SAFETY EVALUATION OF TRAMAL PLUS® (TRAMADOL HYDROCHLORIDE/ACETAMINOPHEN) FOR PAIN MANAGEMENT IN PAKISTANI REAL WORLD PRACTICE (STEP STUDY)

Dr. Syed Shahid Noor, Dr. Irshad Bhutto, Dr. Kazim Najjad, Dr. Ghazanfar and Dr. Ali Yasir Khan*

ABSTRACT

Objective: The objectives of the study were to evaluate adverse effects mainly Central Nervous System (CNS) and Gastrointestinal (GI) in Pakistani subjects by using Tramal Plus® (Tramadol 37.5mg/Paracetamol 325mg) during the pain management in routine practice. Material and methods: This was an Observational, Prospective, multi-centre study conducted as per GCP guidelines at the leading hospitals of Karachi. The study compliances were monitored by Contract Research Organization (CRO). Total number of 310 subjects were enrolled, Tramal Plus® tablets for the duration of 2 weeks (14 days). During the course of treatment, the GI adverse effects were evaluated by valid GI AE’s questionnaire (Dutch questionnaire) whereas CNS adverse effects mainly drowsiness and respiratory depression were also monitored. SPSS version 19 was used for the statistical analysis of the results. Results: As per results of 300 subjects’, none reported respiratory depression whereas 7 subjects (2.3%) reported mild drowsiness and only 5 (1.7%) subjects reported moderate drowsiness. The subjects also reported drowsiness at baseline visit, 39 (13%) subjects had mild drowsiness and 2 (0.7%) subjects had moderate drowsiness, they were already on concomitant medications and were known case of hypertension and Diabetes Mellitus. For GI adverse effects, the most common reported adverse events were mild nausea (5, 1.7%), mild constipation (4, 1.33%), vomiting (2, 0.7%) and epigastric pain (2, 0.7%). Conclusions: The study data of Tramal plus results depicted the reduced incidence of AEs, improved tolerability with no serious adverse events as were reflected in global studies on tramadol and paracetamol combination when compared to Tramadol alone in pain management. It was also observed in local Pakistani population that drowsiness as an adverse effect can be associated with concomitant medications and co-morbid diseases patients while managing the pain.

Keywords: Pain Management, Tramal Plus®, adverse effects, Pakistani population.