Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern Italy
A multicenter-observational study was performed to assess the effectiveness of rac-methadone, levomethadone, and buprenorphine in opioid-dependent patients in polytherapy in Southern Italy. The primary endpoint was the reduction of urinary positivity to the substances and the maintaining doses. Pati...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-02-01
|
| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/14/2/461 |
| _version_ | 1797477191143915520 |
|---|---|
| author | Fatima Maqoud Giada Fabio Nunzio Ciliero Marina Antonacci Francesca Mastrangelo Giorgio Sammarruco Roberto Cataldini Gabriella Schirosi Salvatore De Fazio Domenico Tricarico |
| author_facet | Fatima Maqoud Giada Fabio Nunzio Ciliero Marina Antonacci Francesca Mastrangelo Giorgio Sammarruco Roberto Cataldini Gabriella Schirosi Salvatore De Fazio Domenico Tricarico |
| author_sort | Fatima Maqoud |
| collection | DOAJ |
| description | A multicenter-observational study was performed to assess the effectiveness of rac-methadone, levomethadone, and buprenorphine in opioid-dependent patients in polytherapy in Southern Italy. The primary endpoint was the reduction of urinary positivity to the substances and the maintaining doses. Patients (N = 266, age = 44.80 ± 5.65, male = 79.70%, female = 20.30%) have been recruited. At recruitment, 75% of them were on treatment with rac-methadone, levomethadone, and buprenorphine/naloxone. The patients were grouped into three clusters. The levomethadone patients of Cluster A (N patients = 211), after 180 days, showed stability in urinary methadone positivity, with a marked decrease in heroin −53 ± 4%, cannabinol’s −48 ± 2%, and cocaine −37 ± 6% positivity, with no differences between treatments. A lower QTcF value of 426 ± 8.4 ms was recorded in the levomethadone patients (delta = −19 ms) vs. rac-methadone, at significantly lower doses of levomethadone (−34%, −50.2% in males) (<i>p</i> < 0.05). The Cluster B data were collected from 37 patients, with a high prevalence of comorbidity infections (HIV/HCV/HPV), monitored for 21 months during COVID-19. High doses of levomethadone (58.33 ± 31.58 mg/day) were needed to stabilize those that were negative for opioids and cannabinoids, in contrast to the rac-methadone and buprenorphine/naloxone patients that showed positive toxicology. Eighteen patients of the Cluster C in double diagnosis (major depressive 38.90%, bipolar 27.78%, and schizophrenia 16.67%) were stabilized with high doses of racemate 97.5 ± 8 mg/day, 51.8 ± 5 mg/day of levomethadone (−46.8% vs. rac-methadone; −71% in men), and 2.5 ± 1 mg/day of buprenorphine/naloxone. Three patients in remission were treated with tapering doses of levomethadone. Significantly reduced QTcF values were recorded with levomethadone (delta −32 ms vs. rac-methadone) in the bipolar patients, as well as the schizophrenia patients in remission (delta −45.19 ms vs. rac-methadone). Our patients were safely stabilized. Levomethadone, compared to the racemate, contributes to reducing the illicit use, especially of opioids and cannabinoids at significantly lower doses with cardiovascular safety, which, in bipolar patients, is clinically significant. |
| first_indexed | 2024-03-09T21:14:08Z |
| format | Article |
| id | doaj.art-949213727f1449d2ba6621cceaf001e3 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-09T21:14:08Z |
| publishDate | 2022-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-949213727f1449d2ba6621cceaf001e32023-11-23T21:39:43ZengMDPI AGPharmaceutics1999-49232022-02-0114246110.3390/pharmaceutics14020461Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern ItalyFatima Maqoud0Giada Fabio1Nunzio Ciliero2Marina Antonacci3Francesca Mastrangelo4Giorgio Sammarruco5Roberto Cataldini6Gabriella Schirosi7Salvatore De Fazio8Domenico Tricarico9Department of Pharmacy-Pharmaceutical Sciences, Pharmacology, University of Bari, Via Orabona 4, 70125 Bari, ItalySer.D. Bari, ASL-BA, Via Amendola, 124/C, 70126 Bari, ItalyDepartment of Pharmacy-Pharmaceutical Sciences, Pharmacology, University of Bari, Via Orabona 4, 70125 Bari, ItalyDepartment of Pharmacy-Pharmaceutical Sciences, Pharmacology, University of Bari, Via Orabona 4, 70125 Bari, ItalySer.D. Lanciano, ASL2 Lanciano-Vasto-Chieti, Via Martiri Lancianesi 17/19, 66100 Chieti, ItalySer.D. Poggiardo, Piazza Partigiani, s.n.c., Poggiardo, 73037 Lecce, ItalyU.O. Double Diagnosis Gallipoli, Via Marconi, 1, 73014 Gallipoli, ItalySer.D. Taranto, Contrada “Rondinella” c/o Ospedale “Testa” Strada Statale 106, 74100 Taranto, ItalySer.D. Mesagne Piazza