Fixed-Dose Combination of Canagliflozin and Metformin as an Adjunct to Diet and Exercise in Indian Adults with Type 2 Diabetes Mellitus: Results from a Multicentric, Open-Label, Single-Arm, Phase IV Study.

BACKGROUND: Canagliflozin and metformin fixed-dose combination (CANA/MET FDC), an approved treatment for type 2 diabetes mellitus (T2DM) in India, effectively lowers glycated hemoglobin (HbA1c), promotes weight loss, and improves patient adherence. As a regulatory requirement, we aimed to evaluate the safety and efficacy of CANA/MET FDC in Indian patients with T2DM. RESEARCH DESIGN AND METHODS: This prospective, multicenter, open-label, single-arm, phase IV study included Indian patients with T2DM (aged 18-65 years) inadequately controlled on diet and exercise. Patients received CANA/MET (50/500 and 50/1000 mg) immediate-release (IR) FDC twice daily for 24 weeks. The primary endpoint was safety assessment, including adverse events (AEs) and serious AEs (SAEs). The secondary endpoint included a change in HbA1c from baseline to weeks 12 and 24. Descriptive statistics were used for all continuous safety variables and efficacy parameters. RESULTS: Of the 310 patients screened, 276 were enrolled. 114/274 (41.6%) patients had ≥1 treatment-emergent AE [treatment-emergent AEs (TEAEs), among which 29 (10.6%) were related to study intervention]. The most common TEAEs were dyslipidemia (4.7%), pyrexia (4.7%), genital infections (3.3%), hypoglycemia (3.3%), and urinary tract infections (2.6%). Three (1.1%) patients had serious TEAEs, and all cases were resolved. No deaths were reported. The mean change in HbA1c from baseline was -0.92 and -0.93% at weeks 12 and 24, respectively. CONCLUSION: The study demonstrates the safety and efficacy of CANA/MET FDC in Indian patients with T2DM, presenting a safe therapeutic option for diabetes management in India.

Adequancy of treatment with canaglifozin alter alerts pharmacovigilance in the health management área / Adecuación del tratamiento con canaglifozina tras alerta de farmacovigilancia en un área de gestión sanitaria

Objective: To analyze the impact of a strategy on the suitability of canaglizozin, and its level of acceptance, after issuing recommendations based on drug surveillance alerts issued by the Spanish Medicines and Medical Devices Agency (AEMPS). Method: A prospective intervention from may 2016 to october 2016. Location: South Seville Health Management Area. Participants: Patients with active canagliflozin prescription. Interventions: The study was conducted in three phases, the first one linked to the issuance of the safety information note on the canaglifozin by the AEMPS, the obtaining of the patient lists and the recommendations of the adequacy in the sending of letters. A second phase where the medical professional performed the actions and a final phase in which the degree of acceptance of the recommendations made by the Pharmacy Service is evaluated. Main measurements: Suitability of canaglizozin treatment and the level of acceptance by physicians. Results: A total of 61 patients at baseline were included in treatment canagliflozin. Of the total number of patients referred to, some type of intervention was performed by the family and community medicine doctor after the pharmaceutical intervention (PI), by means of letters (n = 30), 56.7% were monitored, 33.3% were discontinued and 10.0% were closely monitored Conclusions: Interventions aimed at reviewing patients on canagliptin, based on pharmacovigilance alerts, have been effective, with a high degree of acceptance by the family and community medicine practitioner (AU)

Objetivo: Analizar el impacto de una estrategia de adecuación de canaglifozina tras la emisión de recomendaciones en base a las notas de farmacovigilancia emitidas por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), así como el grado de aceptación. Método: Estudio prospectivo de intervención desde mayo de 2016 a octubre de 2016. Emplazamiento: Área de Gestión Sanitaria Sur de Sevilla. Participantes: Pacientes con prescripción activa de canaglifozina. Intervenciones: Se realizó en tres fases: la primera ligada a la emisión de una nota informativa de seguridad sobre canaglifozina por la AEMPS, la obtención de listados de pacientes y las recomendaciones de adecuación mediante cartas, una segunda fase en la que el médico realizaba las actuaciones y una última fase en la cual se evalúo el grado de aceptación de las recomendaciones. Variables principales: Adecuación del tratamiento con canaglifozina y grado de aceptación de las recomendaciones por los facultativos médicos. Resultados: Se incluyeron un total de 61 pacientes en nuestro estudio en tratamiento con canaglifozina. Del total de los pacientes a los que se les realizó algún tipo de intervención por el médico de atención primaria tras la intervención farmacéutica (IF), realizada mediante el envío de cartas (n=30), al 56,7% se les monitorizó, al 33,3% se le suspendió el tratamiento y al 10,0% se les vigiló estrechamente. Conclusiones: Las intervenciones dirigidas a la revisión de pacientes en tratamiento con canaglizozin, en base a las alertas de farmacovigilancia, han sido efectivas, con un alto grado de aceptación por el especialista en medicina familiar y comunitaria (AU)