Arterial thrombosis

CHAPEL HILL, N.C., March 18, 2025 /PRNewswire/ -- SonoVascular, Inc., a clinical stage medical device company focused on bringing to market its SonoThrombectomy™ System for venous thromboembolism (VTE), a novel treatment solution intended to provide better outcomes for millions of patients suffering from deep vein thrombosis (DVT) and pulmonary embolism (PE), has successfully completed an initial set of eight cases in patients with DVT in its First-In-Human (FIH) study. DVT is a condition that occurs when blood clots form in the deep veins of the leg, restricting blood flow back to the heart and causing pain and swelling. Additionally, if part of the clot breaks off it can travel through the bloodstream to the lungs, causing a PE which can be life threatening. To treat these conditions, the SonoThrombectomy System delivers ultrasound energy and microbubbles directly to the clot through the RESONATOR™ Catheter, inducing microbubble-mediated cavitation, which mechanically breaks down the clot. Additionally, a very low dose of tPA is infused in combination with the microbubbles through the catheter to further improve clot breakdown. The System is designed to treat VTE more safely and effectively, and at a lower cost to the health care system than currently approved therapies. SonoThrombectomy treatment was highly effective in the first eight cases of the FIH study, as all cases achieved a complete (100%) Marder score reduction as assessed by an independent core laboratory. Additionally, significant improvements from baseline in Villalta score, revised Venous Clinical Severity Score, and Numeric Pain Rating Scale scores were observed at 30-day follow-up, and there were no device-related adverse events, major bleeding, or deaths. "We are very encouraged by the initial cases in our FIH clinical study." said Daniel Estay, Founder and Chief Executive Officer of SonoVascular. "Thus far, our investigators have observed complete thrombus resolution, no blood loss, and no evidence of adverse affects on the vein wall or venous valves or other safety concerns. Enrollment in the FIH study is ongoing and planned to be completed by the end of Q2 2025. We are honored that Dr. William Marston presented our initial clinical findings at the 2025 annual meeting of the American Venous Forum on February 19th in Atlanta, Georgia." William Marston, MD, Professor of Surgery at the University of North Carolina at Chapel Hill School of Medicine and Past President of the American Venous Forum, remarked: "The results obtained thus far in SonoVascular's FIH study demonstrate the SonoThrombectomy System has the potential to become a disruptive technology that would effectively overcome the shortcomings of available therapies for the treatment of DVT. As a vascular surgeon and researcher who has treated patients suffering from DVT for over 25 years, I find that despite improvements in our ability to treat these patients, currently available devices still have significant challenges and limitations. In the initial cases, the SonoThrombectomy System has demonstrated its ability to eliminate intravenous clot in a single treatment session with no blood loss and with preservation of venous valves. The System is not limited by the presence of previously implanted filters or stents and is highly steerable for treatment of specific areas of residual thrombus. These initial cases suggest that the SonoThrombectomy System is able to eliminate clot with a gentler approach that does not cause blood loss and preserves vessel and valve integrity. This System has the potential to be a revolutionary technology and address critical limitations with current interventional devices and techniques for treatment of DVT." About Venous Thromboembolism Venous thromboembolism is a condition that occurs when a blood clot forms in a vein. As many as 900,000 VTE events occur each year in the United States.1 VTE includes DVT and PE. DVT occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh or pelvis. The most serious complication of DVT happens when a part of the clot breaks off and travels through the bloodstream to the lungs, causing a blockage called PE. If the clot is large, it can stop blood from reaching the lungs and can be fatal. One-third to one-half of people who have a DVT will have long-term complications caused by damage to the valves in the vein called post-thrombotic syndrome (PTS).2 In some cases, PTS symptoms can be so severe that a person becomes disabled. PE can be life-threatening, with 10-30% of individuals dying within one month of diagnosis.3 About SonoVascular, Inc. SonoVascular is a clinical-stage medical device company that has developed the SonoThrombectomy system. SonoThrombectomy is a novel and highly differentiated ultrasound facilitated, thrombolytic enhanced thrombectomy system for venous and arterial thrombosis that utilizes microbubble-mediated cavitation as a core enabling mechanical mechanism of action to more safely and effectively treat VTE. It is a cathlab-based solution designed to maximize the reduction of clot burden, eliminate blood loss and vessel trauma, and harness the benefit of low dose/duration thrombolytic without bleeding risks. SonoVascular is headquartered in Chapel Hill, NC. For more information, visit . Contact: SonoVascular, Inc. Daniel Estay Founder and Chief Executive Officer [email protected] 1 Gregson J, Kaptoge S, Bolton T, et al. Cardiovascular Risk Factors Associated With Venous Thromboembolism. JAMA Cardiol. 2019;4(2):163–173. doi:10.1001/jamacardio.2018.4537. 2 Wendelboe AM, Campbell J, McCumber M; Bratzler D; Ding K, Beckman M, Reyes N; Raskob G. The Design and Implementation of a New Surveillance System for Venous Thromboembolism using Combined Active and Passive Methods. American Heart Journal. 2015. 3 American Lung Association; SOURCE SonoVascular, Inc. 