Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain.

INTRODUCTION: Medical departments have evolved from a position of support to one of strategic leadership. The number of tasks and the complexity of interactions in which they are involved is increasing. However, the spectrum of their activity in the sector differs significantly from one company to another. Therefore, the aim of this study was to describe their situation within the pharmaceutical industry, analyzing the positions, functions, and profiles of their professionals. METHODS: This study consisted of an online survey containing 25 questions grouped into four blocks (structure, medical direction, training, and activities and responsibilities). Medical departments in the Spanish pharmaceutical industry of different sizes and scope were invited to participate. The survey took place in 2021, with a designated response period of three months. It is important to note that all responses collected during this time were treated as anonymous. RESULTS: Thirty companies participated. A total of 93.3% of respondents worked for an international laboratory, with a size of 0-5 or 11-20 people (20.7%). For 27.6% of the companies, the number of medical advisors per medical department was 1 or 4, with varying numbers of medical scientific liaisons (1, 6-10, and > 20). A total of 56.7%, 33.3%, and 6.7% indicated that the country manager, head of regional medical affairs, and head of global medical affairs, respectively, had a solid-line reporting relationship with the medical directorate. Medical directors were mostly graduates in medicine (86.2%) with a doctorate (34.5%), and medical managers were mainly graduates in medicine (77.8%) and pharmacy (66.7%). CONCLUSIONS: This study reveals that respondents predominantly work in internationally focused laboratories, with professionals ranging from experienced medical directors to managers with 6-20 years of experience, each with distinct roles.

Cost-effectiveness of cladribine tablets and dimethyl fumarate in the treatment of relapsing remitting multiple sclerosis in Spain.

Aim: To analyze the cost-effectiveness of treatment of relapsing remitting multiple sclerosis (RRMS) with cladribine tablets (CladT) and dimethyl fumarate (DMF) from the perspective of the Spanish National Health System (NHS). Methods: A probabilistic Markov model (second-order Monte Carlo simulation) with a 10-year time horizon and annual Markov cycles was performed. Results: CladT was the dominant treatment, with lower costs (-74,741 € [95% CI: -67,247; -85,661 €]) and greater effectiveness (0.1920 [95% CI: -0.1659; 0.2173] QALY) per patient, compared with DMF. CladT had a 95.1% probability of being cost-effective and a 94.1% chance of being dominant compared with DMF. Conclusion: CladT is the dominant treatment (lower costs, with more QALYs) compared with DMF in the treatment of RRMS in Spain.

Mixed Pain Can Be Discerned in the Primary Care and Orthopedics Settings in Spain: A Large Cross-Sectional Study.

OBJECTIVES: To assess the value of the concept of mixed pain by investigating its acceptance and interpretation by health care professionals and the differential characteristics in patients with mixed pain. MATERIALS AND METHODS: Data from 5024 patients with pain from 551 sites in Primary Care and Orthopedics settings were analyzed in this cross-sectional study. Pain characteristics, other factors influencing pain, health care-related data and health-related quality of life were summarized and compared among 3 groups of patients according to the type of pain (nociceptive, neuropathic, or mixed), as assigned by the investigators after considering the pathophysiological mechanisms involved. RESULTS: Pain was of mixed pathophysiology in most patients (59.3%; 95% confidence interval [CI], 59.2%-59.5%), followed by nociceptive (31.8%; 95% CI, 31.6%-32.0%) and neuropathic pathophysiology (8.9%; 95% CI, 8.8%-9.1%). Patients with mixed pain had pain in >1 site more frequently than the other groups. Spinal conditions was the attributed cause of pain in >80% of patients with mixed pain, whereas nonspinal osteoarthritis represented almost a third. Patients with mixed pain showed a greater clinical complexity than the remaining patients, as they reflected: more comorbidities, adverse psycho-social factors, health care resource utilization, undertreatment, and perceived difficulties in patient management, but less perceived effectiveness of treatments and a lower health-related quality of life. DISCUSSION: An independent category in the pathophysiological classification of pain is justified based on the differential characteristics of patients with mixed pain, although conceptualization of mixed pain should be improved. Increasing referrals to other specialists or implementing chronic pain management programs would seem advisable. CONCLUSIONS: Patients with mixed pain showed more clinical complexity than patients with other types of pain. The consideration of mixed pain as an independent pathophysiological category may be justifiable on empirical clinical grounds.

