¿Cuál es el rumbo en el tratamiento farmacológico de la DM2: Terapia dual, triple, semanal, oral, inyectable, cúando? Guías 2015. ¿Sigue la metformina como terapia inicial?
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Memorias Conferencia Científica Anual sobre Síndrome Metabólico 2015 - Programa Científico - SOCIEDAD MEXICANA DE NUTRICIÓN Y ENDOCRINOLOGÍA - MESA DE DEBATE - Dra. Raquel Noemí Faradji Hazán - Esp. Endocrinología, Miembro de la Sociedad Mexicana de Nutrición y Endocrinología
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¿Cuál es el rumbo en el tratamiento farmacológico de la DM2: Terapia dual, triple, semanal, oral, inyectable, cúando? Guías 2015. ¿Sigue la metformina como terapia inicial?
- 1. ¿Cuál es el Rumbo en el Tratamiento Farmacológico de la DT2? 7ª Conferencia Científica Anual sobre Síndrome Metabólico Agosto 14, 2015 Dra. Raquel N. Faradji rfaradji@gmail.com
- 2. HbA1c (%) glucosa (mg/dl) 4% - 5.6% 5.7% - 6.4% >= 6.5%diabetes pre-diabetes normal El Riesgo de Complicaciones Micro* y Macrovasculares** existe desde la Intolerancia a la Glucosa *Microvascular complications of impaired glucose tolerance Singleton JR, et al, Diabetes, 2003 **Eur Heart J. 2013 Oct;34(39):3035-87 Faradji R, Sainz E, 2015
- 3. % HbA1c mg/dl de glucosa en sangre sin diabetes/ control IDEAL muy buen control buen control riesgo muy elevado aceptable en algunos casos mg/dl Glucosa pre — posprandial 70-99 — <140 < 110 — <140 < 130 — <180 < 150 — <200 > 150 — >200 Metas de Control para Reducir el Riesgo de Complicaciones Crónicas American Diabetes Association (2015); Ogle, Middlehurst, Silink, y Hanas (2013); American Association of Clinical Endocrinologist (2015). Faradji R, Sainz E, 2015
- 4. Metas de Control American Diabetes Association (2015); Ogle, Middlehurst, Silink, y Hanas (2013); American Association of Clinical Endocrinologist (2015). Glucosa en ayuno Glucosa postprandial (aprox. 2hr después de comer) Hemoglobina glicosilada A1c Normal 70 - 99 mg/dl ≤ 139 mg/dl ≤ 5.6% Adultos (AACE) <110 ≤ 140 mg/dl ≤ 6.5% Adultos (ADA) 80 - 130 mg/dl < 180 mg/dl < 7% Niños/as con DT1 90 - 130 mg/dl < 180mg/dl < 7.5% Embarazo (DT1 o DT2) 60 - 99 mg/dl 100 – 129 mg/dl < 6% Diabetes Gestacional ≤ 95 mg/dl ≤ 120 mg/dl < 6% Las Guías recomiendan niveles de HbA1c lo más cercano a lo normal con la mayor seguridad posibe
- 5. Impacto de la Terapia Intensiva de Diabetes: Resumen de los Estudios Clínicos Principales Estudio Microvasc CVD Mortalidad UKPDS DCCT / EDIC* ACCORD ADVANCE VADT *en DT1 Kendall DM, Bergenstal RM. © International Diabetes Center 2009 UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854. Holman RR et al. N Engl J Med. 2008;359:1577. DCCT Research Group. N Engl J Med 1993;329;977. Nathan DM et al. N Engl J Med. 2005;353:2643. Gerstein HC et al. N Engl J Med. 2008;358:2545. Patel A et al. N Engl J Med 2008;358:2560. Duckworth W et al. N Engl J Med 2009;360:129. (erratum: Moritz T. N Engl J Med 2009;361:1024) Estudio Inicial Seguimiento
- 6. more stringent less stringent Patient attitude and expected treatment efforts highly motivated, adherent, excellent self-care capacities less motivated, non-adherent, poor self-care capacities Risks potentially associated with hypoglycemia and other drug adverse effects low high Disease duration newly diagnosed long-standing Life expectancy long short Important comorbidities absent severefew / mild Established vascular complications absent severefew / mild Readily available limited Usually not modifiable Potentially modifiable HbA1c 7% PATIENT / DISEASE FEATURES Approach to the management of hyperglycemia Resources and support system Modulation of the intensiveness of glucose lowering therapy in T2DM Diabetes Care 2015;38:140-149; Diabetologia 2015;58:429-442
