Washington, D.C.—November 10, 2012
“What we have shown is that inflammatory and thrombotic proteins are elevated in aPL-positive patients and that statins can decrease these proteins,” said Doruk Erkan, MD, an associate attending rheumatologist and clinician researcher at Hospital for Special Surgery in New York City, who was one of the two main investigators in the study together with Silvia Pierangeli, Ph.D., at University of Texas Medical Branch, Galveston, Texas. The researchers note that statins would not be useful in treating individuals who are at risk for pregnancy loss because of aPLs—statins are contraindicated during pregnancy.
For years, researchers have known that aPLs can trigger the production of proteins that can cause inflammation and increase the risk of formation of clots. While some aPL-positive individuals develop blood clots, strokes, and pregnancy complications, others are perfectly healthy. Individuals who are aPL-positive and have either venous thrombosis, arterial thrombosis, or fetal loss are classified as having antiphospholipid syndrome (APS).
The new research was a collaborative effort between investigators at Hospital for Special Surgery and the University of Texas Medical Branch, Galveston, Texas. Investigators enrolled 41 patients who were aPL-positive, some of whom were healthy and some who had APS. They tested their blood for 12 inflammatory and thrombotic (clot forming) proteins, and then compared the results to data from 30 healthy patients who were aPL negative. These controls were matched for sex and age. Nine of the 12 proteins were elevated in aPL-positive patients compared to healthy controls.
The researchers then set out to test whether a statin called fluvastatin could reduce the proteins that were elevated in the individuals with aPLs. “Statins do more than just lowering cholesterol. They also have anti-inflammatory effects,” said Dr. Pierangeli. The 41 aPL-positive patients were given 40 mg of fluvastatin daily for three months and then were instructed to stop taking the drug. Investigators collected blood samples and measured the levels of the inflammatory and thrombotic proteins at baseline and monthly thereafter for six months.
Of the 24 patients who completed the study, the researchers found that fluvastatin significantly decreased the levels of eight of the 12 proteins, all of which had been elevated in aPL-positive individuals compared with controls. The investigators also found that when patients stopped taking the fluvastatin, the levels of six proteins rebounded to high levels.
“Following Dr. Pierangeli’s mouse experiments in which statins decreased inflammatory proteins induced by aPL, this is the first prospective study analyzing these proteins in aPL-positive patients before and after treatment with fluvastatin,” said Dr. Erkan. “Launching a randomized trial to determine the effect of statins on clinical outcomes is the logical next step.”
“An Open-Label Prospective Pilot Mechanistic Study of Fluvastatin in Persistently Antiphospholipid Antibody-Positive Patients” will be presented on Nov. 13 at 3 p.m. ET. Other authors involved in the study are JoAnn Vega from Hospital of Special Surgery; and Rohan Willis, M.D., Vijaya Murthy, M.D., Gurjot Basra, M.D., Emilio Gonzalez, M.D., Ana Laura Carrera Marin, and Patricia Ruiz Limon from the University of Texas Medical Branch, Galveston, Texas.
“Pro-inflammatory and Pro-thrombotic Markers in Persistently Antiphospholipid Antibody-Positive Patients With/Without Systemic Lupus Erythematosus” will be presented on Nov. 13 at 2:45 p.m., ET. Other authors involved in the study are JoAnn Vega from Hospital of Special Surgery; and Gurjot Basra, M.D., Rohan Willis, M.D., Vijaya Murthy, M.D., Shraddha Jatwani, M.D., Neha Dang, M.D., Ana Laura Carrera Marin, Patricia Ruiz Limon, and Emilio Gonzalez, M.D., from the University of Texas Medical Branch, Galveston, Texas.
About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S.News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.