Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Nils Krüger, MD, MPH | Image Credit: TUM

atherosclerotic cardiovascular disease (ASCVD)

 resulted in a lower risk of major adverse cardiovascular events (MACEs) compared to placebo proxy, according to recent data.

Although previous trials have shown tirzepatide’s protective effects on all-cause mortality and hospital admission for 

, evidence for MACEs is more limited. Tirzepatide has currently only proven its noninferiority to dulaglutide in the SURPASS-CVOT trial, while dulaglutide displayed modest cardiovascular event reductions in the placebo-controlled REWIND trial.

“Clinical trials are increasingly comparing active ingredients with one another,” Nils Krüger, MD, MPH, instructor in medicine in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School and lead author on the study, said in a statement. “Database studies that are benchmarked against the results of traditional clinical trials can fill this gap without actually withholding potentially beneficial therapies such as GLP-1 agonists from study participants.”

Krüger and colleagues collected deidentified data from 2 national US administrative claims databases, Optum Clinformatics and Merative MarketScan, including detailed longitudinal data on medical diagnoses, procedures, and outpatient drug dispensations for millions of patients across the US. Patients aged ≥40 years with T2D and established ASCVD were included – these patients were also required to have a BMI ≥25 and documented evidence of previous myocardial infarction, 

, or coronary, peripheral, or carotid artery disease confirmed through diagnostic codes or revascularization procedures.

Index date was defined as the first outpatient dispensing of tirzepatide or sitagliptin, precluding a 183-day washout, that met eligibility criteria. Sitagliptin was selected as the neutral placebo proxy for the study based on several previous trials demonstrating its lack of impact on cardiovascular outcomes. Krüger and colleagues began follow-up on the day after cohort entry and continued until the earliest occurrence of MACE, disenrollment from the health plan, treatment discontinuation or switching, or 1 year.

The study’s primary endpoint of MACE was a composite of myocardial infarction, stroke, and all-cause mortality – this endpoint was assessed as a composite with and without mortality, as well as individually. Krüger and colleagues used validated outcome algorithms based on inpatient diagnostic codes, which showed a positive predictive value of 94% for myocardial infarction and 95% for ischemic stroke. An expanded composite including myocardial infarction, stroke, coronary revascularization, and unstable angina was also utilized.

A total of 52,971 patients were included in the analysis, of whom 35,353 began tirzepatide and 17,618 initiated sitagliptin. Patients in the tirzepatide arm were younger, had higher BMI, and had fewer comorbidities than those in the sitagliptin arm, prior to propensity score weighting. During a pooled mean on-treatment follow-up of 182 days, weighted risk of MACE was 2.9% (95% CI, 2.5% to 3.4%) for patients receiving tirzepatide and 4.4% (95% CI, 3.8% to 4.9%) with sitagliptin, resulting in a risk difference of -1.4% (95% CI, -2.1% to -0.7%). Cumulative incidence curves diverged within the first 3 months after treatment initiation, continuing to separate throughout the observation period.

With mortality excluded from the composite endpoint, effect estimates for myocardial infarction and stroke remained similar (HR, 0.74; 95% CI, 0.61 to 0.91). Among individual components of MACE, myocardial infarction had a hazard ratio of 0.67 (95% CI, 0.52 to 0.87), ischemic stroke had 0.91 (95%, 0.64 to 1.28), and all-cause mortality had 0.55 (95% CI, 0.42 to 0.72). The expanded composite endpoint also favored tirzepatide, with a hazard ratio of 0.92 (95% CI, 0.85 to 0.99).

Ultimately, despite the clarity of these data, Krüger and colleagues noted multiple limitations to the study. Among these were the relatively short follow-up period of 1 year and the reliance on sitagliptin as a proxy given its different administration compared to tirzepatide. Additionally, further confounding from unmeasured factors could partially explain the reduced risk of all-cause mortality and rapid-onset cardiovascular benefits.

“While non-definitive, these findings add to the growing and consistent evidence base from both randomized and trial benchmarked observational studies that the cardiovascular effects of incretin-based treatments may emerge earlier than expected and independently of weight loss,” Krüger and colleagues wrote. “From a patient perspective, framing the protective effects in absolute terms such as the difference in event risk if tirzepatide is added to treatment versus maintaining standard background treatment may help communicate the tangible magnitude of benefit and support shared decision making.”

