during a three-week open-label run-in. Patients completing run-in were randomized to receive tramadol ER 300 mg, 200 mg, or placebo once daily for 12 weeks.Results: Of 619 patients enrolled, 233 (38 percent) withdrew from the run-in, primarily because of adverse event (n = 128) or lack of efficacy (n = 41). A total of 386 patients were then randomized to receive either 300 mg (n = 128), 200 mg (n = 129), or placebo (n = 129). Following randomization, mean scores for pain intensity VAS since the previous visit, averaged over the 12-week study period, increased more in the placebo group (12.2 mm) than in the tramadol ER 300-mg (5.2 mm, p = 0.009) and 200-mg (7.8 mm, p = 0.052) groups. Secondary efficacy scores for current pain intensity VAS, patient global assessment, Roland Disability Index, and overall sleep quality improved significantly (p ≤ 0.029 each) in the tramadol ER groups compared with placebo. The most common adverse events during the double-blind period were nausea, constipation, headache, dizziness, insomnia, and diarrhea.Conclusions: In patients who tolerated and obtained pain relief from tramadol ER, continuation of tramadol ER treatment for 12 weeks maintained pain relief more effectively than placebo. Adverse events were similar to those previously reported for tramadol ER.

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Pharmacokinetics and Safety of Caspofungin in Older Infants and Toddlers

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01027-08 ◽

2008 ◽

Vol 53 (4) ◽

pp. 1450-1456 ◽

Cited By ~ 59

Author(s):

Michael Neely ◽

Hasan S. Jafri ◽

Nita Seibel ◽

Katherine Knapp ◽

Peter C. Adamson ◽

...

Keyword(s):

Adverse Events ◽

Peak Concentration ◽

High Performance ◽

Geometric Mean ◽

Area Under The Curve ◽

Efficacy And Safety ◽

Infants And Toddlers ◽

Dosing Regimen ◽

Elimination Phase ◽

Once Daily

ABSTRACT Although information about the efficacy and safety experience with caspofungin at 50 mg/m2 daily is available for children and adolescents, the dosing regimen in infants and toddlers 3 to 24 months of age has yet to be established. We studied the pharmacokinetics and safety of caspofungin at 50 mg/m2 once daily in nine patients 10 to 22 months (median, 13 months) of age with fever and neutropenia who received caspofungin once daily for 2 to 21 (mean, 9.3) days. Plasma caspofungin concentrations were measured by high-performance liquid chromatography assay on days 1 and 4. On day 4, the area under the curve from 0 to 24 h (AUC0-24) was 130.3 μg-h/ml, the peak concentration (C 1) was 17.2 μg/ml, and the trough concentration (C 24) was 1.6 μg/ml. The day 4 geometric mean ratios (GMRs) and 90% confidence interval (CI) for these parameters in infants/toddlers relative to adults were 1.26 (1.06, 1.50), 1.83 (1.57, 2.14), and 0.81 (0.64, 1.04), respectively. Relative to children (2 to 11 years of age), the day 4 GMRs (and 90% CI) were 1.13 (0.89, 1.44), 1.10 (0.85, 1.42), and 1.12 (0.72, 1.76), respectively. The harmonic mean elimination phase t 1/2 in infants/toddlers (8.8 h) was reduced ∼33% relative to adults (13.0 h) but was similar to that in children (8.2 h). Clinical adverse events occurred in seven patients (78%); none were considered drug related. Laboratory adverse events occurred in five patients (56%) and were considered drug related in three (33%). There were no infusion-related events or discontinuations due to toxicity. Caspofungin at 50 mg/m2 daily was well tolerated in infants and toddlers; the AUC and caspofungin C 24 were generally comparable to those in adults receiving caspofungin at 50 mg daily.

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Icosabutate, a Structurally Engineered Fatty Acid, Improves the Cardiovascular Risk Profile in Statin-Treated Patients with Residual Hypertriglyceridemia

Cardiology ◽

10.1159/000445047 ◽

2016 ◽

Vol 135 (1) ◽

pp. 3-12 ◽

Cited By ~ 7

Author(s):

John J.P. Kastelein ◽

Jonas Hallén ◽

Runar Vige ◽

David A. Fraser ◽

Rong Zhou ◽

...

Keyword(s):

Cardiovascular Risk ◽

Adverse Events ◽

Statin Therapy ◽

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Once Daily ◽

Vldl Cholesterol ◽

Apolipoprotein C ◽

Clinical Hold ◽

To Receive

Objectives: To evaluate the efficacy and safety of icosabutate, an oral, once-daily, first-in-class medication, in reducing non-high-density lipoprotein cholesterol (non-HDL-C) in patients with persistent hypertriglyceridemia despite statin therapy. Methods: The study was designed to randomly assign 140 patients with fasting triglyceride levels ≥200 but <500 mg/dl on a stable dose of statin therapy to receive either masked icosabutate 600 mg once daily or a control for 12 weeks. The primary end point was a percentage change in non-HDL-C from baseline to 12 weeks. Results: With icosabutate, non-HDL-C levels were reduced (-9.2%) when compared with the control (-0.4%) for a between-group difference of -7.4% (p = 0.02). Compared with the control, icosabutate reduced triglycerides (-27.0%, p < 0.001), very- low-density lipoprotein (VLDL) cholesterol (-31.5%, p < 0.001) and apolipoprotein C-III (-22.5%, p < 0.001). LDL-C levels did not change (0.5%, p = 0.87). HDL-C (10.2%, p < 0.001) was increased. After 113 subjects had been randomized, the study was terminated due to a partial clinical hold imposed by US regulators after observing QT prolongation at supratherapeutic doses of icosabutate in a dog study. In this study, adverse events were balanced between treatment arms, and there were no discontinuations due to adverse events. Conclusions: Icosabutate was efficacious in lowering non-HDL-C and other biomarkers of cardiovascular risk and was generally well tolerated.

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

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2021.v14i12.43427 ◽

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.

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

Pain Research and Treatment ◽

10.1155/2012/898347 ◽

2012 ◽

Vol 2012 ◽

pp. 1-12 ◽

Cited By ~ 1

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.

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