Efficacy and safety of ossein-hydroxyapatite complex versus calcium carbonate to prevent bone loss.

Objective: This study aimed to compare the efficacy and safety of ossein-hydroxyapatite complex (OHC) versus calcium carbonate (CC) for preventing bone loss during perimenopause in current clinical practice.Methods: The prospective, comparative, non-randomized, open-label study included 851 perimenopausal women with basal bone mineral density (BMD) T-score ≥-2 standard deviations (SDs). Participants received either OHC (712 mg calcium/day) or CC (1000 mg calcium/day) over 3 years. BMD was evaluated by dual-energy X-ray absorptiometry at the lumbar spine (L2-L4) at baseline and after 18 and 36 months of follow-up. Adverse drug reactions (ADRs) were also recorded.Results: In women receiving OHC, BMD at the L2-L4 site remained stable over the 3-year follow-up period (mean [SD] change 0.00 [0.11] g/cm2). BMD in the CC arm decreased -3.1% (mean [SD] - 0.03 [0.11] g/cm2). Between-group differences were statistically significant (p < 0.001) and favored OHC. ADRs were more frequent in the CC group (7.7% vs. 2.7% in the OHC group; p = 0.001), affecting primarily the gastrointestinal system.Conclusion: OHC showed greater efficacy and tolerability than CC for bone loss prevention in perimenopausal women in real-world practice. As the daily dose of calcium was higher in the CC group, the differences might be linked to the ossein compound in OHC.

Fitoterapia en Urología. Evidencia científica actual de su aplicación en hiperplasia benigna de próstata y adenocarcinoma de próstata / Phytotherapy in Urology. Current scientific evidence of its application in benign prostatic hyperplasia and prostate adenocarcinoma

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[Economic evaluation of medical treatment of benign prostatic hyperplasia (BPH) in the specialised care setting in Spain. Application to the cost-effectiveness of two drugs frequently used in its treatment]. / Evaluación económica del tratamiento médico de la hiperplasia benigna de próstata (HBP) en España en atención especializada. Aplicación al coste- efectividad de dos fármacos habitualmente utilizados en su tratamiento.

OBJECTIVES: To develop a pharmacoeconomic study in order to know the average cost of BPH diagnosis and follow-up in Spain in the Urology Department setting from the perspective of the public health system, considering two frequently used drugs in the Spanish Healthcare environment, an alpha-blocker (tamsulosin) and the lipido-sterolic extract of Serenoa repens (Permixon). MATERIAL AND METHODS: Direct healthcare costs of BPH diagnosis and treatment were determined for each clinical stage according to the International Prostate Symptom Score (IPSS): mild, moderate and severe. Data on the usage and unit costs of healthcare resources were obtained from a semi-structured interview with clinical experts. The clinical efficacy of the medical treatments was obtained from the PERMAL clinical study, where therapeutic equivalence between the two studied drugs was observed. RESULTS: For patients treated in the Urology Department setting, the average annual cost of diagnostic tests and medical visits related to mild, moderate or severe BPH symptoms were, respectively, Euro 124, Euro 207, and Euro 286. The average annual cost of the drugs, including adverse effects treatment, was Euro 211 for Permixon and Euro 346 for tamsulosin. DISCUSSION: Costs of medical care of BPH increases with symptom intensity. Pharmacological treatment makes up a significant part of the disease's cost. According to the model used, treatment with Permixon is considerably more cost-effective than with tamsulosin, offering average yearly savings of Euro 135 per patient.

Evaluación económica del tratamiento médico de la hiperplasia benigna de próstata (HBP) en España en atención especializada. Aplicación al coste-efectividad de dos fármacos habitualmente utilizados en su tratamiento / Economic evaluation of medical treatment of benign prostatic hyperplasia (BPH) in the specialised care setting in Spain. Application to the cost-effectiveness of two drugs frequently used in its treatment

