El cumplimiento terapéutico con insulina en el tratamiento de la diabetes mellitus tipo 2: estudio CUMINDIAB / Therapeutic non-compliance with insulin in the treatment of diabetes mellitus 2

Objetivo: Determinar la magnitud del incumplimiento del tratamiento farmacológico con insulina, en pacientes con diabetes mellitus tipo 2 (DM2). Diseño: Estudio prospectivo, longitudinal y multicéntrico. Emplazamiento: 9 centros de salud. Distrito Huelva-Costa. España. Participantes: 121 diabéticos tipo 2 que precisaron según criterio de su médico inicio o modificación del tratamiento con insulina, con un seguimiento de 2 años. Mediciones principales: Se efectuaron 5 visitas (inclusión, 6, 12, 18 y 24 meses). Variables analizadas: glucemia basal, hemoglobina glucosilada, cumplimiento del tratamiento con insulina, medido mediante recuento de unidades de insulina. Se calculó el tanto por ciento de cumplimiento (PC) (PC=N.° total de unidades de insulina presumiblemente consumida/N.° total de unidades de insulina que debiera haber sido administrada x 100). Se consideró cumplidor aquel cuyo PC estaba entre 80 y 100%. Resultados: Concluyeron 103 pacientes (85,1%) (edad 66,4, DE 11,6 años). Fueron 45 varones (42,8%). El porcentaje de cumplimiento medio fue de 90,9% (IC 84,2-97,6%). Por visitas (6, 12, 18 y 24 meses, respectivamente) fue de 92,1% (IC 85,6-98,6%), 92,3, 90,1 y 89,2% (IC 81,7-96,7%). El porcentaje de cumplidores fue del 74,75% (IC 64,3-85,2%). Por visitas fue respectivamente 82,5 (IC 73,3-91,7%), 77,7, 73,8 y 71,8 (IC 60,9-82,7%) (p<0,05 entre inicio y final). El porcentaje de control final de glucemias basales y hemoglobina glucosilada fueron del 22,33% (IC 12,17-32,49%) y del 11,65% (IC 3,83-19,47%). Conclusiones: Una cuarta parte de los diabéticos fueron incumplidores del tratamiento con insulina(AU)

Objective: To determine the percentage of therapeutic noncompliance among type 2 diabetes patients on treatment with insulin. Design: Prospective multicentre study. Setting: Nine Primary Care Health Centre in Huelva (Spain). Participants: A total of 121 type 2 diabetics, who, in the opinion of their doctor, need to start treatment with insulin or have their insulin treatment modified. Main measurements: Five visits were made (enrolment, 6, 12, 18 and 24 months). The variables analysed were, fasting blood glucose, glycosylated haemoglobin, compliance with insulin treatment, measured by counting insulin units. The percentage compliance (PC) was calculated by (PC = Total No. of insulin units expected to be consumed / Total No. of insulin units that should have been taken x 100). A complier was considered as one who achieved a PC between 80 and 100%. Results: There were 103 evaluable subjects (85.8%) with a mean age of 66.4 (SD 11.6) years, and 45 were male (42.8%). The mean percentage compliance with insulin was 90.9% (95% CI, 84.2-97.6%). At the 6, 12, 18 and 24 months visits it was 92.1% (95% CI, 85.6-98.6%), 92.3, 90.1 and 89.2% (95% CI, 81.7-96.7%), respectively. Overall patient compliance was 74.75% (95% CI, 64.3-85.2%). For the visits, compliance was 82.5% (95% CI, 73.3-91.7%), 77.7%, 73.8% and 71.8% (95% CI, 60.9-82.7%), respectively (P<.05 initial-final). Conclusions: A quarter of the diabetic patients did not comply with their insulin treatment(AU)

[Therapeutic non-compliance with insulin in the treatment of diabetes mellitus 2]. / El cumplimiento terapéutico con insulina en el tratamiento de la diabetes mellitus tipo 2: estudio CUMINDIAB.

