Use of metamizole and other non-opioid analgesics in Switzerland between 2014 and 2019: an observational study using a large health insurance claims database.

OBJECTIVE: To investigate claims patterns for metamizole and other non-opioid analgesics in Switzerland. To characterise users of these non-opioid analgesics regarding sex, age, comedications and canton of residence. METHODS: We conducted a retrospective descriptive study using administrative claims data of outpatient prescribed non-opioid analgesics of the Swiss health insurance company Helsana between January 2014 and December 2019. First, we evaluated the number of claims and defined daily doses  per year of metamizole, ibuprofen, diclofenac and paracetamol in adults aged 18 years or over. Second, we characterised new users of these non-opioid analgesics in terms of sex, age, claimed comedications and canton of residence. RESULTS: From 2014 to 2019, among the investigated non-opioid analgesics, metamizole showed the highest increase in claims (+9545 claims, +50%) and defined daily doses (+86,869 defined daily doses, +84%) per 100,000 adults. Metamizole users had the highest median age (62 years [IQR: 44-77]) compared to ibuprofen (47 years [IQR: 33-62]), diclofenac (57 years [IQR: 43-71]) and paracetamol (58 years [IQR: 39-75]) users. Metamizole users also more frequently claimed proton pump inhibitors, anticoagulants, platelet aggregation inhibitors and antihypertensive drugs than users of other non-opioid analgesics. While metamizole was most frequently claimed in German-speaking regions of Switzerland, ibuprofen and paracetamol were most frequently claimed in the French-speaking regions and diclofenac in German- and Italian-speaking regions. CONCLUSION: In Switzerland, metamizole was increasingly claimed between 2014 and 2019. Metamizole was most frequently claimed by older adults and patients with comedications suggestive of underlying conditions, which can be worsened or caused by use of nonsteroidal anti-inflammatory drugs. The lack of studies regarding the effectiveness and safety of metamizole in this population warrants further investigation.

Diclofenaco para o tratamento da dor crônica musculoesquelética / Diclofenac for the treatment of chronic pain musculoskeletal

INTRODUÇÃO: A dor é definida como uma experiência sensorial e emocional desagradável, associada com dano tecidual real ou potencial. A dor de predomínio nociceptivo, objeto do presente relatório, ocorre por ativação fisiológica de receptores de dor e está relacionada à lesão de tecidos ósseos, musculares ou ligamentares e geralmente responde bem ao tratamento sintomático com analgésicos ou Anti-Inflamatórios Não Esteroides (AINEs). Dada a complexidade do tratamento da dor crônica musculoesquelética, o presente relatório foi elaborado com o objetivo de compreender a viabilidade do uso de diclofenaco de sódio ou potássio no tratamento dessas condições clínicas, visando sua possível incorporação no SUS. TECNOLOGIAS: Diclofenaco de sódio. PERGUNTA: O diclofenaco de sódio/potássio é seguro, eficaz e custo-efetivo para o tratamento de pacientes com osteoartrite ou artrite reumatoide e dor crônica osteoarticular, comparado ao ibuprofeno e naproxeno? EVIDÊNCIAS CIENTÍFICAS: A busca pelas evidências retornou um total de 2.650 referências, das quais duas revisões sistemáticas com meta-análise em

Diclofenaco para o tratamento da dor crônica musculoesquelética / Diclofenac for the treatment of chronic pain musculoskeletal

INTRODUÇÃO: A dor é definida como uma experiência sensorial e emocional desagradável, associada com dano tecidual real ou potencial. A dor de predomínio nociceptivo, objeto do presente relatório, ocorre por ativação fisiológica de receptores de dor e está relacionada à lesão de tecidos ósseos, musculares ou ligamentares e geralmente responde bem ao tratamento sintomático com analgésicos ou Anti-Inflamatórios Não Esteroides (AINEs). Dada a complexidade do tratamento da dor crônica musculoesquelética, o presente relatório foi elaborado com o objetivo de compreender a viabilidade do uso de diclofenaco de sódio ou potássio no tratamento dessas condições clínicas, visando sua possível incorporação no SUS. TECNOLOGIAS: Diclofenaco de sódio. PERGUNTA: O diclofenaco de sódio/potássio é seguro, eficaz e custo-efetivo para o tratamento de pacientes com osteoartrite ou artrite reumatoide e dor crônica osteoarticular, comparado ao ibuprofeno e naproxeno? EVIDÊNCIAS CIENTÍFICAS: A busca pelas evidências retornou um total de 2.650 referências, das quais duas revisões sistemáticas com meta-análise em

Assessment of C-reactive Protein Level and Efficacy of Diclofenac Sodium and Mefenamic Acid in Relieving Pain in Mandibular Impacted Third Molar Surgery.

