A comparative study to assess the efficacy and safety of bepotastine and cetirizine in allergic rhinitis

Background: Pharmacotherapy is the mainstay of allergic rhinitis and many caregivers use over-the-counter antihistamines. Bepotastine is a novel oral second generation non-sedative antihistamine and an effective treatment option for allergic rhinitis. The objectives of the present study were to evaluate the efficacy and safety of bepotastine versus cetirizine an over the counter drug.Methods: A prospective, randomized, open-label, parallel-group study was conducted among 60 patients fulfilling the inclusion and exclusion criteria. Group A (n=30) received tablet cetirizine 10 mg once daily and Group B (n=30) received tablet bepotastine 10 mg once daily. Efficacy was assessed by mean change in total symptom score (TSS) which is the sum of total nasal symptom score and total ocular symptom score at the end of two weeks from baseline.Results: At the end of two weeks of treatment, both groups showed statistically significant (p<0.005) improvements from their baseline TSS. Mean TSS was reduced from12.36±2.12 to 4.2±1.66 in group A and from 13.33±3.039 to 3.033±1.40 in Group B. Significant statistical difference in TSS was seen more in Group B than Group A (p<0.005).Conclusions: Both the groups showed a substantial therapeutic benefit in patients with allergic rhinitis, however bepotastine is more effective.

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Efficacy and safety of different terbinafine regimens in patients of recurrent tinea corporis and cruris

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20212761 ◽

2021 ◽

Author(s):

Noopur Verma ◽

Savita Verma ◽

Surbhi Dayal ◽

M. C. Gupta

Keyword(s):

Safety Concern ◽

Liver Function Tests ◽

Tinea Corporis ◽

Efficacy And Safety ◽

Once Daily ◽

Function Tests ◽

Biochemical Laboratory ◽

Group A ◽

Group B ◽

Oral Terbinafine

Background: Tinea corporis and cruris is said to be recurrent when there is relapse of sign and symptoms after 6 weeks of cure. Recently, there has been increase in cases of recurrent tinea corporis and cruris, with atypical lesions. This study was done to establish efficacy and safety of different terbinafine regimens against recurrent tinea corporis and cruris.Methods: Sixty patients with clinically and mycologically diagnosed recurrent tinea corporis and cruris were enrolled and divided into three groups. Group A was administered oral terbinafine 500 mg once daily for 2 weeks, group B was given terbinafine 250 mg once daily for double duration i.e., 4 weeks, and group C was given standard treatment which is 250 mg once daily for 2 weeks. Physician assessment four-point scale (PA4PS) and KOH wet mount were assessed for clinical and mycological efficacy. Biochemical laboratory parameters (liver function tests and kidney function tests) and adverse drug reactions were assessed for safety.Results: At the end of 6 weeks, reduction in PA4PS from baseline was 46.5%, 95.8%, and 20.4% in groups with double dose, double duration and standard therapy respectively with statistically significant (p<0.05) improvement in group with double duration. Mycological cure at the end of 4 weeks was 80%, 100% and 50%. There was no safety concern in any of the groups.Conclusions: Double duration of terbinafine was found to be more efficacious and safer.

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A comparative study of efficacy and safety of glucosamine plus chondroitin sulphate versus rosehip as add on therapy to NSAIDs in patients suffering from osteoarthritis

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20184336 ◽

2018 ◽

Vol 7 (11) ◽

pp. 2254

Author(s):

Kiranpreet Kaur ◽

Anjleen Kaur ◽

Prabhsimran Singh ◽

Amandeep Singh Bakshi

Keyword(s):