- 7. Healthy eating, weight control, increased physical activity & diabetes education Metformin high low risk neutral/loss GI / lactic acidosis low If HbA1c target not achieved after ~3 months of monotherapy, proceed to 2-drug combination (order not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific factors): Metformin + Metformin + Metformin + Metformin + Metformin + high low risk gain edema, HF, fxs low Thiazolidine- dione intermediate low risk neutral rare high DPP-4 inhibitor highest high risk gain hypoglycemia variable Insulin (basal) Metformin + Metformin + Metformin + Metformin + Metformin + Basal Insulin + Sulfonylurea + TZD DPP-4-i GLP-1-RA Insulin§ or or or or Thiazolidine- dione + SU DPP-4-i GLP-1-RA Insulin§ TZD DPP-4-ior or or GLP-1-RA high low risk loss GI high GLP-1 receptor agonist Sulfonylurea high moderate risk gain hypoglycemia low SGLT2 inhibitor intermediate low risk loss GU, dehydration high SU TZD Insulin§ GLP-1 receptor agonist + SGLT-2 Inhibitor + SU TZD Insulin§ Metformin + Metformin + or or or or SGLT2-i or or or SGLT2-i Mono- therapy Efficacy* Hypo risk Weight Side effects Costs Dual therapy† Efficacy* Hypo risk Weight Side effects Costs Triple therapy or or DPP-4 Inhibitor + SU TZD Insulin§ SGLT2-i or or or SGLT2-i or DPP-4-i If HbA1c target not achieved after ~3 months of dual therapy, proceed to 3-drug combination (order not meant to denote any specific preference - choice dependent on a variety of patient- & disease-specific factors): If HbA1c target not achieved after ~3 months of triple therapy and patient (1) on oral combination, move to injectables, (2) on GLP-1 RA, add basal insulin, or (3) on optimally titrated basal insulin, add GLP-1-RA or mealtime insulin. In refractory patients consider adding TZD or SGL T2-i: Metformin + Combination injectable therapy‡ GLP-1-RAMealtime Insulin Insulin (basal) + Diabetes Care 2015;38:140-149; Diabetologia 2015;58:429-442
- 8. Insulina Basal (usualmente metformina+/− otro agente no insulínico) Inicio: 10 U/día o 0.1–0.2 U/kg/día • Ajuste: 10–15% o 2 – 4 U una o dos veces a la semana hasta llegar a la GPA • Con hipoglucemia: Identifique la causa; reduzca 4 U o 10-20% Approach to starting and adjusting insulin in type 2 diabetes. FBG, fasting blood glucose; GLP-1-RA GLP-1 receptor agonist; hypo, hypoglycemia; mod., moderate; PPG, postprandial glucose; #, number. Adapted with permission from Inzucchi et al. Flexibilidad más flexible menos flexible Cambio a una insulina premezclada 2 veces al día Si no está controlado y la GPA está en meta (o dosis >0.5 U/kg/día), trate elevaciones GPP con insulina en las comidas Agregar una inyección de insulina rápida en la comida principal Inicio: 4 U, 0.1 U/kg, o 10% de la dosis basal. Si la A1C<8%, considere la basal en la misma cantidad • Ajuste: dosis 1-2 U o10-15% una o dos veces al día hasta que SMBG esté en meta • Hipog: Determine y maneje la causa; dosis correspondiente 2-4 U o 10-20% Inicio: Divida la dosis basal actual en 2/3 AM, 1/3 PM o 1/2 AM, 1/2 PM • Ajuste: dosis 1-2 U o 10-15% Una o dos veces semanalmente hasta que SMBG alcance las metas • Hipog: Determine y maneje la causa; dosis correspondiente by 2-4 U or 10- 20% Agregue ≥ 2 injecciones de insulina rápida Antes de las comidas (“basal–bolo”) Inicio: 4 U, 0.1 U/kg, o 10% de la basal dosis/comida. Si A1C<8%, consider basal by same amount • Ajuste: dosis 1-2 U o 10-15% uno o dos veces semanal hasta que SMBG esté en meta • Hipog: Determine y maneje la causa; dosis correspondiente 2-4 U o 10-20% Complejidad baja mod alta # Inyecciones 2 3+ 1 Regresar Si no está controlado considerar basal-bolo Si no está controlado considerar basal-bolo Diabetes Care Volume 38, Supplement 1, January 2015 .
