resum ADA 2012 - RedGDPS · Estructura similar a Exedin 4 2.! Estructura similar a GLP1 No són...

Congrés ADA 2012 Highlights AP Philadelphia 8-12 Juny 2012

F . X a v i e r C o s C l a r a m u n t CAP Sant Martí de Provençals. Barcelona RedGDPS / Primary Care Diabetes Europe

Congrés ADA 2012 Highlights

Sumari

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Management of Hyperglycemia in Type

2

Diabetes: A Patient-Centered Approach

Position Statement of the American Diabetes Association (ADA) and !

the European Association for the Study of Diabetes (EASD)"

ADA-EASD Position Statement: Management of

Hyperglycemia in T2DM: A Patient-Centered

Approach&

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#*#'?EG;6?#Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]!

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ADA-EASD Position Statement: Management of

Hyperglycemia in T2DM: A Patient-Centered

Approach&

Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]!

Initial drug monotherapy

Efficacy (! HbA1c)

Hypoglycemia

Weight

Side effects

Costs

Healthy eating, weight control, increased physical activity

Metformin

high

low risk

neutral/loss

GI / lactic acidosis

low

If needed to reach individualized HbA1c target after ~3 months, proceed to 2-drug combination (order not meant to denote any specific preference):

Metformin +

Metformin +

Metformin +

Metformin +

Metformin +

Efficacy (! HbA1c)

Hypoglycemia

Weight

Major side effect(s)

Costs

high

low risk

gain

edema, HF, fx’s‡

high

Thiazolidine- dione

intermediate

low risk

neutral

rare‡

high

DPP-4 Inhibitor

highest

high risk

gain

hypoglycemia‡

variable

Insulin (usually basal)

Two drug combinations*

Sulfonylurea†

+

Thiazolidine-dione

+

DPP-4 Inhibitor

+

GLP-1 receptor agonist

+


+

Metformin +

Metformin +

Metformin +

Metformin +

Metformin +

TZD

DPP-4-i

GLP-1-RA

Insulin§

SU†

DPP-4-i

GLP-1-RA

Insulin§

SU† SU†

TZD TZD

TZD

DPP-4-i

Insulin§ Insulin§

If combination therapy that includes basal insulin has failed to achieve HbA1c target after 3-6 months, proceed to a more complex insulin strategy, usually in combination with 1-2 non-insulin agents:

Insulin# (multiple daily doses)

Three drug combinations

More complex insulin strategies

or

or

or

or

or

or

or

or

or

or

or

or GLP-1-RA

high

low risk

loss

GI‡

high


Sulfonylurea†

high

moderate risk

gain

hypoglycemia‡

low


&0-N#%?D@=58C<;=B896B#&@8C>5=Y#38?8C>;#,8B:998?7>D:?E#Diabetes Care, Diabetologia. 19 April 2012 !

[Epub ahead of print]!

Initial drug monotherapy

Efficacy (! HbA1c)

Hypoglycemia

Weight

Side effects

Costs

Healthy eating, weight control, increased physical activity

Metformin

high

low risk

neutral/loss

GI / lactic acidosis

low


Metformin +

Metformin +

Metformin +

Metformin +

Metformin +

Efficacy (! HbA1c)

Hypoglycemia

Weight

Major side effect(s)

Costs

high

low risk

gain

edema, HF, fx’s‡

high

Thiazolidine- dione

intermediate

low risk

neutral

rare‡

high

DPP-4 Inhibitor

highest

high risk

gain

hypoglycemia‡

variable


Two drug combinations*

Sulfonylurea†

+

Thiazolidine-dione

+

DPP-4 Inhibitor

+


+


+

Metformin +

Metformin +

Metformin +

Metformin +

Metformin +

TZD

DPP-4-i

GLP-1-RA

Insulin§

SU†

DPP-4-i

GLP-1-RA

Insulin§

SU† SU†

TZD TZD

TZD

DPP-4-i

Insulin§ Insulin§

If combination therapy that includes basal insulin has failed to achieve HbA1c target after 3-6 months, proceed to a more complex insulin strategy, usually in combination with 1-2 non-insulin agents:

Insulin# (multiple daily doses)

Three drug combinations

More complex insulin strategies

or

or

or

or

or

or

or

or

or

or

or

or GLP-1-RA

high

low risk

loss

GI‡

high


Sulfonylurea†

high

moderate risk

gain

hypoglycemia‡

low


Diabetes Care, Diabetologia. !

