scholarly journals A Unique Formulation of Cardioprotective Bio-Actives: An Overview of Their Safety Profile

Medicines ◽  
2019 ◽  
Vol 6 (4) ◽  
pp. 107
Author(s):  
William Salminen ◽  
Mayowa Agbaje-Williams ◽  
Funmilayo Ajayi
Keyword(s):  
Safety Profile ◽  
Clinical Trial Data ◽  
The United States ◽  
Vitamin K2 ◽  
Trial Data ◽  
Healthy Population ◽  
Cvd Risk ◽  
Prevention And Treatment ◽  
The Impact ◽  
Poor Absorption

The burden of cardiovascular disease (CVD) remains high globally and in the United States despite the availability of pharmaceuticals aimed at its prevention and treatment. An invention by Summit Innovation Labs, which is a formula consisting of a unique blend of select polyphenols (i.e., curcumin, quercetin, resveratrol), vitamin K2 as menaquinone-7, and magnesium, was recently developed to modulate the impact of the specific drivers of CVD, namely, vascular calcification, oxidative stress, and chronic inflammation. The SIL formulation is a dietary supplement that was designed leveraging the more bioavailable forms of ingredients with poor absorption, such as curcumin and quercetin. Each ingredient within the SIL formulation has been shown to contribute to CVD risk reduction by moderating the effect of CVD triggers, thereby providing a holistic prevention strategy for CVD in the healthy population. This review focuses on recently published clinical data to support the safety profile of these ingredients following oral administration. The preponderance of clinical trial data reviewed support the overall safety of the bioactives when used singly or in combination. The most commonly reported adverse effects were generally mild dose-related gastrointestinal disturbances, which may be alleviated with diet in some cases. In light of these, we conclude that the combination of the ingredients in the SIL formulation is reasonably expected to be safe.

scholarly journals Setting the IMPACT (IMProve Access to Clinical Trial data) Observatory baseline

2018 ◽  
Vol 28 (1) ◽  
Author(s):  
Mersiha Mahmić-Kaknjo ◽  
Josip Šimić ◽  
Karmela Krleža-Jerić
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Impact ◽  
Improve Access

scholarly journals The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Case Studies ◽  
Real World ◽  
Clinical Trial Data ◽  
Research Impact ◽  
Trial Data ◽  
Patient Reported ◽  
The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

scholarly journals Risk Factors for Cardiovascular Disease (CVD) in Adults with Type 1 Diabetes: Findings from Prospective Real-life T1D Exchange Registry

2020 ◽  
Vol 105 (5) ◽  
pp. e2032-e2038 ◽  
Author(s):  
Viral N Shah ◽  
Ryan Bailey ◽  
Mengdi Wu ◽  
Nicole C Foster ◽  
Rodica Pop-Busui ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Disease ◽  
Type 1 Diabetes ◽  
Diabetic Nephropathy ◽  
The United States ◽  
Cvd Risk Factors ◽  
Cvd Risk ◽  
The Impact

Abstract Context Cardiovascular disease (CVD) is a major cause of mortality in adults with type 1 diabetes. Objective We prospectively evaluated CVD risk factors in a large, contemporary cohort of adults with type 1 diabetes living in the United States. Design Observational study of CVD and CVD risk factors over a median of 5.3 years. Setting The T1D Exchange clinic network. Patients Adults (age ≥ 18 years) with type 1 diabetes and without known CVD diagnosed before or at enrollment. Main Outcome Measure Associations between CVD risk factors and incident CVD were assessed by multivariable logistic regression. Results The study included 8,727 participants (53% female, 88% non-Hispanic white, median age 33 years [interquartile ratio {IQR} = 21, 48], type 1 diabetes duration 16 years [IQR = 9, 26]). At enrollment, median HbA1c was 7.6% (66 mmol/mol) (IQR = 6.9 [52], 8.6 [70]), 33% used a statin, and 37% used blood pressure medication. Over a mean follow-up of 4.6 years, 325 (3.7%) participants developed incident CVD. Ischemic heart disease was the most common CVD event. Increasing age, body mass index, HbA1c, presence of hypertension and dyslipidemia, increasing duration of diabetes, and diabetic nephropathy were associated with increased risk for CVD. There were no significant gender differences in CVD risk. Conclusion HbA1c, hypertension, dyslipidemia and diabetic nephropathy are important risk factors for CVD in adults with type 1 diabetes. A longer follow-up is likely required to assess the impact of other traditional CVD risk factors on incident CVD in the current era.

scholarly journals Public health guidelines should recommend reducing saturated fat consumption as much as possible: NO

2020 ◽  
Vol 112 (1) ◽  
pp. 19-24 ◽  
Author(s):  
Ronald M Krauss ◽  
Penny M Kris-Etherton
Keyword(s):  
Ldl Cholesterol ◽  
Saturated Fat ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Interindividual Variation ◽  
Health Impacts ◽  
Severe Restriction ◽  
Cvd Risk ◽  
Fat Consumption ◽  
Current Consumption