Technical University of Munich. Obesity drug significantly reduces the risk of infections and serious cardiovascular events. 

August 6, 2026. Accessed August 7, 2026. 

https://www.eurekalert.org/news-releases/1139120

Krüger N, Schneeweiss S, Wang SV. Tirzepatide and the risk of atherosclerotic cardiovascular events: Population based cohort study. BMJ. 2026;394. 

Articles

Tirzepatide initiation among US patients aged ≥40 years with T2D, BMI ≥25, and established ASCVD was associated with lower 1-year on-treatment MACE risk versus sitagliptin as a neutral placebo proxy. In two claims databases, propensity-weighted MACE risk was 2.9% with tirzepatide versus 4.4% with sitagliptin (risk difference −1.4%), with curve separation within three months. Hazard ratios favored tirzepatide for MI and all-cause mortality, with less certain stroke effects. Key limitations included short follow-up and residual confounding.

In a trial comparing tirzepatide initiation to sitagliptin, the GLP-1/glucose dual agonist displayed greater reductions in major cardiovascular events.

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Type 2 Diabetes

Atherosclerotic Cardiovascular Disease

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Tirzepatide Demonstrates Cardioprotective Effects in T2D With ASCVD

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

• Brepocitinib 30 mg once daily met the primary endpoint, improving the Total Improvement Score by 15.3 points versus placebo at Week 52 (

 <.001); the 15 mg dose did not separate from placebo.
• Brepocitinib 30 mg was superior to placebo across all 9 key secondary endpoints, including skin disease activity, glucocorticoid tapering and physical function.
• 68% of patients on brepocitinib 30 mg reached at least moderate improvement by Week 52 versus 44% on placebo.
• Serious infections occurred more often with brepocitinib 30 mg than placebo (10% vs 1%), though no deaths were reported.
• An open-label extension is ongoing to characterize longer-term use of brepocitinib.

Brepocitinib, a first-in-class oral TYK2-JAK1 inhibitor, achieved a significantly greater improvement in disease activity than placebo at Week 52 in a phase 3 trial of adults with treatment-refractory 

, according to data resulting from the VALOR trial and published in the 

Dermatomyositis has lacked an approved oral targeted therapy, with glucocorticoids, conventional DMARDs and intravenous immune globulin associated with incomplete efficacy and considerable toxicity.

Brepocitinib blocks TYK2 and JAK1 signaling implicated in the type I and II interferon and interleukin-driven inflammation of dermatomyositis, offering a mechanism distinct from broader JAK inhibition.²

Brepocitinib VALOR Trial Design and Primary Endpoint

The phase 3 VALOR trial (NCT05437263) randomized 241 adults with treatment-refractory dermatomyositis 1:1:1 to once-daily oral brepocitinib 30 mg, brepocitinib 15 mg or placebo for 52 weeks across 90 sites in 20 countries. Patients continued standard background therapy, and glucocorticoids were tapered per protocol starting at Week 12.

The mean patient age was 50.6 years, and 77.6% were women. Nearly all patients (92.9%) were receiving at least 1 dermatomyositis-directed systemic therapy at baseline, and most (81.3%) had moderate to severe disease activity.

The primary endpoint was the Total Improvement Score, a composite myositis index ranging from 0 - 100, at Week 52. Brepocitinib 30 mg produced a mean score of 46.5 versus 31.2 with placebo, a least-squares mean difference of 15.3 points (95% CI, 6.7-24.0; 

 <.001). The 15 mg dose did not separate from placebo (mean score, 37.5; difference, 6.3; 95% CI, -2.4-14.9), and no further hypothesis testing was performed for the 15 mg dose.

Brepocitinib Secondary Endpoints and Safety Profile

Brepocitinib 30 mg was superior to placebo across all 9 prespecified secondary endpoints. A moderate improvement (Total Improvement Score ≥40) was reached by 68% of patients versus 44% on placebo (risk difference, 22.2 percentage points; 95% CI, 7.1-37.3; 

 = .004), and a major improvement (score ≥60) by 46% versus 26% (risk difference, 19.5 percentage points; 95% CI, 4.2-34.8; 

Skin disease activity, measured by the Cutaneous Dermatomyositis Disease Area and Severity Index-Activity, improved by a least-squares mean of 6.4 points at Week 4 with brepocitinib 30 mg versus 3.5 points with placebo (difference, -3.0; 95% CI, -4.6 to -1.4; P <.001). By Weeks 48 to 52, 62% of brepocitinib 30 mg patients on baseline glucocorticoids tapered to 2.5 mg or less of prednisone equivalent daily versus 34% on placebo, and 42% reached 0 mg versus 23% on placebo.