19 April 2012 [Epub ahead of print]!

Basal insulin only (usually with oral agents)

Basal insulin

+ 1 (meal-time)

rapid-acting insulin injection

Basal insulin

+ !2 (meal-time)

rapid-acting insulin injections

Premixed insulin

twice daily

less flexible

Number of

injections

1

Flexibility

Regimen

complexity

low

mod.

Non-insulin regimens

Sequential Insulin Strategies in T2DM Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]!


Nou consens ADA/EASD del tractament de la hiperglicemia en la Diabetes tipus 2

State of the art lecture Dr. Silvio Inzucchi

Cal individualitzar el tractament hipoglicemiant i els objectius terapeutics

Alimentació, activitat fisica i educació són la base del tractament

Metformina és el farmac de primera elecció si no està contraindicat

Després de Metformina cal valorar tractament combinat 1-2 FFOO/ SC.

Prioritzar minimitzar Efectes secundaris

Caldria plantejar-se decisions terapeutiques compartides

(preferències,necesitats i valors)

La reducció de RCV hauria de ser la prioritat en el tractament


IN CRE TINES

Actividad GLP-1 y GIP

Secreción de incretinas

Tracto GI

Comida

Pancreas

Cel Beta Cel Alfa

Reducción de la glucemia

! Captación de glucosa por Musculo y Tejido adiposo

! Insulina Cel beta

(GLP-1 y GIP) Glucosa dependiente

metabolitos

GLP-1 y GIP

X Inhibidor DPP-4

Incretin miméticos

Enzima DPP-4

Drucker DJ. Diabetes Care. 2003;26:2929–40.

!! Glucagon Cel alfa (GLP-1) Glucosa

dependiente

!! Producción hepática de glucosa

Us clínic de les Incretines


IN CRE TINES Anàlegs receptor GLP-1 Incretin miméticos


A C multicentric aleatoritzat Glimepiride vs Exenatide en pacients DM2 mal controlats en monoterapia amb Metformina

Avaluació: HbA1c > 9% els primers 3 mesos o >7% en dues ocasions passats 6 mesos

N= 1029 DM2 mal control MET Edat: 56 (10) anys Sexe: 56% homes IMC: 32.6 kg/m2 HbA1c: 7.5 %

EUREXA trial ADA/Lancet Dr. Schernthaner


EUREXA trial ADA/Lancet Dr. Schernthaner

1.! AC més llarg amb Anàleg GLP1 (4.5 anys) 2.! Millor control HbA1c, reducció de pes i menys Hipoglucemies en

el grup Exenatide. 3.! 4-5 de cada 10 pacients van necesitar afegir un altre farmac per

mantenir el control metabolic


Analegs del GLP 1 Are they all the same? Dr. Filip Knop Dinamarca

•! Categoritzacio per:

•! FK

•! Estructura

•! Tamany

FK Curta durada Llarga durada

Molecules Exenatide1 Lixisenatide1

Exenatide LAR1 Liraglutide2 Albuglutide2

Impacte glicèmic G. Post prandial G. Basal

Nausea +++ ++ 1.! Estructura similar a Exedin 4 2.! Estructura similar a GLP1

No són similars


Analegs del GLP 1 Tenen impacte CV?? Dr. Steven Marso . Cardioleg (Kansas)

Existencia de receptors GLP1 pancrees endocrí, cardiomiocit i

endoteli vascular

Recerca en models animals i humans

Beneficis en xifres PA i lipids

Models experimentals en IAM i I Cardiaca


EASIE trial ADA/Lancet Dr. Pablo Aschner ( Colombia)

A C multicentric aleatoritzat obert I. Glargine I Sitagliptina en pacients DM2 mal controlats en monoterapia amb Metformina

Objectiu: comparar eficacia (HbA1c), tolerabilitat i seguretat d’ambdos molecules

