ueda2016 symposium -the novelty in assessing the patient’s needs - hanan gawish

THE NOVELTY IN ASSESSING

THE PATIENT’S NEEDS

Prof Hanan Gawish, MD,PhD

Diabetes and Endocrinology Unit, Mansoura Uni

Chair of the Egyptian Society of Diabetic Foot

Novelty may be said of some very old places, as of

some very old books, that they are destined to be

forever new.

The nearer we approach them…..the more we

study them, the more we have yet to learn.

This is true of many ancient civilization but of no

place it is so true as of ……..Egypt.

Amelia Blanford Edwards

http://todayinsci.com/E/Edwards_Amelia/EdwardsAmelia-Quotations.htm

AGENDA

Novelty among other Sulfonylureas

11,140 type 2 diabetics.

Average age is 66 years.

8 years of Diabetes.

32% had diagnosed

CVD.

10% had microvascular

complications

CVD risk factors

[Lipids, BP, smoking or

obesity].

ADVANCEN=11,140

The ADVANCE Collaborative Group. N Engl J Med. 2008;358:2560-2572.

Randomized treatment

Intensive

(n=4828)

Standard

(n=4741)

Gliclazide MR

Other Sulfonylureas

92%

0%

0%

59%

Metformin 74% 67%

Thiazolidinediones 17% 11%

Acarbose 19% 13%

Glinides 1% 3%

Insulin 40% 24%

ADVANCEN=11,140

TIGHT GLYCEMIC CONTROL MAINTAINED ON LONG TERM

ADVANCE collaborative group. N Engl J Med 2008; 358:2560-72

COMBINED PRIMARY OUTCOMES

M AJOR MACRO OR MICROVASCULAR EVENT

ADVANCEN=11,140

-10%

The ADVANCE Collaborative Group. Action in Diabetes and Vascular disease: Preterax and Diamicron MR Controlled Evaluation. IDF Annual Meeting.2009.

M AJOR MICROVASCULAR EVENTS

ADVANCEN=11,140

-14%


GLICLAZIDE REDUCES MORTALITY

Cardiovascular death 253 289 12% (-4 to 26)

All deaths 498 533 7% (-6 to 17)

Non-cardiovascular death 245 244 0% (-20 to 16)

Number of patients with event

Intensive Standard

(n=5,571) (n=5,569)

Relative risk

reduction (95%CI)

Favors

Intensive

Favors

Standard

Hazard ratio

0.5 1.0 2.0Cardiovascular Mortality

-12%P=0.12

ADVANCEN=11,140


ACCORDN=10,251

New England Journal of Medicine. N Engl J Med. 2008;358:2545-2559.

New England Journal of Medicine. N Engl J Med. 2008;358:2545-2559.

7.5%

6.4%

6.4 in the intensive group Vs. 7.5 in the Standard

ACCORDN=10,251

VADTN=1,791

Duckworth et al, New eng J Med 2008; ahead of print

Metformin (BMI >27)

or Glimepiride (BMI

<27).

Rosiglitazone.

Insulin.

Other oral agents.

8.4%

6.9%

1. N Engl J Med. 358(2008)2545-59

2. N Engl J Med. 360(2009)129-39

ACCORD1 VADT2

Number 10,251 1,791

Primary CVD

endpoint 10% (p=0.16) 13% (p=0.12)

Mortality

(overall) 22% (p=0.04) 6.5% (p=NS)

CV mortality 39% (p=0.02) 25% (p=NS)

Reduction of CV disease risk in type 2 diabetes:

lessons learned from ACCORD and VADT trials

IDF2012

ACCORD

Guidelines asked to assess the cardiac safety for all the new drugs

EVIDENCE-BASED MEDICINE

SHAPED THE NEW IDF ALGORITHM

THE LOWEST RISK OF HYPOGLYCEMIA

AMONG SUS STRATEGIES

Reached targets below 7%

Accord ADVANCE VADT

Severe hypoglycemia in intensive arm [% participants with ≥ 1 episodes]

16.2% 2,7% 21.2%

Lowest rates of hypoglycemia

A position statement of ADA, ACC and AHA. Diabetes Care, volume 32; 1, January 2009.

CONTROL Group. Diabetologia. 2009, August 6. Epub ahead of print.

ADVANCE TRIAL: STRICT WEIGHT

NEUTRALITY BELOW 7%

2 tablets

ADVANCE TRIAL: STRICT WEIGHT

NEUTRALITY BELOW 7%

1-NO ACTIVE METABOLITES

1. Gribble FM. Diabetologia. 1999;42:845-848.

2. Gribble FM. Diabetes. 1998;47:1412-1418. 3. Song DK. Br J Pharmacol. 2001;133:193-199.

2-

REVERSIBILITY



Why?

3- INSULIN SECRETION



Why?

Gregorio F et al. Diabetes Res Clin Prac. 1992;18:197-206.

3- INSULIN SECRETION

Why?

4- ANTI-OXIDANT

PROPERTIES

Sawada F et al. Metabolism. 2008;57:1038-1045.