Chronic Pain Features Relate to Quality of Life More than Physiopathology: A Cross-Sectional Evaluation in Pain Clinics.

OBJECTIVE: To compare the impact of chronic pain physiopathology on health-related quality of life (HR-QoL), considering the influence of pain features and psychosocial adjustment (intensity, interference, psychological comorbidities, and sleep quality). DESIGN: A cross-sectional study involving 1,025 noncancer patients with predominantly neuropathic, nociceptive, or mixed chronic pain conditions was conducted in 88 pain clinics within Spain. The EuroQol-5 Dimensions instrument (EQ-5D) was used to measure HR-QoL. The Brief Pain Inventory (BPI), Hospital Anxiety and Depression Scale (HADS), and sleep scale developed for the MOS study (MOS-SQ) were used to measure pain features and psychosocial adjustment. Multivariate analyses were used to model HR-QoL measures. RESULTS: All patients reported very low HR-QoL. The mean EQ-5D index scores were 0.33, 0.36, and 0.37 in the mixed, neuropathic, and nociceptive pain groups, respectively. The differences did not reach statistical significance (P = 0.057). Patients with nociceptive pain had less pain (least pain intensity score: 4.7 vs. 5.2 in the other groups; P = 0.006), less interference with daily activities (BPI average interference score: 6.3 vs. 6.6 and 6.7 in the neuropathic and mixed pain groups, respectively; P = 0.013), less anxiety (HADS score: 8.5 vs. 9.6 and 9.7 in the same respective groups; P = 0.001), and fewer sleep problems (MOS-SQ sleep problems index: 46.8 vs. 52.2 and 50.2 in the same respective groups; P = 0.005). In the adjusted analyses, HR-QoL measures were explained by pain intensity, anxiety, and sleep quality, but not by physiopathological pain type. CONCLUSIONS: Pain features, particularly intensity, have a greater impact than pain physiopathology on HR-QoL. Distinct physiopathological mechanisms give rise to different pain features that, in turn, may mediate the HR-QoL of patients with chronic pain. This could be used to improve pain management strategies.

High Prevalence of Neuropathic Pain Features in Patients with Knee Osteoarthritis: A Cross-Sectional Study.

OBJECTIVE: The present epidemiological research evaluated the prevalence of neuropathic pain characteristics in patients with painful knee osteoarthritis (OA) and the plausibility that such neuropathic features were specific of OA. METHODS: Outpatients with chronic pain associated with knee OA who attended orthopedic surgery or rehabilitation clinics were systematically screened for neuropathic pain with the Douleur Neuropathique in 4 questions (DN4) questionnaire. Data from medical files and those obtained during a single structured clinical interview were correlated with the DN4 scores. Information on potential confounders of neuropathic-like qualities of knee pain was collected to evaluate as much as possible only the symptoms attributable to OA. RESULTS: Of 2,776 patients recruited, 2,167 patients provided valid data from 2,992 knees. The DN4 was scored positively (≥ 4) in 1,125 patients (51.9%) and 1,459 knees (48.8%). When patients with potential confounders were excluded, the respective prevalences were 33.3% and 29.4%. Patients who scored positively in the DN4 had more severe pain, greater structural damage, and more potential confounders of neuropathic pain. Three potential confounders conveyed much of the variability explained by regression analyses. However, latent class analyses revealed that the concourse of other factors is required to explain the neuropathic pain qualities. CONCLUSIONS: A relevant proportion of patients with chronic pain associated with knee OA featured neuropathic pain qualities that were not explained by other conditions. The present research has provided reasonable epidemiological grounds to attempt their definite diagnosis and classification.

Effectiveness of opioid rotation in the control of cancer pain: the ROTODOL study.

