Patients’ and rheumatologists’ perspectives on the efficacy and safety of low-dose glucocorticoids in rheumatoid arthritis—an international survey within the GLORIA study

Rheumatology ◽  
2021 ◽  
Author(s):  
T Santiago ◽  
M Voshaar ◽  
M de Wit ◽  
P D Carvalho ◽  
F Buttgereit ◽  
...  
Keyword(s):  
Adverse Events ◽  
Health Professionals ◽  
Low Dose ◽  
Unmet Need ◽  
Signs And Symptoms ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
The Real ◽  
Patient Organizations ◽  
Published Evidence

Abstract Objective To evaluate the current perspectives of patients and health professionals regarding the efficacy and safety of low-dose glucocorticoids (GCs) in RA. Methods Two online surveys were disseminated to patients and health professionals, in their native language, through national patient organizations and national rheumatology medical societies, respectively. SurveyMonkey®, MediGuard.org and the Glucocorticoid Low-dose Outcome in RA Study (GLORIA) website were used to offer and deliver these surveys. Results A total of 1221 RA patients with exposure to GCs, and 414 rheumatologists completed the surveys. Patients and rheumatologists reported high levels of agreement regarding the efficacy of low-dose GCs: at least 70% considered that they are very rapid and effective in the control of signs and symptoms of RA. However, half of the patients also reported having suffered serious adverse events with GCs, and 83% described concerns about safety. The majority of rheumatologists estimated that endocrine, ophthalmologic and cutaneous adverse events affect >4% of all patients treated with low-dose GCs for 2 years, based on a heat map. Conclusions RA patients with self-reported exposure to GCs express high levels of satisfaction with low-dose GCs efficacy, as do rheumatologists. However, both expressed excessive concerns regarding the safety of GCs (greatly exceeding the published evidence data), which may compromise the optimal use of this medication. This study indicates that there is an unmet need for appropriately designed prospective trials that shed light on the real risk associated with low-dose GCs, as well as a need for renovated educational programs on the real benefits and harms of low-dose GCs, for both patients and physicians.

scholarly journals AB1335-HPR HEALTH PROFESSIONALS’ PERSPECTIVE ON THE BENEFITS AND RISKS OF LOW-DOSE GLUCOCORTICOIDS IN RHEUMATOID ARTHRITIS – AN INTERNATIONAL SURVEY OF 444 HEALTH PROFESSIONALS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1955.1-1956
Author(s):  
T. Santiago ◽  
M. Voshaar ◽  
M. De Wit ◽  
P. Carvalho ◽  
M. Boers ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Health Professionals ◽  
Patient Perspective ◽  
Online Survey ◽  
Low Dose ◽  
Low Doses ◽  
Research Support ◽  
Serious Adverse Events ◽  
Patient Organizations