AIM: To compare the efficacy of diclofenac sodium and mefenamic acid in relieving pain in mandibular impacted third molar surgery and to assess the level of the C-reactive protein (CRP) level. MATERIALS AND METHODS: This study was conducted on 90 patients of impacted mandibular third molars. All patients were administered with 2% lignocaine with 1:80,000 adrenaline, and surgical removal of impacted third molar was done following the standardized surgical procedure by a single oral surgeon. Patients were divided into two groups of 45 each. In group I, patients were prescribed 50 mg diclofenac sodium and in group II patients were prescribed 500 mg mefenamic acid for three times a day for 3 days. The CRP level was again evaluated after 3 days of analgesics. Pain was assessed using the visual analog scale (VAS). RESULTS: The mean VAS was 2.58 in group I and 3.46 in group II, which was statistically considerable (p < 0.05). The mean CRP level postoperatively in group I was 15.7 and after 3 days was 27.2 in group I, whereas it was 25.1 postoperatively and 31.5 after 3 days in group II. CONCLUSION: Authors found that diclofenac sodium as useful as mefenamic acid. The CRP level was raised significantly following surgery, thus reflecting that it is an indicator of inflammation. CLINICAL SIGNIFICANCE: Diclofenac sodium can be used to relieve pain. The CRP level evaluation can be helpful to assess inflammation following surgery.

Opioid Free Ureteroscopy: What is the True Failure Rate?

OBJECTIVE: To determine the true failure rate of opioid free ureteroscopy (OF-URS) and rates of new-persistent opioid use utilizing a national prescription drug monitoring program. MATERIAL AND METHODS: We identified 239 patients utilizing our retrospective stone database who underwent OF-URS from Februrary 2018-March 2020. In Feb 2018, we initiated a OF-URS pathway (diclofenac, tamsulosin, acetaminophen, pyridium and oxybutynin). Patients who had a contraindication to NSAIDs were excluded from primary analyses. A prescription drug monitoring program was then utilized to determine the number of patients who failed OF-URS (defined as receipt of an opioid within 31 days of surgery) as well as rates of new-persistent opioid use (defined as receipt of opioid 91-180 days after surgery). All statistical analyses were performed using SAS 9.4. Tests were 2-sided and statistical significance was set at P<0.05. RESULTS: We found a OF-URS failure rate of 16.6% and 14.0% in the total and opioid naïve cohorts, respectively. Rates of new-persistent opioid use were 0.9% and 1.2%, respectively (lower than published expected rate of ~6% after URS with postoperative opioids). 91% of patients obtained opioid from alternative sources. Uni/multivariate analyses were performed for both cohorts. In the total cohort, benzodiazepine users had a lower risk of OF-URS failure on multivariate analysis. No variables were associated with OF-URS failure in the opioid naïve cohort. CONCLUSION: The true failure rate of OF-URS is higher than previously thought at 16.6% and 14.0%. However, efforts to reduce opioid prescriptions with OF-URS pathways have successfully reduced new-persistent opioid use.

[Assessment of the safety, tolerability and effectiveness of first Russian generic aceclofenac in patients with undifferentiated peripheral inflammatory arthritis].

AIM: To evaluate the effectiveness and tolerability of the drug in patients with undifferentiated peripheral inflammatory arthritis (UPIA). MATERIALS AND METHODS: We observed 60 patients (39 women and 21 men) met G. Hazlewood et al., UPIA criteria, 2011. Patients were divided into 3 groups: with monoarthritis, oligoarthritis and polyarthritis. They took aceclofenac 100 mg twice day for 3 weeks. RESULTS: We noted significant decreasing in pain level according to visual analogue scale: in patients with monoarthritis by 69.3 mm (p0.001); in oligoarthritis group by 47.5 mm (p0.001), in patients with polyarthritis by 30 mm (p0.001). The life quality by the EQ-5D-5L index was improved too in all groups from 0.616 to 0.829 (p0.001). The satisfaction with the therapy was: in monoarthritis patients (80% of patients and 93% of doctors noted good results), in oligoarthritis group (53% and 39% accordingly) and polyarthritis (74% and 64% respectively). We suppose the difference was due to the fact that mono- and oligoarthritis patients suffered from initial forms of seronegative spondylarthropathy, in which the effectiveness of NSAIDs is traditionally higher; polyarthritis patients probably had debut of rheumatoid arthritis. Adverse events of therapy were mild. We noted gastrointestinal tract symptoms (dyspepsia) and increased ALT in 10 patients and increased blood pressure in 1 patient. The symptoms did not require discontinuation of therapy. Сonclusion. Post-registration observational study of first Russian generic aceclofenac (Alental, Vertex, Russia) was conducted. In UPIA patients aceclofenac therapy was most effective in mono- and oligoarthritis patients. The first Russian generic aceclofenac (Alental, Vertex, Russia) has good efficacy, tolerability and safety and can be recommended for arthritis treatment.