Comparative Study ◽

Chondroitin Sulphate ◽

Tertiary Care ◽

Efficacy And Safety ◽

Tertiary Care Centre ◽

Open Label ◽

Significant Difference ◽

Group A ◽

Efficacy Parameters ◽

Group B

Background: Osteoarthritis is a chronic and debilitating disease. Management of disease is a big challenge. NSAIDS play an important role but have many adverse reactions. So, this study was designed to evaluate the efficacy and safety of natural compound rosehip versus glucosamine and chondroitin sulphate in patients of osteoarthritis.Methods: An open label, randomized, parallel group comparative study, conducted on patients of either sex with confirmed diagnosis of osteoarthritis on standard NSAIDs therapy, attending the outpatient department of orthopedics in a tertiary care centre. 150 patients were enrolled and divided into three groups (group A, group B and group C) of 50 each. Patients of group A were given Glucosamine plus chondroitin sulphate for 12 weeks. Group B was given rosehip for 12 weeks and group C placebo. These supplements were given as add on therapy. Patients were monitored and adverse drug reactions were noted. The data was analysed statistically using t- test for efficacy and descriptive stats for assessing the safety.Results: Efficacy was assessed by comparing mean reduction in the pain intensity between group A and B, group B gives highly significant results as compared to group A. While comparing joint tenderness, swelling around joint, mean functional capacity and improvement in the overall assessment, group B gives significant results as compared to group A. It was also observed that group A and group B were better than group C in all the efficacy parameters. All the drugs were well tolerated and systemically safe.Conclusions: There was significant difference in efficacy of rosehip compared with glaucosamine and chondroitin sulphate in patients of osteoarthritis. In comparison there was no significant difference in safety of two drugs and both were considered safe in patients.

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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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Efficacy of Oral Bilastine in Comparison with Levocetirizine in Allergic Rhinitis- A Randomised Clinical Study

JOURNAL FOR CLINICAL AND DIAGNOSTIC RESEARCH ◽

10.7860/jcdr/2021/48303.15183 ◽

2021 ◽

Author(s):

M Vanitha ◽

K Sowmini ◽

K Santha Sheela Kumari ◽

Resu Neha Reddy

Keyword(s):

Allergic Rhinitis ◽

Immunoglobulin E ◽

Statistical Significance ◽

Post Treatment ◽

Once Daily ◽

Treatment Groups ◽

Significant Difference ◽

Group A ◽

Group B ◽

Antihistaminic Drugs

Introduction: Allergic rhinitis is a heterogeneous disorder characterised by major symptoms like sneezing, itching, nasal congestion and rhinorrhea. Because of bothersome side effects of first-generation antihistaminic drugs, second generation antihistaminic drugs have been used since few years. Recent studies have showed that novel drug Bilastine has been approved as an effective treatment in Allergic rhinitis. Aim: To evaluate Total Nasal Symptom Scores (TNSS), Serum Immunoglobulin E (IgE), Serum Absolute Eosinophil Count (AEC) in patients with allergic rhinitis, pre and post-treatment with Bilastine and Levocetirizine. Materials and Methods: A randomised, open-labelled, study was conducted between January 2020 to March 2020. Hundred patients with allergic rhinitis were enrolled into the study. They were randomised into two groups of which group A received tablet Bilastine 20 mg once daily for two weeks and group B received tablet Levocetirizine 5 mg once daily for two weeks. The results of TNSS, IgE, AEC and pre and post-treatment values were compared in both the treatment groups. Unpaired t-test was used as the test of significance between the two treatment groups. Results: The prevalence of allergic rhinitis in the study was 49% in males and 51% in females. The mean difference in pre and post-treatment in TNSS (group A=1.627, group B=1.143), serum IgE (A=33.118, B=49.653), serum AEC (A=28.00, B=27.245) showed no statistically significant difference between two groups (p-value >0.05). Conclusion: Bilastine and levocetirizine are equally efficacious. Though there is clinical significance in treatment of allergic rhinitis between the groups, there is no statistical significance which would prove Bilastine is clinically superior to Levocetirizine for the allergic rhinitis treatment.

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Efficacy of intranasal olopatidine hydrochloride as an add on therapy in mild to moderate allergic rhinitis

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20211025 ◽

2021 ◽

Vol 10 (4) ◽

pp. 415

Author(s):

Sam Anbu Sahayam J. ◽

Vasanthira K.

Keyword(s):

