scholarly journals Benefit–Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm

2021 ◽  
Author(s):  
Leslie Citrome ◽  
Margarita Sánchez del Rio ◽  
Yan Dong ◽  
Russell M. Nichols ◽  
Antje Tockhorn-Heidenreich ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Chronic Migraine ◽  
Number Needed To Treat ◽  
Benefit Risk Assessment ◽  
Number Needed To Harm

scholarly journals Systematic benefit-risk assessment for buprenorphine implant: a semiquantitative method to support risk management

2020 ◽  
Vol 25 (6) ◽  
pp. 199-205 ◽  
Author(s):  
Vicki Osborne ◽  
Miranda Davies ◽  
Debabrata Roy ◽  
Francesco Tescione ◽  
Saad A W Shakir
Keyword(s):  
Risk Assessment ◽  
Risk Profile ◽  
European Medicines Agency ◽  
Number Needed To Treat ◽  
The European Union ◽  
Opioid Use ◽  
Sublingual Buprenorphine ◽  
Benefit Risk Assessment ◽  
License Application ◽  
Reduced Risk

BackgroundPrior to approval in the European Union, a systematic benefit-risk assessment was required to compare buprenorphine implant to sublingual buprenorphine as part of the license application to the European Medicines Agency.ObjectiveThe Benefit-Risk Action Team framework was used to describe the overall benefit-risk of buprenorphine implant in comparison to sublingual buprenorphine.Study selection/methodsA value tree of key benefits and risks related to the implant formulation of buprenorphine was constructed. Risk differences (RD) or reporting ORs (ROR) and corresponding 95% CIs were calculated for each outcome, along with the number needed to treat and number needed to harm. Swing weighting was assigned to outcomes and the weighted net clinical benefit (wNCB) was calculated.FindingsKey benefits assessed: reduced risk of illicit opioid use (RD=0.09, 95% CI 0.01 to 0.17), reduced risk of misuse and diversion (ROR=0.13, 95% CI 0.02 to 0.94), improved compliance and convenience (RD=0.20) and quality of life measures (RD=0.03). Key risks assessed: clinically significant implant breakage (RD=0.01, 95% CI 0.00 to 0.01), migration/missing implant (RD=0.01, 95% CI 0.00 to 0.02), infection at insertion/removal site (RD=0.08, 95% CI 0.03 to 0.12) and implant-related allergic reaction (RD=0.07, 95% CI 0.03 to 0.11). The wNCB for buprenorphine implant was 4.96, which suggests a favourable benefit-risk profile.ConclusionsThe benefit-risk profile of buprenorphine implant is considered favourable in comparison to sublingual buprenorphine, based on this semiquantitative analysis using available data. Further data from real-world use on benefits and risks should be used for ongoing monitoring of the benefit-risk profile of buprenorphine implants in the postmarketing setting.

Is it Worth CANVASing for CREDENCE? A Benefit-risk Analysis

2020 ◽  
Vol 16 (5) ◽  
pp. 509-514
Author(s):  
Binayak Sinha ◽  
Samit Ghosal
Keyword(s):  
Adverse Events ◽  
Fungal Infections ◽  
Absolute Risk ◽  
Pooled Analysis ◽  
Major Adverse Cardiovascular Events ◽  
Number Needed To Treat ◽  
Pooled Data ◽  
The Individual ◽  
Fracture Risks ◽  
Number Needed To Harm

Background and Aims: A number of significant positive and negative signals emerged from the CANVAS Program and CREDENCE trial with the use of canagliflozin. These signals are confusing. A Likelihood of being Helped of Harmed (LHH) analysis was conducted to determine the risk, benefit ratio associated with canagliflozin use and address the signals as a continuum. Materials &Methods: LHH was calculated from the number needed to treat (NNT) and number needed to harm (NNH) available from the absolute risk reductions reported with the outcomes of interest, in these two trials. Results: In the CANVAS Program, LHH for major adverse cardiovascular events (MACE) points at a significant benefit with canagliflozin use in comparison to amputation (1.65), fractures (1.65) and euglycaemic diabetic ketoacidosis (euDKA) (16.67) risks. Only genital fungal infections were significant more in both sexes (0.21-M and 0.1-F) when LHH was matched against the positive outcomes. In contrast, the hHF benefits were outweighed by amputation (0.95) and fracture risks (0.95). : In CREDENCE trial, the LHH for Primary composite, Renal composite and MACE, all supported the benefits in comparison to any adverse events encountered in the trial. : The LHH from pooled data (CANVAS Program and CREDENCE trial) was in favour of all the benefits (hHF and renal composites) except for MACE matched against amputation (0.66). Conclusion: The outcome benefits were in favour of canagliflozin in comparison to all reported adverse events, when hHF and renal composite were under consideration, in both the individual and pooled LHH analysis. However, the MACE benefits were overwhelmed by amputation risk in the pooled analysis.

scholarly journals Multi-Criteria Benefit-Risk Assessment of Biological Agents in the Treatment of Moderate to Severe Psoriais: A Stochastical Approach

2013 ◽  
Vol 16 (7) ◽  
pp. A727
Author(s):  
B.S. Riveros ◽  
I. Rotta ◽  
M. Garcia ◽  
T.T. Souza ◽  
R.R. Godoy ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Biological Agents ◽  
Benefit Risk Assessment

scholarly journals Benefit–Risk Assessment of the French Surveillance Protocol of Apparently Healthy Biting Dogs and Cats for Human Rabies Prevention

2021 ◽  
Vol 8 (7) ◽  
pp. 132
Author(s):  
Guillaume Crozet ◽  
Tiffany Charmet ◽  
Florence Cliquet ◽  
Emmanuelle Robardet ◽  
Barbara Dufour ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Traffic Accidents ◽  
Scenario Tree ◽  
Human Rabies ◽  
Post Exposure Prophylaxis ◽  
Policy Makers ◽  
Benefit Risk Assessment ◽  
Surveillance Protocol ◽  
Exposure Prophylaxis ◽  
Apparently Healthy

In France, apparently healthy dogs and cats that bite humans must undergo an observation period of 15 days with three veterinary visits to ascertain that they remain healthy, indicating that no zoonotic transmission of rabies virus occurred via salivary presymptomatic excretion. This surveillance protocol is mandatory for all pets that have bitten humans, despite France’s rabies-free status in non-flying mammals (i.e., a very low rabies risk). In this context, we aimed to perform a benefit–risk assessment of the existing regulatory surveillance protocol of apparently healthy biting animals, as well as alternative surveillance protocols. A scenario-tree modelling approach was used to consider the possible successions of events between a dog or cat bite and a human death attributed to either rabies or to lethal harm associated with the surveillance protocol (e.g., lethal traffic accidents when traveling to veterinary clinics or anti-rabies centers). The results demonstrated that the current French surveillance protocol was not beneficial, as more deaths were generated (traffic accidents) than avoided (by prompt post-exposure prophylaxis administration). We showed here that less stringent risk-based surveillance could prove more appropriate in a French context. The results in this study could allow policy-makers to update and optimize rabies management legislation.

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