Instituto Palacios

Villanueva del Río y Minas, Spain

Instituto Palacios

Villanueva del Río y Minas, Spain
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Palacios S.,Instituto Palacios | Coronado P.J.,San Carlos Clinic Hospital
Minerva Ginecologica | Year: 2017

Menopausal symptoms include vasomotor symptoms (VMS), vulvar-vaginal atrophy, and loss of bone mass associated with an increased risk of fracture. Treatment of VMS consists of lifestyle changes, hormone treatment (estrogens with and without progestogens, tissue selective estrogens complex or conjugated estrogens and bazedoxifene [CECE/BZA], progestogens, and tibolone), and nonhormonal treatments. Genitourinary symptoms due to vulvar-vaginal atrophy are treated with systemic and local hormones, moisturizer creams and gels, CECE/BZA, and a selective estrogen receptor modulator (ospemifene). In addition to lifestyle changes, treatments for the risk of fragility fracture include calcium and vitamin D, hormone treatment, selective estrogen receptor modulators (raloxifene, BZA), bisphosphonates, strontium ranelate, denosumab, and teriparatide. This article reviews treatment options and provides treatment algorithms for women with menopausal symptoms. © 2016 Edizioni Minerva Medica.

Lima J.E.M.,Federal University of Rio Grande do Sul | Lima J.E.M.,University Of Passo Fundo | Palacios S.,Instituto Palacios | Wender M.C.O.,Federal University of Rio Grande do Sul
The Scientific World Journal | Year: 2012

We present the translation, cultural adaptation and validation of the Cervantes Scale to Brazilian Portuguese. The Cervantes Scale (CS) was originally described in Spanish, and is a tool to measure health-related quality of life in perimenopausal and menopausal women. A cross-sectional study was carried out with 180 women aged 45 to 64 years. In addition to the CS, the following questionnaires were applied: Women's Health Questionnaire (WHQ) and abbreviated version of the World Health Organizations Quality of Life Questionnaire (Abbreviated WHOQOL-bref). In conclusion, the Brazilian Portuguese version of the CS is easy to apply and understand. The evaluation of its psychometric properties was satisfactory, and it can be applied to assess health-related QoL in Brazilian perimenopausal and menopausal women. © 2012 José E. M. Lima et al.

Kaufman J.-M.,Ghent University | Palacios S.,Instituto Palacios | Silverman S.,Cedars Sinai Medical Center | Sutradhar S.,Pfizer | Chines A.,Pfizer
Osteoporosis International | Year: 2013

The relationship between baseline Fracture Risk Assessment Tool (FRAX®) and treatment efficacy was evaluated using data from a pivotal phase 3 study. Relative risk of vertebral, nonvertebral, and all clinical fractures decreased with increasing probability of fracture for bazedoxifene (BZA) versus placebo but remained generally constant for raloxifene (RLX). Introduction: To determine whether the FRAX® predicts osteoporosis treatment efficacy, we evaluated reductions in fracture incidence associated with BZA and RLX according to baseline fracture risk determined by FRAX® using data from a phase 3 osteoporosis treatment study. Methods: Hazard ratios (HRs) for effects of BZA and RLX versus placebo on incidence of vertebral, nonvertebral, and all clinical fractures were calculated using a Cox regression model. Cox regression analyses were performed in subgroups at or above 10-year fracture probability thresholds determined by FRAX®. Results: HRs for the risk of vertebral, nonvertebral, and all clinical fractures versus placebo decreased with increasing 10-year fracture probability for BZA, while those for RLX remained stable. In all 10-year fracture probability subgroups, all BZA doses significantly reduced vertebral fracture risk versus placebo (HR = 0.22-0.66). BZA at 20, 40, and 20/40 mg significantly reduced risk of nonvertebral fractures (HR = 0.45, 0.44, and 0.45, respectively) and all clinical fractures (HR = 0.38, 0.41, and 0.40, respectively) for ≥20.0 % fracture probability. Vertebral fracture risk reductions for RLX 60 mg versus placebo were significant in subgroups at lower fracture probabilities (≥2.5- ≥ 10.0 %), but not higher (≥12.5 %), and in no subgroups for nonvertebral or all clinical fractures. Conclusion: The antifracture efficacy of BZA increased with increasing baseline FRAX® score, but there was no clear relationship between RLX and baseline FRAX®. These findings provide independent confirmation of current literature, suggesting that the relationship between FRAX® and treatment efficacy varies for different agents. © 2013 International Osteoporosis Foundation and National Osteoporosis Foundation.

