Pinoy patients respond well to Tramal SR
Local study shows 9 out of 10 get moderate to excellent pain relief
A local postmarketing surveillance study has established the efficacy and tolerability of sustained-release tramadol (Tramal SR) in controlling moderate to severe chronic pain among Filipino patients.
Results of the phase-4 study were bared by Dr. Cenon Cruz, director emeritus of the Pain Management Center of St. Luke's Medical Center, in last year's annual convention of the Pain Society of the Philippines. Cruz said the results showed that 74 percent of patients involved in the study experienced moderate to excellent pain relief (responder rate) in the first week of treatment. This rose to 91.4 percent after three weeks.
More remarkably, the drug came out well tolerated. The number of patients who experienced adverse reactions dropped from 26.62 percent during the first week of therapy to a very low 2.78 percent by the third week.
Based on the results, Cruz said: "Tramal SR is suitable for the treatment of moderate to severe chronic pain caused by malignant and nonmalignant disorders among Filipino patients. Pain of various etiologies can be effectively and safely treated with tramadol 100 mg (Tramal SR) in clinical practice."
Study design
The multicenter, open-label, prospective study involved patients who presented with persistent or recurring moderate to severe pain for four or more weeks and who rated at least 4/10 on a visual analog scale. For one year, 1,864 patients were seen with primary diagnoses of arthritis (36.75 percent), cancer (23.93 percent), low-back pain (29.35 percent) and neuropathy (16.15 percent). Of these, 1,614 completed the study.
The patients were given Tramal SR 100 mg one tablet twice a day for three weeks. If after 48 hours, minimal or no pain relief was reported, the dosage was increased to 400 mg/day for noncancer patients and 600 mg/day for cancer patients.
The clinical efficacy was assessed using primary and secondary efficacy criteria. The primary efficacy criteria, or the responder rate at the end of treatment, referred to the proportion of patients whose pain relief was greater than two based on a four-point scale (1=no relief, 2=slight relief, 3= moderate relief, 4=excellent relief) as recorded in their pain-relief diaries. The secondary efficacy referred to the "proportion of patients requiring rescue medication" and the "patients' and investigators' global assessment of the study medication (bad, fair, good, very good)." To gauge safety and tolerability, all adverse events from the intention-to-treat population were recorded. This included the "intensity and outcome of adverse events and the necessary intervention made by the physician."
Highly rated
Tramal SR also got high overall global assessment rating as a secondary measure of efficacy. Nine out of ten patients and doctors who took part in the study rated its analgesic effect as either good or very good.
The good analgesic efficacy and high responder rate translated to lesser need for rescue medication. Rescue medications were given in only 7.08 percent of patients during the first week of treatment, and this number dropped to 1.98 percent in the third week, a "dramatic decline," according to Cruz. He noted that this was the trend for all types of pain.
While some adverse events were experienced in the first week of medication, these were almost gone by the third week. Overall, not even three for every 100 patients were still experiencing adverse reactions after three weeks. The more common side effects were dizziness, nausea, vomiting, drowsiness, and headache, which Cruz noted were "the most common central- nervous-system effects of any centrally acting drugs or opioid-like drugs working on the central nervous system."
Cruz said the trial demonstrated that prolonged use of sustained-release tramadol is associated with an increased rate of response and reduced incidence of adverse events in patients with moderate to severe chronic pain. The need for rescue analgesia and incidence of adverse events declined over time.
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