Allergic Rhinitis ◽

Nasal Obstruction ◽

Eosinophil Count ◽

Standard Treatment ◽

Saline Group ◽

Nasal Discharge ◽

Open Label ◽

Group A ◽

Group B ◽

To Receive

Background: Treatment with intranasal olopatidine hydrochloride spray is proposed for patients with chronic perennial and seasonal rhinitis. Hence we compared the efficacy of intranasal mometasone furoate as an add-on therapy with existing standard treatment in a randomized, open label comparative study.Methods: A prospective, randomized, single blinded, comparative study in patients with chronic perennial and seasonal rhinitis. Patients were divided into two groups to receive intranasal olopatidine therapy and intranasal saline plus existing standard treatment with levocetrizine and vitamin C orally. Improvement in symptoms like nasal obstruction, nasal discharge, sneezing, nasal itching, itching of eyes, watering of eyes were assessed by a questionnaire at 2, 4, 6 and 8 weeks and by a reduction of eosinophil count in blood and nasal smear examination at baseline and 8 weeks.Results: At the end of 8 weeks the percentage reduction of nasal obstruction in olopatidine hydrochloride and saline were 93.1% and 36.07% respectively, rhinorrhoea was 90.34% and 36.42%, nasal itching was 85.76% and 41.37% sneezing symptoms were 89.6% and 37.86%, itching in the eyes was 94.6% and 44.05% and watering in the eyes were 87.1% in group A and 38.07% in group B. At the end of 8 weeks, there was reduction in absolute eosinophil count and it attributed to 57.5% in olopatidine hydrochloride and 11.9% in saline group and reduction in nasal smear count scoring was 60.7% and 18.2% respectively.Conclusions: Intranasal olopatidine hydrochloride is highly effective, in the treatment of allergic rhinitis.

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Comparison of efficacy and safety of topical luliconazole with topical fluconazole against tinea corporis in a tertiary care hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20212383 ◽

2021 ◽

Vol 10 (7) ◽

pp. 840

Author(s):

E. Seshathri ◽

R. Deepthi Krishna

Keyword(s):

Tertiary Care ◽

Tinea Corporis ◽

Tolerability Profile ◽

Care Hospital ◽

Efficacy And Safety ◽

Once Daily ◽

Significant Difference ◽

Group A ◽

Low Incidence ◽

Group B

Background: Dermatophytosis is a common cutaneous infection worldwide with prevalence varying from 20% to 25%. Luliconazole is a newer topical antifungal applied once daily with greater reservoir property in stratum corneum. Objective of the study was to compare the clinical efficacy and safety of luliconazole 1% cream with Fluconazole 1% cream in patients with mild to severe grades of tinea corporis.Methods: A total of 100 patients with mycologically confirmed tinea corporis were randomised into group A and B respectively. Group A, 50 patients received luliconazole 1% for 2 weeks and group B, 50 patients received fluconazole 1% cream for 4 weeks. Patients were clinically and mycologically evaluated on 0, 2nd and 4th week of treatment and followed up on 8th week for any relapse.Results: Significant improvement in efficacy was seen in Luliconazole while compared with fluconazole group against tinea corporis infection. Mycological cure and clinical improvement showed significant difference in group A. The safety and tolerability profile of both groups were good and statistically comparable.Conclusions: Luliconazole 1% cream is found to be safe, effective and tolerable with low incidence of relapse than fluconazole 1% cream.

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Efficacy and Safety of Oral Ivermectin and Topical Permethrin in the Treatment of Scabies

TAJ Journal of Teachers Association ◽

10.3329/taj.v33i1.49824 ◽

2020 ◽

Vol 33 (1) ◽

pp. 41-47

Author(s):

Mohsena Akhter ◽

Ishrat Bhuiyan ◽

Zulfiqer Hossain Khan ◽

Mahfuza Akhter ◽

Gulam Kazem Ali Ahmad ◽

...

Keyword(s):

Skin Diseases ◽

Close Contact ◽

Randomized Study ◽

Sarcoptes Scabiei ◽

Efficacy And Safety ◽

Common Skin ◽

Group A ◽

The Mean ◽

The Difference ◽

Group B

Background: Scabies is one of the most common skin diseases in our country. It is caused by the mite Sarcoptes scabiei var hominis, which is an ecto-parasite infesting the epidermis. Scabies is highly contagious. Prevalence is high in congested or densely populated areas. Individuals with close contact with an affected person should be treated with scabicidal which is available in both oral and topical formulations. The only oral but highly effective scabicidal known to date is Ivermectin. Amongst topical preparations, Permethrin 5 % cream is the treatment of choice. Objective: To evaluate the efficacy & safety of oral Ivermectin compared to topical Permethrin in the treatment of scabies. Methodology: This prospective, non-randomized study was conducted at the out-patient department of Dermatology and Venereology of Shaheed Suhrawardy Medical College & Hospital over a period of 6 months, from August 2016 to January 2017. The study population consisted of one hundred patients having scabies, enrolled according to inclusion criteria. They were divided into two groups. group A was subjected to oral Ivermectin and the group B to Permethrin 5% cream. Patients were followed up on day 7 and 14 for assessment of efficacy and safety. Result: The mean scoring with SD in group A (Ivermectin) and group B (Permethrin) were 8.26 ± 2.22 and 7.59 ± 2.01 respectively at the time of observation. The difference between the mean score of the two group is not significant (p=0.117) the mean scoring with SD in group A and group B were 4.54 ± 2.05 and 1.64 ± 1.84 respectively at 7thdays. The difference between the mean score of the two group is significant (p<0.001). The mean scoring with SD in group A and group B were 2.68± 2.35 and .36± 1.10 respectively at 14th day difference between the mean score of the group is significant (p<0.001). Conclusion: Topical application of permethrin 5% cream is more effective and safer than oral Ivermectin in the treatment of scabies. TAJ 2020; 33(1): 41-47