Kaufman J.-M.,Ghent University | Audran M.,University of Angers | Bianchi G.,La Colletta Hospital Azienda Sanitaria | Braga V.,Centro Ospedaliero Clinicizzato Of Medicina Riabilitativa E Preventiva | And 8 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Context: Strontium ranelate reduces vertebral and nonvertebral fracture risk in postmenopausal osteoporosis. Objective: Theobjective of this studywasto determine the efficacy and safety of strontium ranelate in osteoporosis in men over 2 years (main analysis after 1 year). Design: This was an international, unbalanced (2:1), double-blind, randomized placebo-controlled trial (MALEO [MALE Osteoporosis]). Setting: This international study included 54 centers in 14 countries. Participants: Participants were 261 white men with primary osteoporosis. Intervention: Strontium ranelate at 2 g/d (n = 174) or placebo (n = 87) was administered. Main Outcome Measures: Lumbar spine (L2-L4), femoral neck, and total hip bone mineral density (BMD), biochemical bone markers, and safety were measured. Results: Baseline characteristics were similar in both groups in the whole population (age, 72.9 ± 6.0 years; lumbar spine BMD T-score, -2.7 ± 1.0; femoral neck BMD T-score, -2.3 ± 0.7). Men who received strontium ranelate over 2 yearshadgreater increases in lumbar spine BMD than those who received placebo (relative change from baseline to end, 9.7% ± 7.5% vs 2.0% ± 5.5%; between group difference estimate (SE), 7.7% (0.9%); 95% confidence interval, 5.9%-9.5%; P<.001). There werealso significant between-group differences in relative changes in femoral neck BMD (P<.001) and total hip BMD (P<.001). At the end of treatment, mean levels of serum cross-linked telopeptides of type I collagen, a marker of bone resorption, were increased in both the strontium ranelate group (10.7% ± 58.0%; P = .022) and the placebo group (34.9% ± 65.8%; P<.001). The corresponding mean changes of bone alkaline phosphatase, a marker of bone formation, were 6.4% ± 28.5% (P = .005) and 1.9% ± 25.4% (P = .505), respectively. After 2 years, the blood strontium level (129 ± 66 μol/L) was similar to that in trials of postmenopausal osteoporosis. Strontium ranelate was generally well tolerated. Conclusions: The effects of strontium ranelate on BMD in osteoporotic men were similar to those in postmenopausal osteoporotic women, supporting its use in the treatment of osteoporosis in men. Copyright © 2013 by The Endocrine Society.

Palacios S.,Instituto Palacios
Gynecological Endocrinology | Year: 2011

Iron-deficiency anaemia, the condition in which anaemia occurs due to a lack of iron, develops when the amount of available iron is insufficient to support normal red blood cell production. Iron deficiency and iron-deficiency anaemia, very prevalent conditions in premenopausal women, are often associated with menometrorrhagia (present in more than two-thirds of cases of iron-deficiency anaemia in premenopausal women). Appropriate identification and treatment of iron deficiency is imperative as iron deficiency can induce important specific clinical manifestations (including fatigue, atrophic changes in the epithelium, oral lesions, dysphagia, nail lesions, reduced immune response). Iron supplementation is the most common strategy used to control iron deficiency. Based on World Health Organisation recommendations, the most appropriate treatment is with an oral ferrous salt in a prolonged-release tablet form, to provide a dose of elemental iron equivalent to 60mg per intake, in the range of 60 and 120mg/day according to the severity of iron-deficiency anaemia. When haemoglobin levels have returned to normal, treatment should continue for about 3 months to fill iron stores. An extended-release formulation of ferrous sulphate with mucoproteose has been shown to be associated with a lower incidence of gastrointestinal adverse effects compared with other ferrous and ferric salts. © 2011 Informa UK, Ltd.

