Cost-effectiveness of weekly gastro-resistant risedronate 35 mg, compared with weekly alendronate 70 mg tablets, in the treatment of postmenopausal osteoporosis in Spain.

Aim: To estimate the cost-effectiveness of treating postmenopausal osteoporosis (PMO) with weekly gastro-resistant risedronate 35 mg gastro-resistant tablets (RIS-GR), compared with weekly alendronate 70 mg tablets (ALN) in Spain. Methods: A probabilistic analysis (second-order Monte Carlo simulation) was performed with a time horizon of 5 years, from the perspective of the Spanish National Health System. The bone fracture probabilities were obtained from a cohort study of 3614 women from USA with PMO treated with RIS-GR (1807) or ALN (1807) (Thomasius, 2022). The pharmacological cost and the cost of fractures were obtained from Spanish sources (€ 2022). The utilities of patients with and without fracture (quality-adjusted life years [QALYs]) were obtained from the medical literature. Results: Compared with ALN, treatment with RIS-GR can avoid 79 fractures (between 75 and 82) every 1000 patients treated, and 0.0119 QALYs would be gained (between 0.0098 and 0.0140) per patient. Additionally, GR-RIS would generate a cost saving per patient of €1994 (€1437-2904) with a probability of 99.7%. The scenario analyses confirmed the stability of the base case results. Conclusion: According to this study, RIS-GR would be the dominant treatment (lower costs with QALY gain) compared with ALN.

Subtotal Petrosectomy (SP) in Cochlear Implantation (CI): A Report of 92 Cases.

In most cases, cochlear implantation is a straightforward procedure. Nevertheless, there are clinical situations in which the presence of the middle ear may compromise access and/or the outcome in terms of complications. This article includes a series of patients for whom we eliminated the middle ear to facilitate placement of the electrode array of the implant and/or reduce potential complications. A total of 92 cases in 83 patients, managed by the senior author, are included in this series. Different indications are outlined that justify associating a subtotal petrosectomy technique with cochlear implantation. The steps of the technique are described. We include complications from this series that compare favorably with standard techniques.

Anatomical Variations of the Intrapetrous Portion of the Facial Nerve.

The intrapetrous facial nerve has the second longest intraosseous course of all cranial nerves, after the mandibular nerve. But it is by far the most complex considering the anatomical structures closely related to it. The auditory and vestibular portions of the inner ear, the dura of the middle fossa and posterior fossa, the sigmoid sinus and jugular bulb, and the internal carotid artery are close enough to merit attention. This article includes an anatomical study on 100 temporal bones with anatomical references as seen from the middle fossa and from the transmastoid approaches that may help identifying the facial nerve and protecting surrounding structures. Anatomical variability was present and noteworthy when considering the venous drainage system through the temporal bone and the mastoid pneumatization. The distance from the geniculate ganglion to the hiatus falopii offered the highest variability with a range of 0 to 7.75 mm and a mean of 3.30 mm. The geniculate ganglion was dehiscent in 20.8% of the specimens and the superior semicircular canal was spontaneously blue-lined in 27% of the cases. Through the transmastoid approach, the highest variability was found regarding the distance between the vertical portion of the facial nerve and the jugular bulb (range from 1.5 to 10.0 mm), the sigmoid sinus (range from 0 to 13.25 mm) and the internal carotid artery (range from 6.0 to 15.0 mm). This study highlights the importance of the relative variability of the facial nerve to other surrounding structures within the petrous portion of the temporal bone. Anat Rec, 302:588-598, 2019. © 2018 Wiley Periodicals, Inc.

[Prediction of glucose and insulin resistance disorders by using anthropometric parameters of central adiposity: PRED-IR study]. / Predicción de la glucemia basal alterada y resistencia a la insulina mediante el uso de medidas antropométricas de adiposidad central: estudio PRED-IR.

BACKGROUND AND OBJECTIVE: To assess the predictive value of some anthropometric parameters of central adiposity for the diagnosis of hyperglycemia and insulin resistance (IR) in the Spanish population. PATIENTS AND METHOD: Multicenter, cross-sectional study carried out in patients visited in primary care and in specialist clinics, of both sexes, between 18 and 79 years of age. IR was estimated in a subsample of patients by the Homeostasis Model Assessment (HOMA-IR). Patients with diagnosis of diabetes were excluded from the study. RESULTS: A total of 3,638 patients were evaluated, 690 out of these participated in the IR substudy. Waist circumference (WC) was the parameter with a better correlation with hyperglycemia and with IR (r = 0.29 and 0.38; p < 0.001). Each increase of 15 cm in the WC was associated with an increase of the risk hyperglycemia and IR (65% and 123%, respectively). The cut-off points that better discriminated men and women, with and without IR, were 105 and 91 cm, with a sensitivity of 62% (95% confidence interval [CI], 46-77%) and 71% (95% CI, 54-85%), and a specificity of 72% (95% CI, 66-78%) and 68 (95% CI, 63-73%), respectively. CONCLUSIONS: WC is a useful anthropometric measure for the detection of hyperglycemia and IR, and the optimal cut-off points for the Spanish population from which IR could be detected are 105 cm for men and 91 for women.

