What are the guidelines for using Diclofenac (Nonsteroidal Anti-Inflammatory Drug (NSAID))?

Guidelines for Using Diclofenac (NSAID)

Diclofenac should be used with caution and only when safer alternatives are insufficient, particularly in patients with cardiovascular disease, as it is associated with a significantly increased risk of mortality (HR 2.40) compared to other NSAIDs. 1

General Recommendations for Diclofenac Use

Indications

• FDA-approved for treatment of primary dysmenorrhea, mild to moderate pain, and relief of signs and symptoms of osteoarthritis and rheumatoid arthritis 2
• Should be used at the lowest effective dose for the shortest possible duration 2

Contraindications

• Known hypersensitivity to diclofenac or components of the drug product 2
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs 2
• In the setting of coronary artery bypass graft (CABG) surgery 2
• Use with extreme caution in patients with established cardiovascular disease 1

Stepped-Care Approach to Pain Management

First-Line Options (Before Considering Diclofenac)

• Begin with acetaminophen, small doses of narcotics, or nonacetylated salicylates 1
• Non-pharmacological approaches should be considered as first-line treatment 1

Second-Line Options

• If first-line therapy is insufficient, consider nonselective NSAIDs with lower cardiovascular risk profiles, such as naproxen 1

Third-Line Options

• Diclofenac and other NSAIDs with higher degrees of COX-2 selectivity should only be considered when intolerable discomfort persists despite attempts with first and second-line options 1
• When used, administer at the lowest effective dose for the shortest possible time 1

Special Considerations

Cardiovascular Risk

• Diclofenac has been associated with significantly increased cardiovascular risk (HR 2.40) compared to other NSAIDs 1
• Risk appears to be dose-related and amplified in patients with established cardiovascular disease 1
• In patients with history of myocardial infarction, diclofenac was associated with higher risk of death (HR 2.40) compared to ibuprofen (HR 1.50) 1

Gastrointestinal Risk

• Consider adding a proton pump inhibitor in patients at increased risk of GI complications 3
• Fixed combination of diclofenac with misoprostol may be considered for patients at high risk for NSAID-related gastrointestinal complications 3

Pregnancy and Fertility

• For early pregnancy exposure, data show no evidence of increased risk of miscarriage or teratogenicity 1
• Should be restricted to first and second trimester and discontinued after gestational week 28 1
• May interfere with ovulation; women with difficulty conceiving should consider discontinuing NSAIDs 1
• When needed during pregnancy, prefer nonselective NSAIDs with short half-life (e.g., ibuprofen) at lowest effective dose for short duration (7-10 days) 1

Drug Interactions

• Monitor patients taking diuretics for signs of worsening renal function 2
• May increase serum concentration and prolong half-life of digoxin 2
• Can increase plasma lithium levels and reduce renal lithium clearance 2
• May increase risk for methotrexate toxicity 2
• May increase cyclosporine's nephrotoxicity 2
• Avoid concomitant use with other NSAIDs or salicylates 2

Topical Formulations

• Topical diclofenac is preferred over systemic treatment due to favorable safety profile 1
• Topical diclofenac gel has shown improvements in pain and function with similar low rates of adverse effects in both low and high-risk patients 1

Monitoring and Follow-up

• Monitor for gastrointestinal bleeding, ulceration, and perforation 2
• Watch for signs of cardiovascular events, particularly in patients with pre-existing cardiovascular disease 1
• Monitor renal function, especially in patients taking diuretics or with pre-existing renal impairment 2

Common Pitfalls to Avoid

• Avoid using ibuprofen in patients on aspirin therapy, as it blocks the antiplatelet effects of aspirin 1
• Do not use diclofenac as first-line therapy when safer alternatives may provide adequate pain relief 1
• Avoid long-term use, particularly in elderly patients and those with cardiovascular risk factors 1
• Do not continue NSAIDs during hospitalization for acute coronary events 1