ABSTRACT
(1) Background: It is essential to focus attention on sex-specific factors which are clinically relevant in pain management, especially with regards to opioid use disorder (OUD) risk. The aim of this study was to explore potential sex-differences in chronic non-cancer pain (CNCP) outpatients. (2) Methods: An observational cross-sectional study was conducted under CNCP outpatients with long-term prescribed opioids (n = 806), wherein 137 patients had an OUD diagnosis (cases, 64% females) and 669 did not (controls, 66% females). Socio-demographic, clinical, and pharmacological outcomes were analyzed. (3) Results: Female controls presented an older age and less intensive pain therapy but higher psychotropic prescriptions and emergency department visits compared to male controls. Meanwhile, cases demonstrated a younger age, higher work disability, double morphine equivalent daily dose, and benzodiazepine use compared with controls. Here, female cases showed an 8% greater substance use disorder (OR 2.04 [1.11-3.76]) and 24% lower tramadol use, while male cases presented a 22% higher fentanyl use (OR 2.97 [1.52-5.81]) and reported the highest number of adverse drug reactions (24%, OR 2.40 [1.12-5.16]) compared with controls. (4) Conclusions: An OUD individual risk profile was evidenced with sex-differences to take into consideration to design equal prevention programs.
ABSTRACT
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Subject(s)
Humans , Pharmacogenetics/methods , Pain/drug therapy , Pain Management/methodsSubject(s)
Analgesics/therapeutic use , Pain/drug therapy , Pharmacogenetics , Precision Medicine , Genetic Markers , Humans , Pain/genetics , Treatment OutcomeABSTRACT
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Subject(s)
Humans , Informed Consent/legislation & jurisprudence , Minors/legislation & jurisprudence , Decision MakingSubject(s)
Decision Making/ethics , Informed Consent/legislation & jurisprudence , Minors/legislation & jurisprudence , Parental Notification/legislation & jurisprudence , Psychology, Adolescent , Abortion, Induced/ethics , Abortion, Induced/legislation & jurisprudence , Adolescent , Contraceptives, Postcoital , Duty to Warn/ethics , Duty to Warn/legislation & jurisprudence , Female , Humans , Informed Consent/ethics , Male , Parental Notification/ethics , Practice Patterns, Physicians' , Spain , Substance-Related Disorders , Treatment Refusal/ethics , Treatment Refusal/legislation & jurisprudence , United StatesABSTRACT
Objetivo: recopilar y analizar la información sobre los efectos de la MDMA obtenida en estudios controlados en humanos. Método: la mayoría de ensayos analizados han sido de diseño enmascarado a doble ciego, cruzados, con asignación aleatoria a la secuencia de tratamientos, y controlados con placebo y/o fármaco patrón. Resultados: además del incremento de la presión y frecuencia cardíaca, la MDMA incrementa el consumo miocárdico de oxígeno sin efectos inotrópicos y puede incrementar el intervalo QTc en el ECG. El aumento de temperatura no fue significativo frente a placebo. Produce euforia, bienestar y activación. No se han descrito ni alucinaciones ni ilusiones. En el EEG aumenta la actividad beta y disminuye la alfa. Aumenta de forma dosis-dependiente las concentraciones de ACTH, cortisol, prolactina, dihidroepiandrosterona y vasopresina. Inmunológicamente su efecto parece ser inmunosupresor. Su farmacocinética parece ser no-lineal con tendencia a la acumulación a dosis alta. Conclusiones: los estudios controlados han permitido conocer mejor la MDMA, profundizando en sus efectos subjetivos, y aportando datos originales en cuanto a cambios hormonales e inmunológicos. Se necesitan más estudios para determinar científicamente los efectos y toxicidad de la MDMA (AU)
Objective: to compile and analyse knowledge about the pharmacodynamics and pharmacokinetics of MDMA from controlled clinical trials in humans. Methods: the typical design of the trials was masked (double blind), randomized, cross-over, and controlled with placebo and/or an active drug. Results: MDMA increases the heart rate, arterial blood pressure, oxygen consumption by the heart and produced an enlargement of the QTC interval in the ECG. No statistical differences were found with placebo in the increase of body temperature. MDMA induce euphoria, wellbeing and activation. Neither ilusions nor hallucinations were described. An increase of beta activity and a decrease of alpha activity in the EEG was seen. A dose-dependent increase in the plasma levels of ACTH, cortisol, prolactin, dehydroepiandrosterone and vasopresine was observed. Immunogically, MDMA posses an immunosupresor effect. Its pharmacokinetic properties seems to be non-lineal, with a tendency to accumulation at high doses. Conclusion: the results obtained in these controlled clinical trials increase our previous knowledge on MDMA and add new data related to its hormonal and immunological effects. Further studies are needed in order to better understand the effects and toxicity of MDMA (AU)
