Knowing Efficacy & Safety of Once-Daily Extended-Release Hydrocodone
Chronic pain is a disease of the central nervous system. It is defined as “pain without apparent biological value that has persisted beyond normal tissue healing time”. Chronic pain may arise from an initial injury, such as a back sprain, or there may be an ongoing cause, such as illness. However, there may also be no clear cause.
Other health problems, such as fatigue, sleep disturbance, decreased appetite, and mood changes, often accompany chronic pain. Chronic pain may limit a person’s movements, which can reduce flexibility, strength, and stamina. Many opioids have been prescribed to treat the chronic pain. Some researchers believed that morphine can worse the chronic pain. As an alternative, hydrocodone was selected to check whether it helps to cure chronic pain or not.
An open label study of 12 months was conducted for the primary analysis. In this post hoc analysis, the effectiveness and safety of hydrocodone bitartrate (HYD) in patients with moderate-to-severe chronic pain was examined in the patients of 88 sites in the United States, who were previously taking extended-release morphine for pain management.
In the study, eligible patients were enrolled and titrated to a once daily dose of HYD 20, 40, 60, 80 or 120 mg for a period of 45 days. After achieving a stable HYD daily dose, patients entered a 12-month maintenance period during which additional dose adjustment could be made and non-opioid or short acting opioid medications could be received. Average pain over the last 24 hours was recorded daily.
On completion of the study, 26 patients who switched from morphine ER to HYD, 19 entered the maintenance period. At study entry, mean “average pain over the last 24 hours” was scored as 5.21. When patients entered into the maintenance phase, with time pain score was reduced to 3.90 and this level of pain control was maintained over the 12-month period with 16 patients and further no changes in dose was required. BPI scores were also decreased for both pain severity and pain interference during the conducted trial.
After analysis, it was suggested that rotation from morphine ER to hydrocodone once in a day in patients with moderate-to-severe chronic pain helped to maintain or improved the pain. Further it does not increase the risk factors involved with the safety of patients.