Painful neuropathy: comparative observational analysis of safety profile of pregabalin and amitriptyline
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20212380Keywords:
Painful neuropathy, Amitriptyline, PregabalinAbstract
Background: Chronic neuropathic pain, caused by a lesion or disease of the somatosensory nervous system is a common debilitating condition in clinical practice. Pregabalin and Amitriptyline are most commonly used drugs for its management. The aim of the study was to study the safety of Pregabalin and Amitriptyline in chronic neuropathic pain.
Methods: Prospective observational study at Department of Medicine and Orthopaedics at All India Institute of Medical Sciences, Rishikesh. Newly diagnosed patients of neuropathic pain who were prescribed either Pregabalin or Amitriptyline were included in the study. Patients were followed up telephonically or during routine visits for a period of 3 months after initiation of any of these drugs. Appropriate measures of central tendency were used to describe demographic and clinical parameters and Correlation test was used between different variables and occurrence of adverse drug reactions.
Results: 317 patients were prescribed these drugs. A total of 276 ADRs were observed (128 with Pregabalin and 148 with Amitriptyline). Central nervous system symptoms like sedation and dizziness were most commonly present in both the groups. Diabetes mellitus (47.1%) was most common etiology for neuropathic pain. Causality assessment showed probable association with Amitriptyline (n=140) and Pregabalin (n=118). Majority of ADRs with Amitriptyline group (49.32%) were moderate in severity whereas it was mild with Pregabalin (59.7%). A weak positive correlation (R=0.273) was seen with number of ADRs occurrence and total drug exposure in patients taking Pregabalin whereas a weak negative correlation (R=-0.623) was seen in Amitriptyline treated group.
Conclusions: Safety profile of Pregabalin was better than Amitriptyline in the present study. The study findings must be replicated in larger patient population and for a prolonged duration for better understanding of the pattern of adverse drug reactions.
References
International Association for the Study of Pain (2007) IASP taxonomy. Available at https://www.iasp-pain.org/Education/Content.aspx?ItemNumber=1698#Neuropathicpain. Accessed on 10th November, 2019.
Backonja M, Glanzman RL. Gabapentin dosing for neuropathic pain: evidence from randomized, placebo-controlled clinical trials. Clin Ther. 2003;25(1):81-104.
Moore RA, Derry S, Aldington D, Cole P, Wiffen PJ. Amitriptyline for neuropathic pain in adults. Cochrane Database Syst Rev. 2015;2015(7):CD008242.
Chakrabarty S, Biswas S, Maiti T, Das A, Mandal A, Banerjee P. Pregabalin and amitriptyline as monotherapy or as low-dose combination in patients of neuropathic pain: A randomized, controlled trial to evaluate efficacy and safety in an Eastern India teaching hospital. Ann Indian Acad Neurol. 2019;22:437-41.
Kamble SV, Motlekar SA, D'souza LL, Kudrigikar VN, Rao SE. Low doses of amitriptyline, pregabalin, and gabapentin are preferred for management of neuropathic pain in India: is there a need for revisiting dosing recommendations?. Korean J Pain. 2017;30(3):183-91.
Jena SS, Jena M, Patro N, Mishra S, Panda M, Dash M. Patterns of prescription and adr monitoring of drugs in the management of neuropathic pain in a tertiary care teaching hospital. International Journal of Pharmacy and Pharmaceutical Sciences. 2006;10(1):246-51.
Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bockbrader H, Knapp LE J Pain. 2005;6(4):253-60.
Backonja M, Glanzman RL. Gabapentin dosing for neuropathic pain: evidence from randomized, placebo-controlled clinical trials. Clin Ther. 2003; 25(1):81-104.
Fuzier R, Serres I, Guitton E, Lapeyre-Mestre M, Montastruc JL. French Network of Pharmacovigilance Centres. Adverse drug reactions to gabapentin and pregabalin: a review of the French pharmacovigilance database. Drug Saf. 2013;36(1):55-62.
Acet G, Kaya A, Akturk S, Akgol G. A comparison of the effectiveness of amitriptilin and pregabalin treatment in fibromyalgia patients. North Clin Istanb. 2017;4(2):151-59.
Shaknar V, Oomen O, Thomas A. Efficacy, Safety and Cost Effectiveness of Amitriptyline and Pregabalin in Patients with Diabetic Peripheral Neuropathy. Indian J Pharm Sci. 2017;79(4):646-50.
Arvinth A, Muthiah NS, Suganya E, Susshmitha R, Sowmya P. Evaluation of adverse drug reactions of gabapentin to pregabalin in patients of painful diabetic peripheral neuropathy. J Chem Pharm Res. 2016;8(7):540-43.