Background:The Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis Study (GLORIA) is an international investigator-initiated pragmatic randomized trial designed to study the effects of low-dose glucocorticoids (GCs) in elderly patients with Rheumatoid Arthritis (RA).The research team is also committed to promote a better understanding of the risks and benefits of these drugs among health professionals and patients. In order to achieve these goals, it is important to assess the current ideas and concerns of patients regarding GCs.Objectives:To evaluate the current patient perspective on the efficacy and risks of GCs in RA patients who are or have been treated with GCs.Methods:Patients with RA completed an online survey (with 5 closed questions regarding efficacy and safety) presented in their native language. RA patients were recruited through a variety of patient organizations representing three continents. Patients were invited to participate through national patient organizations. In the USA, patients were also invited to participate through MediGuard.org. Participants were asked for their level of agreement on a 5-point Likert scale.Results:1344 RA patients with exposure to GCs, from Brazil, USA, UK, Portugal, Netherlands, Germany and 24 other countries** participated: 89% female, mean age (SD) 52 (14) years and mean disease duration 13 (11) years. The majority of participants (84%) had ≥10 years of education. The duration of GCs exposure was 1.6 (4.2) years. The majority of participants had read articles or pamphlets on the benefits or harms of GC therapy.Regarding GCs efficacy (table 1), high levels of endorsement were found: about 2/3 of patients considered that GCs as very useful in their case, more than half considered that GCs were effective even at low doses, and agreed that GC improved RA symptoms within days.Regarding safety (table 1), 1/3 of the participants reported having suffered some form of serious adverse events (AEs) due to GCs, and 9% perceived this as “life-threatening. Adverse events had a serious impact on quality of life, according to about 1/3 of the respondents.Conclusion:Patients with RA exposed to GC report a strong conviction that GCs are very useful and effective for the treatment of their RA, even at low doses. This is accompanied by an important prevalence of serious AEs. Understanding the patient perspective can improve shared decision-making between patient and rheumatologist.Funding statement:This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634886.Disclosure of Interests:Tânia Santiago: None declared, Marieke Voshaar Grant/research support from: part of phd research, Speakers bureau: conducting a workshop (Pfizer), Maarten de Wit Grant/research support from: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Consultant of: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Speakers bureau: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Pedro Carvalho: None declared, Maarten Boers: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Frank Buttgereit Grant/research support from: Amgen, BMS, Celgene, Generic Assays, GSK, Hexal, Horizon, Lilly, medac, Mundipharma, Novartis, Pfizer, Roche, and Sanofi., José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis

scholarly journals PARE0004 PATIENT PERSPECTIVE ON THE EFFICACY AND RISKS OF GLUCOCORTICOIDS IN RHEUMATOID ARTHRITIS – AN INTERNATIONAL SURVEY OF 1344 PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1288.2-1288
Author(s):  
T. Santiago ◽  
M. Voshaar ◽  
M. De Wit ◽  
P. Carvalho ◽  
F. Buttgereit ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Patient Perspective ◽  
Online Survey ◽  
Low Dose ◽  
Low Doses ◽  
Research Support ◽  
Serious Adverse Events ◽  
Horizon 2020 ◽  
Patient Organizations

Background:The Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis Study (GLORIA) is an international investigator-initiated pragmatic randomized trial designed to study the effects of low-dose glucocorticoids (GCs) in elderly patients with Rheumatoid Arthritis (RA).The research team is also committed to promote a better understanding of the risks and benefits of these drugs among health professionals and patients. In order to achieve these goals, it is important to assess the current ideas and concerns of patients regarding GCs.Objectives:To evaluate the current patient perspective on the efficacy and risks of GCs in RA patients who are or have been treated with GCs.Methods:Patients with RA completed an online survey (with 5 closed questions regarding efficacy and safety) presented in their native language. RA patients were recruited through a variety of patient organizations representing three continents. Patients were invited to participate through national patient organizations. In the USA, patients were also invited to participate through MediGuard.org. Participants were asked for their level of agreement on a 5-point Likert scale.Results:1344 RA patients with exposure to GCs, from Brazil, USA, UK, Portugal, Netherlands, Germany and 24 other countries** participated: 89% female, mean age (SD) 52 (14) years and mean disease duration 13 (11) years. The majority of participants (84%) had ≥10 years of education. The duration of GCs exposure was 1.6 (4.2) years. The majority of participants had read articles or pamphlets on the benefits or harms of GC therapy.Regarding GCs efficacy (table 1), high levels of endorsement were found: about 2/3 of patients considered that GCs as very useful in their case, more than half considered that GCs were effective even at low doses, and agreed that GC improved RA symptoms within days.Regarding safety (table 1), 1/3 of the participants reported having suffered some form of serious adverse events (AEs) due to GCs, and 9% perceived this as “life-threatening. Adverse events had a serious impact on quality of life, according to about 1/3 of the respondents.Conclusion:Patients with RA exposed to GC report a strong conviction that GCs are very useful and effective for the treatment of their RA, even at low doses. This is accompanied by an important prevalence of serious AEs. Understanding the patient perspective can improve shared decision-making between patient and rheumatologist.References:Funding statement:This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634886.Disclosure of Interests:Tânia Santiago: None declared, Marieke Voshaar Grant/research support from: part of phd research, Speakers bureau: conducting a workshop (Pfizer), Maarten de Wit Grant/research support from: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Consultant of: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Speakers bureau: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Pedro Carvalho: None declared, Frank Buttgereit Grant/research support from: Amgen, BMS, Celgene, Generic Assays, GSK, Hexal, Horizon, Lilly, medac, Mundipharma, Novartis, Pfizer, Roche, and Sanofi., Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Maarten Boers: None declared, José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis

