Drug Exposure During Pregnancy: A Case-Control Study from a Primary Care Database.

Objective: Drug exposure during pregnancy is frequent, even more during first trimester as pregnant women might not be aware of their condition. We used available electronic health records (EHRs) to describe the use of medications during the first trimester in pregnant women and to compare drug exposure between those women who had an abortion (either elective or spontaneous) compared to those who had live births. Materials and Methods: Case-control study of abortions, either elective or spontaneous (cases), and live birth pregnancies (controls) in Sistema d'Informació per al Desenvolupament de la Investigació en Atenció Primària (Catalan Primary Health electronic health records) from 2012 to 2020. Exposure to drugs during first trimester of pregnancy was considered to estimate the association with abortion by conditional logistic regression and adjusted by health conditions and other drugs exposure. Results: Sixty thousand three hundred fifty episodes of abortions were matched to 118,085 live birth pregnancy episodes. Cases had higher rates of alcohol intake (9.9% vs. 7.2%, p < 0.001), smoking (4.5% vs. 3.6%, p < 0.001), and previous abortions (9.9% vs. 7.8%, p < 0.001). Anxiety (30.3% and 25.1%, p < 0.001), respiratory diseases (10.6% and 9.2%, p < 0.001), and migraine (8.2% and 7.3%, p < 0.001), for cases and controls, respectively, were the most frequent baseline conditions. Cases had lower rate of drug exposure, 40,148 (66.5%) versus 80,449 (68.1%), p < 0.001. Association with abortion was found for systemic antihistamines (adjusted odds ratio [ORadj] 1.23, 95% confidence interval [CI] 1.19-1.27), antidepressants (ORadj 1.11, 95% CI 1.06-1.17), anxiolytics (ORadj 1.31, 95% CI 1.26-1.73), and nonsteroidal anti-inflammatory drugs (ORadj 1. 63, 95% CI 1.59-1.67). Conclusions: These high rates of drug exposures during the first trimester of pregnancy highlights the relevance of informed prescription to women with childbearing potential.

Drug exposure during pregnancy in primary care: an algorithm and observational study from SIDIAP database, Catalunya, Spain.

OBJECTIVES: To develop an algorithm to identify pregnancy episodes in women at childbearing age using SIDIAP (Information System for the Improvement of Research in Primary Care) data (Catalunya, Spain).To describe drugs dispensed during gestation. DESIGN: Construction of an algorithm to identify all pregnancy episodes occurred from January 2011 to June 2020 in women aged 12-50. The variables used to create the algorithm include first day of last menstrual period, reasons for pregnancy termination and diagnoses registered in the primary healthcare records. Population-based cohort study including the pregnancy episodes identified by the algorithm. SETTING: Catalonia, Spain. PARTICIPANTS: All women aged 12-50 with at least one pregnancy episode occurred during January 2011-June 2020. INTERVENTIONS: No interventions performed. PRIMARY AND SECONDARY OUTCOME MEASURES: Identification of pregnancy episodes through an algorithm and description of drug exposure. RESULTS: We identified 327 865 pregnancy episodes in 250 910 people with a mean age of 31.3 years. During the study period, 83.4% of the episodes were exposed to at least one drug. The most frequent groups dispensed were iron preparations (48% of pregnancy episodes), iodine therapy (40.2%), analgesics and antipyretics (28%), penicillins (19.8%), vitamin B12 plus folic acid (19.7%) and non-steroidal anti-inflammatory drugs (NSAIDs, 15.1%). The supplements were more frequently dispensed at least twice, and the drugs for acute conditions were mainly dispensed only once during the pregnancy episode. CONCLUSIONS: We developed an algorithm to automatically identify the pregnancy periods in SIDIAP.We described prescription drugs used during pregnancy. The most used ones were supplements, analgesics, NSAID or antibiotics.SIDIAP might be an efficient database to study drug safety during pregnancy and the consequences of drug use in the offspring. TRIAL REGISTRATION NUMBER: EUPAS37675.

Fracture risk after deprescription of bisphosphonates: Application of real-world data in primary care / Riesgo de fractura después de la desprescripción de bifosfonatos: aplicación de real-world data en atención primaria

Purpose: To compare the effect of discontinuing bisphosphonate treatment on fracture risk in postmenopausal women at high versus low risk of fracture. Design: Retrospective, longitudinal and population-based cohort study. Setting: Barcelona City Primary Care. Catalan Health Institute. Participants: All women attended by primary care teams who in January 2014 had received bisphosphonate treatment for at least five years were included and followed for another five years. Intervention: Patients were classified according to their risk of new fractures, defined as those who had a history of osteoporotic fracture and/or who received treatment with an aromatase inhibitor, and the continuity or deprescription of the bisphosphonate treatment was analyzed over fiver year follow-up. Main measurements: The cumulative incidence of fractures and the incidence density were calculated and analyzed using logistic regression and Cox models. Results: We included 3680 women. There were no significant differences in fracture risk in high-risk women who discontinued versus continued bisphosphonate treatment (hazard ratio [HR] 1.17, 95% confidence interval [CI] 0.87–1.58 for total osteoporotic fractures). However, discontinuers at low risk had a lower incidence of fracture than continuers. This difference was significant for vertebral fractures (HR 0.64, 95% CI 0.47–0.88) and total fractures (HR 0.77, 95% CI 0.64–0.92). Conclusion: Our results suggest that deprescribing bisphosphonates in women who have already received five years of treatment does not increase fracture risk. In low-risk women, continuing this treatment might could even favor the appearance of new osteoporotic fractures.(AU)

