Cost analysis of flavocoxid compared to naproxen for management of mild to moderate OA

Walton, Surrey M.; Schumock, Glen T.; McLain, David

doi:10.1185/03007995.2010.505545

Cited by 5 publications

(5 citation statements)

References 21 publications

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“…The most frequent methods were Delphi or modified Delphi process ( n = 10), 13,36,37,41,42,47,55,58,61,66 while 2 used the SHELF method 63,64 ; both methods rely on multiple rounds of discussion to build consensus among experts. Elicitations were frequently done virtually or over the phone ( n = 13) 14,36,41,46,48,50,53,55,57,66,67,70,71 while only 5 specified that the elicitation was conducted in person. 38,39,48,51,60 Web- or spreadsheet-based elicitation tools were used to facilitate data collection in 9 elicitations.…”

Section: Resultsmentioning

confidence: 99%

“…The most frequently used form of mathematical aggregation was linear pooling ( n = 18). 12,39,40,42,46,49,51,52,55,57,59,61,62,64,65,67,68,71 Performance measures, 73,74 in which the experts’ estimates are weighted based on their responses to seed variables (also known as calibration questions) with answers known to the facilitator but unknown or not readily available to the experts, were only used in 2 studies. 48,57 No other weighting, such as by expert’s reported level of confidence, was used.…”

Section: Resultsmentioning

confidence: 99%

“…Eight studies reported a selection method that used convenience sampling in which experts were selected due to their proximity to the study team. 39,45,46,49,51,59,68,69 Of the remaining studies, 4 used publication records, 13,14,64,66 2 used prescribing records to identify clinicians who have used the medications being evaluated, 67,71 2 consulted external advisors, 52,58 and the rest used snowball sampling, 64,70 trial involvement, 12 all certified obstetricians/gynecologists in the country of study with years of experience, 55 or international reputation. 61 The average number of experts recruited per EE was 11, with a range of 1 to 30.…”

Section: Formal Ee Studiesmentioning

confidence: 99%

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The Use of Expert Elicitation among Computational Modeling Studies in Health Research: A Systematic Review

et al. 2021

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Background Expert elicitation (EE) has been used across disciplines to estimate input parameters for computational modeling research when information is sparse or conflictual. Objectives We conducted a systematic review to compare EE methods used to generate model input parameters in health research. Data Sources PubMed and Web of Science. Study Eligibility Modeling studies that reported the use of EE as the source for model input probabilities were included if they were published in English before June 2021 and reported health outcomes. Data Abstraction and Synthesis Studies were classified as “formal” EE methods if they explicitly reported details of their elicitation process. Those that stated use of expert opinion but provided limited information were classified as “indeterminate” methods. In both groups, we abstracted citation details, study design, modeling methodology, a description of elicited parameters, and elicitation methods. Comparisons were made between elicitation methods. Study Appraisal Studies that conducted a formal EE were appraised on the reporting quality of the EE. Quality appraisal was not conducted for studies of indeterminate methods. Results The search identified 1520 articles, of which 152 were included. Of the included studies, 40 were classified as formal EE and 112 as indeterminate methods. Most studies were cost-effectiveness analyses (77.6%). Forty-seven indeterminate method studies provided no information on methods for generating estimates. Among formal EEs, the average reporting quality score was 9 out of 16. Limitations Elicitations on nonhealth topics and those reported in the gray literature were not included. Conclusions We found poor reporting of EE methods used in modeling studies, making it difficult to discern meaningful differences in approaches. Improved quality standards for EEs would improve the validity and replicability of computational models. Highlights We find extensive use of expert elicitation for the development of model input parameters, but most studies do not provide adequate details of their elicitation methods. Lack of reporting hinders greater discussion of the merits and challenges of using expert elicitation for model input parameter development. There is a need to establish expert elicitation best practices and reporting guidelines.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Formal Ee Studiesmentioning

confidence: 99%

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The Use of Expert Elicitation among Computational Modeling Studies in Health Research: A Systematic Review

et al. 2021

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“…Similarly, a phase-IV-like postmarketing study showed that flavocoxid was well-tolerated in previously NSAID (including celecoxib) intolerant patients who ceased or decreased gastroprotective use by over 30% [11]. Walton et al [68] performed a cost analysis which suggests that this safety advantage would make flavocoxid less expensive compared to generic naproxen in a medicare population over a one-year time frame. A well-controlled endoscopy study is needed to definitively judge flavocoxid's gastrointestinal safety.…”

Section: Discussionmentioning

confidence: 99%

Flavocoxid Inhibits Phospholipase A2, Peroxidase Moieties of the Cyclooxygenases (COX), and 5-Lipoxygenase, Modifies COX-2 Gene Expression, and Acts as an Antioxidant