- 11. PUNTOS PRINCIPALES • Individualizar metas glucémicas y terapias anti-hiperglucémicas. • Alimentación, ejercicio y educación: base de cualquier programa terapeútico en diabetes • Metformina, a menos que este contraindicada = terapia de 1a-línea. • Después de metformina, información limitada. Terapia de Combinación con 1- 2 agentes orales/ inyectables es razonable; minimizar efectos adversos. • Al final, muchos pacientes van a requerir terapia con insulina sola o en combinación con otros agentes para mantener el control glucémico. • Todas las decisiones de tratamiento deben realizarse en conjunto con el paciente (enfoque en preferencias, necesidades y valores.) • Reducción de riesgo CV – foco importante de la terapia Diabetes Care 2012;35:1364–1379 Diabetologia 2012;55:1577–1596
- 13. EL FUTURO DEL TRATAMIENTO DE LA DT2 ¿NO ESTARÁ EN VOLVER A LAS COSTUMBRES DEL PASADO?
Notas del editor
- Overview of the microvascular, macrovascular and mortality outcomes from large T2DM and T1DM randomized clinical trials that focused on the relationship between glycemic control and complications.
- This is a depiction of the elements of decision-making used to determine the intensivenss of efforts to achieve glycemic targets. Greater concerns about a particular domain are represented by increasing height of the ramp. Thus, characteristics/predicaments towards the left justify more stringent efforts to lower HbA1c, whereas those towards the right are compatible with less stringent efforts. In general, most patients should be targeted to <7%, but as previously discussed, tighter targets may benefit younger patients whereas in older individuals, a more conservative approach is necessary. Where possible, such decisions should be made in conjunction with the patient, reflecting his or her preferences, needs and values. This ‘scale’ is not designed to be applied rigidly but to be used as a broad construct to help guide clinical decisions. (Adapted with permission from Ismail-Beigi et al, Ann Intern Med 2011;154:554-559.)
- Previously, when combinations of multiple oral agents (i.e., up to triple combination therapy) were no longer effective at controlling blood glucose, insulin was typically added, initially as a single injection of basal insulin. If this was or became ineffective in controlling HbA1c, post-prandial hyperglycemia was usually to blame. Adding several injections of rapid-acting insulin analogues (‘basal-bolus’ insulin therapy) would be the next step to control meal time glycemic excursions. Over the past several years, there has been increasing evidence that the combination of basal insulin with a GLP-1 receptor agonist may provide equal glucose lowering effect as up to 3 injections of meal time insulin, yet with weight loss instead of weight gain, and with less hypoglycemia. This updated figure therefore underscores the potential value of this specific combination. It should be considered in patients who appear to need more than basal insulin, with or without oral agents. In those patients who do not respond adequately to the addition of a GLP-1 receptor agonist to basal insulin, the “basal–bolus” insulin strategy should be used instead (or twice daily premixed insulin.) In selected patients at this stage of disease, the addition of an SGLT2 inhibitor may further improve control and reduce the amount of insulin required. This is particularly an issue when large doses of insulin are required in obese, highly insulin-resistant patients. Another, older, option, the addition of a TZD (usually pioglitazone), also has an insulin-sparing effect and may also reduce HbA1c, albeit at the expense of weight gain, edema, and increased heart failure risk.