De Villiers T.,University of Cape Town | Odio A.,Heritage Medical Research Institute | Palacios S.,Instituto Palacios | Chapurlat R.,Institute National Of La Sante | And 5 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Context: Odanacatib (ODN) is a selective cathepsin K inhibitor being developed to treat osteoporosis. Objective: The effects ofODNwere evaluatedonbonemineral density (BMD), biochemical markers of bone turnover, and safety in patients previously treated with alendronate. Design: This was a randomized, double-blind, placebo-controlled, 24-month study. Setting: The study was conducted at private or institutional practices. Participants: Postmenopausal women (n = 243) ≥60 years of age with low BMD at the total hip, femoral neck, or trochanter (T-score≤-2.5 but>-3.5 without prior fracture or≤-1.5 but>-3.5 with prior fracture) on alendronate for ≥3 years. Intervention: The intervention included ODN 50 mg or placebo weekly. Main Outcome Measures: The primary end point was percentage change from baseline of femoralneck BMD at month 24. BMD was assessed by dual-energy x-ray absorptiometry at baseline and 6, 12, and 24 months. Biochemical markers of bone turnover (serum C-telopeptides of type 1 collagen,urinary N-telopeptides of type 1 collagen, serum bone specific alkaline phosphatase, and serum N-terminal propeptide of type 1 collagen) were measured at baseline and 3, 6, 12, 18, and 24 months. Results: In the ODN group, BMD changes from baseline at the femoral neck, trochanter, total hip, and lumbar spine at 24 months (1.7%, 1.8%, 0.8%, and 2.3%, respectively) were significantly different from the placebo group. ODN significantly decreased urinary N-telopeptides of type 1collagen to creatinine ratio and significantly increased serum N-terminal propeptide of type 1 collagen compared with placebo. Serum C-telopeptides of type 1 collagen was unexpectedly increasedwith ODN treatment. The safety profile appeared similar between groups.Conclusions: ODN provided incremental BMD gains in osteoporotic women after alendronate treatment. © 2013 by The Endocrine Society.

Audran M.,GEROM | Jakob F.J.,University of Würzburg | Palacios S.,Instituto Palacios | Brandi M.-L.,Policlinico Careggi | And 3 more authors.
Rheumatology International | Year: 2013

Strontium ranelate has been available as an osteoporosis treatment in Europe since 2004. This article describes a large European observational survey of the use of strontium ranelate in clinical daily practice. A retrospective observational registry included 32,446 women consulting for postmenopausal osteoporosis in seven countries. Within the registry, 12,046 women were receiving strontium ranelate and were followed up over 3 years. The baseline characteristics of the follow-up cohort were similar to those of the whole registry cohort (age, 68.9 ± 10.3 years; body mass index, 25.6 ± 4.3 kg/m2; lumbar spine T-score, -2.57 ± 0.85 SD; femoral neck T-score, -2.11 ± 0.86 SD). At baseline, 77 % of patients had at least one risk factor for osteoporosis, and 46 % had a previous history of osteoporotic fracture. Mean duration of follow-up was 32.0 ± 9.7 months, and treatment duration was 25.2 ± 13.7 months (24,956 patient-years of treatment). Persistence with strontium ranelate was 80 % at 1 year, 68 % at 2 years, and 64 % at 32 months; most patients (about 80 %) reported rarely omitting a dose. At least one emergent adverse event was reported in 2,674 (22 %) patients, most frequently gastrointestinal side effects. The crude incidence of venous thromboembolic events was 2.1/1,000 patient-years. No cases of hypersensitivity reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS), Steven-Johnson syndrome, or toxic epidermal necrolysis, were reported. During follow-up, a fracture occurred in 890 patients (7 %); 429 of the fractures were nonvertebral fractures. Our observational survey over 32 months indicated good rates of adherence with strontium ranelate and confirmed its good safety profile in the management of postmenopausal osteoporosis. © 2013 Springer-Verlag Berlin Heidelberg.

Blumel J.E.,University of Chile | Palacios S.,Instituto Palacios | Legorreta D.,Amec Foster Wheeler | Vallejo M.S.,University of Chile | Sarra S.,University of Chile
Maturitas | Year: 2012

Fibromyalgia syndrome (FMS) is a disorder usually affecting middle aged women, who complain of diffuse musculoskeletal aches, pains or stiffness associated with tiredness, anxiety and poor sleep. Neurotransmission disorders linked both to pain perception as well as mood, sleep and cognition modulation are involved in FMS etiopathogenesys. Treatments that may be effective to decrease pain and fatigue include tricyclic antidepressants, dual reuptake inhibitors of serotonin/noradrenalin and pregabalin. The climacteric syndrome is a set of symptoms caused by the decline of ovarian hormone levels, which alters brain neurotransmission and provokes musculoskeletal pains, mood disorders, poor sleep quality and hot flushes. The hormone therapy reverses those symptoms and its risks are marginal if women's own hormones are used through transdermal route. Some antidepressants may be useful for patients with climacteric symptoms. We have found it surprising the epidemiological, etiopathogenic, symptomatic and therapeutic similarity between FMS and climacteric that could lead us to hypothesize that FMS is a part of the climacteric syndrome. However, the existence of FMS non-climacteric patients points out that hormone deficit is not the only physiopathological mechanism involved in this syndrome's etiopathogenesys. Nevertheless, it is likely that hormone disorders are involved in the symptoms genesis of most middle aged women with FMS. Keeping this in mind, we see the point in considering the use of HT in climacteric patients with FMS. Studies assessing the FMS clinical response to HT in a prospective manner and with the current diagnose criteria are still required. © 2012 Elsevier Ireland Ltd. All rights reserved.

