PMCCPMCCPMCC

Search tips
Search criteria 

Advanced

 
Logo of diametsynBioMed CentralBiomed Central Web Sitesearchsubmit a manuscriptregisterthis articleDiabetology & Metabolic SyndromeJournal Front Page
 
Diabetol Metab Syndr. 2010; 2: 35.
Published online 2010 June 8. doi:  10.1186/1758-5996-2-35
PMCID: PMC2904721

Algorithm for the treatment of type 2 diabetes: a position statement of Brazilian Diabetes Society

Abstract

The Brazilian Diabetes Society is starting an innovative project of quantitative assessment of medical arguments of and implementing a new way of elaborating SBD Position Statements. The final aim of this particular project is to propose a new Brazilian algorithm for the treatment of type 2 diabetes, based on the opinions of endocrinologists surveyed from a poll conducted on the Brazilian Diabetes Society website regarding the latest algorithm proposed by American Diabetes Association /European Association for the Study of Diabetes, published in January 2009.

An additional source used, as a basis for the new algorithm, was to assess the acceptability of controversial arguments published in international literature, through a panel of renowned Brazilian specialists. Thirty controversial arguments in diabetes have been selected with their respective references, where each argument was assessed and scored according to its acceptability level and personal conviction of each member of the evaluation panel.

This methodology was adapted using a similar approach to the one adopted in the recent position statement by the American College of Cardiology on coronary revascularization, of which not only cardiologists took part, but also specialists of other related areas.

Module 1

Summary of Brazilian Diabets Society Members Opinions on the New ADA/EASD Algorithm

Considering the great controversy raised by the recommendations at the recent ADA/EASD algorithm, the Brazilian Diabetes Society (BDS) decided to evaluate the opinions of its members, through a survey conducted on the BDS' website during ten days, in November 2008 [1,2]. Two hundred and seventeen associates (endocrinologists) completed this survey.

Table Table11 shows the percentages of answers to the proposed questions to BDS' associates.

Table 1
Percentuals of answers to the proposed questions

General conclusions about the survey results

The results showed that the majority of the brazilian endocrinologists do not agree with the guidelines proposed by the ADA/EASD algorithm regarding the use of glitazone, GLP-1 analogs and DPP-IV inhibitors in the treatment of Type 2 Diabetes.

Considering the need for an algorithm reflecting the opinion of Brazilian endocrinologists, the Brazilian Diabetes Society decided to develop this position statement, whose recommendations shall be dictated by the technical panel assessments, named by the entity and also by the results obtained from the survey.

Module 2

Results of the controversial diabetes argument acceptability assessment

In addition to the feedback from associates obtained through the survey and in order to provide a more robust basis to the algorithm proposed for the treatment of type 2 diabetes, the Brazilian Diabetes Society obtained the opinions of a panel formed by renowned Brazilian specialists regarding recommendations, guidelines and controversial arguments on the treatment of type 2 diabetes in international literature.

Thirty controversial arguments were individually assessed and scored on a 10-point scale by the evaluation panel members, who assigned individual scores (0-10) to the 30 arguments presented, which were made into 5 acceptability levels (1-5).

The correlation between scores and their corresponding acceptability levels, as well as the analytical interpretation of results, are summarized in table table22.

Table 2
Interpretation of acceptability levels of arguments based on individual scores

Average acceptability level of controversial matters assessed and their respective bibliographical references

Table S1, Additional file 1 shows the relation between controversial matters assessed and their respective bibliographical references and the average level of acceptability for each controversial matter, following the calculation methodology as defined in the previous item.