Adverse events occurred at similar rates across groups (90% with brepocitinib 30 mg, 86% with 15 mg and 91% with placebo). Serious infections were more frequent with brepocitinib 30 mg than with the 15 mg dose or placebo (10% vs 2% vs 1%), though these events resolved with medical management and most patients completed treatment.

Adverse events of special interest were uncommon and occurred at similar frequencies across groups. Thromboembolic events and new or recurrent cancers occurred only in the placebo group, and no deaths were reported during the trial.

Priovant Therapeutics, which funded the trial, is continuing to evaluate brepocitinib in an ongoing 52-week open-label extension designed to characterize its use under more flexible background-therapy conditions.

Vleugels RA, Paik JJ, Bauer Ventura I, et al. A phase 3 trial of brepocitinib in dermatomyositis. N Engl J Med. 2026;394(19):1883-1893. 

ClinicalTrials.gov. Study to investigate the efficacy and safety of brepocitinib in adults with dermatomyositis (VALOR). NCT05437263. Accessed August 8, 2026.

Brepocitinib, an oral TYK2-JAK1 inhibitor, demonstrated clinically meaningful efficacy in treatment-refractory dermatomyositis, addressing an area with no approved oral targeted options and substantial reliance on toxic, incompletely effective therapies. In VALOR, brepocitinib 30 mg significantly improved the Total Improvement Score at 52 weeks versus placebo and separated across all prespecified secondary endpoints, including early cutaneous responses and greater glucocorticoid tapering. Overall adverse event rates were comparable, though serious infections were increased with 30 mg.

In the phase 3 VALOR trial, oral brepocitinib 30 mg significantly improved myositis and skin disease activity versus placebo in treatment-refractory dermatomyositis.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Phase 3 Dermatomyositis Trial Sees Brepocitinib Meet Primary Endpoint

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

Credit: Children’s Hospital of Philadelphia

In a prospective cohort study of 100 children and young adults with 

 treated at Children's Hospital of Philadelphia, 94% of initiation challenges were tolerated after a median of 12 weeks of omalizumab (Xolair) pretreatment, allowing most patients to begin oral immunotherapy (OIT) directly at maintenance dosing.¹

Standard OIT protocols require multistep dose escalations and frequent in-office up-dosing visits, creating a substantial treatment burden for patients with multi-food allergy. Investigators evaluated whether a short course of omalizumab pretreatment could allow most patients to skip incremental up-dosing and begin OIT directly at maintenance.

Omalizumab-Facilitated OIT Study Design and Initiation Outcomes

Colleen Shannon, MD, MPH, from the Children’s Hospital of Philadelphia, and colleagues conducted a prospective cohort study of 100 children and young adults who initiated omalizumab-facilitated OIT between July 2024 and October 2025.¹ Patients received ≥ 8 weeks of omalizumab pretreatment before undergoing a 2-dose initiation challenge for each target food. If tolerated, daily OIT dosing began at maintenance for most foods, with abbreviated up-dosing reserved for the remaining foods.

Median omalizumab pretreatment duration was 12 weeks (interquartile range [IQR], 9.5-15.8 weeks). Patients tolerated 181 of 193 initiation challenges (94%), meeting the primary outcome of tolerance without dose-limiting symptoms. In total, 97 patients (97%) initiated daily dosing for ≥ 1 food, and 81 patients (84%) started at target maintenance doses across all foods in their regimen.

These findings indicate the omalizumab-facilitated protocol allowed most patients to bypass the incremental dose-escalation phase required by conventional OIT.

Safety and Follow-Up Outcomes With Omalizumab-Facilitated OIT


Omalizumab-facilitated OIT pairs a short course of omalizumab pretreatment with oral immunotherapy, raising the threshold for allergic reactions before food dosing begins.

How effective was direct initiation at maintenance dosing in this cohort?


