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Diabetes management:

lessons from around


the globe Romania

S. Popa (Romania)
DIABETES MANAGEMENT: LESSONS FROM
AROUND THE GLOBE ROMANIA

SG Popa, M Mota, E Mota, A Mitrea


Agenda

Premises: diabetes as a huge and growing problem


PREDATORR Study
Children with diabetes in Romania
Therapy in type 2 diabetes (CEGEDIM data)
Conclusions
Acknowledgements
Premises

Diabetes (DM) and related comorbidities are major


public health problems in the new millennium in most
countries
Recent studies of the prevalence of DM and
prediabetes were furnished only for few countries
The prevalence of DM, prediabetes and other
metabolic diseases has not undergone until present a
rigorous scientific evaluation in Romania.
Diabetes is a huge and growing problem
2014 2035
and the costs to society are high and escalating
Diabetes is a human and economic burden

4.9 million deaths per year Intersects with all US$612 billion
dimensions of
50% of deaths under 60 development 11% of worldwide healthcare
years of age expenditure
Agenda

Premises: diabetes as a huge and growing problem


PREDATORR Study
Children with diabetes in Romania
Therapy in type 2 diabetes (CEGEDIM data)
Conclusions
Acknowledgements
Protocol number SRDCEB/2012/001;
Eudra CT Number: 2012-004803-12
Beneficiaries:
- Romanian Society of Diabetes, Nutrition and Metabolic
Diseases (RSDNMD)
- Romanian Society of Nephrology (RSN)
Investigators: 101 General physician
CRO: CEBIS International (www.cebis-int.com)
Central Laboratory for the analysis of the study: Synevo
PREDATORR Primary goals

Estimating the prevalence of DM and pre diabetes in


the adult population of Romania
Estimating the prevalence of overweight and obesity
in the adult population of Romania
Estimating the prevalence of the chronic kidney
disease in the adult population of Romania
Note: Prevalence distribution of the pre-specified
subgroups (eg age groups etc) is also expected.
PREDATORR Secondary goals

Estimating the prevalence of DLP in Romania


Estimating the prevalence of Hyperuricemia in Romania
Estimating the prevalence of Metabolic Syndrome in
the population of Romania.
Estimating the prevalence of HTN in Romania
CVR assessment in the population of Romania: SCORE
diagram for the high-risk areas
Metabolic risk evaluation through FINDRISC score
PREDATORR Subject inclusion
Subjects were randomly assigned for screening from the list of
each GP via a random number generator

Inclusion criteria Exclusion criteria


Subjects aged 20-79 years Subjects aged <20 and >79 years
Born and with residence in Born outside Romania
Romania Living for the past 10 years
Living for the past 10 years mostly outside Romania
mainly in Romania Refuse or can not sign the
Included on the list of a GP informed consent
affiliated with CNAS Pregnant or breastfeeding
Signing the I.C. women
ROMANIA at a glance - PREDATORR 2013

Prediabetes
16.5%
Known diabetes
9.2%
Diabetes
11.6%
NGT
71.9%
Unknown diabetes
2.4%
ROMANIA at a glance - PREDATORR 2013
DIABETES
Diabetes in Romania (20-79 years))
Adult Romanian population 15097473
(20-79 years)
Number of people with diabetes 1752000
Age- and sex-adjusted prevalence of 11.6%
diabetes
Undiagnosed cases 362340
(unknown diabetes mellitus UKDM)
Age- and sex-adjusted prevalence of UKDM 2.4%
Diabetes worldwide

Diabetes in Romania - PREDATORR 2013

(Adults 20-79 years); Source: IDF Diabetes Atlas Sixth Edition 2014
Top 10 countries/territories for prevalence (20-79 years)
2013 and 2035

