Uso fuera de indicación de la combinación a dosis fija de tramadol/dexketoprofeno en atención primaria de salud: ¿Basado en la evidencia científica o motivo de preocupación? / Off-label use of fixed-dose combination of tramadol and dexketoprofen in primary health care. Evidence-based or cause for concern?

Introducción: La utilización de la combinación a dosis fija de tramadol/dexketoprofeno en España y en otros países ha aumentado de forma conside-rable. La indicación terapéutica autorizada de este medicamento es el tratamiento sintomático a corto plazo del dolor agudo de moderado a intenso en pacientes adultos. El objetivo de este estudio fue describir el patrón de uso de tramadol/dexketopro-feno en el ámbito de la atención primaria de salud.Método: Se realizó un estudio transversal, descrip-tivo y multicéntrico. La población de estudio incluyó a todos los pacientes de una Dirección de Atención Primaria (53 equipos de Atención Primaria) que tenían activa la prescripción de tramadol/dexke-toprofeno el 28 de marzo de 2018. La población diana fueron aquellos pacientes a los que se les prescribió tramadol/dexketoprofeno durante más de 20 días.Resultados: Un total de 176 pacientes tenía activa la prescripción de tramadol/dexketoprofeno. Todos los pacientes (100%) tuvieron una duración del tratamiento superior a 5 días y el 72,7% (N=128) su-perior a 20 días. La duración media del tratamiento fue de 14±160,9 días en pacientes que tenían me-nos de 20 días de tratamiento y de 224±160,8 días en pacientes que tenían más de 20 días de trata-miento. El 35,1% de los pacientes estaban tratados con más de 2 medicamentos para aliviar el dolor de forma concomitante con tramadol/dexketoprofeno. El médico de atención primaria inició un 65,6% de las prescripciones.Conclusiones: La combinación a dosis fija de tramadol/dexketoprofeno se utilizó con frecuencia fuera de indicación, de acuerdo con la ficha técnica y la evidencia científica disponible. Este estudio alerta sobre los riesgos potenciales asociados a la utilización de este medicamento en la práctica clíni-ca, como son la falta de efectividad y/o la aparición de efectos adversos. (AU)

Introduction: The use of the fixed-dose combi-nation of tramadol/dexketoprofen in Spain and in other countries has increased considerably. The authorized therapeutic indication for this medicinal product is the short-term symptomatic treatment of moderate to severe acute pain in adult patients. The objective of this study was to describe the pat-tern of use of tramadol/dexketoprofen in the field of primary health care.Method: A cross-sectional, descriptive and mul-ticenter study was carried out. The study popu-lation included all patients from a Primary Care Department (53 Primary Care teams) with an active prescription of tramadol/dexketoprofen on March 28, 2018. The target population was those patients who were prescribed tramadol/dexketoprofen. dexketoprofen for >20 days.Results: A total of 176 patients had an active pre-scription for tramadol/dexketoprofen. All patients (100%) had a duration of treatment greater than 5 days and 72.7% (N=128) greater than 20 days. The mean duration of treatment was 14±160.9 days in patients who had less than 20 days of treatment and 224±160.8 days in patients who had more than 20 days of treatment. 35.1% of the patients were treated with >2 pain medications and concomi-tantly with tramadol/dexketoprofen. The general practitioner initiated 65.6% of the prescriptions.Conclusions: The fixed-dose combination of tra-madol/dexketoprofen was frequently used off-la-bel, according to the product characteristics and the available scientific evidence. This study warns about the potential risks associated with the use of this drug in clinical practice, such as lack of effec-tiveness and/or the appearance of adverse effects (AU)

Tapentadol and Oxycodone/Naloxone Prescribing Patterns in Primary Health Care in Catalonia, Spain: A Cross-Sectional Study.

OBJECTIVE: To characterize the use of tapentadol and the combination oxycodone/naloxone in primary health care. Data on their use and possible misuse will allow the identification of risk factors and to design protocols to reduce and prevent avoidable harm to patients being treated for pain. DESIGN: A descriptive, cross-sectional and multicenter study was performed. SETTING: Fifty-three primary health care teams, which provides healthcare for 1,300,000 inhabitants. PATIENTS: A total of 1840 patients had active prescriptions of tapentadol and 985 of oxycodone/naloxone. METHODS: Demographic (age, sex) and clinical (glomerular filtration rate; active liver disease; dosing and duration of treatment), prescribed daily dose (according to age, sex, length of treatment), concomitant analgesic treatment and diagnosis. Patient information was obtained from medical records. RESULTS: Most of the patients were women (>74.0% in both cases), and the average age was 69.3 years (women: 70.1±13.2; men: 66.7±13.9 years) in the case of tapentadol and 70.6 years (women: 64.0±13.6; men: 72.6±14.3 years) in the case of oxycodone/naloxone. Only 12.2% of patients taking tapentadol and 12.1% taking oxycodone/naloxone had a normal renal function. In both cases, 4.1% of patients had active liver disease. The average length of treatment was 246.4 days in oxycodone/naloxone and 199.0 days in tapentadol. It was recorded that 85.1% of patients in the case of tapentadol and 89.0% in the oxycodone/naloxone had at least another drug prescribed for pain. About 42.2% of patients treated with tapentadol and 34.4% of patients treated with oxycodone/naloxone had associated neuralgia as a diagnosis. CONCLUSION: The pattern of use and profile of patients with tapentadol and oxycodone/naloxone had more similarities than differences, and suggested that prescribing practice, and monitoring should be assessed regularly to ensure patient safety and effective management of pain.

Clinical Use of Pregabalin in General Practice in Catalonia, Spain: A Population-Based Cross-Sectional Study.

Objective: The aim of this study was to determine the pattern of use of pregabalin and the appropriateness of treatment, so that interventions could be designed to improve various clinical approaches to the use of pregabalin to include unlicensed indications. Design: A descriptive, cross-sectional, multicenter study was performed between April 2014 and January 2015. Setting: Fifty-three primary health care centers covering 1,250,000 inhabitants. Subjects: A total of 10,155 patients with pregabalin prescriptions. Methods: Demographic (gender, age) and clinical (licensed indications for pregabalin, treatment duration, dosing schedule, diagnoses, kidney function, previous treatment with pregabalin, and additional drug treatment combined with pregabalin) variables obtained from health records were studied. The indicators were related to the daily dose of pregabalin, diagnoses, and treatment. Results: A total of 64.2% of patients treated with pregabalin were female (mean age = 62.3 years; SD = 15.2 years). Twenty-nine patients were younger than age 18 years. A total of 68.2% of patients were taking pregabalin for an appropriate indication, 45.2% were using pregabalin off-label for bone and joint pain, and 15.1% were using pregabalin for fibromyalgia. A total of 71.9% of patients started treatment with pregabalin without previously using firstline drugs, such as amitriptyline or gabapentin, and 66% of active treatments had been initiated during the year before the study. In 47% of patients with glomerular filtration rates lower than 15 mL/min, the dose exceeded the maximum. Conclusions: Our study reveals that pregabalin is used for unlicensed indications and often when firstline drugs have not been trialed and suggests that better routines in diagnosis and prescription may improve treatment outcomes. Our study also provides novel information about the use of doses of pregabalin that are higher than recommended for patients with renal impairment.