scholarly journals POS0630 COMPARISON OF THE EFFICACY AND SAFETY OF ORIGINAL AND BIOSIMILAR ADALIMUMAB MOLECULES IN CHILDHOOD RHEUMATIC DISEASES

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 553.1-553
Author(s):  
K. Ulu ◽  
F. Demir ◽  
T. Coşkuner ◽  
Ş. Çağlayan ◽  
B. Sözeri
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Rheumatic Diseases ◽  
Behcet’S Disease ◽  
Behçet's Disease ◽  
Inactive Disease ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Abp 501

Background:The TNF-α inhibitor adalimumab is a biological disease modifying anti-rheumatic drug (bDMARD) that has been used in different rheumatic diseases with a resistant course. ABP-501 is a biosimilar product (BP) of adalimumab, recently approved by the FDA and EMA. To our knowledge, there is no study assess the efficacy and safety of these two molecules on pediatric patients.Objectives:We aimed to compare the efficacy and safety of the original and biosimilar adalimumab (ABP-501) molecules in childhood rheumatic diseases.Methods:This non-interventional, retrospective, single-centre analysis carried out in Umraniye Training and Resrach Hospital, Pediatric Rheumatology Clinic, Istanbul, Turkey. The study group consisted of patients who were followed due to chronic rheumatic disease between January 1, 2016 and June 1, 2020, and received reference or biosimilar adalimumab therapy for at least three months. Demographic and clinical data of patients were collected at baseline, 3rd, 6th, and 12th months of treatment. Disease activity assessment was made with JADAS-27 in JIA patients, with SUN criteria in uveitis patients, and with Behçet’s Disease Activity Index in BD patients. Efficacy and safety of treatments were compared between reference and biosimilar adalimumab groups.Results:A total of 89 patients (65 with original and 24 with biosimilar molecule) treated with adalimumab, were included in the study. There were 45 female and 44 male in the study, and the median age at the initiation of the adalimumab was 166 months (min-max: 36-231). Of the 89 patients evaluated, the primary diagnoses of 62 were juvenile idiopathic arthritis, 13 were idiopathic uveitis, eight were Behçet’s disease, three were Blau syndrome, two were chronic recurrent multifocal osteomyelitis and one was Vogt-Koyanagi-Harada syndrome. 63 of the patients were biologic-naïve, and 13 were switched from etanercept, 11 from infliximab, and two from other bDMARDs. The median exposure time of adalimumab was 16 months (min-max:3-70) in RP and 14.5 months (min-max: 3-23) in BP. All patients had active disease before treatment. In the group treated with RP, inactive disease was achieved in 60%, 76.6% and 87.2% of the patients at the 3rd, 6th and 12th months, respectively. Also, inactive disease was achieved in 62.5%, 78.2% and 78.2% of the patients at the 3rd, 6th and 12th months in the group treated with BP, respectively. There was no statistically significant difference in efficacy between the groups at the 3rd, 6th and 12th months (p=0.83, 0.07 and 0.32). Serious adverse events were seen in one patient in each groups (lymphoma in RP group, tuberculous meningitis in BP group). Non-serious adverse events were observed in eight patients (12.3%) in the RP group and in two patients (8.3%) in the BP group, without statistically significant difference between groups (p=0.86).Conclusion:No significant difference was observed between the biosimilar adalimumab ABP-501 and RP adalimumab in terms of efficacy and safety.References:[1]Renton, William D et al. Pediatr Rheumatol Online J. 2019;17(1):67.[2]Lovell DJ, Ruperto N, Goodman S, et al. N Engl J Med. 2008;359(8):810-820.[3]Kingsbury, Daniel J et al. Clin Rheumatol 2014;33(10):1433-41.Disclosure of Interests:None declared