Module 3

New SBD algorithm proposal for the treatment of type 2 diabetes

Laboratory goals for characterization of good glycemic control

The desirable goal for A1C, as defined by the previous position statement in 2007, recommended A1C levels < 6.5%. In this new Position Statement, the recommended A1C goal was redefined to <7.0% as shown in table table3.3. However, according to the ADA's 2010 statement, in patients with a history of severe hypoglycemia, patients with limited life expectancies, children, individuals with comorbidities, those with longstanding diabetes, advanced age and those with advanced microvascular or macrovascular complications" intensive glycemic control may outweigh its benefits. But for patients with short duration of diabetes, long life expectancy, and no significant CVD a level of A1c even lower than the general goal of <7%, has been suggested if this can be achieved without significant hypoglycemia or other adverse effects [3-5].

Table 3
Laboratory targets for proper T2DM treatment

Regarding tolerable levels for laboratory goals, they were defined based on the recommendations contained in the bibliographical references [3-5].

New SBD algorithm proposal for treating type 2 diabetes

The new algorithm proposal for the treatment of type 2 diabetes was developed based on the premises and assessments conducted through the survey with SBD members and the assessment of conclusions from the panel of specialists (Table (Table44).

Table 4
Algorithm for the treatment of type 2 diabetes - 2009 update -

The presentation format of the new algorithm proposal was developed taking as fundamental reference the recommendations by the Joslin Diabetes Center & Joslin Clinic and also by the American Association of Clinical Endocrinologists [6-9]..

The present algorithm was completed before the publication of the recent AACE/ACE algorithm [10]. As pointed out in the recent AACE algorithm safety, efficacy and effectiveness must be the priorities and in developing countries like Brazil cost of medications is an important barrier and could Influence the treatment.

Module 4

Summary of therapeutic profile of drugs used for treating type 2 diabetes

Comparative efficacy and potential of A1C reduction of different therapeutic interventions

The various therapeutic interventions present different levels of comparative efficacy and of potential of A1C reduction. Such facts must be taken into account when determining the best therapeutic strategy for each patient (table (table5)5) [11,12].

Table 5
Comparative efficacy of therapeutic interventions for reducing A1C levels

Summary of therapeutic profiles of drugs used for treating type 2 diabetes

The main features of therapeutic profiles of drugs used for treating type 2 diabetes are summarized in table table66[13,14].

Table 6
Pharmacologic options for oral DM-2 treatment

Fixed combinations of oral antidiabetic drugs

Due to its convenience and comparatively lower prices, fixed-combination therapies for treating diabetes are being made available more frequently. There are many presentations of combined treatments, including two oral agents in the same package, however with separate pills (table (table7)7) or a single pill containing both active agents in the same formulation (table (table88).

Table 7
Partial list of oral antidiabetic drugs used in combination therapy: two substances in separate pills
Table 8
Partial relation of oral antidiabetic drugs at combination therapy: two substances in a single pill

Action profile of human insulin and human insulin analogs

Basically, there are three commercial presentation forms of insulin in the Brazilian marketplace: 1) human insulin in monotherapy; 2) human insulin analog in monotherapy; 3) biphasic human insulin analogs.

The addition of insulin to patients with type 2 diabetes must be done as soon as the patient did not reach the target of HbA1c [15]. No definitve conclusions regarding the association between insulin therapy with glargine [16] and malignancies were established.

Table Table99 summarizes the main features of the action profile of insulin preparations available.

Table 9
action profile of human insulin and human insulin analogs

Biphasic insulin analogs have a long-acting insulin component, in a formulation combined with a short-acting insulin component, as shown in table table1010

Table 10
Biphasic rapid and long-acting insulin analogs

Module 5

Treatment cost estimate for various therapeutic options

The concept of Evidence-Based Medicine recognizes three main components to help physicians define therapeutic conduct: the evidence of research per se, the clinical expertise of physicians and patient preferences. Treatment cost must be one of the fundamental factors for patients to fulfill their right of choice in due proportion, in the concept of evidence-based medicine [17].

We added two website suggestions for physicians to obtain information about drug costs for consumers of the therapeutic options they intend to prescribe. In both references, prices are displayed in different rows expressing the costs of each drug, considering the incidence of distinct tax rates, which vary according to Brazilian states. For the physician, the desired piece of information is the maximum retail price (MRP), which may be found in the last row to the right in price tables.

