Efficacy and safety of the antileukotriene drugs: relevant data. RAACI experts conclusion

2020 ◽  
Vol 17 (3) ◽  
pp. 121-129
Author(s):  
Natalya I. Il`ina ◽  
Oksana M. Kurbacheva ◽  
Natalya M. Nenasheva ◽  
Natalya G. Astafieva ◽  
Evgenij K. Beltyukov ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Bronchial Asthma ◽  
Drug Administration ◽  
Expert Opinion ◽  
Adverse Reactions ◽  
Efficacy And Safety ◽  
The World ◽  
Adults And Children ◽  
Expert Commission

In many countries of the world and in Russia, in particular, the pharmacological use of antagonists of cysteinyl receptors LT1 (CysLTR) is a long-proven and well-proven pharmacotherapy of bronchial asthma (BA) and allergic rhinitis (AR) in adults and children. Among antileukotriene drugs the most commonly used medication for the treatment of these diseases is the original montelukast, which is considered a safe drug associated with the appearance of only a few adverse reactions, usually not differing in type and frequency from those that occur with placebo. Currently, there are a large number of generics of montelukast, therefore, practitioners have many questions regarding the benefits and risks of montelukast therapy for patients with BA and AR. In 2020 FDA (Food and Drug Administration USA) analyzed the risk of adverse events during Montelukast treatment and indicated them on the packaging of the drug (original montelukast and its generics). This contributed to the creation of an expert commission to study this issue and form an expert opinion, which is demonstrated in our publication.

scholarly journals Papulopustular rash following Moderna COVID-19 (mRNA-1273) vaccine: A case report

2022 ◽  
Vol 0 ◽  
pp. 1-5
Author(s):  
David Pudukadan
Keyword(s):  
Case Report ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Healthcare Professionals ◽  
Systemic Steroids ◽  
Effective Care ◽  
Short Course ◽  
The World

Coronavirus disease-2019 (COVID-19) has affected countries around the world. The introduction of COVID-19 vaccines has proved the most effective arsenal in the fight against the disease. However, with the vaccination of billions of people, data on vaccine-induced adverse reactions are also emerging. We report a 32-year-old woman who manifested papulopustular rash 7 days after receiving Moderna COVID-19 (mRNA-1273) vaccine. The patient responded to a short course of systemic steroids and antihistamines. Awareness regarding the possible adverse events that can be anticipated after the COVID-19 vaccination may help the healthcare professionals to offer prompt and effective care to the affected.

scholarly journals Clinical efficacy and safety of alemtuzumab in postmarketing practice

2019 ◽  
pp. 56-62
Author(s):  
N. V. Khachanova
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Drug Efficacy ◽  
Safety Monitoring ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Treatment Benefit ◽  
Dosing Schedule ◽  
The World ◽  
Multiple Sclerosis Treatment

Clinical trials confirm alemtuzumab efficacy for multiple sclerosis treatment in terms of both conventional measures and combined criteria such as NEDA (no evidence of disease activity). However, established drug efficacy and convenient dosing schedule are balanced by the risk of serious adverse events. Therefore, it is necessary to inform physicians about the benefits of alemtuzumab therapy along with the pattern of its safety profile.The present review provides the analysis of alemtuzumab real-world studies in Europe, USA and other parts of the world. The information obtained can help physicians to prescribe and administer the drug properly and to perform effective safety monitoring for early detection of adverse events and saving the maximum treatment benefit for the patient.

Azatadine Maleate/Pseudoephedrine Sulfate Repetabs versus Placebo in the Treatment of Severe Seasonal Allergic Rhinitis

1980 ◽  
Vol 8 (6) ◽  
pp. 391-394 ◽  
Author(s):  
Juan Carlos Tarasido
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Marked Improvement ◽  
Adverse Reactions ◽  
Active Drug ◽  
Signs And Symptoms ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Combination Drug ◽  
Double Blind

The symptoms of seasonal allergic rhinitis can be alleviated by the use of an antihistamine and a decongestant. The efficacy and safety of the combination of azatadine maleate and pseudoephedrine sulfate were examined in this double-blind study comparing active drug to placebo. While 74% of the patients administered the combination drug showed marked improvement in the signs and symptoms of seasonal allergic rhinitis, only 29% of patients receiving placebo demonstrated improvement. Adverse reactions were mild and transient.

scholarly journals Safety of Moxibustion: A Systematic Review of Case Reports

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Ji Xu ◽  
Hongyong Deng ◽  
Xueyong Shen
Keyword(s):  
Systematic Review ◽  
Basal Cell Carcinoma ◽  
Adverse Events ◽  
Medical Treatment ◽  
Cell Carcinoma ◽  
Premature Birth ◽  
Adverse Reactions ◽  
Case Reports ◽  
Fetal Distress ◽  
The World