scholarly journals Efficacy and safety of combined endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous occlusion (BRTOcc) of gastrorenal shunts in patients with bleeding gastric fundal varices

2020 ◽  
Author(s):  
Fateh Bazerbachi ◽  
Akira Dobashi ◽  
Swarup Kumar ◽  
Sanjay Misra ◽  
Navtej S Buttar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Gastric Varices ◽  
High Rate ◽  
Efficacy And Safety ◽  
Cyanoacrylate Glue ◽  
Serious Adverse Events ◽  
Gastroesophageal Varices ◽  
Life Threatening ◽  
Glue Embolization

Abstract Background Endoscopic cyanoacrylate (glue) injection of fundal varices may result in life-threatening embolic adverse events through spontaneous gastrorenal shunts (GRSs). Balloon-occluded retrograde transvenous occlusion (BRTOcc) of GRSs during cyanoacrylate injection may prevent serious systemic glue embolization through the shunt. This study aimed to evaluate the efficacy and safety of a combined endoscopic–interventional radiologic (BRTOcc) approach for the treatment of bleeding fundal varices. Methods We retrospectively analysed the data of patients who underwent the combined procedure for acutely bleeding fundal varices between January 2010 and April 2018. Data were extracted for patient demographics, clinical and endoscopic findings, technical details, and adverse events of the endoscopic–BRTOcc approach and patient outcomes. Results We identified 30 patients (13 [43.3%] women; median age 58 [range, 25–92] years) with gastroesophageal varices type 2 (53.3%, 16/30) and isolated gastric varices type 1 (46.7%, 14/30) per Sarin classification, and median clinical and endoscopic follow-up of 151 (range, 4–2,513) days and 98 (range, 3–2,373) days, respectively. The median volume of octyl-cyanoacrylate: Lipiodol injected was 7 (range, 4–22) mL. Procedure-related adverse events occurred in three (10.0%) patients, including transient fever, non-life-threatening pulmonary glue embolism, and an injection-site ulcer bleed. Complete gastric variceal obturation was achieved in 18 of 21 patients (85.7%) at endoscopic follow-up. Delayed variceal rebleeding was confirmed in one patient (3.3%) and suspected in two patients (6.7%). Although no procedure-related deaths occurred, the overall mortality rate was 46.7%, primarily from liver-disease progression and co-morbidities. Conclusion The combined endoscopic–BRTOcc procedure is a relatively safe and effective technique for bleeding fundal varices, with a high rate of variceal obturation and a low rate of serious adverse events.

scholarly journals Efficacy and Safety of Fospropofol Disodium for Injection in General Anesthesia Induction for Adult Patients: A Phase 3 Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Chao-Meng Wu ◽  
Wen-Sheng Zhang ◽  
Jin Liu ◽  
Wei-Yi Zhang ◽  
Bo-Wen Ke
Keyword(s):  
Adverse Events ◽  
General Anesthesia ◽  
Success Rate ◽  
Blood Pressure Reduction ◽  
Intervention Group ◽  
Adult Patients ◽  
Anesthesia Induction ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Study Drug Administration