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Late-breaking results presented at AAD show 80% or more scalp hair coverage at Week 36 in 42.4% of adolescents receiving baricitinib 4 mg Patients treated with baricitinib 4 mg saw significant regrowth of eyebrows and eyelashes at Week 36 compared to placebo Positive data underscore Lilly's continued expansion across dermatologic conditions, with treatments that can improve outcomes for patients with the greatest need INDIANAPOLIS, March 8, 2025 /PRNewswire/ -- Late-breaking results from Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) found adolescent patients (ages 12 to under 18) with severe alopecia areata (AA) treated with once-daily, oral baricitinib 4 mg and 2 mg saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows and eyelashes at Week 36. Findings from the Phase 3 BRAVE-AA-PEDS study were presented in a late-breaker presentation at the American Academy of Dermatology (AAD) Annual Meeting taking place March 7-11 in Orlando.1 AA is an immune system condition that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress over time. Approximately 40% of patients with AA experience first onset by 20 years of age.2 "Early onset alopecia areata can be more severe, leading to extensive hair loss that frequently does not improve with topicals or corticosteroids often prescribed as first-line therapy," said Brittany Craiglow, M.D., Adjunct Associate Professor of Dermatology, Yale School of Medicine. "These initial results are exciting because they demonstrate that baricitinib can provide significant hair regrowth for adolescents at 36 weeks, a promising early signal of baricitinib's potential as an effective treatment for adolescents with severe disease." In the BRAVE-AA-PEDS study, 257 patients were randomized to receive once-daily baricitinib 4 mg, baricitinib 2 mg or placebo. The primary endpoint of this study was a Severity of Alopecia Tool (SALT) score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. At the start of the study, patients had an average of 89% scalp hair loss (near total hair loss), 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3) and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3).1 At Week 36: 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg saw at least a 50% improvement in their disease (as measured by SALT score) compared to 5.7% on placebo (p=0.001). 42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo (p=0.001). 36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage (SALT ≤10), compared to 2.3% on placebo (p=0.001). 50.0% of patients receiving baricitinib 4 mg and 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline) compared to 0% on placebo (p<0.01). 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth, and 25.5% receiving baricitinib 2 mg saw improved eyelash regrowth, compared to 14.0% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg).1 Results achieved by adolescents at 36 weeks were comparable to results achieved by adults after 52 weeks of treatment, suggesting that hair regrowth may be faster in adolescents compared to adults.1 In the BRAVE-AA1 and BRAVE-AA2 studies, 40.9% of adult patients treated with baricitinib 4 mg and 21.2% of patients treated with baricitinib 2 mg achieved 80% or more scalp hair coverage at Week 52.3 "With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families," said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. "We are excited about these initial results, which show baricitinib can provide significant scalp hair regrowth in adolescents, potentially at an even faster rate compared to adults. We look forward to sharing longer-term data results at upcoming congresses and discussing findings with global regulators in the months ahead." The most common treatment-emergent adverse events in BRAVE-AA-PEDS included acne, influenza and upper respiratory tract infection. A higher frequency of serious adverse events was seen in the placebo group compared to baricitinib groups. No deaths, opportunistic infections, major adverse cardiovascular events, venous thromboembolic events or malignancies were reported in the trial.1 The safety profile of baricitinib in adolescents with AA was consistent with the safety profile seen in clinical trials for adolescent patients with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis. Over 14,600 patients have received baricitinib in clinical trials; of these, 866 have been patients between the ages of >1 month to <18 years. Lilly will present additional data from the BRAVE-AA-PEDS study at scientific meetings later this year and submit the results for peer-reviewed publication. Baricitinib is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. In 2022, the U.S. Food and Drug Administration (FDA) approved baricitinib (commercially available as Olumiant) for adult patients with severe AA, making it the first systemic treatment approved in the U.S. for severe disease. Baricitinib is also approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis, in more than 40 countries for the treatment of patients down to the age of two with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in Europe and Japan for adult patients with severe AA. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for baricitinib in multiple countries. About BRAVE-AA-PEDS Study BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase 3 trial involving children ages 6 to under 18 years with severe AA, as measured by a Severity of Alopecia Tool (SALT) score of ≥50 (i.e., who had ≥ 50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. Adolescent participants were randomized in a 1:1:1 ratio to receive once-daily placebo, baricitinib 4 mg or baricitinib 2 mg. The first cohort of patients enrolled included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The next cohort of children ages 6 to under 12 will begin enrollment in the next year. An additional cohort of adolescents were randomized 1:1 to baricitinib 4 mg or baricitinib 2 mg. IMPORTANT SAFETY INFORMATION FOR OLUMIANT (BARICITINIB) TABLETS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include: Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use. Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral, and other infections due to opportunistic pathogens. Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered. Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant. MORTALITY In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant. MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. MAJOR ADVERSE CARDIOVASCULAR EVENTS In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction [MI], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur. THROMBOSIS Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis. HYPERSENSITIVITY Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction. GASTROINTESTINAL PERFORATIONS Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation. LABORATORY ABNORMALITIES Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3. Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3. Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL. Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded. Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia. VACCINATIONS Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines. ADVERSE REACTIONS In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster. In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection. In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase. PREGNANCY AND LACTATION Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose. HEPATIC AND RENAL IMPAIRMENT Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2). Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2. Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide. BA HCP ISI ALL 13JUN2022 About Olumiant Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. FDA approval was granted for Olumiant for the treatment of certain hospitalized adult patients with COVD-19 in May 2022. Marketing authorization for Olumiant in COVID-19 has been granted in six other countries including Japan and Switzerland. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. See the full Prescribing Information here.4 In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Olumiant (baricitinib) as a treatment for alopecia areata and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that Olumiant will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release. References: 1Passeron T, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 36-week efficacy and safety results from a Phase 3 randomized, controlled trial. American Academy of Dermatology Annual Meeting. March 7-11, 2025. 2 Alopecia areata. National Alopecia Areata Foundation website. . Last accessed March 3, 2025. 3 King B, et al. Two Phase 3 trials for baricitinib in alopecia areata. N Engl J Med. 2022;386:1687-1699 DOI: 10.1056/NEJMoa2110343. 4 Olumiant. Prescribing Information. Lilly USA, LLC. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

THURSDAY, Feb. 13, 2025 -- The most common formulation of birth control pills has been linked to a doubling of relative risk of heart attack and stroke , a new study finds. Contraceptive vaginal rings and skin patches formulated in the same way were also linked to higher heart risks. Danish researchers stressed that the absolute risk to any one woman using these pills, patches or rings remains very low. However, they said the findings are something for doctors to think about as they prescribe contraceptives. The pill formulation in question is a combination of the hormones estrogen plus progestin, the team reported Feb. 12 in The BMJ . It's the most-prescribed type of hormonal contraception. “Although absolute risks were low, clinicians should include the potential risk of arterial thrombosis [blood clots] in their assessment of the benefits and risks when prescribing hormonal contraceptive method," wrote researchers led by Dr. Harman Yonis . He's with the Department of Cardiology at Nordsjaellands Hospital in Hilleroed, Denmark. According to the research team, an estimated 250 million women worldwide are thought to use some form of hormonal contraception. Prior research has linked this form of birth control to heightened cardiovascular risk, but findings have varied study-to-study. The new study involved a deep dive into national prescription records for more than 2 million Danish women, who were tracked from 1996 through 2021. They ranged in age from 15 to 49. Contraceptives included estrogen-progestin pills, vaginal rings, patches, progestin-only pills, intrauterine devices (IUDs), under-the-skin implants and intramuscular injections. Yonis' team compared the use of each woman's contraceptive of choice (or no use) against their history (if any) of first-time heart attack and ischemic stroke. (Ischemic strokes, the most common form of stroke, are caused when a clot blocks a vessel supplying blood to the brain). The study did not include women who'd already experienced a blood clot, or those with cancer, liver disease, kidney disease, polycystic ovary syndrome, endometriosis or infertility treatment; as well as those who used psychiatric medications or hormone therapy, or who had undergone a hysterectomy. After accounting for factors such as age, education level and existing conditions such as high blood pressure and diabetes , the team found that women taking the combo estrogen/progestin pill had double the relative risk of an ischemic stroke or heart attack. However, each woman's absolute risk remained low: Use of the estrogen/progestin pill translated to one extra stroke for every 4,760 women using the pill for one year, and one extra heart attack for every 10,000 women per year of use, the researchers noted. Pills and implants that contained progestin only also raised a woman's risk for stroke and heart attack, but only slightly and less than the combination pill. The risk was highest for vaginal rings and skin patches containing the estrogen/progestin combination. These devices raised a woman's risk for ischemic stroke by 2.4-fold and heart attack by 3.8-fold, the team found. Dual-hormone skin patch contraceptives increased ischemic stroke risk by 3.4-fold, according to the study. Only one form of hormonal contraception showed no rise in cardiovascular risk: The progestin-only IUD, which seemed safe even over an extended period of use. Yonis' team stressed that the study was observational in nature, meaning it was not designed to prove that any of the contraceptives caused a rise in heart risks. It could only point to associations. In a linked journal editorial , Therese Johansson, of the Swedish Institute of Technology, stressed that the risk to any one user of hormonal contraceptives remains very low. However, since hundreds of millions of women worldwide use these pills and devices, the study findings remain important. Any effort to improve the safety of contraception is therefore welcome, Johannson said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.