Effectiveness of an intervention to prevent frailty in pre-frail community-dwelling older people consulting in primary care: a randomised controlled trial.

Background: evidence on the effectiveness of interventions to prevent frailty is scarce. Objective: to assess the effect of an intervention in preventing frailty progression in pre-frail older people. Study design: a randomised, open label, controlled trial with two parallel arms. Population: community-dwelling pre-frail older people (≥70 years) consulting in primary care. Intervention: nutritional assessment (and derivation to a Nutritional Unit for usual care in the event of nutritional risk) and a physical activity programme including aerobic exercise and a set of mixed strengthening, balance and coordination exercises. Control group: patients receiving the usual care. Main outcome measure: prevalence of frailty (Fried criteria) at 12 months. Secondary outcomes measures: functional capacity (Barthel index), falls and nutritional status (Short-Form Mini Nutritional Assessment) on follow-up at 12 months. Results: one hundred and seventy-two participants were recruited and randomised (mean age: 78.3 years; mean number of Fried criteria: 1.45). Thirty-nine participants (22.6%) were dropped out during the study. At follow-up, 4.9% of the intervention group and 15.3% of the control group had evolved to frailty, for a crude odds ratio (OR) of 0.29 (95% confidence interval [CI]: 0.08-1.08; P = 0.052) and an adjusted (by age, gender and number of co-morbidities) OR of 0.19 (95% CI: 0.04-0.95; P = 0.044). Intervention group showed a higher outdoors walking hour per day (0.97 versus 0.73; P = 0.019) but no difference was observed in muscle strength, gait speed or other functional indicators. Conclusion: an intervention focused on physical exercise and maintaining good nutritional status may be effective in preventing frailty in community-dwelling pre-frail older individuals. ClinicalTrials.gov identifier: NCT02138968.

Clinical and Functional Characterization of Pre-frailty among Elderly Patients Consulting Primary Care Centres.

BACKGROUND: Characterization of the main features of pre-frailty may contribute to better understanding the mechanisms involved in the development of frailty. OBJECTIVE: To characterize the pre-frail population consulting in primary care centres in Mataró (Catalonia, Spain), to describe the Fried's frailty criteria for this population and to identify the main associated factors. DESIGN: Cross-sectional study. SETTING: Three primary care centres in Catalonia. PARTICIPANTS: Pre-frail subjects recruited from among persons aged 70 years and older consulting primary care centres and screened for frailty according to Fried's criteria. MEASUREMENTS: Clinical, nutritional and functional data. RESULTS: Frailty prevalence of 31.0% and pre-frailty prevalence of 49.0% were observed. Comorbidity was not especially frequent among elderly individuals classified as pre-frail (except for diabetes with 35.8% prevalence). Functional status and nutritional status were both reasonably satisfactory in pre-frail subjects with mean Barthel score of 98 points and 91% classified as well nourished. Among pre-frail subjects, 35% were obese (body mass index>30); 75% reported pain; 12% had an accidental fall in the previous three months; and the mean number of medications ingested was 6.2. Weakness was the most prevalent frailty criterion (70%), followed by slowness (30%). Weakness was associated with age in men and with pain in women. Poor physical activity was associated with pain. CONCLUSIONS: Pre-frailty is very common among elderly subjects consulting primary care centres. Weakness, slowness, diabetes, pain and polypharmacy should alert healthcare professionals to the onset of a frailty process.

[Anti-ribosomal antibodies as activity markers in systemic lupus erythematosus]. / Anticuerpos anti-ribosomales como marcadores de actividad en el LES.

OBJECTIVES: a) to determine the prevalence of anti-ribosomal P antibodies in patients with ESL in our setting; b) to determine if there are associations between clinical signs of ESL and these autoantibodies; c) to analyze if there is any correlation between the presence of anti-P in patients with ESL and the results of other routine lab tests; and d) to assess the usefulness of implementing as routine test the determination of anti-P antibodies. MATERIAL AND METHODS: The study included 60 patients diagnosed of ESL and 61 healthy subjects as the control group. ELISA was used to determine anti-ribosomal antibodies. Chi-square, Fisher and Student t tests were used for the statistical analyses. RESULTS: Of the 60 patients with SLE, 29 (48%) had anti-P antibodies as determined by ELISA. No association was observed between the presence of anti-P antibodies and psychosis, depression, hepatic failure, renal failure or any other clinical signs of ESL. A correlation was found between the levels of anti-P antibodies as determined by ELISA and anti-histone, ANA and AMA antibodies. CONCLUSIONS: The prevalence of anti-P antibodies was high among our ESL patients (48%). Their presence was not significantly associated with any clinical sign; however, an association was found with other lab markers related to the presence of active disease.

Strontium ranelate: dose-dependent effects in established postmenopausal vertebral osteoporosis--a 2-year randomized placebo controlled trial.