Palacios S.,Instituto Palacios | Agodoa I.,Amgen Inc. | Van Den Bergh J.P.,Maastricht University | Ferreira I.,Amgen | And 2 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2015

Context: For many patients, adhering to postmenopausal osteoporosis treatment is a challenge. Higher treatment satisfaction is associated with greater persistence with these therapies, which is associated with better outcomes. Objective: This study aimed to evaluate the change in treatment satisfaction in postmenopausal women who were suboptimally adherent to daily or weekly oral bisphosphonates and who transitioned to denosumab vs a monthly oral bisphosphonate. Design and Setting: Pooled data of outpatients from two international, multicenter, randomized, open-label studies were analyzed. Patients: Postmenopausal women (n = 1703) age 55 years or greater with low bone mineral density who were suboptimally adherent with prior oral bisphosphonate therapy, as assessed by the Osteoporosis-Specific Morisky Medication Adherence Scale, were included in the study. Interventions: Patients received denosumab, a fully human monoclonal antibody to receptor activator of nuclear factor-kappa B ligand, 60 mg sc every 6 months vs the oral bisphosphonates ibandronate or risedronate, 150 mg once monthly for 12 months. Main Outcome Measures: Change in treatment satisfaction scores from baseline to months 6 and 12 were measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is a validated tool that measures perception of four domains of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction. Results: Patients in both treatment groups showed improvement from baseline for all four TSQM domains at 6 and 12 months. However, the denosumab group had significantly (all P < .001) greater improvements among all four TSQM domains at 6 and 12 months compared with the oral bisphosphonate group. Conclusions: Women with low adherence to oral bisphosphonates reported greater treatment satisfaction when transitioned to denosumab vs switching to a monthly oral bisphosphonate. Copyright © 2015 by the Endocrine Society.

Palacios S.,Instituto Palacios | Currie H.,NHS Dumfries and Galloway | Mikkola T.S.,University of Helsinki | Dragon E.,Pfizer
Maturitas | Year: 2015

Current guidelines recommend that hormone therapy (HT) in postmenopausal women with a uterus include a progestin to protect against endometrial hyperplasia. However, many concerns relating to HT use appear to be related to the progestin component, including cardiovascular risk, breast stimulation, and irregular vaginal bleeding. Conjugated estrogens (CE) combined with the selective estrogen receptor modulator bazedoxifene (BZA) is a new progestin-free HT option for alleviating estrogen deficiency symptoms in postmenopausal women with a uterus for whom treatment with progestin-containing therapy is not appropriate. Five double-blind, randomized, placebo-controlled, phase 3 studies, known as the Selective estrogens, Menopause, And Response to Therapy (SMART) trials have investigated the efficacy of CE/BZA for relieving vasomotor symptoms (VMS), and effect on bone mass, as well as endometrial and breast safety in postmenopausal women. In a 12-week study, CE 0.45 mg/BZA 20 mg significantly reduced the number and severity of hot flushes compared with placebo at weeks 4 and 12. Unlike estrogen-progestin therapy (EPT), CE 0.45 mg/BZA 20 mg did not increase breast density compared with placebo. In clinical trials up to 2 years, CE/BZA had a favorable tolerability profile, demonstrated by amenorrhea rates similar to placebo. Vascular disorders including venous thromboembolic events (pulmonary embolism, retinal vein thrombosis, deep vein thrombosis, and thrombophlebitis) were rare events, occurring in less than 1 per 1000 patients. CE/BZA was associated with significantly higher incidences of amenorrhea and lower incidences of bleeding compared with CE/medroxyprogesterone acetate in 2 comparative trials. Therefore, CE 0.45 mg/BZA 20 mg provides an effective, well-tolerated, progestin-free alternative to EPT for postmenopausal women with a uterus. © 2015 Elsevier Ireland Ltd. All rights reserved.

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