Tufts University

WEDNESDAY, Jan. 8, 2025 -- Overall, 9.8 percent of all incident type 2 diabetes (T2D) cases and 3.1 percent of incident cardiovascular disease (CVD) cases were attributable to sugar-sweetened beverages (SSBs) worldwide in 2020, according to a study published online Jan. 6 in Nature Medicine . Laura Lara-Castor, Ph.D., from Tufts University in Boston, and colleagues incorporated data from the Global Dietary Database to estimate SSB-attributed T2D and CVD burdens across 184 countries in 1990 and 2020 globally, regionally, and nationally. The researchers found that in 2020, 2.2 and 1.2 million new T2D cases and CVD cases, respectively, were attributable to SSBs worldwide, representing 9.8 and 3.1 percent of all incident cases, respectively. Proportional SSB-attributable burdens were higher globally among men than women, for younger than older adults, for higher- than lower-educated adults, and in urban versus rural areas. The highest SSB-attributable percentage burdens were in Latin America and the Caribbean (24.4 percent for T2D and 11.3 percent for CVD) and sub-Saharan Africa (21.5 and 10.5 percent for T2D and CVD, respectively) by world region. Sub-Saharan Africa had the largest proportional increases in SSB-attributable incident T2D and CVD from 1990 to 2020 (+8.8 and +4.4 percent, respectively). "These findings emphasize the need for targeted interventions, accounting for social inequities and aligned with global health objectives," the authors write. "While some policies to curb SSB intakes are currently in place in some countries, our study suggests that more work is needed." Several authors disclosed ties to the pharmaceutical and health technology industries. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

AUSTIN, Texas--( BUSINESS WIRE )-- Alleviant Medical, Inc. , a privately held medical device company pioneering a no-implant atrial shunt for heart failure, today announced two significant milestones from the U.S. Food and Drug Administration (FDA). The FDA has granted the company investigational device exemption (IDE) approval to begin a pivotal trial focused on patients with one of the most common forms of heart failure, reduced ejection fraction (HFrEF). The agency also designated the technology with breakthrough status for this patient population. The company’s novel atrial shunt technology, which leaves behind no permanent implant in the body, will now be investigated for patients with the full spectrum of heart failure - both reduced (HFrEF) and preserved ejection fraction (HFpEF), for which it already has FDA breakthrough designation. More than 26 million patients worldwide suffer from some form of heart failure. Alleviant Medical is the only company operating two pivotal trials informed by two prior sham-controlled atrial shunt trials and pursuing FDA approval across the broad spectrum of heart failure. The company has an ongoing global clinical trial in HFpEF, ALLAY-HF , and is now initiating ALLAY-HFrEF. ALLAY-HFrEF will be led by global principal investigators Dr. Gregg Stone and Dr. James Udelson. Dr. Stone serves as the Director of Academic Affairs and is Professor of Medicine and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York. Dr. Udelson serves as Chief of Cardiology and as Interim Chief Physician Executive of the CardioVascular Center at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine in Boston. “We are fortunate to have the results from a prior study that demonstrated substantial clinical benefits in high-risk HFrEF patients with an implanted permanent atrial shunt. These findings informed the design of the ALLAY-HFrEF trial, which is testing a novel device that creates an atrial shunt and leaves no permanent implant behind,” said Dr. Stone. The new trial will evaluate the safety and effectiveness of the Alleviant System in heart failure patients with reduced left ventricular ejection fraction (LVEF ≤ 40%), who remain symptomatic despite guideline-directed medical therapy (GDMT). The trial will have an adaptive design and will begin enrolling approximately 350 randomized patients at select sites globally in early 2025. “Despite progress in treatment options, chronic heart failure remains one of the greatest unmet clinical needs for millions of patients who suffer deeply and whose lives are often cut short by the condition,” said Dr. Udelson. “As we follow the science and expand the evidence base for patients with different ejection fractions, we have the potential to improve clinical outcomes as well as quality of life for millions.” With FDA’s pivotal trial approval and breakthrough designation for HFrEF, Alleviant Medical continues its mission of advancing evidence-based, breakthrough treatments to bring relief to heart failure patients globally. About Alleviant Medical, Inc. Alleviant Medical, Inc. is a privately held medical device company developing minimally invasive therapies to treat heart failure, collaborating with the top leaders in cardiovascular medicine to advance patient care. The Alleviant System has been granted U.S. FDA Breakthrough Device designation for both major forms of heart failure. The company is headquartered in Austin, Texas, and is backed by leading institutional and strategic investors. For more information, visit http://AlleviantMedical.com . Note: The Alleviant System is an Investigational Device and is limited by federal (or U.S.) law to investigational use. Exclusively for clinical investigation.

A Blue Cross Blue Shield licensee serving parts of Pennsylvania says it will not cover some therapies granted accelerated approval for at least 18 months after the FDA signs off. The policy from Independence Blue Cross, which went into effect on Wednesday, says that drugs, biologics or gene therapies granted accelerated approval are considered “a benefit contract exclusion for most plans.” The policy does not include cancer treatments or therapies that must be covered under state or federal mandates. Independence Blue Cross, which serves Philadelphia and parts of southeastern Pennsylvania, did not immediately respond to a request for comment. The umbrella Blue Cross Blue Shield group also did not respond to a request for comment, although Independence operates independently. Three other Blue Cross companies also serve Pennsylvania. No Patient Left Behind, an advocacy group run by doctors, investors and biotech executives, wrote on LinkedIn last week that the policy “should be revoked.” The decision from Independence is unique, but it’s not the first plan to impose coverage restrictions on accelerated approvals. CMS similarly restricted access to Biogen’s new Alzheimer’s drug Aduhelm in 2021, when it first won an accelerated approval, pushing plans away from coverage too. Accelerated approval is granted to treatments that provide an unmet need and suggest potential therapeutic benefit based on a surrogate endpoint or biomarker, like shrinking tumor size. An analysis from April 2024 found that 41% of cancer drugs that received an accelerated approval from 2013 to 2017 did not improve overall survival or quality of life in confirmatory studies after five years of follow up. Under the Biden administration, the FDA has made a more aggressive push to require companies to fully enroll confirmatory trials prior to receiving accelerated approval. Still, the agency has acknowledged that accelerated approvals will be common for gene therapies, especially if they’re treating rare populations that rely on surrogate signals. Peter Marks, director of the Center for Biologics Evaluation and Research, said in February 2024 that accelerated approval will be “the norm” for some gene therapy approvals. And to-date, the norm for insurers has been to cover these approvals, deferring to the FDA’s assessment of the data. A review from Tufts University last year found that “health plans frequently permit their enrollees’ access to [accelerated approval] drugs through coverage policies.” But they acknowledged that those insurers bear the financial risk to drugs that may ultimately not pan out. “Currently, payers lack the independence to deviate from FDA guidance on [accelerated approval] drugs, calling into question how potential program reform will impact payer behavior down the line,” the authors wrote last March. Editor’s note: A spokesperson for Independence Blue Cross directed Endpoints to a new webpage listing the policy.