Patients tolerated 94% (181 of 193) of initiation challenges after a median of 12 weeks of omalizumab pretreatment, and 84% started at target maintenance doses for all foods.


The most common adverse events were abdominal pain (23%) and oral pruritus (13%), with 2 patients discontinuing therapy because of adverse events.

During median follow-up of 27.6 weeks (IQR, 18.1-41.1 weeks), 39 patients (40%) reported ≥ 1 adverse event.¹ The most common events were abdominal pain, reported by 23% of patients, and oral pruritus, reported by 13%. In total, 2 patients discontinued OIT because of adverse events.

Among patients who met criteria for omalizumab discontinuation, median treatment duration was 26.3 weeks (IQR, 20.7-36.4 weeks). Investigators characterized the overall safety profile as acceptable, with treatment discontinuation uncommon across the cohort.

Abdominal pain and oral pruritus are commonly reported with OIT dose escalation, and their frequency in this cohort was consistent with expectations for a multi-food regimen. Omalizumab has an established safety profile across its approved indications, including IgE-mediated food allergy, moderate-to-severe asthma, chronic urticaria, and chronic rhinosinusitis with nasal polyps.² The low discontinuation rate observed here suggests the direct-to-maintenance approach did not introduce new tolerability concerns beyond those seen with standard OIT.

“This approach may reduce treatment burden while maintaining an acceptable safety profile,” investigators concluded.

A separate randomized trial found omalizumab produced significantly greater treatment success than omalizumab-facilitated multiallergen oral immunotherapy (MOIT) in patients with multifood allergy, per stage 2 results from the OUTMATCH trial.³ Among 117 participants with peanut allergy and ≥ 2 additional food allergies, omalizumab was superior to MOIT for the primary endpoint of cumulative tolerated dose in the intention-to-treat population (36% vs 19%; odds ratio, 2.6; 95% CI, 1.1-6.3; 

 =.03). This difference narrowed in the per-protocol population, reflecting a substantially higher discontinuation rate in the MOIT arm (49%) compared with omalizumab (12%).

MOIT also carried a heavier safety burden, with more serious adverse events (31% vs 0%), epinephrine-treated reactions (37% vs 7%), and events meeting anaphylaxis criteria (27% vs 2%) compared with omalizumab.³

"Both treatments can be effective, and both will provide protection from small exposures and even the ability to start eating the food directly," Robert A. Wood, MD, professor of pediatrics, Johns Hopkins University School of Medicine, told 

.³ "The biggest difference we found was the side effects from oral immunotherapy were such a far larger group of patients really couldn't tolerate the therapy.”

Shannon CM, Kennedy KL, Lee J, Hanna E, Spergel J, Cianferoni A. Omalizumab-facilitated oral immunotherapy with direct initiation at maintenance dosing for most foods. 

Smith T. FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults. HCPLive. Published February 16, 2024. Accessed August 7, 2026. 

https://www.hcplive.com/view/fda-approves-omalozumab-first-treatment-of-1-or-more-food-allergies-for-children-adults

Wood R. Omalizumab Outperforms Oral Immunotherapy for Multifood Allergy. HCPLive. Published July 29, 2026. Accessed August 7, 2026. 

https://www.hcplive.com/view/omalizumab-outperforms-oral-immunotherapy-multifood-allergy

A prospective cohort of 100 pediatric and young adult patients with multifood allergy used ≥8 weeks of omalizumab pretreatment to enable oral immunotherapy initiation largely at maintenance dosing. After a median 12-week pretreatment, 94% of 193 two-dose initiation challenges were tolerated; 97% began daily dosing for at least one food, and 84% reached maintenance across all foods. Over ~28 weeks’ follow-up, adverse events were typical for OIT and rarely led to discontinuation. Separate randomized data favored omalizumab over multiallergen OIT due to tolerability.

A prospective cohort study found 94% of patients tolerated direct initiation at maintenance OIT dosing after brief omalizumab pretreatment.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Food Allergy

Omalizumab-Facilitated OIT Enables Maintenance Dosing in Food Allergy

• Socrodeucitinib 12 mg once daily achieved PASI 75 in 72.1% of patients at week 12 versus 7.5% with placebo (

 <.001).
• Responses were dose-dependent across PASI 50, PASI 90, PASI 100 and sPGA 0/1 outcomes, all statistically significant versus placebo at 12 mg.
• Adverse events were more common with socrodeucitinib, most frequently upper respiratory tract infection, but serious adverse events and discontinuations were infrequent.
• No deaths, major adverse cardiovascular events, malignancies or clinically meaningful laboratory abnormalities were reported.
• The 12 mg once-daily dose has advanced into an ongoing phase 3 trial (NCT06672393).

Socrodeucitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, achieved significantly higher rates of psoriasis area and severity index (PASI) 75 response at Week 12 compared with placebo in a phase 2 randomized trial of individuals with 

Journal of the European Academy of Dermatology and Venereology

TYK2 inhibitors have emerged as a differentiated oral option in the systemic psoriasis landscape, positioned as more selective than JAK1/2/3 inhibitors, which carry boxed warnings for cardiovascular events, malignancy and infection. Deucravacitinib and TAK-279 previously demonstrated the clinical potential of pseudokinase-directed TYK2 inhibition, and socrodeucitinib (HS-10374) adds phase 2 data supporting a 12 mg once-daily dose ahead of an ongoing phase 3 program.²

Socrodeucitinib Trial Design and PASI 75 Results

The phase 2, randomized, double-blind, placebo-controlled trial enrolled 125 patients across 38 centers in China between September 2023 and April 2024. Patients were stratified by prior biologic use and randomized 1:1:1 to receive oral socrodeucitinib at 6 mg, 12 mg or placebo once-per-day for 12 weeks.

Eligible adults were 18 to 70 years old with plaque psoriasis for 6 months or longer, a static Physician's Global Assessment (sPGA) score of 3 or higher, a PASI score of 12 or higher and body surface area involvement of 10% or greater. Baseline characteristics were balanced across arms, with a mean PASI score of 20.0 and 26.4% of patients previously treated with a biologic agent.

At Week 12, PASI 75 was achieved by 72.1% of patients on the 12 mg dose and 28.6% on the 6 mg dose, compared with 7.5% on placebo (12 mg, 

 = .013). The proportion difference versus placebo was 65.2 percentage points at the 12 mg dose (95% CI, 50.07-80.34) and 21.2 percentage points at the 6 mg dose (95% CI, 5.47-36.96). Responses emerged as early as Week 4 and were sustained through Week 12 at both doses.

Socrodeucitinib Secondary Endpoints and Safety Profile

Secondary endpoints tracked the primary result at the 12 mg dose. PASI 90 was achieved by 46.5% of patients versus 0% on placebo (P <.001), and PASI 100 by 11.6% versus 0% (

PASI 50 was reached by 81.4% versus 20.0% on placebo (

 <.001), and an sPGA score of 0 or 1 by 65.1% versus 10.0% on placebo (

 <.001). Dermatology Life Quality Index scores improved by a least-squares mean of 6.9 points at the 12 mg dose versus 0.2 points on placebo (

 <.001), with separation from placebo apparent by Week 4.

Adverse events occurred in 88.4% of patients on the 12 mg dose, 76.2% on the 6 mg dose and 70.0% on placebo, with most graded mild to moderate. Upper respiratory tract infection was the most frequent adverse event and showed a dose-dependent pattern, occurring in 23.3% of patients on the 12 mg dose versus 16.7% on the 6 mg dose and 7.5% on placebo.

Serious adverse events were infrequent, reported in one patient on placebo and one on the 6 mg dose, with none on the 12 mg dose. No deaths, major adverse cardiovascular events, thromboses or malignancies were reported, and laboratory parameters showed no clinically meaningful abnormal trends versus placebo.

Based on the efficacy and exposure-response findings, the 12 mg once-daily dose has been selected for an ongoing phase 3 trial (NCT06672393) in patients with moderate to severe plaque psoriasis.

Han L, Geng S, Ding Y, et al. A randomized phase 2 trial of socrodeucitinib in moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol. 2026;00:1-9. 

Chinese Clinical Trial Registry. A randomized, double-blind, placebo-controlled, phase 2 study of socrodeucitinib in patients with moderate to severe plaque psoriasis. CTR20232241. Accessed August 7, 2026.

