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Journal of Clinical Lipidology ; 16(1):e25, 2022.
Artigo em Inglês | EMBASE | ID: covidwho-1778237


Lead Author's Financial Disclosures: Nothing to disclose. Study Funding: Piper Biosciences. Background/Synopsis: The effectiveness of a plant sterol gummy supplement was studied in a South-Asian (SA) patient population with low to moderate cardiovascular disease (CVD) risk as defined by an Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score of < 7.5%, and a low density lipoprotein (LDL)-C level of 120-189 mg/dl. Statin therapy is often not recommended to patients with ASCVD score < 7.5% even in the presence of risk accelerators such as SA ethnicity, to which the 2018 National Lipid Association (NLA) guidelines call attention. Objective/Purpose: Phytosterols are known to lower LDL-C and are included in NLA and other global guidelines. This study aimed to establish their impact on LDL-C levels in 'borderline' risk SAs. Methods: 50 SAs were recruited during the COVID 19 pandemic, mainly from a preventive cardiology clinic dedicated to reducing SA heart disease risk. Eligible subjects had a 10-year CV risk score (ASCVD) <7.5% and LDL-C level of 120-193mg/dl at study enrollment. Subjects intolerant of or refusing statins were also recruited. The study was administered with a fully decentralized design, leveraging mailed supplements, televisits, remote lab collection, and SMS-based communications. Upon completing baseline labs and surveys, subjects were provided a 90-day supply of 1400mg phytosterol gummy supplements in individual packets (Piper Biosciences, Los Altos, CA) to be ingested twice daily. Subjects were instructed to continue current lifestyle habits and report major dietary pattern deviations. The primary endpoint was LDL-C reduction at 3 months. Pre- and post-study surveys were administered to assess diet and lifestyle. Results: 33 of the 50 subjects successfully completed the protocol. A significant overall reduction in LDL-C of 5.8% was observed (p=0.03) (Table 1, Figure 1). Subgroup A (n=27) completed the protocol with no significant dietary variation, demonstrating a significant LDL-C reduction of 6.5% (p=0.002), as well as a total cholesterol (TC) reduction of 4.4% (p=0.01). There was no significant change in other metrics, including BMI, fasting glucose, or HbA1C. Patients who completed the protocol but reported worsening dietary habits (Subgroup B, n=6) showed an average increase in LDL-C of 6% (p=0.2) and in TC of 8% (p=0.002). Survey responses indicate that 94% of subjects would be interested in long-term supplementation if recommended by physician and 80% would prefer taking it proactively to manage cholesterol levels. Conclusions: Plant sterols are an effective and sustainable means to lower LDL-C in middle-aged SAs, whose CV risk is often underestimated. To our knowledge this study represents the first demonstration of phytosterol effectiveness in the highest coronary disease risk population globally.

European Heart Journal ; 42(SUPPL 1):3177, 2021.
Artigo em Inglês | EMBASE | ID: covidwho-1554235


Background: The COVID-19 pandemic has curtailed clinical trial activity significantly. Decentralized clinical trial (DCT) designs may lower cost, expand trial access, and reduce exposure risk for patients and staff. Whether such designs can be used for large, pivotal drug trials is not known. Purpose: We performed a feasibility study to inform whether a large phase 3 Cardiovascular DCT can achieve high quality trial results and also withstand health crises such as the COVID-19 pandemic. The DeTAP (Decentralized Trial in Afib Patients) was a single-arm, observational study that integrated a suite of digital health technologies, including paired home sensor devices, into a 100% virtual trial experience for atrial fibrillation (AF) patients on anticoagulation. Methods: We recruited 100 AF patients over age 55 on oral anticoagulation (OAC) by traditional methods or by social media ads placed Californiawide. Subjects completed an online prescreening, uploaded their active OAC prescription, and completed an e-consent via SMS message link. Participants downloaded a customized study app to integrate surveys and data from study-supplied wireless blood pressure (BP) and 6 lead EKG sensors (Figure 1A). Participants completed pre- and post-study engagement surveys, weekly OAC adherence surveys, 4 study televisits, 4 ECG/BP readings, and 4 post-study surveys over a 6 month period. The primary endpoints were protocol engagement-based measurements that quantified percent completion of: 1) televisits 2) surveys, 3) ECG/BP readings requirements. Secondary endpoints were the % changes in: 1) OAC adherence (OACA), 2) nuisance bleeding (NB), 3) individual patient engagement surveys. Results: 100 participants were recruited in 26 days (traditional: 6 in 2 weeks;social media: 94 in 12 days) with a dramatic surge in enrollment driven by social media ads (Figure 1B, Table). A recruitment overflow occurred with >200 eligible candidates on a waitlist. All key study completion metrics showed high compliance: televisit (91%);surveys (85%);ECG/BP completion (90%). Overall OACA was unchanged, but for subjects who reported low initial OACA, there was significant improvement at 6 months (85±16% to 98±6%;p=0.002). 47 participants (57%) reported NB, which did not correlate with OACA. Participant engagement measure scores (PAM-13) trended higher (baseline, 70%;6 months, 74%, p=0.32). Lastly, study participants exhibited strong interest in participating in a larger experimental drug DCT study (90%) in the future. Conclusion: The DeTAP study, conducted fully during the COVID-19 pandemic, demonstrates that a decentralized CV medical intervention trial is feasible and can achieve rapid recruitment, high study retention, physiologic and adverse event reporting, and high study engagement via the proper integration of digital technologies and a dedicated DCT study coordination effort. These findings could be informative for virtualizing large pivotal clinical trials at scale.