Can Solu-Cortef (hydrocortisone) be stopped after 1 day of use if the patient has improved significantly?

From the Guidelines

Solu-Cortef (hydrocortisone sodium succinate) should not be stopped abruptly after just 1 day of use, even if the patient has improved significantly, as it may lead to adrenal insufficiency. A gradual tapering schedule is recommended to prevent this condition. The body naturally produces cortisol, but when external steroids are administered, the body reduces its own production. Abrupt discontinuation can leave the patient without adequate cortisol levels as the adrenal glands need time to resume normal function. This can lead to withdrawal symptoms including fatigue, weakness, body aches, joint pain, and in severe cases, adrenal crisis. According to the most recent and highest quality study 1, the management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy recommends a gradual tapering of corticosteroids. The appropriate tapering schedule depends on the dose used, duration of treatment, patient's condition, and individual response. Some key points to consider when tapering Solu-Cortef include:

• The dose and duration of treatment: higher doses and longer treatment durations may require a more gradual tapering schedule.
• The patient's condition: patients with a history of adrenal insufficiency or those who are taking other medications that may interact with Solu-Cortef may require a more cautious tapering schedule.
• Individual response: patients may respond differently to tapering, and the schedule may need to be adjusted based on their symptoms and response to treatment. The patient should consult with their healthcare provider before making any changes to their Solu-Cortef regimen, even if symptoms have improved. Additionally, other studies 1 also support the importance of gradual tapering of corticosteroids to prevent adrenal insufficiency, although they may not be as directly relevant to the specific question of stopping Solu-Cortef after 1 day of use. However, the most recent and highest quality study 1 provides the most relevant guidance on this topic.

From the FDA Drug Label

In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized, usually not beyond 48 hours to 72 hours. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

The patient has improved significantly after 1 day of use, but high dose corticosteroid therapy is usually continued until the patient's condition has stabilized, which may take up to 48 hours to 72 hours.

• It is not explicitly stated that the therapy can be stopped after 1 day of use.
• Gradual withdrawal is recommended if the drug is to be stopped after long-term therapy, but it is unclear if this applies to short-term therapy as well. 2

From the Research

Stopping Solu Cortef After 1 Day of Use

• There is no direct evidence to suggest that Solu Cortef can be stopped after 1 day of use if the patient has improved significantly 3, 4, 5, 6, 7.
• The provided studies focus on the effects of hydrocortisone substitution therapy in patients with adrenal insufficiency, but do not address the specific question of stopping treatment after a short period of use.
• Adrenal insufficiency is a life-threatening condition that requires lifelong glucocorticoid substitution therapy, and stopping treatment abruptly can lead to serious consequences 4, 5.
• The decision to stop or adjust Solu Cortef treatment should be made under the guidance of a healthcare professional, taking into account the individual patient's condition and response to treatment.

Considerations for Treatment Adjustment

• Patients with adrenal insufficiency require individualized treatment plans, and adjustments to glucocorticoid replacement therapy should be based on clinical evaluation and monitoring of the patient's condition 3, 5, 6.
• The use of dual-release hydrocortisone has been shown to improve serum and peripheral blood mononuclear cell inflammatory and immune profiles in patients with autoimmune primary adrenal insufficiency 7.
• However, the long-term safety and efficacy of stopping Solu Cortef after a short period of use are not established, and further research is needed to inform treatment decisions.