OBJECTIVE: To determine the percentage of therapeutic noncompliance among type 2 diabetes patients on treatment with insulin. DESIGN: Prospective multicentre study. SETTING: Nine Primary Care Health Centre in Huelva (Spain). PARTICIPANTS: A total of 121 type 2 diabetics, who, in the opinion of their doctor, need to start treatment with insulin or have their insulin treatment modified. MAIN MEASUREMENTS: Five visits were made (enrolment, 6, 12, 18 and 24 months). The variables analysed were, fasting blood glucose, glycosylated haemoglobin, compliance with insulin treatment, measured by counting insulin units. The percentage compliance (PC) was calculated by (PC = Total No. of insulin units expected to be consumed / Total No. of insulin units that should have been taken x 100). A complier was considered as one who achieved a PC between 80 and 100%. RESULTS: There were 103 evaluable subjects (85.8%) with a mean age of 66.4 (SD 11.6) years, and 45 were male (42.8%). The mean percentage compliance with insulin was 90.9% (95% CI, 84.2-97.6%). At the 6, 12, 18 and 24 months visits it was 92.1% (95% CI, 85.6-98.6%), 92.3, 90.1 and 89.2% (95% CI, 81.7-96.7%), respectively. Overall patient compliance was 74.75% (95% CI, 64.3-85.2%). For the visits, compliance was 82.5% (95% CI, 73.3-91.7%), 77.7%, 73.8% and 71.8% (95% CI, 60.9-82.7%), respectively (P<.05 initial-final). CONCLUSIONS: A quarter of the diabetic patients did not comply with their insulin treatment.

[Therapy compliance in cases of hyperlipaemia, as measured through electronic monitors. Is a reminder calendar to avoid forgetfulness effective?]. / El cumplimiento terapéutico en las dislipemias medido mediante monitores electrónicos. Es eficaz un calendario recordatorio para evitar los olvidos?

OBJECTIVE: To analyse the efficacy of the intervention with a calendar reminder of the medication taking in the treatment of the hyperlipidemias. DESIGN: Controlled, randomised clinical trial. SETTING: Twelve clinics at 5 primary care centres, Spain. PARTICIPANTS: Two hundred and twenty people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen. INTERVENTION: Two groups were formed. The control group (CG) of 110 patients, who received the doctor's normal treatment; and the Intervention group (IG) of 110 patients, who received in addition a calendar remider of medication taking. MAIN MEASUREMENTS: Meausured of compliance was performed by moniotrs electronic (MEMS) and cholesterol, triglycerides, HDL-C, and LDL-C determined at the start, and at the third and sixth months. Percentages of patients complying (80%-110%), the mean compliance percentage and the degree of control were compared. The reduction of absolute and relative risk (RAR and RRR) and the mean number of people that required an intervention in order to avoid non-compliance (NI) were calculated. RESULTS: One hundred and eighty eight people (85.45%) completed the survey, 96 in the IG and 92 in the CG; 26.55% were non compliers with the therapy (CI, +/-6.3%) (IG, 10.5%, CI, +/-4.6%; CG, 42.6%, CI, +/-10.1% [P<.0001]). Mean compliance ran at 88,1% (IC, +/-4.6%) overall, at 92% (CI, +/-5.4%) in the IG and at 84% (CI, +/-7.4%) in the IG (P<.05). The RAR was 32.1%, the RRR 75.35%, and the NI was 3.1 patients. The patients with cholesterol controlled ran at 66.7% (CI, +/-9.4%) in the IG and 41.2% in the CG (P<.001). CONCLUSIONS: The calendar reminder intervention is an efficacious way of improving the percentage of patients complying with lipaemia treatment.

El cumplimiento terapéutico en las dislipemias medido mediante monitores electrónicos. ¿Es eficaz un calendario recordatorio para evitar los olvidos? / Therapy compliance in cases of hyperlipaemia, as measured through electronic monitors. Is a reminder calendar to avoid forget fulness effective?