Background: Fospropofol disodium for injection (FospropofolFD) is a prodrug that is metabolized into propofol to produce a general anesthesia effect when administered intravenously.Objective: This study aimed to assess the efficacy and safety of FospropofolFD in comparison with propofol medium/long-chain fat emulsion injections (propofol-MCT/LCT) for general anesthesia induction in adult patients undergoing elective surgeries.Setting: Nine academic medical centers in China.Method: This multicenter, randomized, double-blind, double-simulated, controlled, and non-inferiority trial evaluated 540 eligible adult patients randomly assigned (2:1) to the intervention (20 mg/kg FospropofolFD) or control (2 mg/kg propofol-MCT/LCT) groups.Main Outcome Measure: The primary efficacy endpoint was the success rate, defined as a Modified Observer’s Assessment of Alertness/Sedation Scale score of 1 within 5 min after study drug administration. The safety endpoints consisted of adverse events (AEs) related to consciousness, cognitive function, hemodynamic status, liver and kidney function, and blood tests.Results: A total of 347 (96.3%) and 175 (97.2%) patients in the intervention and control groups, respectively, completed the study. The success rate for the primary outcome was 97.7% for both study drugs. The most frequent AEs in the intervention group were abnormal feeling (62.0%), blood pressure reduction (13.5%), and injection site pain (13.3%). No AEs related to consciousness and mental and cognitive functions or serious adverse events were reported.Conclusion: FospropofolFD (20 mg/kg) is not inferior to propofol-MCT/LCT (2 mg/kg) in general anesthesia induction for American Society of Anesthesiologists (ASA) physical status I-II adult patients undergoing elective surgeries. It is safe and effective for clinical use under anesthesiologist monitoring.Impact on Practice Statement: FospropofolFD can produce a general anesthesia effect and reduce the incidence of pain at the site of injection.

scholarly journals Pilot study in patients with congenital low-flow vascular malformation treated with low dose sirolimus

2020 ◽  
Author(s):  
Veroniek Harbers ◽  
Gerard Rongen ◽  
van der Carine Vleuten ◽  
Bas Verhoeven ◽  
de Peter Laat ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Vascular Malformation ◽  
Low Dose ◽  
Liver Toxicity ◽  
Vascular Malformations ◽  
Low Flow ◽  
Bone Marrow Toxicity ◽  
Serious Adverse Events ◽  
Grade Iii

Abstract Background Patients with congenital low-flow vascular malformations (capillary (CM), lymphatic (LM), venous (VM) or combined) may have an impaired quality of life (QoL), due to their symptoms, which include pain, swelling, bleeding, thrombosis, and functional impairment. Unfortunately, current treatment methods are challenging and not always successful. Previous studies have shown that the mTOR-inhibitor sirolimus is an effective treatment for these patients. Target levels of 10–15 ng/ml were well tolerated; however, grade three adverse events were observed (ranged 20–40%). Methods A pilot study was performed using a Challenge–Dechallenge–Rechallenge (CDR) design to determine the pharmacodynamics of low target levels of sirolimus (target levels 4–10 ng/ml) in respect of efficacy and adverse events in patients with disabling low-flow vascular malformations without treatment alternatives. The patients received sirolimus over a three-to-six-month period (Challenge), followed by the withdrawal of sirolimus (Dechallenge). If the complaints returned, sirolimus was reintroduced during a twelve month period (Rechallenge). Efficacy was determined on pain (end point of the pilot study) and other symptoms related to the vascular malformation; and adverse events were determined in all phases of the study. Results An improvement in symptoms was seen in 92% (n = 11/12) of patients during the Challenge phase. In the Rechallenge phase, a positive response rate of 78% was found (n = 7/9). These response rates are comparable to those found in the literature despite low target levels of sirolimus. However, less serious adverse events were observed with low dose sirolimus, especially bone marrow toxicity and grade III liver toxicity. Conclusions This pilot using low dose sirolimus showed high efficacy in patients with therapy resistant and disabling low-flow malformation, with a lower incidence of serious adverse events (especially bone marrow toxicity and grade III liver toxicity). This is extremely relevant to patients with low-flow vascular malformation, as current clinical protocols tend to advise lifelong treatment. Trial registration The pilot study was part of a phase III study. Trial registration: EudraCT number: 2016-002157-38 and ClinicalTrials.gov Identifier: NCT03987152, registered 06/14/2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03987152?term=sirolimus&cond=Vascular+Malformations&cntry=NL&draw=2&rank=1

