Boston-area clinical trial will test pain medication for treatment of heart disease
BOSTON, Mass. – September 7, 2010 – An anti-inflammatory drug called salsalate, commonly given for arthritis pain, is being tested here to determine whether it can also help prevent cardiac disease. Steven Shoelson, M.D., Ph.D., and Allison Goldfine, M.D., who are affiliated with Joslin Diabetes Center and Harvard Medical School, are teaming up in translational research efforts taking laboratory observations into clinical study.
Salsalate, a generic drug that is chemically similar to aspirin but typically less prone to generate stomach complaints, is being studied after an odd twist of history.
“This research started with a finding made more than 140 years ago that seemed to have been forgotten about,” says Dr. Shoelson, whose lab at Joslin studies inflammation processes in the body. The report, by a 19th-century German doctor, gave interesting clues that a chemical with anti-inflammatory properties called sodium salicylate could aid in treating diabetes.
Studying salsalate, a similar but better-tolerated medication, in animals, Dr. Shoelson found encouraging results not just for treating diabetes but also for reducing atherosclerosis in the arteries of the heart, which may lead to heart attack.
Working with Dr. Goldfine, who is director of clinical research at Joslin, he followed up with preliminary trials in humans—a process made easier because the medication is already marketed and widely employed to control arthritis pain.
In early studies, the scientists found that salsalate offered encouraging results for patients with diabetes—and suggested benefits for cardiovascular conditions in those patients as well. The preliminary work indicated that patients who took salsalate had lowered triglycerides and higher levels of adiponectin, a protein thought to aid against cardiac problems. “These findings, together with the studies in animals with atherosclerosis, provide reason to think that salsalate also could have beneficial effects in patients with heart disease,” says Dr. Goldfine.
While continuing their investigations on diabetes, the two MDs are now also recruiting patients for a trial that will shed light on how salsalate might benefit cardiovascular health more specifically. This study will look at effects of salsalate compared to placebo on the amount of plaque in the coronary arteries.
Working closely with Dr. Melvin Clouse of the Beth Israel Deaconess Medical Center and Harvard Medical School, they are using a novel imaging method called multi-detector CT angiography (MDCTA) to measure the amount of plaque in the arteries of the heart. The MDCTA procedure is non-invasive, unlike cardiac catheterization which is the more common way to look at the coronary arteries. These studies will help to highlight any positive effects of the treatments on patients’ coronary arteries.
The study, called Targeting INflammation using SALsalate in CardioVascular Disease (TINSAL-CVD), is seeking volunteers ages 21 to 75 who have heart disease and are overweight. “If that sounds like you, please consider making a contribution to health research by participating,” says Dr. Goldfine.
The study involves 10-11 visits over about 32 months to Boston’s Joslin Diabetes Center and adjacent Beth Israel Deaconess Medical Center, and compensation is available. For more information, you can call 617-264-2765 or 1-866-622-3884 toll free, or email TINSAL-CVD [at] joslin.harvard.edu.
Funded by the National Heart, Lung and Blood Institute, the trial is being done in collaboration with Drs. Francine Welty and Melvin Clouse of Beth Israel Deaconess Medical Center and Dr. Ernest Schaefer of Tufts University.