A phase IV observational multi-centre, open-label study on efficacy and safety of tolperisone 150 mg in patients with painful muscle spasm associated with degenerative or inflammatory diseases of the musculoskeletal system.

Abstract

AIMS:

To generate real world clinical data on efficacy and tolerability of tolperisone 150 mg in painful muscle spasms in Indian population.

SETTINGS AND DESIGN:

Prospective, open-labelled, non-comparative, multi-centre observational, Post Marketing surveillance study conducted at 174 participating orthopaedic care centres across India

METHODS AND MATERIAL:

Nine hundred and twenty adult patients having painful muscle spasm associated with degenerative or inflammatory conditions were enrolled who received tolperisone 150 mg thrice daily orally for 7 days. Assessment of primary efficacy (muscle spasm) was done by (0-3) Likert scale. Adverse events were monitored for safety and global efficacy assessment was done by clinicians and patients at the end of study period.

RESULTS:

Significant improvements from baseline (p < 0.0001) in scores for muscle tone, mobility & pain were seen on days 3 & 7. At the end of study there was a significant reduction in scores by more than 80% from baseline. A subgroup analysis revealed no statistical difference in the scores in patients receiving Non-Steroidal AntiInflammatory Drug (NSAID) as compared to those receiving Tolperisone alone suggesting that Tolperisone alone could be offered to patients with painful muscle spasm who are intolerant to NSAIDs or in whom NSAIDs are contraindicated. Tolperisone was well tolerated with no sedation reported by any patient during study period. The incidence of common adverse effects like nausea, gastric irritation was less than 2%.

CONCLUSIONS:

Tolperisone is a safe, effective and non sedative alternative in management of acute painful spasm conditions associated with degenerative or inflammatory diseases of the musculoskeletal system. Key Messages: Tolperisone is a skeletal muscle relaxant without concomitant sedation or withdrawal phenomena. In this open-labelled, non-comparative, prospective study tolperisone was proved to be a safe & effective alternative to skeletal muscle relaxants in the management of acute painful spasm conditions associated with degenerative or inflammatory diseases of the musculoskeletal system.

• Authors: Ram Prabhoo, Swapnil Keny, Tanay Prabhoo, Amarinder Singh, Rajiv Rana
• Journal: The Journal of the Association of Physicians of India (J Assoc Physicians India) Vol. 59 Pg. 33-7 (Jan 2011) ISSN: 0004-5772 [Print] India
• PMID: 21751662 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study)

Chemical References

• Muscle Relaxants, Central
• Tolperisone

Topics

• Administration, Oral
• Adult
• Dose-Response Relationship, Drug
• Female
• Humans
• India
• Male
• Middle Aged
• Muscle Relaxants, Central (pharmacology, therapeutic use)
• Muscle, Skeletal (drug effects)
• Muscular Diseases (complications, drug therapy, etiology)
• Pain (drug therapy, etiology)
• Population Surveillance
• Product Surveillance, Postmarketing
• Prospective Studies
• Spasm (complications, drug therapy)
• Tolperisone (pharmacology, therapeutic use)
• Treatment Outcome
• Young Adult