Pulmonary arterial hypertension in the USA: an epidemiological study in a large insured pediatric population.

Pulmonary arterial hypertension (PAH) is rare in children and few data are available in a pediatric general population. This study aims to calculate the annual incidence and prevalence of PAH and to describe these children in a large US population of patients aged under 18 years. Using the US MarketScan claims database we identified 695 children with PAH in 2010-2013. We calculated annual incidence rates and prevalence overall, by age and PAH type (idiopathic and non-idiopathic) using Byar's method. We also described characteristics, co-morbidities, treatment patterns, and diagnostic procedures for these children. In 2010-2013, the annual incidence rates of PAH per 1,000,000 children-years was in the range of 4.8-8.1; 0.5-0.9 for idiopathic PAH and 4.3-7.3 for non-idiopathic PAH. The annual prevalence of PAH was in the range of 25.7-32.6 per 1,000,000 children; 4.4-6.0 for idiopathic PAH and 21.3-27.0 for non-idiopathic PAH. Incidence rates and prevalence were highest in children under age 2 years. Around 36% of affected children were born prematurely. Most (75%) had some type of congenital heart defect and 13% had Down's syndrome. Most patients received PAH monotherapy (83%), while 13% received dual therapy. Phosphodiesterase type 5 inhibitors were the most commonly used treatments. Around 92% had at least one echocardiogram and 37% a right heart catheterization. PAH is very rare in children especially in the absence of etiological factors such as congenital heart defects. A large proportion of diagnoses in children seem to be based on echocardiography rather than right heart catheterization.

Development and Validation of a Predictive Model to Identify Individuals Likely to Have Undiagnosed Chronic Obstructive Pulmonary Disease Using an Administrative Claims Database.

BACKGROUND: Despite the importance of early detection, delayed diagnosis of chronic obstructive pulmonary disease (COPD) is relatively common. Approximately 12 million people in the United States have undiagnosed COPD. Diagnosis of COPD is essential for the timely implementation of interventions, such as smoking cessation programs, drug therapies, and pulmonary rehabilitation, which are aimed at improving outcomes and slowing disease progression. OBJECTIVE: To develop and validate a predictive model to identify patients likely to have undiagnosed COPD using administrative claims data. METHODS: A predictive model was developed and validated utilizing a retro-spective cohort of patients with and without a COPD diagnosis (cases and controls), aged 40-89, with a minimum of 24 months of continuous health plan enrollment (Medicare Advantage Prescription Drug [MAPD] and commercial plans), and identified between January 1, 2009, and December 31, 2012, using Humana's claims database. Stratified random sampling based on plan type (commercial or MAPD) and index year was performed to ensure that cases and controls had a similar distribution of these variables. Cases and controls were compared to identify demographic, clinical, and health care resource utilization (HCRU) characteristics associated with a COPD diagnosis. Stepwise logistic regression (SLR), neural networking, and decision trees were used to develop a series of models. The models were trained, validated, and tested on randomly partitioned subsets of the sample (Training, Validation, and Test data subsets). Measures used to evaluate and compare the models included area under the curve (AUC); index of the receiver operating characteristics (ROC) curve; sensitivity, specificity, positive predictive value (PPV); and negative predictive value (NPV). The optimal model was selected based on AUC index on the Test data subset. RESULTS: A total of 50,880 cases and 50,880 controls were included, with MAPD patients comprising 92% of the study population. Compared with controls, cases had a statistically significantly higher comorbidity burden and HCRU (including hospitalizations, emergency room visits, and medical procedures). The optimal predictive model was generated using SLR, which included 34 variables that were statistically significantly associated with a COPD diagnosis. After adjusting for covariates, anticholinergic bronchodilators (OR = 3.336) and tobacco cessation counseling (OR = 2.871) were found to have a large influence on the model. The final predictive model had an AUC of 0.754, sensitivity of 60%, specificity of 78%, PPV of 73%, and an NPV of 66%. CONCLUSIONS: This claims-based predictive model provides an acceptable level of accuracy in identifying patients likely to have undiagnosed COPD in a large national health plan. Identification of patients with undiagnosed COPD may enable timely management and lead to improved health outcomes and reduced COPD-related health care expenditures.

Efficacy and safety of combining olodaterol Respimat(®) and tiotropium HandiHaler(®) in patients with COPD: results of two randomized, double-blind, active-controlled studies.