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Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Preliminary results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc) for the non-L sarcoma cohort.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.11545 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 11545-11545

Author(s):

Daniel Pink ◽

Dimosthenis Andreou ◽

Anne Flörcken ◽

Alexander Golf ◽

Stephan Richter ◽

...

Keyword(s):

Phase Ii ◽

Single Agent ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Efficacy And Safety ◽

Disease Stabilization ◽

Group A ◽

Pretreated Patients ◽

Grade 3 ◽

Group B

11545 Background: Single-agent PD-1 inhibitors have modest activity in the treatment of most STS. Potential strategies to increase efficacy include combination therapies targeting the tumor microenvironment. Considering that apart from direct growth inhibition and death of malignant cells, trabectedin (Tr) also induces macrophage depletion and/or different immunologic effects, suggesting a possible synergistic effect of combined Tr plus anti-PD-1 treatment. We therefore aimed to evaluate the efficacy and safety of combined Tr and nivolumab (Ni) as a second-line treatment in STS. Methods: The prospective, explorative, two group, non-randomized phase II NiTraSarc trial enrolled pretreated patients (pt) with advanced STS (Group A: lipo- or leiomyosarcomas, Group B: non-L-sarcomas). Pt were initially treated with 3 cycles of Tr 1.5 mg/m2, followed by the combination of Tr 1.5 mg/m2 + Ni 240 mg (“late combination cohort” (LCC)) for up to 16 cycles. After positive results of a preplanned interim analysis, pt received the combination therapy starting with cycle 2 (“early combination cohort” (ECC)). 92 pt were recruited to the trial (55 in Group A, 37 in Group B). Primary efficacy endpoint is progression-free survival rate after 6 months (PFSR6) according to RECIST v.1.1. This is a first analysis of the primary efficacy endpoint in Group B based on a modified intention-to-treat (mITT) population of evaluable 36 pt: 23 and 13 pt from the LCC and ECC, respectively. Results: The most common Group B subtypes comprised undifferentiated pleomorphic/not otherwise specified sarcoma (UPS/NOS, 13pt) and fibromyxoid sarcoma (FMS, 6pt). After a median follow-up of 5 months (m) PFSR6 was 13.9% for all pt, 8.7% in LCC and 23.1% in ECC. Median duration of disease stabilization (DoDS) was 4m in all pt, the LCC and the ECC. Two pt had a partial response (PR), 10 had disease stabilization (SD), while 13 pt progressed, and 11 had missing data. By subtype: PR- UPS/NOS=2 (DoDS 12.7m/12.5m). SD: UPS/NOS=3, epithelioid=2, synovial=2, FMS=1, fibrosarcoma=1, other=1. All 36 pt experienced at least one adverse event (AE) reaching a total of 579 AEs, 141 (24.4%) of which were considered to be grade ≥3 treatment-related AEs. The main grade ≥3 AEs were: leukopenia (47.2% of pt), neutropenia (41.7% of pt), thrombocytopenia (33.3% of pt), increased ALT (30.6% of pt), and anemia (27.8% of pt). Conclusions: Tr+Ni was well tolerated and showed activity in at least some patients with non-L-sarcomas (mostly UPS/NOS) especially in the ECC. Analyses of the collected data, including PD-L1 expression profile, with the goal to establish whether Tr+Ni should be further pursued in these patients, are ongoing. ClinicalTrials.gov Identifier: NCT03590210; EudraCT: 2017-001083-38. Clinical trial information: NCT03590210.

