ABSTRACT
Background and importanceBisphosphonates should be the first choice for osteoporosis treatment, with lower cost and no less benefit than denosumab.Aim and objectivesTo evaluate the indication for treatment with denosumab and to develop proposals for optimising osteoporosis treatment.Material and methodsCross-sectional study in a primary care area (8 centres). Data from the ECAP digital medical record of denosumab-treated patients during January 2020 were reviewed by the Pharmacy Service. Variables: demographic (age and sex), diagnosis, bone mineral density (BMD) and previous fractures, indication, previous treatment and adherence.ResultsA total of 394 denosumab-treated patients, aged 74.9 ± 9.6 years, 92.6% women, were included. BMD T-score was ≤–2.5 (indicative of osteoporosis) in 48.3% of men and 64.1% of women, while it was >–2.5 in 6.9% of men and 14.8% of women. There was no densitometric test in the remaining patients. The most prevalent previous fracture in men was hip fracture (31%), while previous fracture was not present in most women (49.6%). Other fractures in men: 27.6% none, 24.1% vertebral, 17.3% ≥2 vertebral. In women: 16.7% ≥2 vertebral, 13.7% vertebral, 13.4% hip, 6.6% peripheral. Therefore, 80.8% of patients actually suffered from osteoporosis, while 19.2% had no true diagnosis. Osteoporosis patients receiving denosumab without a clear indication were 47.1%. Some 63% received prior treatment and 72.6% were adherent. Regarding those with an indication, 54.9% were due to ≥2 previous vertebral or hip fractures, 21.3% to adverse effects or poor adherence to bisphosphonates, 7.9% to chronic corticosteroid therapy, 7.4% to incident hip fracture or increased risk of fracture with age between 65 and 70 years, 5% to digestive alteration that contraindicates the use of therapeutic alternatives, and finally 3.5% to glomerular filtration <35 mL/min/m2. Denosumab should be withdrawn in 22% of patients and it should be changed to bisphosphonate in 25.1%, thus leading to a theoretical €75 100 annual saving.Conclusion and relevanceDenosumab should be withdrawn or replaced in 47.1% of patients. The proposals of the clinical pharmacist contribute to safe drug use and health system efficiency. It would be necessary to know the final implementation of the proposals by rheumatologists, which were pending due to the COVID-19 pandemic.References and/or acknowledgementsConflict of interestNo conflict of interest
ABSTRACT
Objective To describe the clinical and respiratory characteristics of a cohort of 43 patients with COVID-19 after an evolutive period of 28 days. Design A prospective, single-center observational study was carried out. Setting Intensive care. Patients Patients admitted due to COVID-19 and respiratory failure. Interventions None. Variables Automatic recording was made of demographic variables, severity parameters, laboratory data, assisted ventilation (HFO: high-flow oxygen therapy and IMV: invasive mechanical ventilation), oxygenation (PaO2, PaO2/FiO2) and complications. The patients were divided into three groups: survivors (G1), deceased (G2) and patients remaining under admission (G3). The chi-squared test or Fisher exact test (categorical variables) was used, along with the Mann-Whitney U-test or Wilcoxon test for analyzing the differences between medians. Statistical significance was considered for p < 0.05. Results A total of 43 patients were included (G1 = 28 [65.1%], G2 = 10 [23.3%] and G3 = 5[11.6%]), with a mean age of 65 years (range 52-72), 62% males, APACHE II 18 (15-24), SOFA 6 (4-7). Arterial hypertension (30.2%) and obesity (25.6%) were the most frequent comorbidities. High-flow oxygen therapy was used in 62.7% of the patients, with failure in 85%. In turn, 95% of the patients required IMV and 85% received ventilation in prone decubitus. In the general population, initial PaO2/FiO2 improved after 7 days (165 [125-210] vs.194 [153-285];p = 0.02), in the same way as in G1 (164 [125-197] vs. 207 [160-294];p = 0.07), but not in G2 (163 [95-197] vs. 135 [85-177]). No bacterial coinfection was