Indian Journal of Palliative Care
ORIGINAL ARTICLE
Year : 2009 | Volume : 15 | Issue : 2 | Page : 132--136
Tariq A Tramboo1, Showket Gurkhoo
Context: The α2δ modulators gabapentin and pregabalin are effective against neuropathic pain. Numerous brands of α2δ modulators are available in India, and are expected to have equivalent clinical effects. They are routinely used for management of neuropathic pain associated with radiculopathy.
Aim: To describe clinical outcomes in three series of cases of neuropathic pain treated with three available brands of a2d modulators.
Settings and Design: Retrospective analysis of clinical outcomes in patients attending an interventional pain clinic
Patients and Methods: One hundred and ninety-four consecutive patients with neuropathic pain secondary to Magnetic Resonance Imaging (MRI)-documented compression radiculopathy received either LYRICA (LYR), a locally available generic brand of pregabalin (PGN), or a locally available generic brand of gabapentin (GBN), respectively. Drug treatment was continued till adequate pain relief was achieved. In each of the three groups, mean pain scores were analyzed at Days 0, 15, 60 and 90, and daytime sedation scores at Days 1, 15, 60 and 90.
Statistical Analysis used: Analysis of variance (ANOVA) followed by pair-wise comparison using two-tailed unpaired t-test (if P value was significant).
Results: Mean pain score was significantly lower in the LYR series as compared to the PGN and GBN series at Days 15, 60 and 90. As compared to the PGN and GBN series, a greater proportion of patients in the LYR series could discontinue drug therapy following adequate pain relief, by Day 90. Daytime sedation scores were significantly lower in the LYR series as compared to the PGN and GBN series at Days 1, 15 and 60, and as compared to the PGN series at Day 90.
Conclusion: These results indicate the effectiveness of a2d modulators for management of neuropathic pain secondary to compression radiculopathy. The results also suggest a possible therapeutic superiority of LYRICA over locally available generic brands of pregabalin and gabapentin. These findings need to be further examined in randomized, controlled trials.
Showing posts with label Pregabalin. Show all posts
Showing posts with label Pregabalin. Show all posts
Monday, December 21, 2009
Friday, October 16, 2009
Pregabalin: a novel gamma-aminobutyric acid analogue in the treatment of neuropathic pain, partial-onset seizures, and anxiety disorders.
Clin Ther. 2007 Jan;29(1):26-48.
Tassone DM, Boyce E, Guyer J, Nuzum D.
Wingate University School of Pharmacy, Wingate, North Carolina 28174, USA. dtassone@wingate.edu
BACKGROUND: The US Food and Drug Administration (FDA) approved pregabalin in December 2004 for the treatment of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Pregabalin is the first drug approved in the United States and in Europe for both conditions. In June 2005, pregabalin was approved as an adjunctive treatment in adults with partial-onset seizures. The FDA currently is considering the approval of pregabalin as adjunctive therapy in adults with generalized anxiety disorder (GAD) or social anxiety disorder (SAD). OBJECTIVES: The goals of this review were to summarize the pharmacology, pharmacokinetics, efficacy, and tolerability of pregabalin; review its approved uses in the management of neuropathic pain and refractory partial-onset seizures; and investigate its potential use in patients with GAD or SAD. METHODS: Relevant English-language literature was identified through a search of MEDLINE (1993-June 2006) and International Pharmaceutical Abstracts (2000-June 2006). The search terms included pregabalin, Lyrica, S-(+)-3 isobutyl-gaba, PN, DPN, diabetic peripheral neuropathy, PHN, postherpetic neuralgia, partial seizures, epilepsy, generalized anxiety disorder, and CI-1008. RESULTS: In 4 clinical trials in a total of 1068 patients with diabetic peripheral neuropathy, the patients receiving pregabalin 300 to 600 mg/d had significantly greater improvement in mean pain scores than placebo recipients (P < or = 0.01). Patients with postherpetic neuralgia receiving pregabalin 450 to 600 mg/d had significantly greater improvement in relief of pain and pain-related sleep interference than placebo recipients (P < or = 0.002). Patients with refractory partial-onset seizures who received pregabalin 150 to 600 mg/d (divided into 2 or 3 doses) concomitantly with antiepileptic drugs had significantly fewer seizures than placebo recipients (P < or = 0.001). In the 3 studies that evaluated the efficacy of pregabalin in patients with GAD or SAD, the patients receiving pregabalin 200 to 600 mg/d (divided into 2 or 3 daily doses) had a significantly greater reduction in mean pain scores on the Hamilton Anxiety Scale than placebo recipients (P < or = 0.01). Across all the reviewed clinical trials, the most commonly reported adverse effects (AEs) were those affecting the central nervous system, including somnolence (< or =50%), dizziness (< or =49%), and headache (< or =29%). AEs resulted in withdrawal from the study in < or =32% of patients.