Prise en charge thérapeutique des kératoses actiniques: Treatment of actinic keratoses.

Dermatologists have many therapeutic options for the management of actinic keratoses (AK), in order to treat individual lesions or wider areas. Field cancerization is an area of sun-damaged skin, where visible and subclinical lesions co-exist, and is prone to the development of further AK lesions and sun-related skin cancers (SC). Treatments available are instrumental or medical. Resistance to treatment or atypical symptoms must lead to a biopsy for histological exam. Cryotherapy is the most frequently used method to destroy small or isolated AK, whereas photodynamic therapy (PDT), 5-fluoro-uracil (5-FU), imiquimod, ingenol mebutate and diclofenac are required for large, multiple lesions, and for the treatment of field cancerization. Side-effects of these therapies are essentially local, including pain, irritation, erythema, edema and scars. There is no randomized comparative study reviewing all these treatments, therefore physicians must also consider clinical characteristics, patient's compliance, side-effects and cost when treating AK. Medicoeconomic data of these treatments have been analyzed in several countries, and annual costs are estimated between 250 € and 2 000 €, with an uncertain cost-effective relation. Finally, beyond treatment of AK lesions, patients with AK are at high risk of developing SC, and must therefore have regular full-body examination, in order to be detected and treated precociously. © 2019 Elsevier Masson SAS. All rights reserved. Cet article fait partie du numéro supplément Kératoses actiniques : comprendre et traiter réalisé avec le soutien institutionnel de Galderma International.

Evaluation of the treatment costs and duration of topical treatments for multiple actinic keratosis based on the area of the cancerization field and not on the number of lesions.

BACKGROUND: The cost of topical treatments for actinic keratosis (AK) has historically been evaluated in relation to the number of lesions requiring treatment or simply by the price of a single tube/sachet of the drug used. OBJECTIVE: To demonstrate a new method of costing topical treatments in AK, which takes into account the actual cancerization area treated. METHODS: In order to evaluate the actual cost of each treatment, the official approval status of the drug was used to estimate the amount of cream needed per one cm2 . This value was then applied to the hypothetical cancerization area sizes to demonstrate the impact of the size treated on the actual cost of treatment. The price considered was the ex-factory price in Italy. RESULTS: Areas which could be treated with a single tube/sachet of Metvix® , Picato® , Aldara® , Solaraze® and Zyclara® were 200, 25, 25, 33.3 and 200 cm2 , respectively. For the treatment of smaller areas (<100 cm2 ), treatment with Metvix® was the most costly topical option in Italy. However, for the treatment of cancerization areas larger than 100 cm2 , Metvix® was the least expensive treatment option. Treatment with Metvix® was least long, requiring a single day of treatment for an area of up to 200 cm2 , compared with up to 224 days of treatment with Aldara® for the treatment of a similar size. CONCLUSION: Changing treatment costing strategy in the management of multiple AKs towards costing per cancerization area instead of costing per lesion is a much more accurate representation of the 'real world cost' for AK.

Analgesic prescribing patterns of dental practitioners in Germany.