BACKGROUND: Combining bronchodilators with different mechanisms of action may improve efficacy and reduce risk of side effects compared to increasing the dose of a single agent in chronic obstructive pulmonary disease (COPD). We investigated this by combining two long-acting bronchodilators: once-daily muscarinic antagonist tiotropium and once-daily ß2-agonist olodaterol. METHODS: Two replicate, double-blind, randomized, 12-week studies (ANHELTO 1 [NCT01694771] and ANHELTO 2 [NCT01696058]) evaluated the efficacy and safety of olodaterol 5 µg once daily (via Respimat(®)) combined with tiotropium 18 µg once daily (via HandiHaler(®)) versus tiotropium 18 µg once daily (via HandiHaler(®)) combined with placebo (via Respimat(®)) in patients with moderate to severe COPD. Primary efficacy end points were area under the curve from 0-3 hours of forced expiratory volume in 1 second (FEV1 AUC0-3) and trough FEV1 after 12 weeks (for the individual trials). A key secondary end point was health status by St George's Respiratory Questionnaire (SGRQ) total score (combined data set). RESULTS: Olodaterol + tiotropium resulted in significant improvements over tiotropium + placebo in FEV1 AUC0-3 (treatment differences: 0.117 L [P<0.001], ANHELTO 1; 0.106 L [P<0.001], ANHELTO 2) and trough FEV1 (treatment differences: 0.062 L [P<0.001], ANHELTO 1; 0.040 L [P=0.0029], ANHELTO 2); these were supported by secondary end points. These effects translated to improvements in SGRQ total scores (treatment difference -1.85; P<0.0001). The tolerability profile of olodaterol + tiotropium was similar to tiotropium monotherapy. CONCLUSION: These studies demonstrated that olodaterol (Respimat(®)) and tiotropium (HandiHaler(®)) provided bronchodilatory effects above tiotropium alone in patients with COPD. In general, both treatments were well tolerated.

Experiencia terapéutica con desloratadina en urticaria crónica idiopática / Therapeutic experience with desloratadine in idiopathic chronic urticaria

La urticaria es una afección común de la piel que puede presentarse en un 15 a un 20 por ciento de la población general. La desloratadina es un nuevo antagonista de los receptortes periféricos H1, de histamina, sin efectos sedantes. Estudios internacionales en urticaria crónica han demostrado que la desloratadina es segura y eficaz. El presente estudio observacional, fase IV, prospectivo, abierto multicéntrico evalúa la eficacia y seguridad y reporta la experiencia local con la desloratadina en el manejo de la urticaria crónica idiopática. Se administraron 5 mg de Desloratadina vía oral, una vez al día durante un período total de 30 días. La respesta clínica se evaluó de acuerdo a una escala que tomó en cuenta 4 parámetros: número de habones, severidad del prurito, interrupción de la actividad diaria e interrupción del sueño; cada parámetro con 4 grados en la evaluación (0-3). Se incluyeron 86 pacientes entre 12 y 73 años (39 ± 15). Sesenta y cinco por ciento de los sujetos fueron del sexo femenino. El Puntaje Total de Síntomas tuvo un promedio de 7,56 ± 2,32 al inicio, disminuyendo hasta 1,26 ± 1,59, al completar la terapia; la diferencia promedio observada resultó 6,20 (p<0,001). La propuesta fue señalada como excelente y buena por 76 médicos (88,37 por ciento) mientras que 75 pacientes se manifestaron como satisfechos o con resolución total de su enfermedad (87,2 por ciento). La incidencia de eventos adversos fue de 6,9 por ciento (ninguno serio). Así, Desloratadina, 5 mg diariamente, resulta una opción eficaz para controlar los síntomas de la urticaria idiopática crónica y los efectos que la misma produce en las actividades cotidianas y el sueño con baja incidencia de eventos adversos

Furoato de mometasona aerosol nasal (FMSN) en el tratamiento de la rinitis alérgica persistente / Furoato of mometasona aerosols nasal (FMSN) in the treatment of the rhinitis allergic perennial

En Venezuela la rinitis alérgica tiene una prevalencia estimada en 20-30 por ciento (escolares). Los síntomas son la obstrucción nasal, estornudos, rinorrea, y prurito nasal, ocular y lacrimeo. Las patologías asociadas son: otitis media, asma, sinusitis y goteo nasal posterior con tos o bronquitis. El consenso ARIA (Allergic Rhinitis and its Impact on Asthma) clasifica a la rinitis alérgica en intermitente y persistente, si tiene más o menos 4 semanas de duración. Entre las opciones terapéuticas, los corticoides nasales representan la más efectiva. Furoato de Mometasona (FM) ha demostrado poseer una alta potencia para reducir el número de mediadores involucrados en la respuesta inflamatoria tanto en su fase precoz como tardía; las experiencias controladas en Venezuela con FM en aerosol nasal (FMSN) u otros esteroides intranasales en rinitis alérgica persistente e intermitente son escasas.