CONCLUSIONS: Pregabalin appears to be an effective therapy in patients with diabetic peripheral neuropathy, postherpetic neuralgia, and adults with refractory partial-onset seizures. The available data suggest that pregabalin may be beneficial as an adjunctive therapy in adult patients with GAD or SAD.
Publication Types:
Review
PMID: 17379045 [PubMed - indexed for MEDLINE]
Address correspondence to: Daniel M. Tassone, PharmD, Wingate University School of Pharmacy, Campus Box 3087, Wingate, NC 28174.
Tassone DM, Boyce E, Guyer J, Nuzum D.
Wingate University School of Pharmacy, Wingate, North Carolina 28174, USA. dtassone@wingate.edu
BACKGROUND: The US Food and Drug Administration (FDA) approved pregabalin in December 2004 for the treatment of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Pregabalin is the first drug approved in the United States and in Europe for both conditions. In June 2005, pregabalin was approved as an adjunctive treatment in adults with partial-onset seizures. The FDA currently is considering the approval of pregabalin as adjunctive therapy in adults with generalized anxiety disorder (GAD) or social anxiety disorder (SAD). OBJECTIVES: The goals of this review were to summarize the pharmacology, pharmacokinetics, efficacy, and tolerability of pregabalin; review its approved uses in the management of neuropathic pain and refractory partial-onset seizures; and investigate its potential use in patients with GAD or SAD. METHODS: Relevant English-language literature was identified through a search of MEDLINE (1993-June 2006) and International Pharmaceutical Abstracts (2000-June 2006). The search terms included pregabalin, Lyrica, S-(+)-3 isobutyl-gaba, PN, DPN, diabetic peripheral neuropathy, PHN, postherpetic neuralgia, partial seizures, epilepsy, generalized anxiety disorder, and CI-1008. RESULTS: In 4 clinical trials in a total of 1068 patients with diabetic peripheral neuropathy, the patients receiving pregabalin 300 to 600 mg/d had significantly greater improvement in mean pain scores than placebo recipients (P < or = 0.01). Patients with postherpetic neuralgia receiving pregabalin 450 to 600 mg/d had significantly greater improvement in relief of pain and pain-related sleep interference than placebo recipients (P < or = 0.002). Patients with refractory partial-onset seizures who received pregabalin 150 to 600 mg/d (divided into 2 or 3 doses) concomitantly with antiepileptic drugs had significantly fewer seizures than placebo recipients (P < or = 0.001). In the 3 studies that evaluated the efficacy of pregabalin in patients with GAD or SAD, the patients receiving pregabalin 200 to 600 mg/d (divided into 2 or 3 daily doses) had a significantly greater reduction in mean pain scores on the Hamilton Anxiety Scale than placebo recipients (P < or = 0.01). Across all the reviewed clinical trials, the most commonly reported adverse effects (AEs) were those affecting the central nervous system, including somnolence (< or =50%), dizziness (< or =49%), and headache (< or =29%). AEs resulted in withdrawal from the study in < or =32% of patients.
CONCLUSIONS: Pregabalin appears to be an effective therapy in patients with diabetic peripheral neuropathy, postherpetic neuralgia, and adults with refractory partial-onset seizures. The available data suggest that pregabalin may be beneficial as an adjunctive therapy in adult patients with GAD or SAD.