PURPOSE: To analyze the prescribing patterns of analgesics by dentists in Germany during an investigation period of five years in comparison to analgesic prescriptions by physicians and in relation to international prescribing data. MATERIALS AND METHODS: We analyzed nationwide data of all prescriptions of analgesics and antiphlogistics (except strong opioids) on the basis of the annual reports of the German statutory health insurances from 2012 to 2016. The types of analgesics, the number of prescriptions and the prescribed 'defined daily doses' (DDD) itemized by dentists and physicians were analyzed. The results were compared with each other and assigned to international dental prescribing data. RESULTS: During the investigation period the number of dental prescriptions of analgesics decreased by 3.4%, on the part of the physicians the increase amounted to 10.4%. Ibuprofen is the first line analgesic in Germany, its share in the dental analgesic prescription volume increased from 61.9% in 2012 to 88.1% in 2016. In the international comparison it could be demonstrated that nonsteroidal anti-inflammatory drugs (NSAIDs) play the most important role in nearly all countries. CONCLUSIONS: Continual training activities and international monitoring of dental analgesic prescription patterns are necessary to develop guidelines for the rational and appropriate use of analgesics in dentistry.

Assessment of the Effect of 3% Diclofenac Sodium on Photodamaged Skin by Means of Reflectance Confocal Microscopy.

Treatment of actinic keratosis with 3% diclofenac sodium w/w in hyaluronic acid is associated with a concomitant improvement in signs of photodamaged skin. However this effect has not yet been examined in depth. Twenty patients with actinic keratosis and signs of photodamaged skin were studied. They received treatment with diclofenac sodium w/w in hyaluronic acid for 2 months. Clinical and reflectance confocal microscopy assessment on signs of photodamaged skin were performed. Regarding reflectance confocal microscopy, the most common descriptors were: irregular honeycomb pattern in 18/20 patients (90%), mottled pigmentation in 17/20 (85%), coarse collagen structures in all patients, and huddled collagen and curled bright structures in 16/20 (77.8%). After treatment, significant improvement in clinical parameters: irregular pigmentation and coarseness, and confocal parameters: irregular honeycomb pattern and mottled pigmentation, were noted. Reflectance confocal microscopy is a useful tool in monitoring changes in photodamaged skin after treatment. The use of diclofenac sodium w/w in hyaluronic acid is associated with an improvement in some clinical and reflectance confocal microscopy parameters of photodamaged skin.

Assessment of the antinociceptive and ulcerogenic activity of the tapentadol-diclofenac combination in rodents.

Preclinical Research & Development The objective of the present study was to evaluate the tapentadol-diclofenac combination in three dose-ratios in the mouse acetic acid-induced visceral pain and their ulcerogenic activity on the stomachal mucous. Dose-response curves were generated for tapentadol, diclofenac, and their combination in the acetic acid-induced writhing test in mice. Moreover, the stomachs of animals were surgically removal and gastrointestinal ulcerogenic action of the combination was assessed. The isobolographic analysis, interaction index, and ANOVA were used to analyze the data. The isobolographic analysis and interaction index showed a similar antinociceptive activity for the three combinations of the analgesic mixture. Moreover, tapentadol and the proportions 1:1 or 3:1 of the analgesic combination caused a mild gastrointestinal damage. These data indicate that the systemic co-administration of tapentadol and diclofenac produced a synergistic interaction in the acetic acid-induced visceral pain test with an acceptable gastric damage profile in mice.

Cost-effectiveness of Ingenol Mebutate Gel for the Treatment of Actinic Keratosis in Greece.

PURPOSE: The present study aimed to perform a cost-effectiveness analysis of ingenol mebutate (IM) versus other topical alternatives for the treatment of actinic keratosis (AK). METHODS: The analysis used a decision tree to calculate the clinical effects and costs of AK first-line treatments, IM (2-3 days), diclofenac 3% (for 8 or 12 weeks), imiquimod 5% (for 4 or 8 weeks), during a 24-month horizon, using discrete intervals of 6 months. A hypothetical cohort of immunocompetent adult patients with clinically confirmed AK on the face and scalp or trunk and extremities was considered. Clinical data on the relative efficacy were obtained from a network meta-analysis. Inputs concerning resource use derived from an expert panel. All costs were calculated from a Greek third-party payer perspective. FINDINGS: IM 0.015% and 0.05% were both cost-effective compared with diclofenac and below a willingness-to-pay threshold of €30,000 per quality-adjusted life-year (QALY) (€199 and €167 per QALY, respectively). Comparing IM on the face and scalp AK lesions for 3 days versus imiquimod for 4 weeks resulted in an incremental cost-effectiveness ratio of €10,868 per QALY. IM was dominant during the 8-week imiquimod period. IM use on the trunk and extremities compared with diclofenac (8 or 12 weeks) led to incremental cost-effectiveness ratios estimated at €1584 and €1316 per QALY accordingly. Results remained robust to deterministic and probabilistic sensitivity analyses. IMPLICATIONS: From a social insurance perspective in Greece, IM 0.015% and IM 0.05% could be the most cost-effective first-line topical field treatment options in all cases for AK treatment.