N = I. Glargina: 250 Sitagliptina: 265 Duració: 24 setmanes

Edat: 53.6 (9) anys Sexe: 51% homes IMC: 31.1 kg/m2 Duració DM2: 4.5 anys HbA1c: 8.5 %

Dosis Sitagliptina 100 mg/d

Dosis insulina final del estudi 0.5UI/kg/dia


EASIE trial ADA/Lancet Dr. Pablo Aschner ( Colombia)

Despres de 24 setmanes

I. Glargina Sitagliptina

HbA1c < 7% 68% 42% p< 0.0001

Hipoglucemia (pacient/any) 4.21 0.50 p< 0.0001


DPP4 Inh Are they all the same? Dr. Adrian Vella ( Mayo Clinic) USA

Tenen estructures quimiques diferents

Comparteixen el mateix mecanisme d’acció amb similar inh

enzimatica ( 80%)

Existeixen diferencies en la seva FK

Reduccio HbA1c 0.7% aprox

Baix risc Hipoglicemia

No increment de pes

Efectes adversos similars Si, són similars


Debat: AGC si o no????

Pro Dr. Lutz Heinemann (Germany)

-! MA i RS AGC es relaciona reduc. de HbA1c de 0.2 a 0.4

-! Estudis amb limitacions (randomització, entrenament ,…)

-! M. Franciosi et al. Diabetic Med 2011;28:798 reduc.

HbA1c 0.5%

-! Eina d’empoderament del pacient en l’autocontrol


Debat: AGC si o no????

Contra Dr. Jeffrey Stephens (UK)

-! Argumenta que les reduccions d’HbA1c observades no

són clinicament rellevants.

-! Excepció per els diabètics de recent diagnostic amb valors

HbA1c més elevats

-! Importancia en que cal saber fer la tecnica i tambe

ENTENDRE els resultats i actuar en consequencia

-! Apropiat en pacients amb risc de HIPOS i de forma

transitoria (canvi de tractament o malaltia intercorrent)

Delay in Progression to Type 2 Diabetes among High-Risk Spanish Individuals DE-PLAN-CAT study

Delay in Progression to Type 2 Diabetes among High-Risk Spanish Individuals Following Lifestyle Intervention in Real-Life Primary Care

DE-PLAN CAT #4$,W&Diabetes in Europe - Prevention using Lifestyle, Physical Activity and Nutritional intervention

XAVIER COS1, BERNADO COSTA1, FRANCISCO BARRIO1, JOAN J. CABRÉ1, JOSEP LLUIS PIÑOL1, SONIA SARRET1, CLAUSTRE SOLÉ1, XAVIER MUNDET1, TERESA MUR1, MONTSERRAT COT1, JACINT CAULA1, FRANCESC PUJOL1, JAANA LINDSTRÖM2, JAAKKO TUOMILEHTO2, DE-PLAN-CAT RESEARCH GROUP1

1Primary Care University reasearch institute. IDIAP Jordi Gol. Barcelona, Spain 2Department of Public Health, University of Helsinki, Finland

Área de Investigación en Diabetes y Enfermedades Endocrino-Metabólicas Prevencion de Diabetes Research Agenda (IDIAP Jordi Gol) .

The DE-PLAN study (2004) DE - PLAN CAT (2005) Diabetes in Europe - Prevention using Lifestyle, Physical Activity and Nutritional intervention Financiacion de la UE (DG SANCO), FIS (Instituto de Salud Carlos III) y Departamento de Salut Publica de la Generalitat de Catalunya

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

DE PLAN

DE PLAN-CAT

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Metodos 1

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Performed OGTT n=591 (44.2%)

Performed OGTT n=601 (83.9%)

Low-Moderate Risk at FINDRISC n=1338 (65.1%)

High-Very High Risk at FINDRISC n=716 (34.9%)

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Resultados 1

0

5

10

15

20

25

30

35

Year 1 Year 2 Year 3 Year 4

Standard care Group

Intensive Group

Complete Group

Años 1 2 3 4 Grupo Standard 20 (6) 41 (12.3) 53 (15.9) 61 (18.3) Standard-Care Intervention Group 17 (7.8) 37 (16.9) 51 (23.3) 63 (28.8) No acumulado de diabetes 37 (6.7) 78 (14.1) 104 (18.8) 124 (22.5)

