A drug approved for the treatment of arthritis may have a role in reducing the risk of diabetes and heart trouble developing in young obese individuals, Harvard researchers report.
Compared with an inactive placebo, the anti-inflammatory drug salsalate reduced glucose levels by an average of 13 percent in 20 non-diabetic adults no older than 30 years of age with a body mass index (BMI) of at least 30 (classified as obese).
For the study, Dr. Allison B. Goldfine of the Joslin Diabetes Center in Boston and colleagues randomly assigned the participants to take 4 milligrams of salsalate daily in two divided doses, or placebo, for 4 weeks.
As well as reducing fasting glucose levels, salsalate decreased the glycemic response after an oral glucose tolerance test, improved insulin sensitivity and curbed markers of inflammation, the researchers report in the medical journal Diabetes Care.
“This proof-of-principle study demonstrates that salsalate reduces glycemia and may improve inflammatory cardiovascular risk indexes in overweight individuals,” Goldfine and colleagues conclude. They say the findings support the idea of targeting inflammation to help prevent diabetes.
“Salsalate is marketed in the United States for the treatment of arthritic pain. It is not approved for use in obesity,” Goldfine emphasized in an interview with Reuters Health.
“The drug has a good safety profile in people with arthritis. We are examining the safety profile specifically in people with this different cluster of disease,” she continued.
Several clinical trials with salsalate are ongoing. “If it is efficacious to treat or prevent diabetes, and/or cardiovascular disease, the health economic implications are exciting,” Goldfine noted, “as the product is inexpensive to manufacture and generic, which is important as the number of persons with these health issues is large.”
Salsalate Drug Information
Generic Name: salsalate
Brand Names: Disalcid, Salsitab
What is salsalate?
Salsalate is in a class of drugs called salicylates. It works by reducing substances in the body that cause pain and inflammation.
Salsalate is used to reduce pain and inflammation caused by conditions such as rheumatoid arthritis, osteoarthritis, and related rheumatic conditions.
Salsalate may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about salsalate?
Take salsalate with food, milk, or an antacid to lessen stomach upset, unless you are taking any enteric coated tablet. Do not break, chew, or crush the enteric-coated tablets. Swallow them whole.
Watch for bloody, black, or tarry stools or blood in your vomit. These symptoms could indicate damage to the stomach.
Avoid alcohol during treatment with salsalate. Together, alcohol and salsalate may increase the risk of bleeding in the stomach.
What should I discuss with my healthcare provider before taking salsalate?
Before taking this medication, tell your doctor if you
- have an allergy to aspirin or any other NSAIDs,
- have an ulcer or bleeding in your stomach,
- drink more than three alcoholic beverages a day,
- have liver or kidney disease,
- have a coagulation (bleeding) disorder,
- have congestive heart failure,
- have fluid retention,
- have heart disease, or
- have high blood pressure.
You may not be able to take salsalate, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Salsalate is in the FDA pregnancy category C. This means that it is not known whether salsalate will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether salsalate passes into breast milk. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby. Do not use salsalate to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 18 years of age, salsalate may increase the risk of Reye’s syndrome, a rare but often fatal condition.
How should I take salsalate?
Take salsalate exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Take salsalate with milk, food, or an antacid to lessen stomach upset.
Do not take salsalate more often than every 4 hours, and do not take more than is recommended. If your condition does not improve within 3 to 4 days, seek medical attention.
Be aware of the salicylate (aspirin) content of other over-the-counter and prescription products. Care should be taken to avoid taking more than the recommended amount of salicylate per dose or per day.
Store salsalate at room temperature away from moisture and heat.
What should I avoid while taking salsalate?
Be aware of the salicylate (aspirin) content of other over-the-counter and prescription products. Care should be taken to avoid taking more than the recommended amount of salicylate per dose or per day.
Avoid prolonged exposure to sunlight. Salsalate may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Avoid alcohol during treatment with salsalate. Together, alcohol and salsalate may increase the risk of bleeding in the stomach.
Salsalate side effects
Stop taking salsalate and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- black, bloody, or tarry stools;
- nausea, vomiting, or abdominal pain;
- uncontrolled fever;
- blood in urine or vomit;
- decreased hearing or ringing in the ears;
- seizures; or
- dizziness, confusion, or hallucinations.
If you experience any of the following less serious side effects, notify your doctor:
- heartburn or indigestion,
- faint ringing in the ears,
- drowsiness, or
- headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect salsalate?
Do not take salsalate without first talking to your doctor if you are taking any of the following medicines:
- an anticoagulant such as warfarin (Coumadin), heparin, enoxaparin (Lovenox), dalteparin (Fragmin), danaparoid (Orgaran), ardeparin (Normiflo), or tinzaparin (Innohep);
- a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), or tolmetin (Tolectin); or
- another salicylate such as aspirin (Acuprin, Ecotrin, Ascriptin, Bayer, others) or choline salicylate and/or magnesium salicylate (Magan, Doan’s, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal).
You may not be able to take salsalate, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with salsalate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.