Efficacy of paracetamol, diclofenac and advice for acute low back pain in general practice: design of a randomized controlled trial (PACE Plus).

BACKGROUND: Low back pain is common and associated with a considerable burden to patients and society. There is uncertainty regarding the relative benefit of paracetamol and diclofenac and regarding the additional effect of pain medication compared with advice only in patients with acute low back pain. This trial will assess the effectiveness of paracetamol, diclofenac and placebo for acute low back pain over a period of 4 weeks. Furthermore, this trial will assess the additional effectiveness of paracetamol, diclofenac and placebo compared with advice only for acute low back pain over a period of 4 weeks. METHODS: The PACE Plus trial is a multi-center, placebo-blinded, superiority randomized controlled trial in primary care, with a follow-up of 12 weeks. Patients with acute low back pain aged 18-60 years presenting in general practice will be included. Patients are randomized into four groups: 1) Advice only (usual care conforming with the clinical guideline of the Dutch College of General Practitioners); 2) Advice and paracetamol; 3) Advice and diclofenac; 4) Advice and placebo. The primary outcome is low back pain intensity measured with a numerical rating scale (0-10). Secondary outcomes include compliance to treatment, disability, perceived recovery, costs, adverse reactions, satisfaction, sleep quality, co-interventions and adequacy of blinding. Between group differences for low back pain intensity will be evaluated using a repeated measurements analysis with linear effects models. An economic evaluation will be performed using a cost-effectiveness analysis with low back pain intensity and a cost-utility analysis with quality of life. Explorative analyses will be performed to assess effect modification by predefined variables. Ethical approval has been granted. Trial results will be released to an appropriate peer-viewed journal. DISCUSSION: This paper presents the design of the PACE Plus trial: a multi-center, placebo-blinded, superiority randomized controlled trial in primary care that will assess the effectiveness of advice only, paracetamol, diclofenac and placebo for acute low back pain. TRIAL REGISTRATION: Dutch Trial Registration NTR6089 , registered September 14th, 2016. PROTOCOL: Version 4, June 2016.

Análisis de impacto presupuestal de medicamentos para el tratamiento del episodio agudo de migraña en Colombia / Analysis of the budget impact of medications for the treatment of acute migraine episodes in Colombia