Objetivo. Analizar la eficacia de la intervención mediante un calendario recordatorio de la toma de medicación en el cumplimiento terapéutico de las dislipemias. Diseño. Ensayo clínico controlado, aleatorizado. Emplazamiento. Doce consultas de 5 centros de atención primaria. Participantes. Se seleccionó a 220 pacientes con hipercolesterolemia diagnosticados según criterios del National Cholesterol Education Program (NCEP). Intervención. Se formaron 2 grupos: a) grupo control (GC), con 110 pacientes, que recibieron la intervención habitual, y b) grupo intervención (GI), con 110 pacientes que recibieron además un calendario recordatorio de la toma de medicación. Mediciones principales. Se estudió el cumplimiento mediante monitores electrónicos de control de medicación (MEMS) y se determinó el colesterol, los triglicéridos, el colesterol de las lipoproteínas de alta densidad (cHDL) y el de las de baja densidad (cLDL) al inicio, al tercero y al sexto mes. Se compararon los porcentajes de cumplidores (80-110%), el porcentaje medio de cumplimiento y el grado de control. Se calculó la reducción del riesgo absoluto (RRA) y el relativo (RRR) y el número de individuos que se necesita tratar para evitar un incumplimiento (NNT). Resultados. Finalizaron 188 sujetos (el 85,45% de la muestra); el GI lo componían 96 individuos, y el GC, 92. Hubo un 26,55% (intervalo de confianza [IC], ±6,3%) de incumplidores, el 10,5% (IC, ±6,1%) en el GI y el 42,6% (IC, ±10,1%) en el GC (p < 0,001). La media del porcentaje de cumplimiento fue del 88,1% (IC, ±4,6%), el 92% (IC, ±5,4%) en el GI y el 84% (IC, ±7,4%) en el GC (p < 0,05). Se observaron descensos significativos en el GI para el colesterol total y el cLDL. El porcentaje de pacientes con colesterol controlado fue del 66,7% (IC, ±9,4%) en el GI y el 41,2% (IC, ±10%) en el GC (p < 0,01), y el cLDL en el 41,2% del GI y el 35,8% en el GC (p = NS). La RRA fue del 32,1%, la RRR del 75,35% y el NNT de 3,1 pacientes. Conclusiones. La intervención con un calendario recordatorio es una medida eficaz para mejorar el porcentaje de cumplidores en el tratamiento de las dislipemias

Objective. To analyse the efficacy of the intervention with a calendar reminder of the medication taking in the treatment of the hyperlipidemias. Design. Controlled, randomised clinical trial. Setting. Twelve clinics at 5 primary care centres, Spain. Participants. Two hundred and twenty people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen. Intervention. Two groups were formed. The control group (CG) of 110 patients, who received the doctor's normal treatment; and the Intervention group (IG) of 110 patients, who received in addition a calendar remider of medication taking. Main measurements. Meausured of compliance was performed by moniotrs electronic (MEMS) and cholesterol, triglycerides, HDL-C, and LDL-C determined at the start, and at the third and sixth months. Percentages of patients complying (80%-110%), the mean compliance percentage and the degree of control were compared. The reduction of absolute and relative risk (RAR and RRR) and the mean number of people that required an intervention in order to avoid non-compliance (NI) were calculated. Results. One hundred and eighty eight people (85.45%) completed the survey, 96 in the IG and 92 in the CG; 26.55% were non compliers with the therapy (CI, ±6.3%) (IG, 10.5%, CI, ±4.6%; CG, 42.6%, CI, ±10.1% [P<.0001]). Mean compliance ran at 88,1% (IC, ±4.6%) overall, at 92% (CI, ±5.4%) in the IG and at 84% (CI, ±7.4%) in the IG (P<.05). The RAR was 32.1%, the RRR 75.35%, and the NI was 3.1 patients. The patients with cholesterol controlled ran at 66.7% (CI, ±9.4%) in the IG and 41.2% in the CG (P<.001). Conclusions. The calendar reminder intervention is an efficacious way of improving the percentage of patients complying with lipaemia treatment