Romania PREDATORR 2013


11,6%
Source: IDF Diabetes Atlas Sixth Edition 2013
EUROPE at a glance

Romania at glance
PREDATORR 2013

Source: IDF Diabetes Atlas Sixth Edition 2014


Diabetes surge in EUROPE
PREDATORR

Romania
1.752 million

Romania
11.6%
Spain 2012 13.8%
Portugal 2010 11.7%
(Adults 20-79 years)
Source: IDF Diabetes Atlas Sixth Edition 2014
Diagnosed and undiagnosed diabetes among
people aged 20 years or older, United States, 2012

Romania PREDATORR 2013


1.752 million people have diabetes (11.6% of adult Romanian population)
3.623 million people have undiagnosed diabetes (20.69% of people of diabetes)

Source: 20092012 National Health and Nutrition Examination Survey estimates applied to 2012 U.S. Census data
ROMANIA at a glance - PREDATORR 2013
Prevalence of impaired glucose regulation by sex and age groups

50,4% 49,3%
35,5%
29,4%

11,5% 8,1%

Mota M. Prevalence of Diabetes Mellitus and Prediabetes in the Adult Romanian Population: PREDATORR Study. Journal of diabetes. 2015 in press
(available at http://onlinelibrary.wiley.com/doi/10.1111/1753-0407.12297/abstract)
ROMANIA at a glance - PREDATORR 2013
Prevalence of DIABETES and PREDIABETES by age groups

22%

4,3%

13.3%
27,8%
3,2%
18,9% 17,7%
2.9%
10,1%
0,2% 6,9%
2,7%

Mota M. Prevalence of Diabetes Mellitus and Prediabetes in the Adult Romanian Population: PREDATORR Study. Journal of diabetes. 2015 in press
(available at http://onlinelibrary.wiley.com/doi/10.1111/1753-0407.12297/abstract)
ROMANIA at a glance - PREDATORR 2013
Prevalence of DIABETES and PREDIABETES by sex

13.6%

2,9%
9.8%

1,9% 16,7%
16,3%

10,7%
7,9%

Mota M. Prevalence of Diabetes Mellitus and Prediabetes in the Adult Romanian Population: PREDATORR Study. Journal of diabetes. 2015 in press
(available at http://onlinelibrary.wiley.com/doi/10.1111/1753-0407.12297/abstract)
ROMANIA at a glance - PREDATORR 2013
Prevalence of DIABETES by sex and age groups
24.3%

4,6% 20%

17%
4,1%

4,9%

10.2%
1,8% 19,7%
15,9%
3.5% 12,1%
0 2.4% 8,4%
0,5%
3,5%
1,9%

Mota M. Prevalence of Diabetes Mellitus and Prediabetes in the Adult Romanian Population: PREDATORR Study. Journal of diabetes. 2015 in press
(available at http://onlinelibrary.wiley.com/doi/10.1111/1753-0407.12297/abstract)
Prevalence (%) of people with diabetes by age
and sex, 2013

(Adults 20-79 years) Source: IDF Diabetes Atlas Sixth Edition 2013
ROMANIA at a glance - PREDATORR 2013
PREDIABETES

Prediabetes in Romania (20-79 years))


Adult Romanian 15097473
(20-79 years)
Number of people with prediabetes 2491083
Age- and sex-adjusted prevalence of 16.5%
prediabetes

Mota M. Prevalence of Diabetes Mellitus and Prediabetes in the Adult Romanian Population: PREDATORR Study. Journal of diabetes. 2015 in press
(available at http://onlinelibrary.wiley.com/doi/10.1111/1753-0407.12297/abstract)
Prediabetes worldwide

Study population Prediabetes Observations


prevalence
US; 20 years 37% Prediabetes
Portuguese; 20-79 years 27% IFG and/or IGT
Spanish; 18 years 14.8% IFG and/or IGT
European; 20-79 years 9.2% IGT
Romanian; 20-79 years 16.5% Prediabetes