Objetivos: Llevar a cabo un estudio fármaco económico para conocer el coste medio del diagnóstico y seguimiento de la HBP en España en el ámbito de la atención especializada desde la perspectiva del sistema público de salud, considerando dos fármacos frecuentemente utilizados en el entorno sanitario español, un alfabloqueante (tamsulosina) y el extracto lipido esterólico de Serenoa repens (Permixón(R)).Material y métodos: Se determinaron los costes sanitarios directos del diagnóstico y tratamiento de la HBP para cada presentación clínica según el valor del International Prostate Symptom Score (IPSS): leve, moderada y grave. Los datos sobre el consumo y los costes unitarios de los recursos sanitarios se recogieron mediante una encuesta semi-estructurada a expertos clínicos. La eficacia clínica del tratamiento médico fue obtenida del estudio clínico PERMAL, en el que se observó equivalencia terapéutica entre ambos fármacos. Resultados: El coste medio anual de pruebas diagnósticas y visitas médicas de la HBP sintomática según fuese leve, moderada o grave fueron, respectivamente, 124 €, 207€ y 286€ para pacientes tratados en atención especializada. El coste medio anual del tratamiento médico, incluyendo la atención de los efectos adversos fue de 211€ para Permixón(R) y 346 € paratamsulosina. Discusión: El coste de la atención médica de la HBP es proporcional a la intensidad de la sintomatología. El tratamiento farmacológico constituye una parte significativa del coste de la enfermedad. En base al modelo utilizado, el tratamiento con Permixón(R) es sensiblemente más coste-efectivo que el tratamiento con tamsulosina, representando un ahorro medio de 135€ por paciente y año (AU)

Objectives: To develop a pharmaco economic study in order to know the average cost of BPH diagnosis and follow-up in Spain in the Urology Department setting from the perspective of the public health system, considering two frequently used drugs in the Spanish Healthcare environment, an alpha-blocker (tamsulosin) and the lipido-sterolic extract of Serenoa repens (Permixon(R)).Material and methods: Direct healthcare costs of BPH diagnosis and treatment were determined for each clinical stage according to the International Prostate Symptom Score (IPSS): mild, moderate and severe. Data on the usage and unit costs of healthcare resources were obtained from a semi-structured interview with clinical experts. The clinical efficacy of the medical treatments was obtained from the PERMAL clinical study, where therapeutic equivalence between the two studied drugs was observed. Results: For patients treated in the Urology Department setting, the average annual cost of diagnostic tests and medical visits related to mild, moderate or severe BPH symptoms were, respectively, € 124, € 207, and € 286. The average annual cost of the drugs, including adverse effects treatment, was € 211 for Permixon(R) and € 346 for tamsulosin. Discussion: Costs of medical care of BPH increases with symptom intensity. Pharmacological treatment makes up a significant part of the disease’s cost. According to the model used, treatment with Permixon(R) is considerably more cost-effective than with tamsulosin, offering average yearly savings of € 135 per patient (AU)

Epidemiology of chronic venous insufficiency of the lower limbs in the primary care setting.

AIM: The objective of the study was to describe the general characteristics, risk factors and clinical symptoms of patients seeking medical care at the primary care setting because of chronic venous insufficiency. METHODS: A total of 606 general practitioners throughout Spain participated in this epidemiological, cross-sectional, multicenter study in which 6 695 patients were included. During a 3-month period, each participating physician filled out a questionnaire for all consecutive patients with venous leg complaints attended at his/her consultation. The following data were recorded: demographic features and anthropometric characteristics, level of physical activity, tobacco and/or alcohol consumption, number of pregnancies, other risk factors for chronic venous insufficiency, clinical manifestations, and signs on physical examination. RESULTS: Women accounted for 81.3% of the sample. Risk factors included tobacco smoking in 33.8% of cases, alcohol consumption in 25%, low physical activity in 55.7%, and family history in 47.2%. Patients recognized prolonged standing as the most frequent factor probably related to the origin of the symptoms (30.7%). Heaviness in the legs (84.8%) and itching (53.9%) were the most common symptoms, whereas ankle edema (43.6%) was the most frequent sign followed by telangiectases (37.6%). The presence of family history, a higher body mass index an age older than 45 years seems to be related with an increased frequency of clinical manifestations. CONCLUSION: Among patients seeking medical care because of chronic venous insufficiency, women seemed to ask for attention more frequently than men and the beginning of symptoms was mainly related to a prolonged orthostatic posture, being overweight the second cause stated. Heavy legs was the most frequent symptom followed by itching, and ankle edema was the most frequent sign.