Check out “What’s New in Research” to find out about discoveries and advancements from Brigham researchers. This month, we feature new research from Brigham researchers on reducing cardiovascular risk among people with rheumatoid arthritis, findings on a drug that benefits patients with heart failure with improved ejection fraction, interventions to treat and reduce costs associated with spine pain, and more.
Randomized Trial Finds Therapies for Spine Pain Improved Disability and Quality of Life But Did Not Decrease Healthcare Spending
Pain in the back or the neck is extremely common and accounts for more healthcare spending than any other health condition. A study led by investigators from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, compared two non-invasive interventions for treating spine pain, assessing both how well these methods worked at reducing pain and whether either method reduced spine-related healthcare spending. In a clinical trial of 2,971 participants, patients with spine pain were randomized to receive usual care or one of two interventions. The first intervention used the identify, coordinate and enhance (ICE) model, in which patients receive specialized counseling, physical therapy and a specialist in pain medicine or psychiatry consults with their primary care physician. The second intervention was individualized postural therapy (IPT), a technique that attempts to realign and rebalance spinal muscles to relieve pain. Compared to usual care, both interventions provided a small but significant improvement in pain-related disability after three months. These changes were sustained and clinically meaningful at 12 months, long after the interventions were over. Both interventions reduced resource utilization (such as diagnostic imaging, procedures, and specialist visits). Overall, the ICE intervention lowered spine-related spending by $139 per person compared to usual care (p=0.04), although this difference was not statically significant at the threshold used in the trial. Spine-related spending for the IPT intervention was significantly higher than usual care.
“Both methods examined in this clinical trial led to small but meaningful reductions in pain-related disability,” said corresponding author Niteesh Choudhry, MD, PhD, executive director for BWH’s Center for Healthcare Delivery Sciences and a practicing hospitalist. “Given the high cost of spine-related healthcare spending, it is critically important to find cost-effective ways to effectively improve pain management.”
Read more in JAMA.
Study Finds that Patients with Heart Failure with Improved Ejection Fraction Benefit from the SGLT2 Inhibitor Dapagliflozin
With modern therapies for heart failure (HF) with reduced ejection fraction (HFrEF), some patients can improve their cardiac function during treatment. But despite this improvement in the ability of their hearts to pump, these patients with so called heart failure with improved ejection fraction (HFimpEF) remain at high risk for adverse outcomes. Unfortunately, they have been excluded from virtually all clinical trials in heart failure and there has been little evidence about how best to improve clinical management for this growing patient population. Researchers from Brigham and Women’s Hospital, a founding member of Mass General Brigham, and collaborators from the University of Minnesota and University of Glasgow have conducted an analysis that suggests that this patient population may further benefit from initiation of the SGLT2 inhibitor dapagliflozin, a heart failure medication that has received attention after presentations earlier this year on data from the randomized, controlled DELIVER clinical trial. In a prespecified analysis of data from the DELIVER trial, researchers looked at outcomes for 1,151 patients with HFimpEF and found that dapagliflozin reduced the primary composite outcome, first worsening heart failure events, cardiovascular death and total worsening heart failure events.
“These are essentially the first large-scale randomized outcomes data in patients with heart failure and improved ejection fraction,” said co-corresponding author Scott D. Solomon, MD, of the BWH Division of Cardiovascular Medicine. “As current therapy of heart failure with reduced ejection fraction gets better, and more and more patients show improvement, this group is becoming larger. These data suggest that addition of an SGLT2 inhibitor can benefit these patients and should inform treatment decision-making.”
Read more in Nature Medicine.
Trial Compares Therapies for Reducing Cardiovascular Risk Among People with Rheumatoid Arthritis
People with rheumatoid arthritis (RA) are at increased risk of cardiovascular (CV) disease, with studies indicating an approximate 50 percent increase in risk of CV events such as heart attack and stroke. Some immunomodulators—drugs that decrease inflammation—have been shown to reduce CV risk in the general population. Researchers from Brigham and Women’s Hospital and Columbia University Irving Medical Center led a consortium that conducted a randomized clinical trial among people with rheumatoid arthritis to assess the impact of two anti-inflammatory strategies. All 115 patients in the trial had moderate or high disease activity despite being on low-dose methotrexate. Participants continued to take methotrexate and were randomized to additionally receive a TNF inhibitor (TNFi) or hydroxychloroquine and sulfasalazine (triple therapy). Both groups had statistically significant reductions in disease activity and in arterial inflammation, with no differences noted between the groups.
“Our results highlight the importance of conducting clinical trials specifically among patients with RA rather than the general population,” said corresponding author Daniel H. Solomon of the Division of Rheumatology, Inflammation and Immunology. “Prior trials in the general population have shown differential effects on CV risk between different immunomodulators, but in our trial, two different immunomodulator treatment strategies produced similar reductions in CV risk.”
The research was supported by the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases under award number U01AR068043.
Read more in Annals of Rheumatic Diseases.