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.

scholarly journals A prospective study of efficacy and safety of olopatadine versus azelastine in allergic conjunctivitis at a tertiary care hospital

2017 ◽  
Vol 6 (8) ◽  
pp. 1948 ◽  
Author(s):  
Jayanthi C. R. ◽  
Nanthini R. ◽  
. Vijayalakshmi
Keyword(s):  
Mast Cell ◽  
Adverse Events ◽  
Allergic Conjunctivitis ◽  
Tertiary Care ◽  
Signs And Symptoms ◽  
Eye Drops ◽  
Care Hospital ◽  
Efficacy And Safety ◽  
H1 Receptor ◽  
Olopatadine Hydrochloride

Background: Allergic conjunctivitis, an ocular surface inflammatory disease with significant social and economic impact affects approximately 25% of the general population. H1 receptor blockers, mast cell stabilizers and drugs that block cytokine and prostaglandin formation form the treatment armamentarium. Olopatadine hydrochloride and Azelastine hydrochloride are dual-acting selective H1 receptor antagonist with mast-cell stabilizing property. This study was undertaken to assess the efficacy and safety of olopatadine hydrochloride 0.1% and Azelastine hydrochloride 0.05% in allergic conjunctivitis amongst Indians.Methods: After obtaining Institutional Ethics Committee approval and written informed consent, 120 patients diagnosed with allergic conjunctivitis fulfilling the inclusion/exclusion criteria were enrolled in the study. Study was done from April 2014 to June 2015 at Minto eye hospital. Study subjects were treated with olopatadine hydrochloride 0.1% and Azelastine hydrochloride 0.05% eye drops BD for 15 days. Ocular symptoms, instead of and signs and adverse events, if any were recorded on the day 8 and day 15 follow up visits.Results: At the end of the study period, the reduction in the ocular itching score from baseline was higher in the olopatadine group compared to the azelastine group (p<0.002). Similarly, the scores of ocular congestion (p<0.008), foreign body sensation (p<0.009), tearing (p<0.001), erythema (p<0.002) and chemosis (p<0.015) also showed larger reduction in the olopatadine treated patients. The common adverse events encountered in both the groups were stinging after instillation, burning, bitter taste and headache.Conclusions: In allergic conjunctivitis, both olopatadine and azelastine were found to be effective in relieving ocular signs and symptoms, but olopatadine was found to be superior in terms of efficacy, safety and tolerability with minimal side effects.

scholarly journals Efficacy and safety of eltrombopag in the treatment of severe chronic immune thrombocytopenia in children of China: A single-center observational study

2019 ◽  
Vol 33 ◽  
pp. 205873841987212 ◽  
Author(s):  
Xiaoling Cheng ◽  
Kuo Yan ◽  
Jingyao Ma ◽  
Zhenping Chen ◽  
Libo Zhao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Immune Thrombocytopenia ◽  
Response Rates ◽  
Drug Dosage ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Serious Adverse Events ◽  
Durable Response ◽  
Chronic Immune Thrombocytopenia

The treatment of severe chronic immune thrombocytopenia (SCITP) in pediatric patients is challenging. We evaluated the clinical efficacy and safety of eltrombopag in children with SCITP in China. This observational study was carried out at the Hematology Oncology Center, Beijing Children’s Hospital between April 2017 and July 2018. Patients with SCITP who had at least 12 weeks of eltrombopag treatment and follow-up data were included. Baseline data, such as age, drug dosage, pre-study platelet count, concomitant medications, and bleeding severity, were collected. Treatment response rates, durable response rates, bleeding events, and adverse events were assessed during eltrombopag therapy for at least 12 weeks. The median duration of eltrombopag therapy was 16 (12–48) weeks. The overall, complete, and partial response rates were 75% (15/20), 35% (7/20), and 40% (8/20), respectively. The durable response rate was 70% (14/20). No serious bleeding events or serious adverse events occurred during the study period. Eltrombopag appears to be effective and safe in children with SCITP, although additional research is needed to confirm this.