INTRODUCCIÓN: El análisis de impacto presupuestal de los medicamentos para el tratamiento preventivo y del episodio agudo de pacientes con migraña en Colombia se desarrolla en el marco del mecanismo técnico-científico para la ampliación progresiva del plan de beneficios y la definición de la lista de exclusiones, establecido en el artículo 15 de la Ley 1751 de 2015. Estas tecnologías fueron seleccionadas por la Dirección de Beneficios, Costos y Tarifas del Aseguramiento en Salud del Ministerio de Salud y Protección Social (MinSalud), y remitidas al Instituto de Evaluación Tecnológica en Salud (IETS) para su evaluación. Este análisis de impacto presupuestal sigue las pautas del Manual Metodológico para la elaboración del análisis de impacto presupuestal y del Manual Metodológico de Participación y Deliberación publicados por el Instituto de Evaluación Tecnológica en Salud (IETS). Como etapa subsecuente al reporte de efectividad y seguridad, actualmente en elaboración, esta evaluación se ceñirá a los parámetros de la pregunta PICO que allí se especifiquen. La migraña es una condición neurológica altamente prevalente, que genera un impacto importante en la calidad de vida relacionada con la salud; se asocia con discapacidad funcional, que afecta, tanto aspectos de la vida social y familiar, como aspectos académicos y ocupacionales, generando pérdidas de productividad significativas y, por ende, una carga socioeconómica considerable. Ha sido reconocida por la Organización Mundial de la Salud (OMS) como una de las 20 primeras causas de discapacidad en el mundo y según el estudio de carga de enfermedad global del año 2010, la migraña representa la octava causa, en términos de años vividos con discapacidad (AVD). La migraña es un tipo de cefalea primaria que se manifiesta generalmente entre los 25 y 50 años de edad; afecta con mayor frecuencia a las mujeres, en una relación estimada de 3:1 comparado con hombres y presenta un componente hereditario importante, reportándose en familiares de primer grado, un riesgo de padecer migraña de 1.5 a 4 veces mayor que el de la población general. Aunque existe una importante variabilidad en la presentación clínica, la migraña generalmente se caracteriza por episodios de cefalea pulsátil unilateral, asociada a síntomas como náusea, vómito, fotofobia y fonofobia. Se estima una prevalencia entre 3% y 24% en la población mundial y de acuerdo con cifras reportadas para América Latina, en Colombia el 13.8% de las mujeres y el 4.8% de los hombres padecen de esta condición. De los 4.5 millones de personas que padecen de migraña en el país, aproximadamente 30% requieren tratamiento preventivo. La Clasificación Internacional de Cefaleas (ICHD, por su sigla en inglés), define la migraña crónica como la presencia de cefalea 15 o más días al mes, durante al menos tres meses, de los cuales, al menos ocho, deben cumplir criterios de migraña. Las formas crónicas de la migraña se asocian con mayor discapacidad y deterioro de la calidad de vida, en comparación con las formas episódicas, lo que genera la necesidad de instaurar terapias preventivas, cuyo objetivo es disminuir la frecuencia de los días de cefalea, la intensidad de los episodios, y la mejoría de la calidad de vida de estos pacientes. El tratamiento del episodio agudo de migraña, tiene como objetivo disminuir la duración y la intensidad del mismo, restaurar la funcionalidad del paciente y minimizar el uso de medicación de rescate. Dentro de las alternativas terapéuticas, se encuentran los agentes antimigrañosos específicos como los triptanes y los ergotamínicos y los agentes no específicos, como los analgésicos y los antiinflamatorios no esteroideos (AINES). Por otro lado, el tratamiento preventivo debe ser considerado en aquellos pacientes en quienes la frecuencia e intensidad de los episodios de cefalea generan un impacto significativo en la calidad de vida, a pesar del uso adecuado de medicamentos durante el episodio agudo y un adecuado control de factores desencadenantes, o cuando la frecuencia de los episodios es tan alta, que se genera un riesgo importante de sobreuso de medicamentos. Se recomienda que la duración del tratamiento preventivo sea de al menos un año, con el propósito de reducir la frecuencia de las crisis en al menos 50%, disminuir su intensidad, duración y limitar la dependencia a la medicación aguda. Este documento tiene como objetivo presentar el análisis de impacto presupuestal que tendría incorporar al Plan de Beneficios en Salud con cargo a la UPC (PBSUPC) los siguientes medicamentos: naratriptán, sumatriptán, sumatriptán/naproxeno, zolmitriptán, acetaminofén más ácido acetil salicílico más cafeína para el tratamiento del episodio agudo; flunarizina, y topiramato para el tratamiento preventivo de migraña en Colombia. El documento se encuentra organizado en cuatro secciones: la primera contiene una introducción que describe la indicación de interés y el objetivo del documento. La segunda parte describe todas las tecnologías evaluadas en el análisis de impacto presupuestal; la tercera el modelo y la cuarta la presentación de resultados. INSUMOS Y MÉTODOS: Esta sección presenta los supuestos, parámetros y métodos utilizados para el modelo de estimación del impacto presupuestal describiendo la siguiente información: Perspectiva: La perspectiva de este AIP corresponde al tercero pagador, que en este caso es el Sistema General de Seguridad Social en Salud. Horizonte temporal: El horizonte temporal de este AIP en el caso base corresponde a un año. Adicionalmente, se reportan las estimaciones del impacto presupuestal para los años 2 y 3, bajo el supuesto de la inclusión en el PBSUPC en el año 1. Población total: La población total en el análisis corresponde a hombres y mujeres mayores de 18 años en Colombia con diagnóstico de migraña e indicación para manejo farmacológico. RESULTADOS: Los resultados de este AIP, presentados en la tabla 10, indican que en el caso base y con los precios actuales, la inclusión de naratriptán, sumatriptán, sumatriptán/naproxeno, zolmitriptán, la combinación acetaminofén más ácido acetil salicílico y cafeína, como tratamiento para el episodio agudo de migraña implica un esfuerzo presupuestal en el escenario 1 de $1.420.755.082 en el año 1, de $6.952.980.454 en el año 2 y de $12.202.503.302 en el año 3. La segunda parte de los resultados, presentados en la tabla 11, indican que en el caso base y con los precios actuales, la inclusión de la flunarizina y el topiramato para el tratamiento preventivo de migraña, implica un esfuerzo presupuestal de $461.316.332 en el año 1, $5.893.128.981 en el año 2 y de $7.996.160.915 en el año 3. Finalmente, en las tablas 12 y 13 se presentan los análisis de sensibilidad para cada escenario.