Socrodeucitinib, an oral TYK2 inhibitor, demonstrated dose-dependent clinical activity in moderate-to-severe plaque psoriasis over 12 weeks in a multicenter China-based phase 2 trial. PASI 75 responses were substantially higher with 12 mg once daily versus placebo, with separation by Week 4 and sustained benefit through Week 12. Higher-stringency endpoints (PASI 90/100), sPGA 0/1, and DLQI improvements similarly favored 12 mg. Adverse events were mostly mild-to-moderate, with dose-related upper respiratory tract infections and no observed MACE, thrombosis, malignancy, or deaths.

Oral socrodeucitinib 12 mg significantly improved PASI 75 and sPGA responses versus placebo at Week 12 in a 125-patient phase 2 trial.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Socrodeucitinib Meets Primary Endpoint in Phase 2 Psoriasis Study

Marc Bonaca, MD, MPH, is the executive director at CPC Clinical Research, director of vascular research at the University of Colorado Anschutz, and a cardiologist with Brigham and Women’s Hospital and the VA Boston Healthcare System.

The phase 3 VESALIUS-CV trial has shown that evolocumab protects against cardiovascular disease in at-risk patients with 

 prior to screening, hinting at a new treatment pathway for cardiovascular disease.

VESALIUS-CV: Evolocumab Prevents Cardiovascular Disease in High-Risk Diabetes

These data were discussed at the American Society for Preventive Cardiology (ASPC) 2026 Congress on Cardiovascular Disease Prevention in Scottsdale, Arizona, by Marc Bonaca, MD, MPH, executive director at CPC Clinical Research, director of vascular research at the University of Colorado Anschutz, and a cardiologist with Brigham and Women’s Hospital and the VA Boston Healthcare System.

“VESALIUS moved backwards in terms of risk,” Bonaca told 

 in an exclusive interview. “It included patients who were either at high risk without known 

, or those who had it but who had not yet had an event. VESALIUS really asked the question of whether PCSK9 inhibition benefits patients who are at high risk or have the disease but haven’t yet experienced an event.”

VESALIUS-CV was a double-blind, randomized, placebo-controlled, multicenter phase 3 study examining evolocumab’s impact on MACEs in patients at high cardiovascular risk without prior MI or stroke. The study was conducted across 852 locations worldwide and ultimately enrolled over 6000 patients. To be eligible for inclusion, patients needed to be ≥50 years (men) or ≥55 years (women) and <80 years and have LDL-C ≥90 mg/dL, non-HDL-C ≥120 mg/dL, or apolipoprotein B ≥80 mg/dL. Additionally, patients were required to meet ≥1 of the following at screening:

Significant coronary artery disease (CAD)

Significant atherosclerotic cerebrovascular disease

Patients were excluded from the trial if they had experienced an MI or stroke prior to randomization, had undergone coronary artery bypass grafting (CABG) <3 months before surgery, or eGFR <15 mL/min/1.73m

, among other criteria. The primary outcomes were the number of patients experiencing coronary heart disease (CHD), MI, or ischemic stroke, whichever occurred first, as well as the number of patients experiencing CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurred first.

The team ultimately enrolled 6002 patients with high-risk diabetes. Of these, 67% were on a high-intensity statin, and 24% were on an SGLT2 inhibitor or a GLP-1 receptor agonist at baseline. Median LDL-C at 48 weeks was 47 mg/dL and 109 mg/dL in the evolocumab and placebo arms, respectively (

Following a median follow-up of 4.6 years, evolocumab was found to have decreased the relative rates of 3-point MACE and 4-point MACE by 29% (HR, 0.71; 95% CI, 0.59-0.86; 

 = .0004) and 21% (HR, 0.79; 95% CI, 0.69-0.91; 

 = .0013), respectively. Additionally, these findings were consistent irrespective of the presence or absence of atherosclerosis, baseline LDL-C, statin treatment intensity, and SGLT2 inhibitor or GLP-1 RA use. Investigators noted that the proportion of patients with all-cause mortality was 8.8% in the evolocumab arm versus 11% in the placebo arm (HR, 0.79; 95% CI, 0.67-0.93).

Ultimately, investigators concluded that evolocumab effectively reduced the rate of cardiovascular events in this patient cohort, regardless of the background use of other protective agents or the presence or absence of qualifying atherosclerosis.