Links to browse drug prices

http://portal2.saude.gov.br/BPS/visao/consultapublica/publico_interno_item.cfm[18]

Using the internal resource of research to obtain the desired price http://www.elomedico.com.br[19]

Requires previous and free subscription. Search for item "drugs/prices" on the left row in the homepage

Competing interests

ACL - The author declare that he has no competing interest

ARC - Research grants from Eli Lilly, Sanofi-Aventis, Roche, Novartis, MSD, Novo Nordisk

Advisory board: AZ, BMS, Sanofi-Aventis, Novo Nordisk

APN - External Medical Consultant for Roche Diagnostics; Speaker GSK, Eli Lily

DM - Committee Member: NONE

Research Grant: NONE

Speakers' Bureau: SANOFI-AVENTIS

Honoraria: SANOFI-AVENTIS

Expert Witness: NONE

Stock Ownership: NONE

Board of Directors: NONE

Consultant:: NONE

Scientific Advisory Board: SANOFI-AVENTIS

Steering Committee: NONE

JLG - Research Grants: Abbott, Bristol-Myers Squibb, Eli Lilly, Glaxo Smith Kline, Merck Sharp & Dohme, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis

Speaker: Bristol-Myers Squibb, Eli Lilly, Glaxo Smith Kline, Merck Sharp & Dohme, Novo Nordisk, Sanofi-Aventis

Member Advisory Board: Glaxo Smith Kline, Merck Sharp & Dohme, Novo Nordisk, Sanofi-Aventis

JEPO - Member Advisory Board Sanofi-Aventis

MBG - The author declare that she has no competing interest

RDS - Member Advisory Board GSK, MerckSharp&Dhome

Speaker: Astra Zeneca, Pfizer, MerckSharp&Dhome, Bristol Meyers Squibb, GSK, Novartis

RMCF - The author declare that she has no competing interest

RB - The author declare that he has no competing interest

RR - Member Advisoy board Lantus

Speaker: SanofiAventis, Abbott, MerckSharp&Dhome, Eli Lily, Novonordisk, GSK

Authors' contributions

APN wrote the manuscript.

MBG partipated in the design of the study and wrote the manuscript.

ACL, ARC, DM, JLG, JEPO, RDS, RMCF, RB, RR: all have partipated in the technical panel.

All authors read and approved the final manuscript.

Supplementary Material

Additional file 1:

Table S1. average acceptability level of controversial matters assessed and their respective bibliographic references.