OBJECTIVE: To assess the effectiveness of opioid rotation (OR) to manage cancer pain. To describe the adverse events (AEs) associated with OR. SETTING: Thirty-nine tertiary hospital services. PATIENTS: Sixty-seven oncological patients with cancer-related pain treated at outpatient clinics. INTERVENTION: Prospective multicenter study. Pain intensity was scored using a Numerical Rating Scale (NRS) of 0-10. Average pain (AP) intensity in the last 24 hours, breakthrough pain (BTP), and the number of episodes of BTP on the days before and 1 week after OR were assessed. The pre-OR and post-OR opioid were recorded. The presence and intensity of any AEs occurring after OR were also recorded. RESULTS: In the 67 patients evaluated, 75 ORs were recorded. In all cases, the main reason for OR was poor pain control. Pain intensity decreased by ≥2 points after OR in 75.4 percent and 57.8 percent of cases for AP and BTP, respectively. If the initial NRS score was ≥4, a decrease below <4 accounted for 50.9 percent and 32.3 percent of cases for AP and BTP, respectively. The number of episodes of BTP also decreased significantly (p<0.001). A total of 107 AEs were reported, most of which were mild in intensity, with gastrointestinal symptoms predominating. CONCLUSIONS: Opioid rotation appears to be both safe and effective in the management of basal and breakthrough cancer pain.

Chronic noncancer pain intensity is inversely related to analgesic adherence in pain clinics.

OBJECTIVE: The relationship between chronic noncancer pain (CNCP) control and pain medication (analgesic) adherence has not been widely documented. The primary aim of this study was to evaluate the relationship between pain intensity and the degree of adherence to analgesic medication prescribed in pain clinics. There was also a special emphasis on the influence of polypharmacy on adherence. METHODS: A cross-sectional clinical survey was carried out in pain clinics across Spain. Demographic and clinical data were collected from patients: pain intensity, analgesic prescription and adherence, and the presence of concomitant medical conditions and treatments. The relationship between analgesic adherence and pain intensity was analyzed using correlations and propensity scores based on ordinal logistic regression. Correlates of pain intensity were explored using multiple linear regression. RESULTS: Data was gathered from 1407 patients; 1321 were eligible for analysis. Their mean (standard deviation) age was 61.6 (14.7) years and the majority (67.3%) were women. More than half (57.9%) received step 3 analgesics. Pain intensity was scored 5 out of 10 on average. Just 65.9% of patients were reported to not have missed any analgesic dose during the previous week. Pain intensity correlated negatively with analgesic adherence (r(s) = -0.151, p < 0.001). Moderate versus very intense pain was predicted in patients with 'good' and 'very poor' adherence, respectively. The presence of concomitant medications also correlated negatively with analgesic adherence (r(s) = -0.074, p = 0.007). However, few investigators reported such a negative effect of polypharmacy. LIMITATIONS: Key limitations of this research are its cross-sectional design and the absence of an objective means of measuring medication adherence. CONCLUSIONS: This study has shown that there is a small but significant inverse relationship between analgesic adherence and CNCP control, which has remained elusive to date and should be further evaluated. Polypharmacy also had a negative influence on adherence, although this was not acknowledged by all investigators.

Psychometric validation of the neuropathic pain symptom inventory for its use in Spanish.

CONTEXT: Clinical instruments are required for the assessment of neuropathic pain (NP). OBJECTIVES: The primary aim of this study was to perform a complete psychometric validation of the Neuropathic Pain Symptom Inventory (NPSI) in Spanish patients. METHODS: A linguistically validated version in Spanish of the NPSI and other clinical instruments for NP were administered on two occasions separated by at least one month to 548 patients suffering from chronic NP. The authors evaluated the responsiveness, the construct validity, and the internal structure of the NPSI by means of, respectively, receiver operating characteristic (ROC) curves analysis and calculation of reliable change indices, a multitrait-multimethod (MTMM) design, and primary component analysis. Internal consistency and test-retest reliability were evaluated, respectively, by calculating several Cronbach's alpha coefficients and intraclass correlation coefficients of some scores selected appropriately. RESULTS: The areas under the ROC curves were greater than 0.85. The MTMM design found convergent-discriminant correlations correctly aligned for all NPSI subscores in the first assessment, and for all but paresthesia/dysesthesia subscores in the second assessment. The five components of the NPSI described by its authors were confirmed on one occasion, but the "electric shocks" and "stabbing" items did not associate consistently, as in the original version, the first time the NPSI was administered. All reliability coefficients were above 0.70. CONCLUSION: The Spanish NPSI has good concurrent and construct validity and is reliable for a wide range of patients with NP. One exception to the original structure was found affecting one item, presumably relating to a cultural feature.

