statin

Statins Linked to 61% Reduced Cancer Mortality in CLL/SLL Patients on Targeted Therapy

22 days ago

• Groundbreaking research reveals patients with chronic lymphocytic leukemia or small lymphocytic lymphoma taking statins showed 61% lower cancer mortality and 38% reduced all-cause mortality when receiving targeted therapies like ibrutinib. • The collaborative study analyzed data from 1,467 patients across four international clinical trials conducted between 2012-2019, finding statin use was also associated with 26% lower disease progression without increasing severe side effects. • Researchers from University of Sharjah and Burjeel Cancer Institute caution that while promising, these observational findings require confirmation through dedicated clinical trials before statins can be recommended as supportive cancer treatment.

Early Combination of Statins and Ezetimibe Could Prevent Thousands of Heart Attacks, Study Finds

2 months ago

• Researchers from Imperial College London and Lund University found that early combination therapy with statins and ezetimibe significantly reduces the risk of subsequent heart attacks and death in cardiac patients. • The study analyzed data from 36,000 heart attack patients, revealing that those receiving combination treatment within 12 weeks had better outcomes than patients receiving delayed treatment or statins alone. • Implementation of early combination therapy could prevent an estimated 133 heart attacks per 10,000 patients over three years, potentially saving 5,000 heart attacks in the UK over a decade.

Lipoprotein(a): The Overlooked Cardiovascular Risk Factor Gaining Clinical Recognition

2 months ago

• Elevated lipoprotein(a) affects approximately 20% of adults and is primarily genetically determined, serving as a significant risk marker for atherosclerotic cardiovascular disease, aortic stenosis, heart failure, and atrial fibrillation. • Early identification of cardiovascular risk factors like Lp(a) is crucial for preventing disease progression, reducing healthcare costs, and improving patient outcomes and quality of life. • While Lp(a) testing is generally well-covered by insurance, it is not typically considered a preventative service like traditional lipid panels, potentially resulting in cost-sharing for patients on commercial health plans.

Merck to Present Phase 3 ZENITH Trial Results for WINREVAIR in High-Risk PAH Patients at ACC.25

2 months ago

• Merck will present late-breaking data from the Phase 3 ZENITH trial evaluating WINREVAIR (sotatercept-csrk) in high-risk pulmonary arterial hypertension patients, which was concluded early due to overwhelming efficacy. • The company will also share four research presentations on cholesterol management, highlighting gaps in LDL-C goal achievement and the impact on patient outcomes and healthcare utilization. • WINREVAIR, the first FDA-approved activin signaling inhibitor for PAH, works by improving the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation.

Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors

2 months ago

• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes. • As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage. • Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.

Integrase Inhibitor HIV Regimens Linked to Higher Cardiometabolic Risks, REPRIEVE Study Reveals

2 months ago

• ACTG researchers found that HIV patients switching to integrase inhibitor-based antiretroviral regimens faced increased risks of obesity, diabetes, hypertension, and metabolic syndrome over five years. • The REPRIEVE study, presented at CROI 2025, analyzed 2,708 participants and found no elevated risk of major adverse cardiovascular events despite the metabolic changes. • Experts recommend long-term monitoring for cardiometabolic complications in patients using integrase inhibitor-containing regimens, with 82% of study participants using dolutegravir-based treatments.

Esperion Expands Global Reach: New Partnerships with CSL Seqirus and HLS Therapeutics for NEXLETOL and NEXLIZET

3 months ago

• Esperion Therapeutics has secured exclusive commercialization agreements with CSL Seqirus for Australia/New Zealand and HLS Therapeutics for Canada, expanding global access to its cholesterol-lowering medications NEXLETOL and NEXLIZET. • The partnerships include upfront payments and milestone-based compensation, with CSL Seqirus deal worth up to $5 million plus transfer pricing and HLS agreement including royalties on future Canadian sales. • Both medications are indicated to reduce cardiovascular risk and lower LDL-C in patients unable to take statins, addressing significant unmet needs in regions where cardiovascular disease affects millions.