Objetivo: Comparar el efecto de la desprescripción de bifosfonatos sobre el riesgo de fractura en mujeres posmenopáusicas con alto y bajo riesgo de fractura. Diseño: Estudio de cohortes retrospectivo, longitudinal y de base poblacional. Emplazamiento: Atención primaria Barcelona. Institut Català de la Salut. Participantes: Se incluyeron todas las mujeres atendidas por los equipos de atención primaria que a enero de 2014 habían recibido tratamiento con bifosfonatos durante al menos cinco años. Intervención: Se clasificó a las pacientes según su riesgo de nuevas fracturas, definido como presencia de antecedentes de fractura osteoporótica y/o tratamiento con un inhibidor de la aromatasa, y se analizó la continuidad o desprescripción del tratamiento con bifosfonatos a lo largo de cinco años de seguimiento. Mediciones principales: La incidencia acumulada de fracturas y la densidad de incidencia se calcularon y analizaron mediante regresión logística y modelos de Cox. Resultados: Se incluyeron 3.680 mujeres. No hubo diferencias significativas en el riesgo de fractura en mujeres de alto riesgo que desprescribieron el bisfosfonato comparado con aquellas que continuaron (hazard ratio [HR] 1,17, intervalo de confianza [IC] de 95% 0,87-1,58 para fracturas osteoporóticas totales). Sin embargo, los que discontinuaron con bajo riesgo tuvieron una menor incidencia de fractura que los que continuaron. Esta diferencia fue significativa para fracturas vertebrales (HR 0,64, IC 95% 0,47-0,88) y fracturas totales (HR 0,77, IC 95% 0,64-0,92). Conclusiones: Nuestros resultados sugieren que la desprescripción de bifosfonatos en mujeres que ya han recibido cinco años de tratamiento no aumenta el riesgo de fractura. En mujeres de bajo riesgo, la continuación de este tratamiento podría incluso favorecer la aparición de nuevas fracturas osteoporóticas.(AU)

Fracture risk after deprescription of bisphosphonates: Application of real-world data in primary care.

PURPOSE: To compare the effect of discontinuing bisphosphonate treatment on fracture risk in postmenopausal women at high versus low risk of fracture. DESIGN: Retrospective, longitudinal and population-based cohort study. SETTING: Barcelona City Primary Care. Catalan Health Institute. PARTICIPANTS: All women attended by primary care teams who in January 2014 had received bisphosphonate treatment for at least five years were included and followed for another five years. INTERVENTION: Patients were classified according to their risk of new fractures, defined as those who had a history of osteoporotic fracture and/or who received treatment with an aromatase inhibitor, and the continuity or deprescription of the bisphosphonate treatment was analyzed over fiver year follow-up. MAIN MEASUREMENTS: The cumulative incidence of fractures and the incidence density were calculated and analyzed using logistic regression and Cox models. RESULTS: We included 3680 women. There were no significant differences in fracture risk in high-risk women who discontinued versus continued bisphosphonate treatment (hazard ratio [HR] 1.17, 95% confidence interval [CI] 0.87-1.58 for total osteoporotic fractures). However, discontinuers at low risk had a lower incidence of fracture than continuers. This difference was significant for vertebral fractures (HR 0.64, 95% CI 0.47-0.88) and total fractures (HR 0.77, 95% CI 0.64-0.92). CONCLUSION: Our results suggest that deprescribing bisphosphonates in women who have already received five years of treatment does not increase fracture risk. In low-risk women, continuing this treatment might could even favor the appearance of new osteoporotic fractures.

Sars-Cov-2 Infection in Patients on Long-Term Treatment with Macrolides in Spain: A National Cross-Sectional Study.

The aim of this study was to know the prevalence and severity of COVID-19 in patients treated with long-term macrolides and to describe the factors associated with worse outcomes. A cross-sectional study was conducted in Primary Care setting. Patients with macrolides dispensed continuously from 1 October 2019 to 31 March 2020, were considered. Main outcome: diagnosis of coronavirus disease-19 (COVID-19). Secondary outcomes: symptoms, severity, characteristics of patients, comorbidities, concomitant treatments. A total of 3057 patients met the inclusion criteria. Median age: 73 (64-81) years; 55% were men; 62% smokers/ex-smokers; 56% obese/overweight. Overall, 95% of patients had chronic respiratory diseases and four comorbidities as a median. Prevalence of COVID-19: 4.8%. This was in accordance with official data during the first wave of the pandemic. The most common symptoms were respiratory: shortness of breath, cough, and pneumonia. Additionally, 53% percent of patients had mild/moderate symptoms, 28% required hospital admission, and 19% died with COVID-19. The percentage of patients hospitalized and deaths were 2.6 and 5.8 times higher, respectively, in the COVID-19 group (p < 0.001). There was no evidence of a beneficial effect of long-term courses of macrolides in preventing SARS-CoV-2 infection or the progression to worse outcomes in old patients with underlying chronic respiratory diseases and a high burden of comorbidity.