Transdermal buprenorphine for the treatment of cancer pain: results from a multicenter, observational, post-marketing study in Spain (RELIEF study).

UNLABELLED: SUMMARY  AIM: This study evaluated health outcomes in patients with cancer pain during treatment with transdermal buprenorphine, including quality of life, effectiveness, tolerability, and functional consequences for patients and their carers. METHODS: In this 3-month, noncomparative, multicenter, observational study performed in a normal clinical practice setting in Spain, patients received transdermal buprenorphine 37, 52.5 or 70 µg/h, with patches changed every 96 h. The effect of transdermal buprenorphine on quality of life (primary study focus) was assessed using the Visual Analog Scale (VAS) component of the EuroQol 5 Dimensions™ (EQ-5D). In addition, pain (assessed using the Brief Pain Inventory - Short Form [BPI-SF] and VAS-pain), the impact of pain on patients and carers (assessed using the Beck Depression Inventory, sleep quality analysis, VAS-patient limitation, VAS-carer limitation and the Palliative Care Scale), patient's use of health resources, patient satisfaction, and tolerability, were evaluated. RESULTS: Of 116 patients entering the study, 42 completed the 3-month study period. Five patients withdrew due to adverse events. The two main reasons for study discontinuation were nontreatment-related death (27.1%) and lost to follow-up (18.8%). The mean age was 62.9 years and the mean baseline duration of pain was 7.78 weeks. In the month prior to starting transdermal buprenorphine, 80% of patients had received at least one nonopioid analgesic medication; 21% had received an opioid analgesic (most commonly tramadol). The most common dose of transdermal buprenorphine used was 35 µg/h. The mean improvement from baseline in the EQ-5D VAS score among 65 patients with data was 15.20 ± 24.96 (p < 0.0001). EQ-5D descriptive parameters also improved during the study (not statistically significant). Mean improvements in BPI scores for worst pain (3.76) and average pain (3.03) were significant (p < 0.0001). The other measures of pain relief also supported transdermal buprenorphine as an effective analgesic. Sleep quality improved during the study. VAS scores (100 mm scale) for patient limitation and caregiver burden due to pain improved, with a significant mean change in VAS-carer limitation score (30.34; p < 0.0001). Adverse events were reported by ten (8.6%) patients, most commonly affecting the gastrointestinal system (vomiting [4.3% of patients], nausea [2.6%] and constipation [0.9%]). The majority of patients reported satisfaction with their analgesic treatment. CONCLUSIONS: In this observational study in normal clinical practice, transdermal buprenorphine provided effective pain relief and was generally well tolerated by patients with cancer pain. It also improved quality of life for patients and reduced caregiver burden. Considering the high number of study discontinuations (mainly due to nontreatment-related death and lost to follow-up), the results of this study need to be evaluated with caution.

Incidence of oral mucositis, its treatment and pain management in patients receiving cancer treatment at Radiation Oncology Departments in Spanish hospitals (MUCODOL Study).