Long-term Evolocumab Shows Strong Benefits for Elderly ASCVD Patients in FOURIER Trial Analysis

4 months ago

• Analysis of FOURIER trial reveals evolocumab (Repatha) provides greater absolute cardiovascular risk reduction in ASCVD patients aged 75 and older compared to younger patients, with a notably lower number needed to treat. • Elderly patients showed a significant 46% reduction in stroke risk with evolocumab treatment, while maintaining a favorable safety profile comparable to placebo. • Despite strong evidence supporting aggressive LDL-lowering in elderly ASCVD patients, current treatment rates remain suboptimal with less than 50% receiving statins and only 0.2% on PCSK9 inhibitors.

AstraZeneca's Oral PCSK9 Inhibitor Shows Promise in Phase 1 Trial

4 months ago

• AstraZeneca's oral PCSK9 inhibitor, AZD0780, demonstrated a 52% reduction in LDL cholesterol when added to statin therapy in a Phase 1 trial. • The study included treatment-naive participants with hypercholesterolemia, showing a 78% total reduction from baseline in LDL-C levels. • AZD0780's efficacy appears comparable to injectable PCSK9 inhibitors, with the added convenience of oral administration, unaffected by food intake. • AstraZeneca plans to advance AZD0780 into a Phase 2 program, joining MSD in the race to provide oral alternatives to injectable cholesterol-lowering drugs.

Essentia Recognized as Highest Enrolling Site for Important Study

4 months ago

Essentia Health has been acknowledged as the top enrolling site for the PREVENTABLE study, a significant clinical trial investigating the effects of statins on older adults' health. With 563 participants enrolled, Essentia leads in contributing to research that could impact future generations.

Madrigal's Rezdiffra Shows Promise in MASH Cirrhosis with Two-Year Data

4 months ago

• Madrigal Pharmaceuticals reports Rezdiffra (resmetirom) demonstrates potential benefits in patients with compensated MASH cirrhosis (F4c). • Two-year data from the MAESTRO-NAFLD-1 trial shows a mean 6.7 kPa reduction in liver stiffness, the largest reported in this patient group. • 51% of patients achieved a ≥25% reduction in liver stiffness, associated with reduced progression to end-stage liver disease. • Rezdiffra's safety profile remains consistent, supporting its potential as a treatment for F2-F4c MASH pending further trial outcomes.

LIB Therapeutics' Lerodalcibep BLA Accepted by FDA for LDL-C Reduction

5 months ago

• The FDA has accepted LIB Therapeutics' BLA for lerodalcibep, a PCSK9 inhibitor, with a PDUFA date set for December 12, 2025. • Lerodalcibep targets LDL-C reduction in patients with ASCVD or at high risk, including those with heterozygous and homozygous familial hypercholesterolemia. • Clinical trials demonstrated robust LDL-C lowering with convenient monthly subcutaneous injection and no need for refrigeration, enhancing patient adherence. • LIB Therapeutics anticipates submitting a Marketing Authorization Application to the EMA in Q2 2025, with commercial launch preparations underway.

Neurologist Diagnosed with Alzheimer's Shares Insights on Disease Management and Research

6 months ago

• Dr. Daniel Gibbs, a neurologist with early-stage Alzheimer's, shares his experiences and strategies for slowing disease progression, including diet and exercise. • Genetic testing revealed Dr. Gibbs carries two copies of the APOE-4 allele, significantly increasing his risk for Alzheimer's, prompting proactive lifestyle changes. • Dr. Gibbs participates in Alzheimer's research, including clinical trials of amyloid-reducing drugs, and emphasizes the importance of early intervention. • Lifestyle modifications, such as the MIND diet and regular aerobic exercise, alongside managing cardiovascular risk factors, are crucial in managing Alzheimer's progression.

Obicetrapib Shows Promise in Phase 3 BROADWAY Trial, Reduces LDL-C and MACE

6 months ago

• NewAmsterdam Pharma's Obicetrapib significantly reduced LDL-C by 33% in patients with ASCVD and/or HeFH on maximally tolerated lipid-lowering therapies. • The BROADWAY trial observed a 21% reduction in major adverse cardiovascular events (MACE) with Obicetrapib at one year. • Obicetrapib demonstrated a favorable safety profile, comparable to placebo, with similar rates of treatment discontinuation and adverse events. • NewAmsterdam plans regulatory filings in 2025, presenting further data at upcoming scientific sessions.