Moxibustion is a traditional medical treatment originating in China. It involves using the heat of burning moxa to stimulate acupoints. It is considered safe and effective and is widely used throughout the world. The increasing use of moxibustion has drawn attention to the procedure’s adverse events (AEs). This review covers a total of 64 cases of AEs associated with moxibustion in 24 articles, reported in six countries. Some evidence of the risks of moxibustion has been found in these cases. AEs include allergies, burns, infection, coughing, nausea, vomiting, fetal distress, premature birth, basal cell carcinoma (BCC), ectropion, hyperpigmentation, and even death. The position, duration, distance between moxa and skin, proficiency of the practitioners, conditions of the patients, presence of smoke, and even the environment of treatment can affect the safety of moxibustion. Improving practitioner skill and regulating operations may reduce the incidence of adverse reactions and improve the security of moxibustion.

Clinical Efficacy and Safety of Omalizumab in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis of Randomized Clinical Trials

2019 ◽  
Vol 34 (2) ◽  
pp. 196-208 ◽  
Author(s):  
Chenjie Yu ◽  
Kaijian Wang ◽  
Xinyan Cui ◽  
Ling Lu ◽  
Jianfei Dong ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Symptom Score ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Symptom Scores

Background Patients with moderate to severe allergic rhinitis (AR) who are treated according to the current rhinitis management guidelines may be inadequately controlled. These patients are at risk of serious comorbidities, such as asthma and chronic sinusitis. These symptoms, sneezing and an itchy, runny, stuffy nose, may have a negative impact on patients’ daily functioning. Omalizumab is being developed as a new choice for the treatment of AR. We therefore undertook a meta-analysis to assess the efficacy and safety of omalizumab in the treatment of AR. Methods We systematically searched PubMed, Cochrane Library, and MEDLINE databases for randomized controlled studies on the treatment of AR with omalizumab. Our evaluation outcomes were symptom scores, medication efficacy, combined symptom and medication scores, and adverse events. We descriptively summarized and quantitatively synthesized original data to evaluate the efficacy and safety of omalizumab in the treatment of AR by using Stata12.0 software for meta-analyses. Results The results of our meta-analysis showed that there were statistically significant differences between the omalizumab group and the control group in the following aspects: daily nasal symptom score (standardized mean difference [SMD] = –0.443, 95% confidence interval [CI]: –0.538 to –0.347, P < .001); daily ocular symptom score (SMD = –0.385, 95% CI: –0.5 to –0.269, P < .001); daily nasal medication symptom scores (SMD = –0.421, 95% CI: –0.591 to –0.251, P < .001); proportion of days of emergency drug use (risk ratio [RR] = 0.488, 95% CI: 0.307 to 0.788, P < .005); rhinoconjunctivitis-specific quality of life questionnaire (SMD = –0.286, 95% CI: –0.418 to –0.154, P < .001); and overall evaluation (RR = 1.435, 95% CI: 1.303–1.582, P < .001). There was no statistically significant difference in safety indicator: adverse events (RR = 1.026, 95% CI: 0.916–1.150, P = .655). Conclusion Omalizumab is effective and relatively safe in patients with AR; omalizumab used in conjunction with special immunotherapy has shown promising results, especially in reducing adverse events.

Disophrol® Syrup versus Rinomar® Syrup in the Treatment of Allergic Rhinitis in Children

1982 ◽  
Vol 10 (6) ◽  
pp. 426-430 ◽  
Author(s):  
Friedrich Horak
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Adverse Reactions ◽  
Nasal Secretion ◽  
Response To Therapy ◽  
Efficacy And Safety ◽  
Patient Response ◽  
Treatment Groups ◽  
Significant Difference ◽  
Single Blind

In this single-blind study, the efficacy and safety of Disophrol® Syrup was compared to Rinomar® Syrup in seventy-eight paediatric patients with seasonal allergic rhinitis. Patients took 5–10 ml of the randomly assigned medication three to four times daily for a 2-week period. Severity of nasal obstruction, nasal secretion and mucosal swelling was graded and patient response to each week of therapy evaluated. An overall favourable response to Disophrol® Syrup was observed in thirty-one out of thirty-five (89%) patients and in thirty out of thirty-five (86%) patients in the Rinomar® group. No statistically significant difference in patient response to therapy between treatment groups was noted and no mentionable adverse reactions were reported.