'?B678?B6>#>BG9G;>7>#78#-6>J8A8E#

La incidencia de diabetes tras una mediana de 4,2 años fue 7,2 y 4,6 casos-100 personas-año (RRR=36,5%; p<0,005)

Resultados 2

Participantes a riesgo Año 1 Año 2 Año 3 Año 4 Total no. 514 476 453 430 N. Acumulado de pacientes diabetes 37 78 104 124 Grupo Intensivo 20 41 53 61 Grupo Standard 17 37 51 63

Y&6&:&5&7&

71a&

71H&

719&

7&

517&

Follow-up time (years) p = 0.005 (Log Rank)

Cum

ula

tive p

robabili

ty o

f re

main

ing d

iabete

s-fr

ee

NNT = 9.5

El número necesario de participantes a tratar durante 4 años para reducir un caso de diabetes fue 9,5.

Resultados 3

1.! Se observa una reduccion del 36% en la incidencia de in

Diabetes

2.! Todos los participantes mostraron beneficios de la Intervencion en

estilos de vida, independientemente de la edad y el sexo.

3.! Es necesario tratar 10 individuos de alto riesgo durante 4 años

con un programa de educacion de 6 horas para evitar (prevenir or

retrasar) 1 caso de diabetes.

4.! Es posible conseguir una reduccion de la incidencia de

Diabetes en sujetos de alto riesgo con intervenciones de estilos de

vida en el ambito de la Atencion Primaria.

F.(-+$#2.("#&


TINSAL trial Dr. Allison Goldfine (Joslin Diabetes Center)


TINSAL trial Dr. Allison Goldfine (Joslin Diabetes Center)

A C multicentric aleatoritzat salsalat 3.5 gr/d o PCB 48 set

Objectiu: Canvi de la HbA1c

Criteris inclusió Edat 18 a 75 anys DM2 en FFOO A1c 7-9.5%

Criteris Exclusió Tt. Amb Glitazones, Insulina o Analegs GLP 1 Tt. Crònic amb AINES FG< 60 ml/min

N= 286 DM2 no controlada


TINSAL trial resultats Dr. Allison Goldfine (Joslin Diabetes Center)

N= 286 Edat: 56(10) anys Sexe: 55% homes IMC: 33.3 kg/m2 HbA1c: 7.7(0.7) %

Met 88% Secretagog 82% (mono 41% bi 49% tri 6%)

Aspirina 41% Estatines 60%

Despres de 48 setmanes

Reducció HBA1C 0.24% (Salsalat vs PCB) p< 0.001

Reducció de Leucocits (Neutròfils i Limfòcits)

No canvis Prot C Reactiva

Reducció del aclariment insulina hepàtic

Canvis perfil lipidic (! Col total i LDL c, " TG ) p< 0.02

1.! Aquest estudi permet afirmar que la hipotesis inflamatoria pot tenir un paper en la fisiopatologia de la DM2

2.! El Salsalat no es pot considerar un tractament per la DM2


TODAY trial Dr. Philip Zeitler (University of Colorado)

Opcions terapeutiques en pacients diabetics tipus 2 adolescents o joves

Criteris inclusió Edat 10 a 17 anys DM2 < 2 anys evolució IMC > percentil 85 Ac’s antipancreàtics neg /C peptit > 0.6 ng/ml

15 centres

N= 699 (Edat 14 anys, IMC 34.9 kg/m2, 7.8 mesos desde Dx DM2)

3 grups de intervenció: Met, Met + Rosigli i Met+SV


TODAY trial resultats Dr. Philip Zeitler (University of Colorado)

Inici del estudi - 26% HTA - 13% mircoalbuminuria - 80% HDL-c baixa - 10% TG elevats - nivell SE i educacio pares baix

End point A1c > 8% 6 mesos o descompensacio metabolica persistent

Seguiment 3.9 anys

Raons per End point similars a tots els grups.

IMC no va influenciar en els resultats

-! Metformina menys efectiva en pacients de color

-! > 50% no van aconseguir control glicemic amb Met

-! Important deteriorament funcionalisme !

