title: A clinical study to compare the efficacy and safety of pregabalin sustained release formulation with pregabalin immediate release formulation in patients of diabetic peripheral neuropathic pain.
abstract: OBJECTIVE
  To compare the efficacy and safety of sustained release (SR) formulation of pregabalin with immediate release (IR) formulation in patient with diabetic peripheral neuropathic pain.
  
  
  METHODS
  In this open label, randomized, comparative, multicentric study, the primary efficacy measure was reduction in visual analogue scale (VAS) of short form McGill pain questionnaire (SF-MPQ) score from baseline to last visit. The secondary evaluation measures included reduction in SF-MPQ descriptive score and present pain intensity score and change in clinical global impression - improvement of illness (CGI-I) and clinical global impression - severity of illness (CGI-S) from baseline to last visit. Total duration of the study was 12 weeks. Safety evaluation was done by recording treatment emergent adverse events and laboratory investigations at baseline and end of treatment.
  
  
  RESULTS
  Of 265 randomized patients, 133 received pregabalin SR tablets and 132 pregabalin IR. Patients randomized to both treatments responded to respective treatments. The least square means of VAS score in both the groups were reduced significantly (P <0.01). Reduction in both groups was similar (P = ns). At the end of the trial in both the groups, there was a significant reduction in the SF-MPQ descriptive score (P <0.01), severity of illness as well as clinically significant improvement in the symptoms. Difference between the groups for CGI-I (P = 0.37) and CGI-S (P = 0.41) score was not statistically significant. Treatment in both the groups was found safe and well tolerated.
  
  
  CONCLUSIONS
  The study shows that the pregabalin SR is safe and effective in patients of diabetic peripheral neuropathic pain. The results of the study demonstrated that pregabalin SR has comparable efficacy and safety as pregabalin IR.
authors.affiliation: Torrent Pharmaceuticals Limited, Ahmedabad, Gujarat, India.
authors.forename: A
authors.initials: A
authors.lastname: Srivastava
authors.forename: S
authors.initials: S
authors.lastname: Shah
authors.forename: A
authors.initials: A
authors.lastname: Maseeh
authors.forename: B
authors.initials: B
authors.lastname: Vyasa
authors.forename: M
authors.initials: M
authors.lastname: Balaji
authors.forename: S
authors.initials: S
authors.lastname: Bhatter
authors.forename: P
authors.initials: P
authors.lastname: Buch
authors.forename: D
authors.initials: D
authors.lastname: Dantara
authors.forename: J
authors.initials: J
authors.lastname: Karnani
authors.forename: V
authors.initials: V
authors.lastname: Kumar
authors.forename: S
authors.initials: S
authors.lastname: Lodha
authors.forename: D
authors.initials: D
authors.lastname: Maji
authors.forename: A
authors.initials: A
authors.lastname: Moses
authors.forename: S
authors.initials: S
authors.lastname: Phatak
authors.forename: S
authors.initials: S
authors.lastname: Polarappu
authors.forename: S
authors.initials: S
authors.lastname: Shah
authors.forename: B
authors.initials: B
authors.lastname: Upadhayay
keywords: Immediate release formulation; pregabalin; sustained release formulation
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references.pmid: 18356405
references.citation: BMC Neurol. 2011 Jan 20;11:7
references.pmid: 21251268