Cardiopulmonary Adverse Effects of Oral and Subcutaneous Terbutaline for Tocolysis

1996 ◽  
Vol 9 (3) ◽  
pp. 181-187
Author(s):  
James O'Donnell ◽  
Leslie Iffy
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Pulmonary Edema ◽  
Magnesium Sulfate ◽  
Drug Administration ◽  
Clinical Case ◽  
Adverse Reactions ◽  
Package Insert ◽  
Cardiovascular Risks ◽  
Tocolytic Agents

Are there differences between the expected or reported adverse reactions associated with terbutaline when administered orally as opposed to the parenteral routes (such as subcutaneously or intravenously)? This is a report on a pulmonary edema and subsequent death of a laboring woman who was treated with a combination of tocolytic agents in an attempt to prolong the gestation. The agents included magnesium sulfate, and subcutaneous and oral terbutaline. The intention is to alert the reader to the cardiovascular risks associated with combining tocolytic agents, and to dispel a pervasive myth that serious adverse reactions do not occur with oral tocolysis (i.e., terbutaline).1 Until recently, the package insert sheets for both manufacturers of terbutaline restricted the attribution of serious cardiovascular risks to parenteral administration only. The clinical case will be presented, followed by a review of the published literature and the reports on file in the unpublished Food and Drug Administration MedWatch database. Finally, the comparative pharmacokinetics of the oral and parenteral terbutaline is presented to help the reader understand how these adverse events are to be expected with any route of administration of the tocolytic.

scholarly journals Mini-Review Discussing the Reliability and Efficiency of COVID-19 Vaccines

Diagnostics ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 579
Author(s):  
Bogdan Doroftei ◽  
Alin Ciobica ◽  
Ovidiu-Dumitru Ilie ◽  
Radu Maftei ◽  
Ciprian Ilea
Keyword(s):  
Side Effects ◽  
Severe Acute Respiratory Syndrome ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Age Group ◽  
Efficacy And Safety ◽  
Short Time ◽  
Dose Dependent ◽  
Severe Adverse Reactions ◽  
Age And Sex

Severe Acute Respiratory Syndrome Coronavirus 2 is a novel strain of human beta-coronavirus that has produced over two million deaths and affected one hundred million individuals worldwide. As all the proposed drugs proved to be unstable, inducing side effects, the need to develop a vaccine crystallized in a short time. As a result, we searched the databases for articles in which the authors reported the efficacy and safety of the use of several vaccines vaccines by sex, age group, and frequency of adverse reactions. We identified a total of 19 relevant articles that were discussed throughout this manuscript. We concluded that from all eleven vaccines, three had an efficacy >90% (Pfizer–BioNTech (~95%), Moderna (~94%), and Sputnik V (~92%)) except for Oxford–AstraZeneca (~81%). However, Moderna, Sputnik V, and Oxford–AstraZeneca also alleviate severe adverse reactions, whereas in Pfizer–BioNTech this was not revealed. The remaining five (Convidicea (AD5-nCOV); Johnson & Johnson (Ad26.COV2.S); Sinopharm (BBIBP-CorV); Covaxin (BBV152), and Sinovac (CoronaVac)) were discussed based on their immunogenicity, and safety reported by the recipients since only phases 1 and 2 were conducted without clear evidence published regarding their efficacy. CoviVac and EpiVacCorona have just been approved, which is why no published article could be found. All adverse events reported following the administration of one of the four vaccines ranged from mild to moderate; limited exceptions in which the patients either developed severe forms or died, because most effects were dose-dependent. It can be concluded that aforementioned vaccines are efficient and safe, regardless of age and sex, being well-tolerated by the recipients.

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 Polyfunctional antiallergic potencies of Д-antihistamine levocetirizine

2014 ◽  
Vol 11 (2) ◽  
pp. 11-24
Author(s):  
I S Gushchin
Keyword(s):  
Public Health ◽  
Allergic Rhinitis ◽  
Public Health Problem ◽  
Receptor Occupancy ◽  
Allergic Diseases ◽  
Therapeutic Benefit ◽  
Efficacy And Safety ◽  
Adults And Children ◽  
Anti Inflammatory

The burden of allergic diseases worldwide is such that it represents a serious public health problem that attracts considerable efforts to identify effective and safe therapies. Antihistamines are an important part of the therapeutic options for allergic diseases. Levocetirizine is the R-enantiomer of cetirizine with pharmacokinetically and pharmacodynamically favourable characteristics. It is a potent inverse agonist of H 1-receptors with anti-inflammatory/anti-allergic properties. It appears to have grater in vivo H 1-receptor occupancy comparatively with other 2 nd generation H 1-antihistamines. This may confer an advantageous efficacy and safety profile. clinical trials indicate that it is safe and effective for the treatment of allergic rhinitis, chronic urticaria and some other allergic conditions in adults and children with a minimal number of untoward reactions. It is also becoming clearer that, in addition to its being a potent antihistamine, levocetirizine has several anti-inflammatory/anti-allergic effects that are observed at clinically relevant concentrations that may enhance its therapeutic benefit.

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