ABSTRACT The proposition that dietary SFAs should be restricted to the maximal extent possible (e.g., to achieve approximately half of current consumption) is based primarily on observational and clinical trial data that are interpreted as indicating a benefit of such limitation on cardiovascular disease (CVD) risk. Further support is believed to derive from the capacity of SFAs to raise LDL cholesterol, and the evidence that LDL-cholesterol lowering reduces CVD incidence. Despite their apparent merit, these arguments are flawed. In fact, although it is possible that dietary intake of SFAs has a causal role in CVD, the evidence to support this contention is inconclusive. Moreover, other considerations argue against a guideline focused primarily on limiting SFA intake, including the heterogeneity of individual SFAs, the likelihood of clinically meaningful interindividual variation in response to SFA reduction, the potential for unintended health consequences of population-wide promotion of severe restriction, and the critical differences in health impacts among individual SFA-containing foods.

Pathways to faster access to medicines

2018 ◽  
Vol 56 (8) ◽  
pp. 93-96 ◽  
Keyword(s):  
Treatment Options ◽  
Clinical Trial Data ◽  
Access To Medicines ◽  
Trial Data ◽  
European Medicines Agency ◽  
The European Union ◽  
Life Threatening ◽  
The Uk ◽  
New Treatments ◽  
The Impact

Before a medicine can be marketed in the UK, marketing authorisation approval is needed from the European Medicines Agency (EMA) or the Medicines and Healthcare products Regulatory Agency (MHRA). However, the time it takes to appraise a medicine is considered by some to delay access to new treatments for people with serious or life-threatening conditions who have no other treatment options. Also, the standard regulatory process may be less suitable for medicines for rare conditions in which it is difficult to gather a large amount of clinical trial data. Here we look at a range of new regulatory and access pathways that have been developed to respond to these challenges and consider some of their potential pitfalls. In a future article we will review the impact that the UK’s departure from the European Union (EU) will have on licensing processes.

The impact of immunotherapy education on GI cancers.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 479-479
Author(s):  
Kinjal Parikh ◽  
Katie Lucero ◽  
Charlotte Warren ◽  
Emily Sherene Van Laar ◽  
Patrick Kugel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Checkpoint Inhibitors ◽  
Statistical Significance ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Educational Activities ◽  
Cancer Subtypes ◽  
Gi Cancers ◽  
The Impact

479 Background: Gastrointestinal (GI) cancers are a heterogeneous group of cancers with varying underlying pathophysiology and distinct treatment paradigms. Immunotherapy (IO) is unique in each of the subtypes and biomarkers utility varies. With the expansion of IO in each cancer subtypes, education remains essential to optimize patient outcomes through integration of the latest evidence-based data at point of care. Through the partnership between Medscape Oncology and the Society for Immunotherapy of Cancer, 2 educational activities were designed to increase the knowledge and competence of oncologists surrounding the role of IO in patients with advanced GI cancers. Methods: The 2 educational activities included a text based online activity with 3 chapters focused on gastroesophageal cancers, colorectal cancers, and hepatocellular carcinoma (HCC) and a 30-minute online, video discussion with 3 faculty and synchronized slides on HCC. Educational effectiveness was assessed with repeated paired pre/post assessment where learners served as their own controls. A chi-square test was used to identify statistical significance in proportion of correct responses. The first activity launched 11/27/2019 and the second activity launched on 5/8/20. Data were collected and reported through 8/25/2020. Results: A total of 8433 learners, including 1543 oncologists, participated from 11/2019 through 8/2020. Participation in education resulted in significant relative improvements among oncologist learners on IO in GI cancers in (n = 641): 110%: role or eligibility of immune checkpoint inhibitors (ICIs) (p < .001) 38%: clinical trial data of ICIs (p < .001) Subsequent education on unresectable HCC demonstrated a significant relative improvement in both knowledge and competence for oncologist learners (n = 902): 19%: regarding clinical trial data in unresectable HCC (p = .073) 19%; competence identifying role of ICIs in unresectable HCC (p < .05) 59%: competence managing irAEs in unresectable HCC (p < .001). Conclusions: These 2 online CME-certified educational activities resulted in statistically significant gains in oncologist knowledge surrounding the use of IO in advanced GI cancers Follow-up education on HCC demonstrated the value and benefit of multi-modal and sequential activities on improving competence among oncologists caring for patients with unresectable HCC There remains a need for continuous education as more oncologists utilize IO in their practice while the understanding and availability of clinical data continues to expand and evolve in the varying GI cancer subtypes. More than 50% of learners continued to demonstrate a need in understanding the clinical trial data or role of IO in metastatic GI cancers with more than 40% of the learners demonstrating continued need on clinical trial data or role of IO in HCC specifically.

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