Efficacy, Safety and Tolerability Of Valsartan Plus HCTZ in Patients With Essential Hypertension: A Multicentre Observational Study in Bangladesh

1970 ◽  
Vol 3 (1) ◽  
pp. 37-44
Author(s):  
MN Islam
Keyword(s):  
Adverse Event ◽  
Essential Hypertension ◽  
Adverse Events ◽  
Global Assessment ◽  
Paired Comparison ◽  
Additional Treatment ◽  
Serious Adverse Events ◽  
Published Evidence ◽  
Bangladeshi Population

Background: Valsartan is an established drug for treatment of essential hypertension. It blocks the action of Angiotensin II irrespective of its sources. A large proportion of patients need additional treatment with two or more drugs of different pharmacological classes for achieving target blood pressure. Published evidence demonstrated synergistic effect of Thiazides with ARB. Coadministration of valsartan and Hydrochlorothiazide has the potential to reverse the untoward effect of each other. Current study aimed at evaluating the efficacy, safety and tolerability of Valsartan plus Hydrochlorothiazide combination, and thus validating the regimen in the treatment of essential hypertension in Bangladeshi population, a population significantly different from Caucasian population where most studies were done. Methods: Current study is a prospective interventional study involving 404 Adult, patients, with Stage I (SBP 140-159 mmHg/DBP 90-99 mmHg) or Stage II (SBP≥160 mmHg/DBP ≥100 mmHg) essential hypertension or patients uncontrolled on current mono-therapy or other combination therapy. Valsartan plus HCTZ 80/12.5 mg once daily tablet were prescribed to continue till the following visit or for the remainder of the study. In case of inadequate control increment in dose was made on the following visit. Patients were assessed at baseline, at 4th weeks, 12th week and 24th week. One of the major outcome parameter set for the study was the percentage of participant having BP controlled that is a SBP <140 mmHg and DBP <90 mmHg or a reduction >10 mmHg for DBP and/ or >20 mmHg SBP versus baseline values at 24 weeks. At final follow-up, in addition to repetition of the baseline measurements and examinations, data on Safety of the drug was collected by enquiring and recording all adverse events or serious adverse events. Global assessment of efficacy and tolerability of treatment was also done by both the physicians and patients on a 4-point scale. Result: The percentage of participant having BP controlled at the end of the trial was 91%. Besides, Significant reduction in mean SBP and mean DBP was also evident (P<.001) through paired comparison from baseline to end of the study. Average reduction of 32.4 ± 19.5 mmHg was seen in systolic BP and 17.4 ± 9.3 mmHg in diastolic BP. Global assessment based on both physician and patients reported greater satisfaction with the efficacy of treatment modality. Total adverse event reported by only six (1.5%) participants. Of the six cases three of the adverse effect was reported at 3rd visit and another three were reported at 4th visit. Total five dropouts (1.24%) were reported of which 1 in 3rd visit and 4 in 4th visit. Among the dropout patient three were withdrawn from the study and two didn’t attend the final follow-up. Global assessment of safety and tolerability based on both physician and patient’s opinion reveals greater satisfaction level with the safety and tolerability of combination treatment. Conclusion: The combination of valsartan and hydrochlorothiazide is an effective treatment for patients with essential hypertension. The combination is also effective in patients not responding to monotherapy with either agent. The drug is found to be well tolerated with minimal adverse event during the course of treatment. Key words: Valsartan; Hydrochlorothiazide; Hypertension. DOI: 10.3329/cardio.v3i1.6425Cardiovasc. j. 2010; 3(1): 37-44

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