Gioberti 1, 72023 Brindisi, ItalyDepartment of Pharmacy-Pharmaceutical Sciences, Pharmacology, University of Bari, Via Orabona 4, 70125 Bari, ItalyA multicenter-observational study was performed to assess the effectiveness of rac-methadone, levomethadone, and buprenorphine in opioid-dependent patients in polytherapy in Southern Italy. The primary endpoint was the reduction of urinary positivity to the substances and the maintaining doses. Patients (N = 266, age = 44.80 ± 5.65, male = 79.70%, female = 20.30%) have been recruited. At recruitment, 75% of them were on treatment with rac-methadone, levomethadone, and buprenorphine/naloxone. The patients were grouped into three clusters. The levomethadone patients of Cluster A (N patients = 211), after 180 days, showed stability in urinary methadone positivity, with a marked decrease in heroin −53 ± 4%, cannabinol’s −48 ± 2%, and cocaine −37 ± 6% positivity, with no differences between treatments. A lower QTcF value of 426 ± 8.4 ms was recorded in the levomethadone patients (delta = −19 ms) vs. rac-methadone, at significantly lower doses of levomethadone (−34%, −50.2% in males) (<i>p</i> < 0.05). The Cluster B data were collected from 37 patients, with a high prevalence of comorbidity infections (HIV/HCV/HPV), monitored for 21 months during COVID-19. High doses of levomethadone (58.33 ± 31.58 mg/day) were needed to stabilize those that were negative for opioids and cannabinoids, in contrast to the rac-methadone and buprenorphine/naloxone patients that showed positive toxicology. Eighteen patients of the Cluster C in double diagnosis (major depressive 38.90%, bipolar 27.78%, and schizophrenia 16.67%) were stabilized with high doses of racemate 97.5 ± 8 mg/day, 51.8 ± 5 mg/day of levomethadone (−46.8% vs. rac-methadone; −71% in men), and 2.5 ± 1 mg/day of buprenorphine/naloxone. Three patients in remission were treated with tapering doses of levomethadone. Significantly reduced QTcF values were recorded with levomethadone (delta −32 ms vs. rac-methadone) in the bipolar patients, as well as the schizophrenia patients in remission (delta −45.19 ms vs. rac-methadone). Our patients were safely stabilized. Levomethadone, compared to the racemate, contributes to reducing the illicit use, especially of opioids and cannabinoids at significantly lower doses with cardiovascular safety, which, in bipolar patients, is clinically significant.https://www.mdpi.com/1999-4923/14/2/461levomethadoneabuse substanceclinical studyQTcdouble diagnosis |
| spellingShingle | Fatima Maqoud Giada Fabio Nunzio Ciliero Marina Antonacci Francesca Mastrangelo Giorgio Sammarruco Roberto Cataldini Gabriella Schirosi Salvatore De Fazio Domenico Tricarico Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern Italy Pharmaceutics levomethadone abuse substance clinical study QTc double diagnosis |
| title | Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern Italy |
| title_full | Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern Italy |
| title_fullStr | Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern Italy |
| title_full_unstemmed | Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern Italy |
| title_short | Multicenter Observational/Exploratory Study Addressed to the Evaluation of the Effectiveness and Safety of Pharmacological Therapy in Opioid-Dependent Patients in Maintenance Therapy in Southern Italy |
| title_sort | multicenter observational exploratory study addressed to the evaluation of the effectiveness and safety of pharmacological therapy in opioid dependent patients in maintenance therapy in southern italy |
| topic | levomethadone abuse substance clinical study QTc double diagnosis |
| url | https://www.mdpi.com/1999-4923/14/2/461 |
| work_keys_str_mv | AT fatimamaqoud multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT giadafabio multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT nunziociliero multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT marinaantonacci multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT francescamastrangelo multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT giorgiosammarruco multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT robertocataldini multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT gabriellaschirosi multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT salvatoredefazio multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly AT domenicotricarico multicenterobservationalexploratorystudyaddressedtotheevaluationoftheeffectivenessandsafetyofpharmacologicaltherapyinopioiddependentpatientsinmaintenancetherapyinsouthernitaly |