OBJECTIVE: To estimate the incidence of oral mucositis (OM) in patients receiving radiotherapy, describe the treatments used to manage pain in OM grades 3 and 4 and assess relief of pain and patient satisfaction. PATIENTS AND METHODS: All patients older than 18 years consecutively attending a Radiation Oncology Department over 5 working days were included in a cross-sectional study. The data recorded were RTOG scale of OM (1, 2, 3 or 4), age and sex. In a second stage, a clinical cohort was followed for 2 months. Pain management was assessed in patients with grades 3 and 4. RESULTS: Two thousand and forty-seven patients (98.5%) from 55 participating centres were eligible for the fi rst stage. The overall risk of OM was 16.4% (95% CI 14.8- 18.1); prevalence was 26.4%. In the second stage, 282 (91.6%) of the patients recruited were eligible. At the baseline visit, 95.7% of the population had OM grade 3 and 4.3% grade 4. At two months, OM was resolved in 62.3%, grade 1 in 20%, grade 2 in 10.3% and grade 3 in only 7.4% (p<0.05). 98.9% of the patients had head and neck cancer. From baseline to the two-months session, reported pain fell from 96.1% of affected patients to 39.8%(p<0.01), while chronic pain increased (19.5% vs. 38.2%, p<0.05). Verbal scale OM pain intensity indicated intense pain at baseline in 42.2% and a mean visual analogue scale (VAS) score of 5.6 (2.3). Mean VAS scores fell significantly according to pain intensity due to the OM and cancer (p<0.01). CONCLUSIONS: Pain due to OM, a common complication of chemotherapy and radiation, limits nutritional intake and oral function. Analgesia protocols need to be assessed to improve the quality of life of these patients.

Evaluación del tratamiento del dolor crónico en pacientes oncológicos con buprenorfina transdérmica / Evaluation of transdertnal buprenorphine for the treattnent of chronic pain in cáncer patients

Introducción: El dolor crónico severo en el paciente oncológico no terminal es un problema creciente porque los avances de los tratamientos antineoplásicos están aumentando la supervivencia de los pacientes. Es necesario, pues, el desarrollo de nuevos tratamientos analgésicos eficaces y seguros para estos pacientes. Para ello, la comparación con los resultados terapéuticos en pacientes no oncológicos con dolor crónico resulta de interés. Material y métodos: Se realizó un estudio de post-autorización observacional prospectivo no controlado en el que se siguió durante tres meses a pacientes que comenzaron tratamiento con buprenorfina transdérmica. Se recogió información sistemática sobre el grado de alivio del dolor, la calidad de vida (cuestionario EuroQol-5D), el manejo del parche y los acontecimientos adversos. Los datos ausentes se cubrieron arrastrando valores anteriores válidos. Se presentan comparativamente los resultados obtenidos en un subgrupo de 207 pacientes oncológicos con los de 968 pacientes no oncológicos que participaron en el mismo estudio. Resultados: El 30% de los pacientes oncológicos tenían un tratamiento previo con opioides. El 44’1% precisó de un aumento de dosis, en su mayoría durante el primer mes de tratamiento; proporción significativamente mayor (p<0’001) que entre los no oncológicos (18’8%). Más de dos tercios obtuvieron alivio satisfactorio con independencia del origen del dolor. Se produjo un aumento significativo de la calidad de vida, que fue menor entre los oncológicos (12’2 mm en promedio en una escala analógica visual) que entre los no oncológicos (17’1 mm); y que un análisis ajustado atribuyó principalmente a la mejoría del dolor. La proporción de pacientes que presentaron acontecimientos adversos fue menor entre los oncológicos (42’0%) que entre los no oncológicos (49’1%), p=0’010. Ello mismo ocurrió con los acontecimientos adversos relacionados o los que motivaron el abandono (…) (AU)

Introduction: The concern with chronic severe pain in cáncer patients is growing as antineoplastic therapeutic advances are procuring prolonged survival in many patients. This necessitates the development of new effective and safe analgesic treatments. For this purpose, the comparison of therapeutic outcomes with that obtained in non-cancer patients may be helpful. Methods: A prospective, uncontrolled observational study that included a 3 month follow-up of patients starting transdermal buprenorphine was performed. Information was collected systematically on pain relief, quality of life (EuroQol-5D questionnaire), comfort of patch use and adverse events. Missing data were imputed by carrying forward former observations. This article refers to the comparative results of a subgroup of 207 cáncer patients with that of 968 non-cancer patients that participated in the same study. Results and conclusions: 30% of cáncer patients switched to transdermal buprenorphine from other opioid drug. Dose increases were required by 44% of patients, and most occurred in the first month; this proportion being significantly greater (p<0.001) than among non-cancer patients (18.8%). More than two third achieved satisfactory pain relief, regardless of the origin of pain. There was a significant increase of quality of life score that was, nevertheless, lower among cáncer patients (by an average of 12.2 mm in a visual analogue scale) than among non-cancer patients (17.1 mm); that was mainly attributed to pain improvement. The proportion of patients with adverse events was significantly lower among cancer (42.0%) than non-cancer patients (49.1%), p=0.010. This was true also for related adverse events and withdrawals because of adverse events. Conversely, more cáncer patients had serious adverse events or died during follow-up; although in none case these were related to buprenorphine treatment (...) (AU)

