Tolerance, safety and efficacy of Hedera helix extract in inflammatory bronchial diseases under clinical practice conditions: A prospective, open, multicentre postmarketing study in 9657 patients

Phytomedicine ◽  
2009 ◽  
Vol 16 (1) ◽  
pp. 17-24 ◽  
Author(s):  
S. Fazio ◽  
J. Pouso ◽  
D. Dolinsky ◽  
A. Fernandez ◽  
M. Hernandez ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Hedera Helix ◽  
Safety And Efficacy ◽  
Bronchial Diseases

scholarly journals Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network

2020 ◽  
Vol 10 (4) ◽  
pp. 266-276 ◽  
Author(s):  
Carlo Lavalle ◽  
Luca Di Lullo ◽  
Antonio Bellasi ◽  
Claudio Ronco ◽  
Stefano Radicchia ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Market Share ◽  
Adverse Drug Reactions ◽  
Oral Anticoagulants ◽  
Risk Index ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Drug Reactions ◽  
Safety And Efficacy ◽  
Pharmacovigilance Database

Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.

Safety and efficacy of lenvatinib in Child-Pugh A and B patients with unresectable hepatocellular carcinoma in clinical practice

2020 ◽  
Vol 73 ◽  
pp. S901-S903
Author(s):  
Katsuaki Ogushi ◽  
Makoto Chuma ◽  
Kazushi Numata ◽  
Haruki Uojima ◽  
Hisash Hidaka ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Practice ◽  
Safety And Efficacy ◽  
Unresectable Hepatocellular Carcinoma

scholarly journals Cephalosporins: A Focus on Side Chains and β-Lactam Cross-Reactivity

Pharmacy ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 103 ◽  
Author(s):  
Saira B. Chaudhry ◽  
Michael P. Veve ◽  
Jamie L. Wagner
Keyword(s):  
Risk Factors ◽  
Clinical Practice ◽  
Antimicrobial Stewardship ◽  
Clinical Utility ◽  
Cross Reactivity ◽  
Penicillin Allergy ◽  
Side Chain ◽  
Safety And Efficacy ◽  
History Of

Cephalosporins are among the most commonly prescribed antibiotic classes due to their wide clinical utility and general tolerability, with approximately 1–3% of the population reporting a cephalosporin allergy. However, clinicians may avoid the use of cephalosporins in patients with reported penicillin allergies despite the low potential for cross-reactivity. The misdiagnosis of β-lactam allergies and misunderstanding of cross-reactivity among β-lactams, including within the cephalosporin class, often leads to use of broader spectrum antibiotics with poor safety and efficacy profiles and represents a serious obstacle for antimicrobial stewardship. Risk factors for cephalosporin allergies are broad and include female sex, advanced age, and a history of another antibiotic or penicillin allergy; however, cephalosporins are readily tolerated even among individuals with true immediate-type allergies to penicillins. Cephalosporin cross-reactivity potential is related to the structural R1 side chain, and clinicians should be cognizant of R1 side chain similarities when prescribing alternate β-lactams in allergic individuals or when new cephalosporins are brought to market. Clinicians should consider the low likelihood of true cephalosporin allergy when clinically indicated. The purpose of this review is to provide an overview of the role of cephalosporins in clinical practice, and to highlight the incidence of, risk factors for, and cross-reactivity of cephalosporins with other antibiotics.

scholarly journals Long-term safety and efficacy of breast biopsy markers in clinical practice

2020 ◽  
pp. 1-7
Author(s):  
Sharon Smith ◽  
Clayton R. Taylor ◽  
Estella Kanevsky ◽  
Stephen P. Povoski ◽  
Jeffrey R. Hawley
Keyword(s):  
Clinical Practice ◽  
Breast Biopsy ◽  
Safety And Efficacy

Off-Label High-Dose Secukinumab for the Treatment of Moderate-to-Severe Psoriasis

2019 ◽  
Vol 23 (4) ◽  
pp. 391-393 ◽  
Author(s):  
Michelle Phung ◽  
Arvin Ighani ◽  
Jorge R Georgakopoulos ◽  
Ron Vender ◽  
Lyne Giroux ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Dose Escalation ◽  
Case Series ◽  
Severe Psoriasis ◽  
Adult Patients ◽  
High Dose ◽  
Physician Global Assessment ◽  
Upper Respiratory Tract ◽  
Safety And Efficacy ◽  
Off Label

Background: Secukinumab is an anti-IL-17A monoclonal antibody approved for the treatment of moderate-to-severe psoriasis in adult patients. Despite its favourable safety and efficacy profile in clinical trials, some patients in clinical practice fail to respond adequately to the approved maintenance regimen of 300 mg subcutaneous monthly. Some clinicians manage these patients by using off-label high-dose secukinumab regimens, which include shortening the dosing interval to 300 mg every 2 or 3 weeks instead of monthly, or increasing the monthly dose to 450 mg. Objective: This study aims to investigate the safety and efficacy of high-dose secukinumab regimens for the treatment of psoriasis to inform real-world clinical practice. Methods: We performed a retrospective chart review at 5 dermatology clinics for adult patients diagnosed with moderate-to-severe psoriasis treated with an off-label high-dose secukinumab regimen. Efficacy was measured using the Psoriasis Area and Severity Index or a Physician Global Assessment score of 0 or 1 after dose escalation. Adverse events were recorded to assess safety outcomes. Results: Twenty-five patients were included in this case series, and 14 of them achieved efficacy from dose escalation with secukinumab based on our study endpoints. There was 1 case of the common cold and 1 upper respiratory tract infection reported after dose escalation. Conclusion: Our study provides evidence that dose escalation with secukinumab results in clinical benefit and is well tolerated among patients with moderate-to-severe psoriasis who failed to respond adequately to the approved regimen. This work necessitates larger studies to fully characterize the efficacy and long-term safety profile of secukinumab dose escalation.

scholarly journals Unorthodox Parenteral β-Lactam and β-Lactamase Inhibitor Combinations: Flouting Antimicrobial Stewardship and Compromising Patient Care

2020 ◽  
Vol 64 (5) ◽  
Author(s):  
Snehal Palwe ◽  
Balaji Veeraraghavan ◽  
Hariharan Periasamy ◽  
Kshama Khobragade ◽  
Arun S. Kharat
Keyword(s):  
Clinical Practice ◽  
Drug Development ◽  
Patient Care ◽  
Clinical Outcomes ◽  
Antimicrobial Stewardship ◽  
Fixed Dose ◽  
Resistance Development ◽  
Safety And Efficacy ◽  
India And China ◽  
Lactamase Inhibitor

ABSTRACT In India and China, indigenous drug manufacturers market arbitrarily combined parenteral β-lactam and β-lactamase inhibitors (BL-BLIs). In these fixed-dose combinations, sulbactam or tazobactam is indiscriminately combined with parenteral cephalosporins, with BLI doses kept in ratios similar to those for the approved BL-BLIs. Such combinations have been introduced into clinical practice without mandatory drug development studies involving pharmacokinetic/pharmacodynamic, safety, and efficacy assessments being undertaken. Such unorthodox combinations compromise clinical outcomes and also potentially contribute to resistance development.

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