Source: 20092012 National Health and Nutrition Examination Survey estimates applied to 2012 U.S. Census data
Gardete-Correia L et al. First diabetes prevalence study in Portugal: PREVADIAB study. Diabet Med. 2010; 27: 87981
Soriguer F et al. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: The Di@bet.es Study. Diabetologia. 2012; 55:8893.
IDF Diabetes Atlas Sixth Edition 2013
ROMANIA at a glance - PREDATORR 2013
Prevalence of PREDIABETES by sex and age groups

29,3%
26,1%

18,5% 19,2%

8%
5,7%

Mota M. Prevalence of Diabetes Mellitus and Prediabetes in the Adult Romanian Population: PREDATORR Study. Journal of diabetes. 2015 in press
(available at http://onlinelibrary.wiley.com/doi/10.1111/1753-0407.12297/abstract)
Prevalence (%) of IGT (20-79 years) by age and sex,
2013

(Adults 20-79 years) Source: IDF Diabetes Atlas Sixth Edition 2013
Agenda

Premises: diabetes as a huge and growing problem


PREDATORR Study
Children with diabetes in Romania
Therapy in type 2 diabetes (CEGEDIM data)
Conclusions
Acknowledgements
Children with diabetes in Romania

1996: National Diabetes Register of the Child


2014: 401 new cases of type 1 diabetes and 6 new cases of
type 2 diabetes in children
2014: type 1 diabetes incidence was 10.7/100000
2014: 2809 Children with diabetes in Romania
There is a public hospital specialized in pediatric diabetes
(Medical Center "Cristian Serban" European Centre of
Excellence in Pediatric Diabetes in 2011).

Vlad A ONROCAD Study group, 2015.


Agenda

Premises: diabetes as a huge and growing problem


PREDATORR Study
Children with diabetes in Romania
Therapy in type 2 diabetes (CEGEDIM data)
Conclusions
Acknowledgements
Type of therapy for type 2 diabetes patients

2% 2%

18% 13%

47% Diet
45%
Polytherapy
Bitherapy
Monotherapy

36% 38%

TOTAL = 1409 PATIENTS (weighted)


2014 2013
Bitherapy includes fixed combinations
Type of therapy
Classes in monotherapy
66%
BIGUANIDES 62%
16%
SULPHONYLUREAS 21%
14%
INSULINS 13%

2%
AGI 1%

2%
DPP-IV INHIBITORS 0,4%

0,40%
GLP-1 AGONISTS 1%

0,10%
GLINIDES 1%
2014 2013
GLITAZONES 1%
Displaying categories >2%
Type of therapy,
Classes in bitherapy
35%
BIGUANIDES+SULPHONYLUREAS 39%

24%
BIGUANIDES+INSULINS 24%

12%
INSULINS+INSULINS 9%

9%
DPP-IV INHIBITORS+BIGUANIDES 6%

5%
SULPHONYLUREAS+INSULINS 5%

4%
BIGUANIDES+GLP-1 AGONISTS 1%

2%
BIGUANIDES+AGI 1%
2014 2013
Displaying categories >2%
Type of therapy,
Classes in polyherapy
31%
BIGUANIDES+SULPHONYLUREAS+INSULINS 29%
18%
BIGUANIDES+INSULINS+INSULINS 26%
10%
DPP-IV INHIBITORS+BIGUANIDES+SULPHONYLUREAS 13%
9%
AGI+BIGUANIDES+SULPHONYLUREAS 10%
6%
BIGUANIDES+GLP-1 AGONISTS+SULPHONYLUREAS 1%
5%
DPP-IV INHIBITORS+BIGUANIDES 1%
4%
BIGUANIDES+INSULINS 5%
2%
BIGUANIDES+AGI+INSULINS 1%
2%
BIGUANIDES+BIGUANIDES 1%
2%
BIGUANIDES+SULPHONYLUREAS+GLITAZONES 1%

2014 2013
Displaying categories >2%
Type of therapy
Brands
Brands in monotherapy Brands in bitherapy Brands in polytherapy

