Sulindac is used for anti-inflammatory and analgesic effects in the symptomatic treatment of acute and chronic rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Sulindac is also used for symptomatic treatment of acute gouty arthritis and acute painful shoulder (bursitis and/or tendinitis).
Sulindac has been used to reduce the number of adenomatous colorectal polyps in adults with familial adenomatous polyposis (FAP).
The potential benefits and risks of sulindac therapy as well as alternative therapies should be considered prior to initiating sulindac therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.
Rheumatoid Arthritis and Osteoarthritis
When used in the treatment of rheumatoid arthritis or osteoarthritis, sulindac has relieved pain and stiffness, reduced swelling and the number of joints involved, and improved mobility and grip strength. In patients with osteoarthritis, sulindac has relieved pain and stiffness, reduced swelling and tenderness, and improved mobility. Sulindac appears to be only palliative in these conditions and has not been shown to permanently arrest or reverse the underlying disease process. Safety and efficacy of sulindac in patients who are incapacitated, largely or wholly bedridden, or confined to a wheelchair with little or no capacity for self care (Functional Class IV rheumatoid arthritis) have not been established.
Most clinical studies have shown that the analgesic and anti-inflammatory effects of usual dosages of sulindac in the management of rheumatoid arthritis or osteoarthritis are greater than those of placebo and about equal to those of usual dosages of salicylates. In patients with osteoarthritis, the therapeutic effects of usual dosages of sulindac are also about equal to those of ibuprofen. Patient response to NSAIAs is variable; patients who do not respond to or cannot tolerate one drug may be successfully treated with a different agent. However, NSAIAs are generally contraindicated in patients in whom sensitivity reactions (e.g., urticaria, bronchospasm, severe rhinitis) are precipitated by aspirin or other NSAIAs.
(See Cautions: Precautions and Contraindications.)
In the management of rheumatoid arthritis in adults, NSAIAs may be useful for initial symptomatic treatment; however, NSAIAs do not alter the course of the disease or prevent joint destruction. Disease modifying antirheumatic drugs (DMARDs) (e.g., azathioprine, cyclosporine, etanercept, oral or injectable gold compounds, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, penicillamine, sulfasalazine) have the potential to reduce or prevent joint damage, preserve joint integrity and function, and reduce total health care costs, and all patients with rheumatoid arthritis are candidates for DMARD therapy. DMARDs should be initiated early in the disease course and should not be delayed beyond 3 months in patients with active disease (i.e., ongoing joint pain, substantial morning stiffness, fatigue, active synovitis, persistent elevation of erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP], radiographic evidence of joint damage) despite an adequate regimen of NSAIAs. NSAIA therapy may be continued in conjunction with DMARD therapy or, depending on patient response, may be discontinued.
The manufacturers state that, in some patients with rheumatoid arthritis, sulindac has produced additional therapeutic benefit when used in conjunction with gold compounds.
Use of sulindac with aspirin is not recommended by the manufacturers. There is inadequate proof that the combination is more effective than either drug alone, the potential for adverse reactions may be increased, and there is some evidence that aspirin decreases plasma concentrations of sulindac's sulfide metabolite.
(See Drug Interactions: Nonsteroidal Anti-inflammatory Agents.)
Other Inflammatory Conditions
When used in patients with ankylosing spondylitis, sulindac has relieved night pain and spinal pain, tenderness, and/or spasm; reduced stiffness; and improved chest expansion and spinal mobility. In a limited number of studies, the anti-inflammatory and analgesic effects of usual dosages of sulindac in the management of ankylosing spondylitis were greater than those of placebo and about equal to those of usual dosages of indomethacin or phenylbutazone (no longer commercially available in the US).
When used in the symptomatic treatment of acute painful shoulder (bursitis and/or tendinitis), the anti-inflammatory and analgesic effects of sulindac are about equal to those of oxyphenbutazone (no longer commercially available in the US).
Colchicine, phenylbutazone (no longer commercially available in the US), or indomethacin are considered the drugs of choice to relieve attacks of acute gouty arthritis. Although the precise role has not been determined, sulindac also has relieved the pain, swelling, and tenderness of acute gouty arthritis. Sulindac is used for its anti-inflammatory and analgesic effects in the short-term management of acute attacks. In short-term clinical studies, the anti-inflammatory and analgesic effects of usual dosages of sulindac were about equal to those of usual dosages of phenylbutazone (no longer commercially available in the US) in relieving attacks of acute gouty arthritis; the drugs were equally well tolerated. Sulindac is not indicated for long-term prophylactic treatment of gouty arthritis.
Results of observational studies and randomized controlled studies indicate that administration of sulindac is associated with a reduction in the number of polyps in adults with familial adenomatous polyposis (FAP). It is unclear whether the effect of sulindac in reducing the number of polyps persists with long-term therapy.
While sulindac may reduce the number of polyps in patients with FAP, the drug does not appear to prevent the development of adenomatous colorectal polyps in individuals with FAP. In a randomized, placebo-controlled study in children, adolescents, and young adults (8-25 years of age) with the inherited mutation in the adenomatous polyposis coli (APC) gene but no evidence of disease (i.e., no colorectal adenomatous polyps detected on endoscopy at baseline and no prior colonic surgery), administration of sulindac (75 or 150 mg 2 times daily for those weighing 20-44 or greater than 44 kg, respectively) for 4 years was not associated with a difference in number or size of polyps compared with those receiving placebo.
Results from a large, prospective, population-based cohort study in geriatric individuals indicate a lower prevalence of Alzheimer's disease among patients who received an NSAIA for 2 years or longer. Similar findings have been reported from some other, but not all, observational studies.