Vishwnath Yaligod1, D Gokul Raj2, Ateet B Sharma3, Mallikarjun Swami B4, Sumit Batra5, Apurv Acharya6, Sanjaykumar H Maroo7, Ketan R Patel8, Vipul Prajapati9. 1. Doctor, Department of Orthopedics, Saptagiri Institute of Medical Science and Research Centre , Bangalore, India . 2. Doctor, Department of Orthopedics, Sri Ramchandra Medical College and Research Institute , Ramchandra Nagar, Porur, Chennai, India . 3. Doctor, Satellite Orthopaedic Hospital , 302, Vraj Complex, Opp Dhananjay Tower, 100ft Ring Road, Satellite, Ahmedabad, India . 4. Doctor, Department of Orthopaedic, St. John's Medical College & Hospital , Sarjapur Road, Bangalore, India . 5. Doctor, Central Institute of Orthopedics, Safdarjung Hospital , New Delhi, India . 6. Doctor, Siddhi Vinayak Hospital , Kankaria, Maninagar, Ahmedabad, India . 7. Senior General Manager, Medical Services Department, Troikaa Pharmaceuticals Ltd ., Ahmedabad, Gujarat, India . 8. Chairman and Managing Director, Troikaa Pharmaceuticals Limited , Ahmedabad, Gujarat, India . 9. AGM, Medical Services Department, Troikaa Pharmaceuticals Limited , Commerce House 1, Bodakdev, Ahmedabad, India .
Abstract
BACKGROUND:Paracetamol is recommended as first line agent for pain management in osteoarthritis (OA) by various guidelines. The main problem associated with management of osteoarthritis is long term patient compliance to paracetamol due to its frequent dosing. OBJECTIVE: To evaluate the efficacy and safety of Paracetamol 650 mg dual release tablet twice daily (PCM 650 dual release) compared to paracetamol 500mg immediate release tablet thrice daily (PCM 500 IR) in the treatment of Knee OA. MATERIALS AND METHODS: In this randomized, open label, parallel, active controlled clinical study, 250 patients of OA knee meeting inclusion criteria were randomized to receive either PCM 650 dual release two times daily or PCM 500 IR three times daily for 6 weeks. Patients were assessed at baseline, 2, 4 and 6 weeks. Primary efficacy measures were severity of pain (Visual Analogue Scale) and Knee injury and osteoarthritis outcome score (KOOS) subscale for pain at week 2, 4 and 6. Other KOOS subscales (symptoms other than pain, function in daily living, function in sport and recreation, quality of life) and patient's and physicians global assessment of therapy were included as secondary endpoints. RESULTS: Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving PCM 650 dual release showed significant improvement of pain in both primary endpoints at each study visit compared to patients receiving PCM 500 IR (p<0.001). PCM 650 dual release was significantly superior to PCM 500 IR for improvement in all KOOS subscales at each study visit (p<0.01). Less number of patients required additional rescue analgesics in PCM 650 dual release group (16% patients vs 26%, PCM 500 IR; p>0.05). Adverse effects were significantly less in PCM 650 dual release group (6% vs. 14% in PCM 500 IR; p<0.05). Patient's and physician's global assessment of therapy favoured PCM 650 dual release than PCM 500 IR (p<0.001). CONCLUSION: Patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with PCM 650 dual release than PCM 500 IR with better tolerability.
RCT Entities:
BACKGROUND:Paracetamol is recommended as first line agent for pain management in osteoarthritis (OA) by various guidelines. The main problem associated with management of osteoarthritis is long term patient compliance to paracetamol due to its frequent dosing. OBJECTIVE: To evaluate the efficacy and safety of Paracetamol 650 mg dual release tablet twice daily (PCM 650 dual release) compared to paracetamol 500mg immediate release tablet thrice daily (PCM 500 IR) in the treatment of Knee OA. MATERIALS AND METHODS: In this randomized, open label, parallel, active controlled clinical study, 250 patients of OA knee meeting inclusion criteria were randomized to receive either PCM 650 dual release two times daily or PCM 500 IR three times daily for 6 weeks. Patients were assessed at baseline, 2, 4 and 6 weeks. Primary efficacy measures were severity of pain (Visual Analogue Scale) and Knee injury and osteoarthritis outcome score (KOOS) subscale for pain at week 2, 4 and 6. Other KOOS subscales (symptoms other than pain, function in daily living, function in sport and recreation, quality of life) and patient's and physicians global assessment of therapy were included as secondary endpoints. RESULTS: Both treatment groups showed improvement in primary endpoints at each evaluation visit. Patients receiving PCM 650 dual release showed significant improvement of pain in both primary endpoints at each study visit compared to patients receiving PCM 500 IR (p<0.001). PCM 650 dual release was significantly superior to PCM 500 IR for improvement in all KOOS subscales at each study visit (p<0.01). Less number of patients required additional rescue analgesics in PCM 650 dual release group (16% patients vs 26%, PCM 500 IR; p>0.05). Adverse effects were significantly less in PCM 650 dual release group (6% vs. 14% in PCM 500 IR; p<0.05). Patient's and physician's global assessment of therapy favoured PCM 650 dual release than PCM 500 IR (p<0.001). CONCLUSION:Patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with PCM 650 dual release than PCM 500 IR with better tolerability.
Entities:
Keywords:
Acetaminophen; Extended release; Immediate release; KOOS; OA knee; VAS
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