ADenoVirus Initiative Study in Epidemiology (ADVISE): resultados de un estudio epidemiológico multicéntrico en España / ADenoVirus Initiative Study in Epidemiology (ADVISE): Results of a multicentric epidemiology study in Spain

Objetivo: Estudio epidemiológico, observacional, no intervencionista, cuya finalidad es determinar las características clínicas y la frecuencia de la conjuntivitis adenovírica diagnosticada con AdenoPlus® en pacientes que presentaban signos y síntomas de conjuntivitis aguda, así como establecer la seguridad de dicho test. Método: Este trabajo presenta los datos recogidos de los 386 pacientes incluidos en España. Los pacientes debían presentar signos o síntomas de conjuntivitis aguda de ≤ 7 días de evolución. La edad mínima para participar era de 1 año. Se excluyeron los pacientes ya tratados con diversos fármacos (antivíricos tópicos, esteroides tópicos o inmunomoduladores). Se utilizó un cuestionario estandarizado para recoger los datos del paciente y los resultados del test. Resultados: Veintidós centros reclutaron 386 pacientes, de los cuales 329 fueron analizados. El porcentaje de «AdenoPlus ® positivo» fue del 36,2% (119/329). En el 84,1% de casos los investigadores consideraron que la conjuntivitis era de origen vírico, pero solo el 50,3% de ellos vio su criterio clínico confirmado por el test. Los pacientes con resultado positivo a adenovirus tendían a presentar más signos y síntomas comparados con el resto de pacientes. Conclusiones: Ningún signo ni síntoma puede considerarse patognomónico de la enfermedad, dificultando el diagnóstico por parte del clínico. El test AdenoPlus® es una prueba de inmunoanálisis rápida para la detección de adenovirus directamente de secreción lagrimal, y puede ser una herramienta útil para ayudar en el diagnóstico diferencial precoz en pacientes con signos y síntomas de conjuntivitis con una evolución de 7 días o menos (AU)

Objective: Non-interventional, observational, epidemiology study to assess clinical characteristics and frequency of adenovirus conjunctivitis diagnosed by AdenoPlus® in patients who presented with signs and symptoms of acute conjunctivitis. Safety aspects during use of the test were analyzed as well. Method: This analysis presents the data obtained from the 386 patients enrolled in Spain. Patients had to present with acute signs and symptoms of conjunctivitis ≤ 7days. The minimum age was 1 year old. Patients who had already used local antiviral therapies, topical steroids or immuno-modulators were not allowed to enter the study. A standardized questionnaire was used to collect patient's ocular history and test results. Results: A total of 386 patients were recruited in 22 sites, being analyzed 329 patients. Among them, the percentage of "AdenoPlus® positive" was 36,2% (119/329). Before the test was performed, in 84,1% of the cases, investigators believed that the conjunctivitis was of viral origin but only 50,3% of the investigators had their clinical assessment confirmed by the test. Patients who tested positive for adenoviral conjunctivitis presented higher percentages of signs and symptoms than the rest of the patients. Conclusions: None of the signs or symptoms could be qualified as pathognomonic of the disease, being difficult for the clinicians to perform an accurate diagnosis. AdenoPlus® test is an antigen based immunoassay test that detects the presence of adenovirus directly from tears, and it can be an useful tool to help early differential diagnosis in patients with conjunctivitis signs and symptoms lasting for less than or equal to 7 days (AU)

ADenoVirus Initiative Study in Epidemiology (ADVISE): Results of a multicentric epidemiology study in Spain. / ADenoVirus Initiative Study in Epidemiology (ADVISE): resultados de un estudio epidemiológico multicéntrico en España.

OBJECTIVE: Non-interventional, observational, epidemiology study to assess clinical characteristics and frequency of adenovirus conjunctivitis diagnosed by AdenoPlus® in patients who presented with signs and symptoms of acute conjunctivitis. Safety aspects during use of the test were analyzed as well. METHOD: This analysis presents the data obtained from the 386 patients enrolled in Spain. Patients had to present with acute signs and symptoms of conjunctivitis ≤7days. The minimum age was 1year old. Patients who had already used local antiviral therapies, topical steroids or immuno-modulators were not allowed to enter the study. A standardized questionnaire was used to collect patient's ocular history and test results. RESULTS: A total of 386 patients were recruited in 22 sites, being analyzed 329 patients. Among them, the percentage of "AdenoPlus® positive" was 36,2% (119/329). Before the test was performed, in 84,1% of the cases, investigators believed that the conjunctivitis was of viral origin but only 50,3% of the investigators had their clinical assessment confirmed by the test. Patients who tested positive for adenoviral conjunctivitis presented higher percentages of signs and symptoms than the rest of the patients. CONCLUSIONS: None of the signs or symptoms could be qualified as pathognomonic of the disease, being difficult for the clinicians to perform an accurate diagnosis. AdenoPlus® test is an antigen based immunoassay test that detects the presence of adenovirus directly from tears, and it can be an useful tool to help early differential diagnosis in patients with conjunctivitis signs and symptoms lasting for less than or equal to 7days.

Efficacy and safety of naproxcinod in the treatment of patients with osteoarthritis of the knee: a 13-week prospective, randomized, multicenter study.

OBJECTIVE: To evaluate the efficacy and safety of the cyclooxygenase-inhibiting nitric-oxide donator, naproxcinod, compared with naproxen and placebo in patients with osteoarthritis (OA) of the knee. METHOD: 918 eligible patients were randomly assigned to double-blind treatment with either naproxcinod 375 mg, naproxcinod 750 mg, naproxen 500 mg or placebo, twice daily for 13 weeks. The primary objective was to show superiority of naproxcinod compared to placebo. Main efficacy criteria were assessment of pain and physical function using the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) and patients' overall rating of disease status (Likert scale). The main secondary objectives were to show that naproxcinod was non-inferior to naproxen 500 mg and to evaluate overall safety. RESULTS: Both doses of naproxcinod were statistically and clinically superior to placebo in relieving signs and symptoms of OA of the knee after 13 weeks of treatment, as demonstrated by all three co-primary endpoints (P< or =0.0003). The evaluation of the other secondary efficacy measures was consistent with the primary endpoint results. Naproxcinod 750 mg was non-inferior to equimolar doses of naproxen 500 mg in the Intent-to-Treat (ITT) population. 24.5% of patients discontinued prematurely, with a higher incidence in the placebo group (18.6%) than the active groups (4.3-7.1%) discontinuing due to lack of efficacy. Both doses of naproxcinod were well-tolerated, with most adverse events being mild or moderate. Compared to placebo, naproxcinod 750 mg and 375 mg showed a similar blood pressure (BP) profile in contrast to naproxen which increased BP. CONCLUSIONS: These results demonstrated the clinical efficacy and safety of naproxcinod in the management of the signs and symptoms of OA. Naproxcinod was well-tolerated, with BP effects similar to placebo and different from naproxen. Clinical Trials.gov identifier: NCT00542555.