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Efficacy and Safety of Bilastine in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis

Frontiers in Pharmacology ◽

10.3389/fphar.2021.731201 ◽

2022 ◽

Vol 12 ◽

Author(s):

Aranjit Singh Randhawa ◽

Norhayati Mohd Noor ◽

Mohd Khairi Md Daud ◽

Baharudin Abdullah

Keyword(s):

Allergic Rhinitis ◽

Symptom Score ◽

Meta Analysis ◽

Nasal Symptom ◽

Comparable Efficacy ◽

Controlled Trials ◽

Cochrane Central Register ◽

Efficacy And Safety ◽

Quality Of Evidence

Bilastine is a non-sedating second generation H1 oral antihistamine (OAH) for treating allergic rhinitis (AR) patients. The effect of bilastine has not previously been evaluated in a meta-analysis. The aim of this review was to determine the efficacy and safety of bilastine in treating AR. An electronic literature search was performed using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Science Direct and Google Scholar up to March 2021. Randomized controlled trials comparing bilastine with placebo and standard pharmacotherapy were included. The included studies must have diagnosis of AR established by clinicians and the outcomes must have a minimum of 2 weeks of follow-up period. The primary outcomes assessed were total symptom score (TSS), nasal symptom score (NSS) and non-nasal symptom score (NNSS). The secondary outcomes were discomfort due to rhinitis, quality of life (QOL) and adverse events. The risk of bias and quality of evidence for all studies were appraised. The meta-analysis was done using Review Manager 5.3 software based on the random-effects model. The search identified 135 records after removal of duplicates. Following screening and review of the records, fifteen full-text articles were assessed for eligibility. Five trials involving 3,329 patients met the inclusion criteria. Bilastine was superior to placebo in improving TSS, NSS, NNSS, rhinitis discomfort score and QOL but has comparable efficacy with other OAHs in TSS, NSS, NNS, rhinitis discomfort score and QOL. There was no difference in adverse effects when bilastine was compared against placebo and other OAHs except for somnolence. Bilastine has fewer incidence of somnolence compared to cetirizine. The overall quality of evidence ranged from moderate to high quality. Bilastine is effective and safe in treating the overall symptoms of AR with comparable efficacy and safety with other OAHs except somnolence. Whilst bilastine has similar efficacy to cetirizine, somnolence is notably less in bilastine.

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Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study

10.2337/figshare.13369553 ◽

2021 ◽

Author(s):

Lawrence Blonde ◽

Julio Rosenstock ◽

Juan Frias ◽

Andreas L. Birkenfeld ◽

Elisabeth Niemoeller ◽

...

Keyword(s):

Type 2 Diabetes ◽

Fixed Ratio ◽

Efficacy And Safety ◽

Open Label ◽

Once Daily ◽

Glucagon Like Peptide ◽

Glucagon Like Peptide 1 ◽

Design And Methods ◽

Extension Period

Objective <a>In the LixiLan-G trial, switching to iGlarLixi, a once-daily titratable fixed-ratio combination of insulin glargine </a>100 units/mL and the glucagon-like peptide-1 receptor agonist (GLP-1 RA) lixisenatide, improved glucose control in type 2 diabetes (T2D) uncontrolled with GLP-1 RAs over 26 weeks versus continuing prior GLP-1 RA. A prespecified, 26-week, single-arm extension of LixiLan-G aimed to determine the durability of iGlarLixi efficacy and safety over 52 weeks. Research Design and Methods Participants with T2D uncontrolled by GLP-1 RAs (HbA1c 7–9 % [53–75 mmol/mol]) were initially randomized to switch to iGlarLixi or continue prior GLP-1 RA. Those randomized to iGlarLixi who completed the 26-week primary endpoint period could continue iGlarLixi open-label treatment over a 26-week extension to assess durability of efficacy and safety. Results Glycemic control achieved with iGlarLixi at week 26 (mean HbA1c 6.7 % [50 mmol/mol]) was maintained at week 52 (mean HbA1c 6.7 % [50 mmol/mol]; mean ± standard deviation change from baseline at week 52: −1.0 ± 0.9 % [11 ± 10 mmol/mol]). Proportions of participants reaching HbA1c <7 % (53 mmol/mol) with iGlarLixi were similar at week 26 (62%) and 52 (64%), as were those reaching this target without documented symptomatic (<3.0 mmol/L) hypoglycemia (57% and 58%). Safety of iGlarLixi was similar at weeks 26 and 52, with low rates of documented symptomatic hypoglycemia and gastrointestinal events. Conclusions The efficacy and safety of iGlarLixi at the end of the 26-week randomized treatment period was maintained over the 26-week extension period in the LixiLan-G trial.

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