Predicción de la glucemia basal alterada y resistencia a la insulina mediante el uso de medidas antropométricas de adiposidad central: estudio PRED-IR / Prediction of glucose and insulin resistance disorders by using anthropometric parameters of central adiposity: PRED-IR study

FUNDAMENTO Y OBJETIVO: El propósito del estudio ha sido evaluar el valor predictivo de medidasantropométricas de adiposidad central para el diagnóstico de la glucemia basal alterada y deresistencia a la insulina (RI) en población española.PACIENTES Y MÉTODO: Se ha realizado un estudio multicéntrico y transversal en pacientes de ambossexos, atendidos en consultas de atención primaria y consultas especializadas, con edadcomprendida entre los 18 y los 79 años. La RI se analizó en una submuestra mediante el HomeostasisModel Assessment (índice HOMA). Los pacientes con diagnóstico de diabetes se excluyerondel estudio.RESULTADOS: Se evaluó a 3.638 pacientes, de los que 690 participaron en el subestudio de RI.El perímetro de cintura (PC) fue la variable que mejor se correlacionó con las alteraciones de laglucosa y la RI (r = 0,29 y 0,38, respectivamente; p < 0,001). Cada aumento de 15 cm en elPC se asoció a un aumento del riesgo de presentar glucemia basal alterada y RI (el 65 y el123%, respectivamente). Los puntos de corte del PC que mejor diferencian a varones y mujeres,con y sin RI, son de 105 y 91 cm, respectivamente, con una sensibilidad de 62% (intervalode confianza [IC] del 95%, 46-77%) y del 71 (IC del 95%, 54-85%), y una especificad del72% (IC del 95%, 66-78%) y del 68 (IC del 95%, 63-73%), respectivamente.CONCLUSIONES: El PC es una medida antropométrica útil para la detección de la glucemia basalalterada y RI, y los puntos de corte óptimos en población española a partir de los cuales se podríadetectar RI son de 105 cm para varones y 91 cm para mujeres

BACKGROUND AND OBJECTIVE: To assess the predictive value of some anthropometric parameters ofcentral adiposity for the diagnosis of hyperglycemia and insulin resistance (IR) in the Spanishpopulation.PATIENTS AND METHOD: Multicenter, cross-sectional study carried out in patients visited in primarycare and in specialist clinics, of both sexes, between 18 and 79 years of age. IR was estimatedin a subsample of patients by the Homeostasis Model Assessment (HOMA-IR). Patients withdiagnosis of diabetes were excluded from the study.RESULTS: A total of 3638 patients were evaluated, 690 out of these participated in the IR substudy.Waist circumference (WC) was the parameter with a better correlation with hyperglycemiaand with IR (r = 0.29 and 0.38; p < 0.001). Each increase of 15 cm in the WC was associatedwith an increase of the risk hyperglycemia and IR (65% and 123%, respectively). The cut-offpoints that better discriminated men and women, with and without IR, were 105 and 91 cm,with a sensitivity of 62% (95% confidence interval [CI], 46-77%) and 71% (95% CI, 54-85%), and a specificity of 72% (95% CI, 66-78%) and 68 (95% CI, 63-73%), respectively.CONCLUSIONS: WC is a useful anthropometric measure for the detection of hyperglycemia and IR,and the optimal cut-off points for the Spanish population from which IR could be detected are105 cm for men and 91 for women

The KARTAN study: a postmarketing assessment of Irbesartan in patients with hypertension.