9%
20% LANTUS+DIAPREL+SIOFOR 6%
48% DIAPREL+SIOFOR 18%
SIOFOR 42% 6%
8% DIAPREL+SIOFOR+LEVEMIR 1%
9% LANTUS+SIOFOR 7%
DIAPREL 13% SIOFOR+AMARYL+LANTUS
5%
7% 12%
9% JANUVIA+SIOFOR 4%
METFOGAMMA 5%
11%
6%
JANUVIA+SIOFOR+AMARYL 4%
6% AMARYL+SIOFOR 11% 4%
LANTUS 4% SIOFOR+DIAPREL+JANUVIA 7%
4%
SIOFOR+LEVEMIR 4% 4%
4% SIOFOR+AMARYL+GLUCOBAY 5%
GLUCOPHAGE 4% 4%
DIAPREL+METFOGAMMA 4% 4%
4% GLUCOBAY+SIOFOR+DIAPREL 3%
GLURENORM 3% 4%
NOVOMIX 30+SIOFOR 4% 4%
3% JANUVIA+GLIBOMET 1%
metforminum 3% 3%
GLIBOMET 8% LEVEMIR+NOVORAPID+SIOFOR
3%
3%
2%
NOVOMIX 3% 2% 3%
LEVEMIR+NOVORAPID 2% LEVEMIR+AMARYL+SIOFOR 1%
2% 2%
AMARYL 3% SIOFOR+GLUCOBAY 1% BYDUREON+DIAPREL+SIOFOR
3%
2% 2% 2%
HUMALOG 2% LANTUS+APIDRA 1% BYETTA+DIAPREL+SIOFOR
2% 2% 2%
LEVEMIR 1% METFOGAMMA+LANTUS 1% SIOFOR+NOVORAPID+LANTUS 4%
2% 2% 2%
GLUCOBAY NOVORAPID+LANTUS 1% LANTUS+GLIBOMET 3%
1%
2% 2%
2% HUMALOG+LANTUS 1%
SIOFOR+LANTUS+APIDRA 2%
HUMULIN 1%
2% 2%
2% BYDUREON+SIOFOR AMARYL+METFOGAMMA+LANTUS 1%
JANUVIA 0,4% 2%
SIOFOR+APIDRA+LANTUS 1%
2014 2013
2014 2013 2014 2013

Displaying categories >2%


Agenda

Premises: diabetes as a huge and growing problem


PREDATORR Study
Children with diabetes in Romania
Therapy in type 2 diabetes (CEGEDIM data)
Conclusions
Acknowledgements
Conclusions
The PREDATORR study, for the first time, provides data for
Romania on the prevalence of DM and prediabetes and their
relationship with important risk factors in a representative
sample of the Romanian adult population.
The final data of the PREDATORR study indicate an increased
prevalence of diabetes and prediabetes, which has doubled
compared to previous estimations
These results are of high value for the health authorities and
can be used to help inform decision making in order to
initiate the implementation of prevention programs that
may reduce the economic burden of DM in Romania.
Agenda

Premises: diabetes as a huge and growing problem


PREDATORR Study
Children with diabetes in Romania
Therapy in type 2 diabetes (CEGEDIM data)
Conclusions
Acknowledgements
Acknowledgements
Sponsors: Romanian Society of Diabetes Nutrition and Metabolic Diseases
(RSDNMD), IHS Sofmedica, Abbott, Astra Zeneca, Novo Nordisk, MSD, Servier,
Novartis, Worvag Pharma

The Company CEBIS International (www.cebis-int.com), for: Study


Documentation Development, Feasibility, Project Management, Monitoring, Data
Management, Statistical Analysis and Final Report

Profesor Cristian Baicus - Head of the Clinical Epidemiology Unit of Bucharest, in


the RECIF (Reseau dEpidemiologie Clinique International Francophone) and INCLEN
(International Clinical Epidemiology Network) for review / validation of the statistical
analysis

Synevo Central Laboratory, for performing the analysis of the study

Those 101 general physicians who who enrolled the participants, filled in the
study questionnaires, and collected blood and urine samples from the participants

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