Lp(a)-Lowering Therapies Show Promise in Phase II Trials

6 months ago

• Zerlasiran, a siRNA therapy, demonstrated an 85% reduction in Lp(a) levels over 36 weeks in the ALPACAR-360 trial, showing promise for ASCVD patients. • Muvalaplin, an oral agent, reduced Lp(a) by up to 85% in the KRAKEN trial, offering a potential alternative to injectable therapies for high Lp(a). • Both therapies were well-tolerated in phase II studies, with no significant safety concerns, marking a step forward in addressing unmet needs for Lp(a) lowering. • Clinical trials for both drugs are ongoing, with results expected in 2025 and 2026, which will determine whether lowering Lp(a) reduces cardiovascular events.

Jongkundang Receives FDA Clearance for Phase 1 Trial of Novel Hyperlipidemia Drug CKD-508

7 months ago

• Jongkundang has received FDA approval to begin Phase 1 clinical trials in the U.S. for CKD-508, a new hyperlipidemia treatment. • CKD-508 aims to lower LDL-C and raise HDL-C by inhibiting cholesterol ester transfer protein (CETP), offering a new approach to managing cholesterol. • Preclinical studies have demonstrated CKD-508's effectiveness in reducing LDL-C and apolipoprotein B, a key marker of hyperlipidemia. • CKD-508 is designed to overcome the limitations of previous CETP inhibitors, potentially benefiting patients resistant to statin treatments.

Singapore Trial to Evaluate Multicomponent Intervention for Chronic Kidney Disease Management

7 months ago

• A new study will evaluate a multicomponent intervention (SKOPE) for managing kidney outcomes in patients with chronic kidney disease (CKD). • The SKOPE intervention includes training for nurses and physicians, regular case review meetings, and subsidies for SGLT2i medications. • The primary outcome will be the eGFR total slope from randomization to final follow-up at 36 months, with secondary outcomes including CVD risk score and quality of life. • The trial aims to determine if the SKOPE interventions can be adopted into clinical practice for patients with CKD, compared to usual care.

CCTA-Guided Lipid Management Strategy Trial in Asymptomatic Individuals

8 months ago

• The RESPECT2 trial is evaluating a CCTA-guided strategy for lipid management versus usual care in asymptomatic individuals aged 40-69 in Nanjing, China. • The primary outcome measures the proportion of participants regularly taking lipid-lowering medication at 6 and 12 months. • Secondary outcomes include the proportion achieving LDL-C targets, changes in TC and LDL-C levels, and cardiovascular events. • The study aims to determine the prevalence of subclinical CAD and assess the impact of CCTA on adherence to lipid-lowering medication.

Colchicine's Tolerability Unaffected by Common Drug Interactions in COVID-19 Patients

9 months ago

• A secondary analysis of the COLCORONA trial assessed the impact of drug-drug interactions on colchicine's safety and efficacy in COVID-19 patients. • The study found that common interactions with statins and calcium channel blockers did not significantly increase adverse events with colchicine. • Drug-drug interaction status did not modify colchicine's effect on COVID-19 hospitalization or death, suggesting clinical tolerability. • Findings suggest low-dose colchicine can be safely used with certain interacting drugs in closely monitored, select patients.

AI Decision Support Tool Shows No Improvement in Cardiovascular Outcomes for Chest Pain Patients

9 months ago

• The RAPIDxAI trial assessed an AI tool's impact on managing emergency department patients with elevated high-sensitivity cardiac troponin (hs-cTn). • The study found no significant difference in the composite of cardiovascular death, myocardial infarction, and unplanned CV readmission at 6 months between the AI and standard care groups. • The AI-based tool improved adherence to evidence-based therapies like statins and antiplatelet agents without increasing short-term adverse events. • The AI algorithm showed potential in reinforcing guideline-directed medical therapies for type 1 myocardial infarction, suggesting future refinement and cost-effectiveness evaluations are needed.

Drug Development Updates