PMID- 31745220 OWN - NLM STAT- MEDLINE DCOM- 20210329 LR - 20210329 IS - 1473-1150 (Electronic) IS - 1470-269X (Linking) VI - 20 IP - 2 DP - 2020 Apr TI - Gender based differences, pharmacogenetics and adverse events in chronic pain management. PG - 320-328 LID - 10.1038/s41397-019-0118-9 [doi] AB - Safety data in chronic non-cancer pain (CNCP) with long-term opioid therapy has been poorly studied and can be differently influenced by gender. Furthermore, pharmacogenetics (PGx) could possibly be used to tailor pain medication based on the individual's genetic background. The aim was to assess whether PGx applied to a pharmacovigilance system could help to improve a patient's security profile. A pharmacovigilance data recording system was conducted over 24 months, including genotyping of OPRM1 variants (opioid receptor, A118G) and COMT (enzyme that degrades catecholamines such as norepinephrine, G1947A). Pain intensity (visual analogue scale, VAS), morphine equivalent daily dose (MEDD), adverse events (AEs) and suspected adverse drug reactions (ADRs) were recorded and analysed by gender. The Ethics Committee approved the study and data were analysed with R 3.6.0 software. A total of 748 patients were recruited in the study (67% female, VAS 62 +/- 29 mm, MEDD 119 +/- 114 mg/day) reporting a median of 6 (3.5-9) AEs/patient. Women presented more nausea, headaches, insomnia, loss of appetite, weight change, depression and dizziness than men. Analysis by genotype demonstrated that PGx influenced the prevalence of vomiting and depression in men, dizziness in women and sexual dysfunction in both. Physicians notified 150 ADRs mostly in females (79%) related to nervous system disorders. PGx applied to a pharmacovigilance recording system provides important information to achieve a better knowledge about AEs in CNCP pharmacological therapy. OPRM1 and COMT polymorphisms were associated with AEs in CNCP patients that differed according to gender. FAU - Planelles, Beatriz AU - Planelles B AD - Pain Unit, Department of Health, Alicante General Hospital, Alicante, Spain. AD - Neuropharmacology apply to Pain and Functional Diversity (NED). ISABIAL-FISABIO Foundation, General University Hospital of Alicante, Alicante, Spain. FAU - Margarit, Cesar AU - Margarit C AD - Pain Unit, Department of Health, Alicante General Hospital, Alicante, Spain. AD - Neuropharmacology apply to Pain and Functional Diversity (NED). ISABIAL-FISABIO Foundation, General University Hospital of Alicante, Alicante, Spain. FAU - Inda, Maria-Del-Mar AU - Inda MD AD - Neuropharmacology apply to Pain and Functional Diversity (NED). ISABIAL-FISABIO Foundation, General University Hospital of Alicante, Alicante, Spain. FAU - Ballester, Pura AU - Ballester P AD - Neuropharmacology apply to Pain and Functional Diversity (NED). ISABIAL-FISABIO Foundation, General University Hospital of Alicante, Alicante, Spain. FAU - Muriel, Javier AU - Muriel J AD - Neuropharmacology apply to Pain and Functional Diversity (NED). ISABIAL-FISABIO Foundation, General University Hospital of Alicante, Alicante, Spain. FAU - Barrachina, Jordi AU - Barrachina J AD - Occupational Observatory, Miguel Hernandez University, Elche, Spain. FAU - Ajo, Raquel AU - Ajo R AD - Neuropharmacology apply to Pain and Functional Diversity (NED). ISABIAL-FISABIO Foundation, General University Hospital of Alicante, Alicante, Spain. FAU - Esteban, Maria-Dolores AU - Esteban MD AD - Center of Operations Research, Miguel Hernandez University, Elche, Spain. FAU - Peiro, Ana M AU - Peiro AM AUID- ORCID: 0000-0002-2385-3749 AD - Pain Unit, Department of Health, Alicante General Hospital, Alicante, Spain. peiro_ana@gva.es. AD - Neuropharmacology apply to Pain and Functional Diversity (NED). ISABIAL-FISABIO Foundation, General University Hospital of Alicante, Alicante, Spain. peiro_ana@gva.es. AD - Clinical Pharmacology Unit, Department of Health, Alicante General Hospital, Alicante, Spain. peiro_ana@gva.es. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20191120 PL - United States TA - Pharmacogenomics J JT - The pharmacogenomics journal JID - 101083949 RN - 0 (Analgesics, Opioid) SB - IM MH - Aged MH - Aged, 80 and over MH - Analgesics, Opioid/administration & dosage/*adverse effects MH - Chronic Pain/drug therapy/epidemiology/*genetics MH - Drug-Related Side Effects and Adverse Reactions/epidemiology/*genetics MH - Female MH - Humans MH - Male MH - Middle Aged MH - Pain Management/*methods MH - Pain Measurement/methods MH - Pharmacogenetics/*methods MH - Polymorphism, Single Nucleotide/genetics MH - *Sex Characteristics MH - Spain/epidemiology EDAT- 2019/11/21 06:00 MHDA- 2021/03/30 06:00 CRDT- 2019/11/21 06:00 PHST- 2018/08/07 00:00 [received] PHST- 2019/11/06 00:00 [accepted] PHST- 2019/10/08 00:00 [revised] PHST- 2019/11/21 06:00 [pubmed] PHST- 2021/03/30 06:00 [medline] PHST- 2019/11/21 06:00 [entrez] AID - 10.1038/s41397-019-0118-9 [pii] AID - 10.1038/s41397-019-0118-9 [doi] PST - ppublish SO - Pharmacogenomics J. 2020 Apr;20(2):320-328. doi: 10.1038/s41397-019-0118-9. Epub 2019 Nov 20.