“The field is shifting as we become much more sophisticated about understanding atherosclerosis,” Bonaca said. “If you think about it, for cancer screenings, we don’t wait for people to become symptomatic to treat them, and we don’t treat them based on guessing whether or not they have disease. We image – we conduct colonoscopies, mammograms, biopsies, and we treat accordingly. And for the number one killer in the world, cardiovascular disease, we now have tools that allow a much more sophisticated approach.”

Editors’ Note: Bonaca reports disclosures with Abbott, Amgen, BMS, Merck, NovoNordisk, Sanofi, and others.

Leiter LA, Giugliano RP, Marston NA, et al. Evolocumab in patients with high-risk diabetes: Results from the vesalius-CV trial. Diabetes Care. 2026;49(8):1366-1373. 

Amgen. Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV). ClinicalTrials.gov Identifier: NCT03872401. Updated June 25, 2026. Accessed 

https://clinicaltrials.gov/study/NCT03872401

Videos

The phase 3 trial of evolocumab showed cardioprotective effects in patients without prior MI or stroke, regardless of qualifying atherosclerosis or background therapy.

Structural Heart Disease

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

A new BEACON-HCC framework for liver cancer treatment matched expert decisions 96.6% of the time in a pilot study, outperforming BCLC 2025.

New Liver Cancer BEACON-HCC Framework Shows 96.6% Concordance in Pilot

Stacey Rifkin-Zenenberg, DO, is a Pediatric Hematologist Oncologist in Hackensack, NJ. She has 30 years of experience and is board certified in Hospice Care and Palliative Medicine.

Stacey Rifkin-Zenenberg, DO, on early gene therapy outcomes and the long-term questions still being tracked in sickle cell disease.

Strategic Alliance Partnership

After Sickle Cell Gene Therapy, What Comes Next?

Examining individual pregnancy outcomes rather than defining women by the presence or absence of complications more reliably predicts later CVD death.

Adverse Pregnancy Outcomes as a Predictor of Cardiovascular Disease Mortality

Roxana Daneshjou, MD, PhD, is a board-certified dermatologist and physician-scientist who serves at Stanford University as an assistant professor in both the Department of Biomedical Data Science and the Department of Dermatology.

A Stanford dermatologist explains how AI systems can reinforce racial bias in health care and underperform on skin cancer detection in darker skin.

Podcasts

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Does Artificial Intelligence Worsen Health Care Disparities?

Elizabeth Spencer, MD, MS, is an assistant professor of pediatrics in the division of pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai and at the Mount Sinai Kravis Children’s Hospital.

PFAS found in cord blood linked to childhood gut inflammation and IBD risk; Elizabeth Spencer, MD, explains what it means for patients.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

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On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

"Forever Chemicals" Are in Cord Blood And Tied to Gut Inflammation in Kids

In RESOLVE-Lung, the anti-GM-CSF antibody namilumab did not reduce rescue events or improve lung function versus placebo in chronic pulmonary sarcoidosis.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Namilumab Fails to Meet Primary End Point in Pulmonary Sarcoidosis

A more precise, endotype-driven understanding of bronchiectasis, paired with an expanding treatment pipeline, is reshaping expectations for what long-term disease control can look like.

Video Series

The Future of Bronchiectasis Care: Precision Medicine Ahead

Turning new bronchiectasis guidelines into everyday practice demands more than awareness, requiring hands-on familiarity with unfamiliar therapies and dedicated staff to share the treatment burden.

Bringing Bronchiectasis Guidelines Into Everyday Practice

Additional DPP1 inhibitors in development show early promise, even as persistent gaps in physician education and validated biomarkers continue to limit optimal bronchiectasis care.

Emerging DPP1 Inhibitors and Closing the Education Gap in Bronchiectasis

With multiple therapeutic classes now available, sequencing macrolides, DPP1 inhibitors, and emerging antibody therapies requires weighing safety, cost, and each patient's underlying disease drivers.

Latest News

Tirzepatide Demonstrates Cardioprotective Effects in T2D With ASCVD

Phase 3 Dermatomyositis Trial Sees Brepocitinib Meet Primary Endpoint

Omalizumab-Facilitated OIT Enables Maintenance Dosing in Food Allergy

Socrodeucitinib Meets Primary Endpoint in Phase 2 Psoriasis Study

VESALIUS-CV: Evolocumab Prevents Cardiovascular Disease in High-Risk Diabetes