References

  • Patel MR, Dehemer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Resvascularization. J Am Coll Cardiol. 2009;53(6):530–553. doi: 10.1016/j.jacc.2008.10.005. http://content.onlinejacc.org/cgi/reprint/j.jacc.2008.10.005v1.pdf [PubMed] [Cross Ref]
  • Gomes MB. Enquete sobre Algoritmo American Diabetes Association/European Association for the Study of Diabetes - December 2008 - 217 SBD Associates. http://www.diabetes.org.br/agenda/comunicados/index.php?id=1838 Accessed on 07/13/09.
  • Grupo Interdisciplinar de Padronização da Hemoglobina Glicada - A1C. Atualização sobre Hemoglobina Glicada (A1C) para Avaliação do Controle Glicêmico e para o Diagnóstico do Diabetes: Aspectos Clínicos e Laboratoriais. Posicionamento Oficial 3ª Edição. Brazilian Diabetes Society, Brazilian Endocrinology and Metabolim Society, Brazilian Clinical and Pathology Society, National Diabetes Federation. 2009.
  • American Diabetes Association. Standards of Medical Care in Diabetes - 2009. Diabetes Care. 2010;32(Suppl 1):S16–S61.
  • Pignone M. Decisions about intensity of glycemic control should depend on age and functional status. Clinical Diabetes. 2009;27:147–8. doi: 10.2337/diaclin.27.4.147. [Cross Ref]
  • Joslin Diabetes Center & Joslin Clinic. Clinical Guideline for Pharmacological Management of Type 2 Diabetes, 2007. http://www.joslin.org/Files/Pharm_ClinGuide9706final.pdf Accessed on 07/13/09.
  • Joslin Diabetes Center & Joslin Clinic. Clinical guideline for adults with diabetes,2009. http://www.joslin.org/Files/Adult_guidelines_041109_grade_updating.pdf Accessed on 07/13/09.
  • Blonde L, Einhorn D, Grunberger G, Handelsman Y, Hellsman Y, Hellman R, Lebovitz H, Levy P, Roberts VL. for the ACE/AACE Diabetes Road Map Task Force. Road Maps to Achieve Glycemic Control in Type 2 Diabetes Mellitus. Endocrine Practice. 2007;13(3):260–261. http://www.aace.com/pub/roadmap/Diabetes Roadmap.ppt Accessed on 13/02/2010. [PubMed]
  • Rodbard HW, Blonde L, Braithwaite SS, Brett EM, Cobin RH, Handelsman Y, Hellman R, Jellinger PS, Jovanovic LG, Levy P, Mechanick JI, Zangeneh F. AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007;13(Suppl1):1–68. http://www.aace.com/pub/pdf/guidelines/DMGuidelines2007.pdf [PubMed]
  • Rodbard HW, Jellinger PS, Davidson JA, Einhorn D, Garber A, Grunberger G, Handelsman Y, Horton ES, Lebovitz H, Levy P, Moghissi ES, Schartz SS. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology Consensus Panel on type 2 diabetes mellitus:an algorithm for glycemic control. Endocrine Practice. 2009;15:540–559. [PubMed]
  • Grant RW. How Doctors Choose Medications to Treat T2DM. Diabetes Care. 2007;30:1448–1453. doi: 10.2337/dc06-2499. [PubMed] [Cross Ref]
  • Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. Diabetes Care. 2009;32:193–20. doi: 10.2337/dc08-9025. [PMC free article] [PubMed] [Cross Ref]
  • Matveyenko AV, Dry S, Cox HI, Moshtahian A, Gurlo T, Galasso R, Butler AE, Butler PC. Beneficial endocrine but adverse exocrine effects of sitaglipitinin the HIP rat model of type 2 diabetes, interactions with metformin. Diabetes. 2008;58:1604–1615. doi: 10.2337/db09-0058. [PMC free article] [PubMed] [Cross Ref]
  • Nachani JS, Bulchadani DG, Nookala A, Herndon B, Molteni A, Pandya P, Taylor R, Weide L, Alba LM. Biochemical and histological effects of exendin-4(exenatide) on the rat pancreas. Diabetologia. 2010;53:153–159. doi: 10.1007/s00125-009-1515-4. [PubMed] [Cross Ref]
  • McMahon GT, Dlhy RG. Intention to Treat -- Initiating Insulin and the 4-T Study. N Engl J Med. 2000;357(17):1759–61. doi: 10.1056/NEJMe078196. 17. [PubMed] [Cross Ref]
  • Hemkens LG, Grouven U, Bender R, Günster C, Gutschmidt S, Selke GW Sawicki PT. Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study. Diabetologia. 2009;52:1732–44. doi: 10.1007/s00125-009-1418-4. [PMC free article] [PubMed] [Cross Ref]
  • Deyo JP;, Ramsey RA. Evidence-Based Clinical Practice: Concepts and Approaches. Butterworth-Heinemann. Boston, USA; 2000.
  • Lista de Preços de Medicamentos. http://portal2.saude.gov.br/BPS/visao/consultapublica/publico_interno_item.cfm Accessed on 03/20/2010.
  • Lista de preços de medicamentos. Portal Elomédico. http://www.elomedico.com.br Accessed on 07/13/09.

Articles from Diabetology & Metabolic Syndrome are provided here courtesy of BioMed Central