What are the considerations for using duloxetine (Cymbalta) in older adults?

From the Guidelines

Duloxetine can be appropriate for older adults but requires careful consideration, with a recommended starting dose of 20-30mg once daily, gradual increases as needed, and cautious use in those with kidney or liver impairment, as evidenced by the most recent study 1. When using duloxetine in older adults, it is essential to consider the potential for increased sensitivity to side effects, including dizziness, dry mouth, constipation, and increased fall risk.

• The medication should be used cautiously in those with kidney or liver impairment, as noted in the study 1.
• Drug interactions with NSAIDs, blood thinners, and certain antidepressants should be monitored, as reported in the study 1.
• Regular follow-up appointments are essential to monitor effectiveness and side effects, with dose adjustments made as needed, as recommended in the study 1.
• Abrupt discontinuation should be avoided to prevent withdrawal symptoms, as warned in the study 1. The medication works by increasing serotonin and norepinephrine levels in the brain, which helps regulate mood, pain signals, and anxiety.
• Treatment duration depends on the condition being treated, with depression typically requiring at least 6-12 months after symptom improvement, as suggested in the study 1.
• Older adults may require closer monitoring due to the potential for adverse events, as noted in the study 1. Overall, duloxetine can be a valuable treatment option for older adults, but it is crucial to carefully weigh the potential benefits and risks, as emphasized in the study 1.

From the FDA Drug Label

In all 3 trials, duloxetine delayed-release capsules demonstrated superiority over placebo as measured by greater improvement in the Hamilton Anxiety Scale (HAM-A) total score GAD Trial in Geriatric Patients The efficacy of duloxetine delayed-release capsules in the treatment of patients ≥65 years of age with GAD was established in one 10-week flexible-dose, randomized, double-blind, placebo-controlled trial in adults ≥65 years of age meeting the DSM-IV criteria for GAD (Study GAD-5) In Study GAD-5, the starting dose was 30 mg once daily for 2 weeks before further dose increases in 30 mg increments at treatment weeks 2,4, and 7 up to 120 mg once daily were allowed based on investigator judgment of clinical response and tolerability. The mean dosage for patients completing the 10-week acute treatment phase was 51 mg Patients treated with duloxetine delayed-release capsules (N=151) demonstrated significantly greater improvement compared with placebo (N=140) on mean change from baseline to endpoint as measured by the HAM-A total score

The considerations for using duloxetine (Cymbalta) in older adults include:

• Starting dose: 30 mg once daily for 2 weeks before further dose increases
• Dose titration: increases in 30 mg increments at treatment weeks 2,4, and 7 up to 120 mg once daily based on investigator judgment of clinical response and tolerability
• Mean dosage: 51 mg for patients completing the 10-week acute treatment phase
• Efficacy: demonstrated superiority over placebo as measured by greater improvement in the Hamilton Anxiety Scale (HAM-A) total score 2

From the Research

Considerations for Using Duloxetine in Older Adults

• When prescribing duloxetine to older adults, it is essential to consider the potential for cardiovascular risks, particularly in those with pre-existing cardiovascular diseases 3.
• Regular monitoring of cardiovascular function and early steps such as dose adjustment or drug withdrawal of duloxetine may reduce the prognosis of adverse drug reactions (ADRs) 3.
• Duloxetine has been shown to be efficacious in the treatment of generalized anxiety disorder (GAD) in older adult patients, with a safety profile consistent with previous GAD studies 4.
• However, treatment-emergent adverse events, such as constipation, dry mouth, and somnolence, occurred in ≥5% of duloxetine-treated patients and at a rate twice that of placebo 4.
• In older adults with comorbid major depressive disorder and chronic low back pain, duloxetine pharmacotherapy and Depression and Pain Care Management (DPCM) resulted in significant improvements in depression and pain symptoms, as well as health-related quality of life, anxiety, and sleep quality 5.
• Patient demographic characteristics, such as age, hepatic function, and renal function, can influence the pharmacokinetics of duloxetine, and impaired hepatic function or severely impaired renal function may warrant specific warnings or dose recommendations 6.
• Duloxetine may interact with other medications, such as CYP1A2 inhibitors, which can increase duloxetine exposure to a clinically significant degree, and CYP2D6 inhibitors, which can increase the exposure of drugs metabolized by CYP2D6 6.