observed. The incidence of IMV-associated pneumonia was high (13 episodes/1000 days of IMV). Conclusions Patients with COVID-19 require early IMV, a high frequency of ventilation in prone decubitus, and have a high incidence of failed HFO. The lack of improvement of PaO2/FiO2 at 7 days could be a prognostic marker. Resumen Objetivo Describir las características clínicas y respiratorias de una cohorte de 43 pacientes con COVID-19 tras 28 días de evolución. Diseño Prospectivo observacional en un solo centro Ámbito Medicina intensiva Pacientes Pacientes ingresados por COVID-19 e insuficiencia respiratoria Intervenciones Ninguna. Variables Se obtuvieron de forma automática variables demográficas, de gravedad, de laboratorio, de asistencia ventilatoria recibida (OAF: oxigenoterapia alto flujo y VMI: ventilación mecánica invasiva), de oxigenación (PaO2, PaO2/FiO2) y de complicaciones. Los pacientes se dividieron en 3 grupos: supervivientes(G1), fallecidos(G2) y aquellos que continuaban ingresados(G3). Se utilizó “chi” cuadrado o Fisher (variables categóricas) y “U” Mann-Whitney o Wilcoxon para analizar la diferencia entre medianas. Se consideró significativo un valor de p < 0.05. Resultados Se incluyeron 43 pacientes (G1 = 28[65,1%],G2 = 10[23,3%] y G3 = 5[11,6%]), edad 65(52-72) años, 62% hombres, APACHE II 18(15-24), SOFA 6(4-7), Hipertensión arterial(30,2%) y obesidad(25,6%) fueron las comorbilidades más frecuentes. La OAF fue usada en el 62,7% de pacientes, 85% fracasó. El 95% de los pacientes necesitó VMI y el 85% ventilación en prono. En la población general, la PaO2/FiO2 inicial mejoró a los 7 días (165[125-210] vs. 194[153-285], p = 0.02), al igual que en G1(164[125-197] vs. 207[160-294], p = 0.07) pero no en G2 (163[95-197] vs. 135[85-177]). No se observó co-infección bacteriana. El desarrollo de neumonía asociada a la VMI fue elevado (13 episodios/1000 días de VMI). Conclusiones Los pacientes con Covid-19 requieren VMI precoz, elevada frecuencia de ventilación en prono y presentan alta prevalencia de fracaso a OAF. La falta de mejoría de la PaO2/FiO2 a los 7 días podría ser un marcador de pronóstico.
ABSTRACT
OBJECTIVE: To describe the clinical and respiratory characteristics of a cohort of 43 patients with COVID-19 after an evolutive period of 28 days. DESIGN: A prospective, single-center observational study was carried out. SETTING: Intensive care. PATIENTS: Patients admitted due to COVID-19 and respiratory failure. INTERVENTIONS: None. VARIABLES: Automatic recording was made of demographic variables, severity parameters, laboratory data, assisted ventilation (HFO: high-flow oxygen therapy and IMV: invasive mechanical ventilation), oxygenation (PaO2, PaO2/FiO2) and complications. The patients were divided into three groups: survivors (G1), deceased (G2) and patients remaining under admission (G3). The chi-squared test or Fisher exact test (categorical variables) was used, along with the Mann-Whitney U-test or Wilcoxon test for analyzing the differences between medians. Statistical significance was considered for p<0.05. RESULTS: A total of 43 patients were included (G1=28 [65.1%]; G2=10 [23.3%] and G3=5 [11.6%]), with a mean age of 65 years (range: 52-72), 62% males, APACHE II 18 (15-24), SOFA 6 (4-7). Arterial hypertension (30.2%) and obesity (25.6%) were the most frequent comorbidities. High-flow oxygen therapy was used in 62.7% of the patients, with failure in 85%. In turn, 95% of the patients required IMV and 85% received ventilation in prone decubitus. In the general population, initial PaO2/FiO2 improved after 7 days (165 [125-210] vs.194 [153-285]; p=0.02), in the same way as in G1 (164 [125-197] vs. 207 [160-294]; p=0.07), but not in G2 (163 [95-197] vs. 135 [85-177]). No bacterial coinfection was observed. The incidence of IMV-associated pneumonia was high (13 episodes/1000 days of IMV). CONCLUSIONS: Patients with COVID-19 require early IMV, a high frequency of ventilation in prone decubitus, and have a high incidence of failed HFO. The lack of improvement of PaO2/FiO2 at 7 days could be a prognostic marker. .