Why?

Canadian therapeutic algorithm for

management of patients with T2D 2013)

NHG Standard on T2DM (third edition)

Deutsch guidelines for T2DM (2013).

SLOVAK therapeutic algorithm for

management of patients with T2D

(Slovak diabetology society,

June 2015)

AGENDA


Novelty among other new groups

NOVELTY AMONG OTHER GROUPS

sulphonylureas

TZDs

DPP-4

inhs

GlinidesGLP-1

agonists

SGLT2

AGENDA


Novelty among other new groups:

Efficacy


NOVELTY IN EFFICACY

1.RAPID .

2.REACHING THE TARGET WHATEVER THE BASELINE.

3.SUITABLE FOR MOST OF THE PATIENTS.

4.CONTROL RATE.

5.MAINTAINED CONTROL.

1. DIAGONAL study. Congress of the Federation of the International Danube Symposia on Diabetes Mellitus,2012. Hungary, Budapest. Abstract. Available at

http://fid2012.shp.hu/hpc/web.php?a=fid2012&o=abstracts_8qQs 2. Satoh J et al. Diabetes Res Clin Pract. 2005;70:291-297.

PATIENTS STARTED WITH GLICLAZIDE 60 MR 1-2 TABLETS.

RAPID GLYCEMIC CONTROL


NOVELTY IN EFFICACY

1.RAPID .



4.CONTROL RATE.



STRONG REDUCTION WHATEVER THE

HBA1C BASELINE

INITIAL FIXED-DOSE COMBINATION THERAPY

WITH SITA+ MET VS METFORMIN MONO-THERAPY: CHANGE FROM BASELINE IN HBA1CAT WEEK 18

Diabetes, Obesity and Metabolism 13: 644–652, 2011.

MBANYA, JUNE.2015

IDF-WPR abstract: Singapore, 21-24 November 2014,prof.mbanya

ADA , JUNE.2014

Hassanein et al. Vascular Health & Risk Management, 10(2014)319-26


NOVELTY IN EFFICACY

1.RAPID .



4.CONTROL RATE.



WHATEVER THE BMI


WHATEVER THE DURATION OF

DIABETES


WHATEVER THE AGE


WHATEVER THE BASELINE

TREATMENT


NOVELTY IN EFFICACY

1.RAPID .



4.CONTROL RATE.


% OF PATIENTS CONTROLLED BELOW

7%

*Esposito et al. Acta Diabetol. 2014;51:305-311.

HIGHEST

% OF PATIENTS CONTROLLED BELOW

7%



NOVELTY IN EFFICACY

1.RAPID .



4.CONTROL RATE.


Objectives: To evaluate glycaemic durability with (DPP-4)

inhibitors in type 2 diabetes.

Interventions: (sitagliptin, vildagliptin, saxagliptin,

linagliptin and alogliptin).

Inclusion: We screened 12 trials in 14,829 participants.

In conclusion, the analysis of 12 randomized trials with duration

up to 108 weeks suggests that the effect of DPP-4 inhibitors on

HbA1c decreases after the first year of treatment.

Downloaded from bmjopen.bmj.com on June 18, 2014 - Published by group.bmj.com

Maintained CONTROL FOR 5 YEARS IN

ADVANCE


EASD,SEPT,2014

THE EARLY START WITH GLICLAZIDE 60

MR DECREASES THE NEED FOR INSULIN.

Gliclazide 60 MR

2 tabs

120 mg

DOI: 10.1056/NEJMoa1407963

Maintained for 15 years if compared with

other SUs

Satoh J et al. Diabetes Res Clin Pract. 2005;70:291-297.

2 tabs

120 mg

AGENDA



Efficacy

CKD Patients

WHY DIAMICRON 60 MR is preferred

without dose adjustment ?

1. UKPDS Group (33). Lancet. 1998;352:837-853. 2. VADT Investigators. N Engl J Med. 2009;360:129-139. 3. Ismail-Beigi F et al. Lancet. 2010;376:419-

430. 4. ADVANCE Collaborative Group. N Engl J Med. 2008;358:2560-2572. 5. Zoungas S et al. Diabetologia. 2011;54(suppl 1):S23.

ADVANCE TRIAL:

UNIQUE KIDNEY PROTECTION IN ALL THE STAGES

AGENDA



Efficacy

CKD Patients

Having long record in the market

AGENDA



Efficacy

CKD Patients

Having long record in the market

Cost effectiveness

WHO Model List of Essential Medicines 18th list. Accessed on May 2015

NOVELTY IN COST EFFECTIVENESS

WHOAugust 2015

Criteria for Selection of Essential Medicines: Essential medicines are selected with due regard to disease prevalence, evidence on

efficacy , safety, and comparative cost-effectiveness

Conclusion:Treatment decision should be based on :

• Practice (Results and Durability)

• Evidence ( Efficacy and Safety)

• Cost Effectiveness

ueda2016 symposium -the novelty in assessing the patient’s needs - hanan gawish

Health & Medicine