Burnett

Bitto

Altavilla

et al. 2011

Mediators of Inflammation

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The multiple mechanisms of action for flavocoxid relating to arachidonic acid (AA) formation and metabolism were studied in vitro. Flavocoxid titrated into rat peritoneal macrophage cultures inhibited cellular phospholipase A2 (PLA2) (IC50 = 60 μg/mL). In in vitro enzyme assays, flavocoxid showed little anti-cyclooxygenase (CO) activity on COX-1/-2 enzymes, but inhibited the COX-1 (IC50 = 12.3) and COX-2 (IC50 = 11.3 μg/mL) peroxidase (PO) moieties as well as 5-lipoxygenase (5-LOX) (IC50 = 110 μg/mL). No detectable 5-LOX inhibition was found for multiple traditional and COX-2 selective NSAIDs. Flavocoxid also exhibited strong and varied antioxidant capacities in vitro and decreased nitrite levels (IC50 = 38 μg/mL) in rat peritoneal macrophages. Finally, in contrast to celecoxib and ibuprofen, which upregulated the cox-2 gene, flavocoxid strongly decreased expression. This work suggests that clinically favourable effects of flavocoxid for management of osteoarthritis (OA) are achieved by simultaneous modification of multiple molecular pathways relating to AA metabolism, oxidative induction of inflammation, and neutralization of reactive oxygen species (ROS).

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“…The clinical trials and phase-IV study cited above, in addition to national rheumatologist opinion, and literature comparisons were utilized to perform a pharmacoeconomic analysis. This analysis demonstrated that the cost of care, using a "one year window of treatment" decision model to estimate the total costs associated with use of flavocoxid or naproxen for patients with mild to moderate OA over age 65, that Limbrel (flavocoxid) was lower in the flavocoxid treated patients in the first year of therapy [130]. Thus, even though generic NSAIDs may have a cheaper initial cost, when the cost of gastroprotective medications and side effect treatment, including hospitalizations for upper GI events are taken into account, flavocoxid is the safer and less expensive option.…”

Section: Flavocoxid Clinical Safety and Efficacymentioning

confidence: 96%

Flavocoxid (Limbrel ®) manages osteoarthritis through modification of multiple inflammatory pathways: a review

Burnett

Levy

2012

FFHD

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Limbrel (flavocoxid) is marketed as an FDA-regulated medical food for the clinical dietary management of osteoarthritis (OA) to be used under physician supervision. Flavocoxid is composed of a >90% mixture of baicalin and catechin and represents a non-targeted anti-inflammatory which works differently than non-steroidal anti-inflammatory drugs (NSAIDs) that bind to and only inhibit the cyclooxygenase moieties of COX-1 and COX-2. Flavocoxid binds to and weakly modulates the peroxidase activity of the COX enzymes permitting low level expression of prostaglandins (PGs), prostacyclin (PGI2) and thromboxane (TxA2). In addition, flavocoxid weakly inhibits phospholipase A2 (PLA2) and 5-lipoxygenase (5-LOX) as well as increases IϰBα and prevents nuclear factor kappa B (NFϰB) activation/induction of inflammatory genes such as tumor necrosis factor-alpha (TNFα), interleukin-1β (IL-1 β), IL-6, COX-2, inducible nitric oxide synthase (iNOS) and 5-LOX. In clinical studies, flavocoxid shows equivalent efficacy to naproxen with statistically fewer renal (edema) and upper gastrointestinal (GI) side effects, does not affect platelet function and bleeding times, does not change international normalized ratio (INR) in warfarinized patients, is well-tolerated in patients with previous NSAID-induced GI side effects, and decreases or eliminates the use of gastroprotective medications in patients who previously required them to tolerate NSAIDs. With its broad, non-targeted and multiple weak activities which result in fewer side effects compared to NSAIDs, flavocoxid represents a different way managing OA by working on the underlying and multiple causes of cartilage degradation as well as joint inflammation. Keywords: Flavocoxid, Limbrel, osteoarthritis, inflammatory pathways, and medical foods

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Cost analysis of flavocoxid compared to naproxen for management of mild to moderate OA

Abstract: In patients over 65 years of age who suffer from mild to moderate OA, flavocoxid may result in lower overall costs, despite a higher acquisition cost. Managed care organizations should consider total health care costs in the decision to include flavocoxid as a covered benefit.

Cited by 5 publications

References 21 publications

The Use of Expert Elicitation among Computational Modeling Studies in Health Research: A Systematic Review

The Use of Expert Elicitation among Computational Modeling Studies in Health Research: A Systematic Review

Flavocoxid Inhibits Phospholipase A2, Peroxidase Moieties of the Cyclooxygenases (COX), and 5-Lipoxygenase, Modifies COX-2 Gene Expression, and Acts as an Antioxidant

Flavocoxid (Limbrel ®) manages osteoarthritis through modification of multiple inflammatory pathways: a review

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