The Big Picture - ORIGIN

•! A large international RCT in people with new or recently diagnosed diabetes, IFG or IGT & additional CV risk factors lasting > 6 years

•! Assessed the effect of 2 independent therapies on serious CV outcomes in > 12,500 people:

a)! titrated basal insulin using insulin glargine b)! 1 g of omega 3 FA

ORIGIN Research Questions

Participants (Key Inclusion Criteria)

Glargine Standard Care

Omega 3 FA* Glargine + Omega 3 Omega 3

Placebo Glargine + Placebo Placebo

Recruitment: Sept ‘03 – Dec’05 Final Visit: Q4 2011

Median (IQR) Follow-up: 6.2 y (5.8-6.6)

Glargine (Lantus): open vs. standard care

Omega 3 FA (Omacor): double-blind; 1 cap/day*

*Omacor contains EPA 465 mg & DHA 375 mg

Major Outcomes: Glargine Trial Primary

•! CV death OR MI OR stroke

•! CV death OR MI OR stroke OR revasc OR CHF hosp’n

Secondary

•! Microvascular composite

(i.e. doubling of serum Cr, progression of albuminuria category, dialysis/renal transplant, laser Rx/vitrectomy for retinopathy)

•! New type 2 diabetes (in those without baseline diabetes)

•! All cause death

•! Cancers

•! Angina, amputation for ischemia,

•! CV & other hospitalizations

•! Hypoglycemia, weight

•! Cognition

•! Erectile dysfunction

Other Outcomes & Measures

Randomized By Region N=12537 from 573 sites in 40 countries

N. America 1314 (11%) Europe/Africa 6060 (48%) Australia 202 (2%)

S. America 3853 (31%) Asia 1108 (9%)

Characteristic % Drug Use %

Smoking 12 Statin 54

Hypertension 80 ACE-I/ARB 69

Any Albuminuria 15 Thiazide 19

Previous CVD 59 Beta Blocker 53

Other BP Drug 41

Antiplatelet 69

Baseline Characteristics Mean Age = 63.5 yrs; Females = 35%

Conventional Units

SI Units

BMI (kg/m2) 29.8 29.8

Blood Pressure (mm) 146/84 146/84

Cholesterol (mg/dl or mM) 190 4.9

LDL (mg/dl or mM) 112 2.90

HDL (mg/dl or mM) 46 1.19

TG (Median mg/dl or mM) 140 1.58

Baseline Characteristics (Mean Level)

Median A1C Levels

IQR 5.5 – 6.5

IQR 5.8 – 6.9

Insulin Glargine

Standard Care

P

Cholesterol (mg/dl) 175 177 0.09

LDL (mg/dl) 102 102 0.51

HDL (mg/dl) 45 46 <0.001

Triglyceride (mg/dl) 124 128 <0.001

HR 69.2 69.7 0.08

SBP/DBP 141/79 141/79 0.4

Final CV Risk Factors ConventionaI Units

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1st Co-primary: MI, Stroke, or CV Death

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2nd Co-Primary: MI, Stroke, CV Death, Revascularization, Heart Failure

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All-cause Death

Summary of Findings

•! 1st CV Composite: HR = 1.02 (0.94, 1.11)

•! 2nd CV Composite: HR = 1.04 (0.97, 1.11)

•! Microvascular Composite: HR = 0.97 (0.90, 1.05)

•! Death: HR = 0.98 (0.90, 1.08)

•! Cancer: HR = 1.00 (0.88, 1.13)

•! Conversion IFG/IGT to DM: HR = 0.72 (0.58, 0.91) P=0.006

ORIGIN clearly assessed the effect of basal insulin

glargine on important health outcomes:

Summary of Findings


Abstrats deadline 3 Setembre www.pcdeurope.org http://pcdeurope2012.semfyccongresos.com/registration


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resum ADA 2012 - RedGDPS · Estructura similar a Exedin 4 2.! Estructura similar a GLP1 No són...

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Transcript of resum ADA 2012 - RedGDPS · Estructura similar a Exedin 4 2.! Estructura similar a GLP1 No són...