Análisis de impacto presupuestal de medicamentos para el tratamiento preventivo de migraña en Colombia / Analysis of the budgetary impact of medications for the preventive treatment of migraine in Colombia

INTRODUCCIÓN: El análisis de impacto presupuestal de los medicamentos para el tratamiento preventivo y del episodio agudo de pacientes con migraña en Colombia se desarrolla en el marco del mecanismo técnico-científico para la ampliación progresiva del plan de beneficios y la definición de la lista de exclusiones, establecido en el artículo 15 de la Ley 1751 de 2015. Estas tecnologías fueron seleccionadas por la Dirección de Beneficios, Costos y Tarifas del Aseguramiento en Salud del Ministerio de Salud y Protección Social (MinSalud), y remitidas al Instituto de Evaluación Tecnológica en Salud (IETS) para su evaluación. Este análisis de impacto presupuestal sigue las pautas del Manual Metodológico para la elaboración del análisis de impacto presupuestal y del Manual Metodológico de Participación y Deliberación publicados por el Instituto de Evaluación Tecnológica en Salud (IETS). Como etapa subsecuente al reporte de efectividad y seguridad, actualmente en elaboración, esta evaluación se ceñirá a los parámetros de la pregunta PICO que allí se especifiquen. La migraña es una condic

Pharmacoeconomy of drugs used in the treatment of actinic keratoses.

Actinic keratosis (AK) represents an emerging issue in the area of skin diseases which undergo high risk for developing squamous cell carcinoma (SCC). Recently, evidence has been accumulated that 3% diclofenac sodium and ingenol mubetate may efficiently counteract the development of progressive AK even if the pharmacoeconomic impact of such a treatment remains poorly defined. With the objective of assessing the efficacy of 3% diclofenac sodium versus ingenol mebutate, a comparative cost-efficacy analysis was performed between both pharmacological treatments. In the present analysis, data of efficacy of clinical studies were combined with information on the quality of life associated with AK lesions based on available literature data. Furthermore, the cost associated with the management of these lesions in Italy has been taken into account. To this purpose, we carried out a literature survey on the clinical and economic data among clinical reports available in Italy based on the assessment of related expenditure of public resources and their relationship with the subsequent health benefits.

Macular assessment using Optical Coherence Tomography in patients after uneventful phacoemulsification treated postoperatively with bromfenac, diclofenac or dexamethasone.

Aim: To assess macular thickness and volume using optical coherence tomography in patients treated with different anti-inflammatory agents after uneventful phacoemulsification. Material and methods: We analysed macular parameters using optical coherence tomography in 50 consecutive patients (mean age 70.5 years) who underwent uneventful phacoemulsification cataract surgery at the Ophthalmology Department, Medical University of Warsaw between March 2012 and January 2013. Patients were divided into 3 groups, according to 3 different anti- -inflammatory agents used during the postoperative period: group T receiving dexamethasone 0.1% (n=17), group Y receiving bromfenac sodium 0.09% (n=16) and group D receiving diclofenac sodium (n=17). We evaluated macular scans obtained the day before surgery and on days 1., 7., 30. and 90. postoperatively. Central subfield thickness, cube volume and cube average thickness were measured during the optical coherent tomography. The data was analysed statistically using the SAS 9.2 software. The graphs were prepared using the STATISTICA 12 software. Results: A significant increase in central subfield thickness was observed on day 30. postoperatively. However, there were no statistically significant differences in macular thickness between the study groups. Conclusions: Central retinal thickness increases after uneventful phacoemulsification despite active anti-inflammatory treatment and irrespective of the drug class used.

A cost-utility analysis of ingenol mebutate gel for the treatment of actinic keratosis: a Scottish perspective.