BACKGROUND: An important purpose of postmarketing surveillance of drugs is to better characterize the safety profile of drug therapy in the clinical setting. Another goal is to confirm the effectiveness of these drugs in patients who are candidates for antihypertensive therapy and who may have been excluded from Phase III studies. Irbesartan is a long-acting angiotensin II-receptor blocker specific for the angiotensin 1-receptor subtype that, in clinical trials in patients with hypertension, reduces blood pressure. OBJECTIVES: The KARTAN (this word was derived from the first and last syllables of Karvea [trademark of Bristol-Myers Squibb Group, Madrid, Spain] and irbesartan) study was designed to confirm and extend the findings from previous clinical trials using data from a large number of patients with hypertension treated with irbesartan in routine clinical practice. The primary goal was to assess the types and incidences of adverse drug reactions (ADRs) occurring at a low frequency (<0.05%) with irbesartan. The secondary objectives were to study the effect of irbesartan as an antihypertensive agent, to assess the types and incidences of the most frequent ADRs (>/=0.05%) occurring in routine clinical practice, and to detect possible interactions between irbesartan and other drugs frequently used in the primary care setting. METHODS: This 6-month, observational, open-label, uncontrolled, national, longitudinal, prospective study was conducted by 852 primary care physicians across Spain. Men and women aged >/=18 years with mild to moderate hypertension who, in their physicians' opinion, should have been treated with irbesartan were included. Each patient was followed up for 6 months, attending visits at baseline (ie, the start of treatment) and 1, 3, and 6 months after the start of treatment. A sample size of 3219 patients was calculated for the detection of >/=1 low-incidence (<0.05%) ADR. After the baseline visit, therapy typically was begun with irbesartan 150 mg/d. The initial dose was titrated up, at 300-mg increments based on the patient's response, at each visit as needed to achieve the treatment goals (systolic blood pressure, <140 mm Hg; diastolic blood pressure, <90 mm Hg). Information regarding ADRs was collected on case-report forms designed for each visit and analyzed by the scientific committee of the study. All recruited patients were included in the tolerability analysis. RESULTS: A total of 4887 patients were enrolled (2165 men, 2 772 women; mean [SD] age, 61.1 [11.0] years [range, 19-94 years]; 23.3% of patients were aged >70 years); 4612 were assessable for efficacy. One hundred eight patients (2.2%) experienced ADRs over the 6-month treatment period; 3 of these patients (0.1%) experienced >1 ADR. Of the total number of clinical manifestations of ADRs, 24 occurred at an incidence <0.05%. Irbesartan produced reductions in blood pressure that were statistically significant from the first visit (all p < 0.001), and 39.9% of the patients achieved the treatment goal at the end of the follow-up period. CONCLUSION: In this postmarketing surveillance study of patients with hypertension treated in routine clinical practice, irbesartan showed a satisfactory tolerability profile that was consistent with that seen in randomized, controlled trials.

Dieta y riesgo cardiovascular en España (DRECE II). Descripción de la evolución del perfil cardiovascular / Diet and cardiovascular risk in Spain (DRECE II study). Description of the evolution of cardiovascular profile

OBJETIVOS: Describir la evolución del perfil de riesgo cardiovascular en una muestra de la población general de distintos puntos de la geografía española. PACIENTES Y MÉTODO: Cohorte de 1.800 sujetos procedentes del estudio Dieta y Riesgo Cardiovascular en España (DRECE I) con riesgo cardiovascular o sin él seguidos durante 5 años. A cada paciente se le realizó un examen médico completo con anamnesis dirigida sobre presencia y modificación de factores de riesgo cardiovascular (FRC), episodios cardiovasculares, cuestionario dietético y pruebas de laboratorio. RESULTADOS: El tiempo medio de seguimiento fue de 4,8 años. La hipertensión arterial ( 140/90 mmHg), colesterol total > 200 mg/dl, triglicéridos > 150 mg/dl y HDL < 35 mg/dl aparecen en un 55,6, 85,8, 42,9 y 13,4 por ciento, respectivamente, de los sujetos con riesgo cardiovascular según criterios de la Sociedad Española de Arteriosclerosis (RCSEA). Un 31 por ciento de los sujetos sin RCSEA desarrolla hipercolesterolemia y un 11,5 por ciento hipertensión. Hubo episodios de accidente cerebrovascular, ataque isquémico transitorio, angina e infarto de miocardio en 4, 3, 12 y 12 casos en el grupo con RCSEA y 5, 0, 1 y 1 en el grupo sin RCSEA, respectivamente. La incidencia de infarto de miocardio fue de 3,3 y 1,2/1.000 personas-año en los grupos con/sin RCSEA, respectivamente. Los triglicéridos se asociaron a la presencia de infarto (OR = 10,08; IC del 95 por ciento, 2,1-46,4). CONCLUSIONES: El perfil cardiovascular ha empeorado en la cohorte. Los individuos con RCSEA tienen un patrón de morbimortalidad cardiovascular más acusado que aquellos sin riesgo previo. Los FRC tienden a presentarse agrupados en los mismos sujetos (AU)