The aim of the strontium ranelate (SR) for treatment of osteoporosis (STRATOS) trial was to investigate the efficacy and safety of different doses of SR, a novel agent in the treatment of postmenopausal osteoporosis. A randomized, multicenter, double-blind, placebo-controlled trial was undertaken in 353 osteoporotic women with at least one previous vertebral fracture and a lumbar T-score <-2.4. Patients were randomized to receive placebo, 0.5 g, 1 g, or 2 g SR/d for 2 yr. The primary efficacy endpoint was lumbar bone mineral density (BMD), assessed by dual-energy x-ray absorptiometry. Secondary outcome measures included femoral BMD, incidence of new vertebral deformities, and biochemical markers of bone metabolism. Lumbar BMD, adjusted for bone strontium content, increased in a dose-dependent manner in the intention-to-treat population: mean annual slope increased from 1.4% with 0.5 g/d SR to 3.0% with 2 g/d SR, which was significantly higher than placebo (P < 0.01). There was a significant reduction in the number of patients experiencing new vertebral deformities in the second year of treatment with 2 g/d SR [relative risk 0.56; 95% confidence interval (0.35; 0.89)]. In the 2 g/d group, there was a significant increase in serum levels of bone alkaline phosphatase, whereas urinary excretion of cross-linked N-telopeptide, a marker of bone resorption, was lower with SR than with placebo. All tested doses were well tolerated; the 2 g/d dose was considered to offer the best combination of efficacy and safety. In conclusion, SR therapy increased vertebral BMD and reduced the incidence of vertebral fractures.

Anticuerpos anti-ribosomales como marcadores de actividad en el LES / Anti-ribosomal antibodies as markers of activity in patients with erythematosus systemic lupus (ESL)

Objetivos: a) determinar la prevalencia de anticuerpos anti-riboso males P en pacientes con LES en nuestro medio; b) averiguar si existen asociaciones entre manifestaciones clínicas en el LES y estos autoanticuerpos; c) analizar si existe correlación entre la presencia de anti-P en pacientes con LES y otros parámetros de laboratorio determinados habitualmente, y d) valorar la utilidad de introducir, como determinación habitual los anticuerpos anti-P.Material y métodos: Se incluyeron en el estudio 60 pacientes diagnosticados de LES y 61 individuos sanos como grupo control. La determinación de anticuerpos anti-ribosomales se realizó mediante ELISA. En el análisis estadístico se utilizaron los test de Chi-cuadrado, Fisher y t de Student. Resultados: De los 60 pacientes con LES, 29 (48 por ciento) tenían anticuerpos anti-P mediante ELISA. No se observó asociación entre la presencia de anticuerpos anti-P y psicosis, depresión, afectación hepática, afectación renal o cualquier otra manifestación clínica del LES.Se encontró correlación entre los niveles de anticuerpos anti-P determinados por ELISA y los anticuerpos anti-histonas, ANA y AMA. Conclusiones: La prevalencia de los anticuerpos anti-P en nuestros enfermos de LES es elevada (48 por ciento). Su presencia no se asoció significativamente con ninguna manifestación clínica, pero sí con otros marcadores de laboratorio relacionados con la presencia de enfermedad activa. (AU)

Molecular diagnosis of alkaptonuria mutation by analysis of homogentisate 1,2 dioxygenase mRNA from urine and blood.

Alkaptonuria (AKU) is caused by lack of homogentisate 1, 2 dioxygenase (HGO) activity. From the complete sequence of a human HGO cDNA, primers were designed in order to obtain reverse transcription-polymerase chain reaction products from tissues with ectopic transcription amenable to diagnostic analysis. A search for mutations in HGO cDNA was performed in an AKU family using urine and blood samples. The results show complete cosegregation (Z = 6.32; theta = 0) between a C-->T transition at position 817 of the human HGO cDNA and AKU. This mutation predicts a Pro-->Ser replacement at amino acid 230, and generates an EcoRV site.

Systemic lupus erythematosus: clinical manifestations and immunological parameters in 194 patients. Subgroup classification of SLE.

We analysed the prevalence of clinical manifestations and immunological parameters in 194 patients with SLE and classified them in subgroups according to age at onset, gender and type of antibodies: we detected significant differences in the various subgroups. In SLE that initiated before the age of 20 years, the most frequent manifestation at onset was malar rash (25% vs 14%). During the course of the disease, this group had a greater prevalence of malar rash (70% vs 45%), mouth ulcers (48% vs 29%), and convulsions or psychosis (35% vs. 17%). In SLE that initiated late in life (after 50 years) malar rash was less frequent at onset and during subsequent evolution of the disease (27% vs 45%). The existence of ANA, and elevated values of anti-dsDNA, anti-ENA and antiphospholipid antibodies also differentiated the SLE subgroups with clinical significance.

Single dose pharmacokinetics of fenspiride hydrochloride: phase I clinical trial.

The absolute bioavailability of fenspiride has been studied in twelve healthy volunteers. It was administered IV and orally in single doses of 80 mg fenspiride hydrochloride according to a randomised crossover pattern. Following IV administration, the plasma clearance of fenspiride was about 184 ml.min-1, and its apparent volume of distribution was moderately large (215 l). When given orally as a tablet, fenspiride exhibited fairly slow ab- sorption; the maximum plasma concentration (206 ng.ml-1) was achieved 6 h after administration. The absolute bioavailability was almost complete (90%). The tablet had slow release characteristics. The elimination half-life obtained from the plasma data was 14 to 16 h independent of the route of administration.