BACKGROUND: Actinic keratosis (AK) is a UV-induced, pre-malignant skin condition that is common in adults over 60 years of age with fair skin in Scotland. The most commonly prescribed first-line treatment for AK in Scotland is currently diclofenac gel (3 %). Ingenol mebutate gel is a recently developed topical therapy available in two strengths for the treatment of AK lesions on the face and scalp (150 mcg/g once daily for 3 consecutive days) or trunk and extremities (500 mcg/g once daily for 2 consecutive days). OBJECTIVE: To compare the cost-effectiveness of two strengths of ingenol mebutate gel developed to treat AK lesions on the face and scalp (150 mcg/g once daily for 3 consecutive days) or trunk and extremities (500 mcg/g once daily for 2 consecutive days) with other first-line AK therapies including diclofenac gel, 5-FU, 5-FU/salicylic acid, and cryotherapy for the first-line treatment of AK in adult patients, from the perspective of the National Health Service (NHS) in Scotland. METHODS: A cost-utility analysis was conducted using a decision-tree approach to calculate the costs and benefits of different treatment strategies for AK on the face and scalp or trunk and limbs over a 12-month time horizon. Data on the relative efficacy of treatments were obtained from a systematic literature review and meta-analysis. Utility scores and resource-use data were obtained from published sources. RESULTS: Over 12 months, ingenol mebutate 150 mcg/g gel and 500 mcg/g gel were cost-effective compared with the most commonly used topical therapy in Scotland, diclofenac (3 %) gel, at a willingness-to-pay threshold of £20,000 per QALY, with a minimal additional cost of £43 and £105, respectively per QALY gained. CONCLUSIONS: Ingenol mebutate gel is a cost-effective therapy for the first-line treatment of AK from a Scottish NHS perspective.

Introduction of a manual vacuum aspiration service: a model of service within a NHS Sexual Health Service.

BACKGROUND: We assessed the applicability, acceptability and cost implications of introducing the manual vacuum aspiration (MVA) technique with local anaesthesia for fully conscious first-trimester termination of pregnancy within our service and for our population. SETTING: The outpatient setting of a Pregnancy Advisory Service within a NHS Sexual Health Service. METHODS: Self-administered misoprostol and diclofenac, extra-amniotic local anaesthetic gel and paracervical mepivicaine prior to MVA. Routinely collected data were used to provide information on uptake, demographic details, timing, pain score, complications, contraceptive uptake, and economic implications for our service. RESULTS: MVA was chosen by 305/1681 potentially eligible women. Forty percent had the procedure on the day they attended for assessment. Seventy-nine percent gave a pain score of 3 or less out of 10. Complications occurred in six cases (2%); these included cervical rigidity, a false passage, retained products of conception, bleeding (more than 200 ml) and one allergic reaction. Eighty percent of women chose to commence a long-acting reversible contraception (LARC) method at the time of MVA. Operating theatre utilisation was reduced by one termination list per week and cost savings of around £60,000 per annum were realised. CONCLUSIONS: The technique for fully conscious MVA was very suitable for our outpatient setting. It was associated with very low levels of pain and bleeding. The uptake of LARC was high, and particularly the ability to provide intrauterine contraception at MVA was associated with a very high uptake.

Assessment of Pharmacological Prophylaxis for Acute Pancreatitis Following ERCP in Patients with Choledoholithiasis.

UNLABELLED: Endoscopic retrograde cholangiopancreatography (ERCP) is an effective tool in the diagnostics and treatment of bile duct diseases. Although minimally invasive, the procedure is associated with a risk of complications, with acute pancreatitis being the most serious. In recent years, high hopes have been placed on pharmacological prevention of acute pancreatitis after ERCP. The aim of the study was assessment of the efficacy of low-molecular-weight heparin and somatostatin in combination with diclofenac in the prevention of acute pancreatitis after ERCP. MATERIAL AND METHODS: The study enrolled three groups of 30 patients diagnosed with cholelithiasis; group I: patients who received low-molecular-weight heparin prior to ERCP, group II: patients who received somatostatin and diclofenac, group III: control group. The study assessed the incidence of acute pancreatitis, hyperamylasemia and increased CRP levels. RESULTS: Acute pancreatitis was observed in 13.3% of group I patients, 10% of group II patients and 16.7% of group III patients (no statistical significance). Hyperamylasemia was observed in 16.7% of group I patients, 16.7% of group II patients and 43.3% of group III patients. These differences were statistically significant. No significant differences were found in the occurrence of increased CRP levels among the study groups. CONCLUSIONS: No significant reduction in the occurrence of acute pancreatitis after ERCP was observed in patients who received pharmacological prophylaxis. A significant reduction in the occurrence of hyperamylasemia was found in drug-treated patients.