[Effectiveness and safety of transdermal buprenorphine for chronic pain treatment in the elderly: a prospective observational study]. / Efectividad y seguridad de la buprenorfina transdérmica en el tratamiento del dolor crónico en el anciano: estudio de postautorización observacional y prospectivo.

BACKGROUND AND OBJECTIVE: A number of subjects aged over 65 suffer from some kind of chronic pain. The constant growth of this demographic group makes research of new and efficacious treatment strategies necessary. Transdermal buprenorphine has shown to be a safe and efficacious pharmacotherapy for patients with moderate to severe chronic pain in clinical trials. This paper provides the outcome of this drug in routine clinical practice. PATIENTS AND METHOD: A prospective, uncontrolled observational study that included a 3-month follow-up of patients starting transdermal buprenorphine was performed. Information was collected systematically on pain relief, quality of life (EuroQol-5D questionnaire), comfort of patch use and adverse events. Missing data were imputed by the <>. RESULTS: Out of 1,188 patients with known age, 564 were under 65, 337 were between 65 and 75, and 287 were over 75 years. Within these respective age groups, 63.9%, 66.3% and 67.7% of patients showed <> or <> pain relief; 60.4%, 60.7% and 65.2% showed improvement of sleep quality; and the mean increases of the score of the EuroQol-5D visual analogue scale were 16.0 mm, 15.8 mm and 16.8 mm. Drug-related adverse events were reported in 39.6%, 35.4% and 31.9% of patients, respectively. CONCLUSIONS: This study performed in the routine-care setting supports the findings from previous randomised controlled clinical trials of transdermal buprenorphine.

Efectividad y seguridad de la buprenorfina transdérmica en el tratamiento del dolor crónico en el anciano: estudio de postautorización observacional y prospectivo / Effectiveness and safety of transdermal buprenorphine for chronic pain treatment in the elderly: a prospective observational study

Fundamento y objetivo: Una importante proporción de personas mayores de 65 años experimenta algún tipo de dolor crónico. Debido al crecimiento demográfico de este segmento de población, es necesario investigar nuevas estrategias de tratamiento eficaces. Los estudios clínicos han mostrado que la buprenorfina por vía transdérmica es una farmacoterapia eficaz y segura en pacientes con dolor crónico de moderado a intenso. El presente estudio presenta resultados obtenidos en condiciones de práctica clínica habitual. Pacientes y método: Se ha realizado un estudio de postautorización observacional, prospectivo y no controlado, en el que se siguió durante 3 meses a pacientes que comenzaron tratamiento con buprenorfina transdérmica. Se recogió información sistemática sobre el grado de alivio del dolor, la calidad de vida (mediante el cuestionario EuroQol-5D), el manejo del parche y los acontecimientos adversos. Los datos que faltaban se cubrieron empleando la estrategia del «peor caso». Resultados: De los 1.188 pacientes con edad conocida, 564 tenían menos de 65 años, 337 entre 65 y 75 años, y 287 más de 75 años. En estos grupos de edad, un 63,9, un 66,3 y un 67,7%, respectivamente, presentaron alivio del dolor «bueno» o «muy bueno», y un 60,4, un 60,7 y un 65,2%, respectivamente, mejoría de la calidad del sueño. Los aumentos medios de puntuación en la escala analógica visual del EuroQol-5D fueron de 16,0; 15,8, y 16,8 mm, respectivamente. Presentaron acontecimientos adversos relacionados con la buprenorfina el 39,6, el 35,4 y el 31,9%, respectivamente. Conclusiones: Este estudio confirma, en condiciones de práctica clínica habitual, los resultados obtenidos con la buprenorfina transdérmica en los ensayos clínicos aleatorizados y controlados