Publication Types:
Review
PMID: 17379045 [PubMed - indexed for MEDLINE]
Address correspondence to: Daniel M. Tassone, PharmD, Wingate University School of Pharmacy, Campus Box 3087, Wingate, NC 28174.
Patient-reported-outcomes in subjects with painful lumbar or cervical radiculopathy treated with pregabalin: evidence from medical practice in primary
Rheumatology International
Original Article
Thursday, October 01, 2009
María Teresa Saldaña1, 2 , Ana Navarro3, Concepción Pérez4, Xavier Masramón5 and Javier Rejas6
(1) Centro de Salud de Raíces, Av. del Campón 67, 33400 Castrillón (Asturias), Spain
(2) Raíces Primary Care Center, Castrillón, Asturias, Spain
(3) Puerta del Ángel Primary Care Center, Madrid, Spain
(4) Pain Clinic, De la Princesa Hospital, Madrid, Spain
(5) Department of Statistics, European Biometrics Institute, Barcelona, Spain
(6) Health Outcomes Research Department, Medical Unit, Pfizer Spain, Alcobendas, Spain
Received: 28 October 2008 Accepted: 5 August 2009 Published online: 2 October 2009
Abstract The objective of this study was to evaluate the effect of pregabalin in painful cervical or lumbosacral radiculopathy treated in Primary Care settings under routine clinical practice. An observational, prospective 12-week secondary analysis was carried-out. Male and female above 18 years, naïve to PGB, with refractory chronic pain secondary to cervical/lumbosacral radiculopathy were enrolled. SF-MPQ, Sheehan Disability Inventory, MOS Sleep Scale, Hospital Anxiety and Depression Scale and the EQ-5D were administered. A total of 490 (34%) patients were prescribed PGB-monotherapy, 702 (48%) received PGB add-on, and 159 (11%) were administered non-PGB drugs. After 12 weeks, significant improvements in pain, associated symptoms of anxiety, depression and sleep disturbances, general health; and level of disability were observed in the three groups, being significantly greater in PGB groups. In routine medical practice, monotherapy or add-on pregabalin is associated with substantial pain alleviation and associated symptoms improvements in painful cervical or lumbosacral radiculopathy.
Original Article
Thursday, October 01, 2009
María Teresa Saldaña1, 2 , Ana Navarro3, Concepción Pérez4, Xavier Masramón5 and Javier Rejas6
(1) Centro de Salud de Raíces, Av. del Campón 67, 33400 Castrillón (Asturias), Spain
(2) Raíces Primary Care Center, Castrillón, Asturias, Spain
(3) Puerta del Ángel Primary Care Center, Madrid, Spain
(4) Pain Clinic, De la Princesa Hospital, Madrid, Spain
(5) Department of Statistics, European Biometrics Institute, Barcelona, Spain
(6) Health Outcomes Research Department, Medical Unit, Pfizer Spain, Alcobendas, Spain
Received: 28 October 2008 Accepted: 5 August 2009 Published online: 2 October 2009
Abstract The objective of this study was to evaluate the effect of pregabalin in painful cervical or lumbosacral radiculopathy treated in Primary Care settings under routine clinical practice. An observational, prospective 12-week secondary analysis was carried-out. Male and female above 18 years, naïve to PGB, with refractory chronic pain secondary to cervical/lumbosacral radiculopathy were enrolled. SF-MPQ, Sheehan Disability Inventory, MOS Sleep Scale, Hospital Anxiety and Depression Scale and the EQ-5D were administered. A total of 490 (34%) patients were prescribed PGB-monotherapy, 702 (48%) received PGB add-on, and 159 (11%) were administered non-PGB drugs. After 12 weeks, significant improvements in pain, associated symptoms of anxiety, depression and sleep disturbances, general health; and level of disability were observed in the three groups, being significantly greater in PGB groups. In routine medical practice, monotherapy or add-on pregabalin is associated with substantial pain alleviation and associated symptoms improvements in painful cervical or lumbosacral radiculopathy.
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