Background and objective: A number of subjects aged over 65 suffer from some kind of chronic pain. The constant growth of this demographic group makes research of new and efficacious treatment strategies necessary. Transdermal buprenorphine has shown to be a safe and efficacious pharmacotherapy for patients with moderate to severe chronic pain in clinical trials. This paper provides the outcome of this drug in routine clinical practice. Patients and method: A prospective, uncontrolled observational study that included a 3-month follow-up of patients starting transdermal buprenorphine was performed. Information was collected systematically on pain relief, quality of life (EuroQol-5D questionnaire), comfort of patch use and adverse events. Missing data were imputed by the «worst case». Results: Out of 1,188 patients with known age, 564 were under 65, 337 were between 65 and 75, and 287 were over 75 years. Within these respective age groups, 63.9%, 66.3% and 67.7% of patients showed «good» or «very good» pain relief; 60.4%, 60.7% and 65.2% showed improvement of sleep quality; and the mean increases of the score of the EuroQol-5D visual analogue scale were 16.0 mm, 15.8 mm and 16.8 mm. Drug-related adverse events were reported in 39.6%, 35.4% and 31.9% of patients, respectively. Conclusions: This study performed in the routine-care setting supports the findings from previous randomised controlled clinical trials of transdermal buprenorphine

Effectiveness and tolerability of the buprenorphine transdermal system in patients with moderate to severe chronic pain: a multicenter, open-label, uncontrolled, prospective, observational clinical study.

BACKGROUND: A new transdermal delivery system (TDS) for the rate-controlled systemic delivery of buprenorphine is available in 3 patch strengths, with release rates of 35, 52.5, and 70 microg/h over 72 hours, delivering daily amounts of 0.8, 1.2, and 1.6 mg, respectively. Randomized, double-blind, placebo-controlled, Phase III clinical trials in >400 patients with severe pain of malignant or nonmalignant origin have shown the analgesic efficacy of buprenorphine TDS. OBJECTIVE: This study investigated the effectiveness and tolerability of buprenorphine TDS for the relief of chronic pain in routine clinical practice. METHODS: This was a multicenter, open-label, uncontrolled, prospective, observational, 3-month follow-up study in patients who were beginning buprenorphine TDS treatment for moderate to severe cancer or noncancer pain that had not responded to nonopioid analgesics. Patches were to be changed every 72 hours. Patients were evaluated at 1 and 3 months after the start of treatment. Those who dropped out were considered treatment failures. Pain relief was assessed on a 5-category verbal rating scale, and quality of life was assessed using the European Quality of Life 5D (EQ-5D) questionnaire. Tolerability was determined based on adverse events recorded during the follow-up period. RESULTS: The study recruited 1223 patients, most of whom were outpatients. Of the 1212 patients for whom sex data were available, 820 (67.7%) were women. In the 1188 patients with age data, the mean (SD) age was 64.9 (12.9) years. In the 1175 patients with data on the etiology of pain, 82.4% had noncancer pain. Six hundred eighty-eight (56.3%) patients completed the 3-month follow-up period. The median daily amount of buprenorphine TDS received at the beginning of the study was 0.8 mg (corresponding to 35 microg/h). Over the study period, there was a significant increase in the proportion of patients reporting very good or good pain relief (P < 0.001), from 3.6% (43/1205) at baseline to 63.2% (762/1205) after 1 month and 56.8% (685/1205) after 3 months. Quality of life also improved, from a mean (SD) EQ-5D score of 40.6 (20.5) at baseline to 56.8 (23.5) at 3 months (P < 0.001). Five hundred seventeen (42.3%) of the original 1223 patients experienced adverse events; the investigator judged 397 (32.5%) of these events possibly or probably related to study drug. The likelihood of experiencing a drug-related adverse event was greater in noncancer patients than in cancer patients. The most common adverse events were nausea (11.0%), vomiting (9.2%), and constipation (7.8%); the most common local adverse events were pruritus (1.4%), dermatitis (1.3%), and erythema (1.3%). CONCLUSION: In the population studied, buprenorphine TDS was effective in alleviating cancer and noncancer pain and was well tolerated overall.