Sign In
Register
eISSN:2278-5299

International Journal of Latest Research in Science and Technology

DOI:10.29111/ijlrst   ISRA Impact Factor:3.35,  Peer-reviewed, Open-access Journal

A News Letter Sign UP!
A NEW TOOL FOR DETECTING ADVERSE EVENTS ASSOCIATED WITH ORALANTIDIABETIC AGENTS

Research Paper Open Access

International Journal of Latest Research in Science and Technology Vol.5 Issue 1, pp 61-65,Year 2016

A NEW TOOL FOR DETECTING ADVERSE EVENTS ASSOCIATED WITH ORALANTIDIABETIC AGENTS

Rui Santos Cruz, Margarida Tenente Pocinho, Luiz Miguel Santiago, Carlos Fontes Ribeiro

Correspondence should be addressed to :

Received : 17 February 2016; Accepted : 24 February 2016 ; Published : 29 February 2016

Share
Download 125
View 178
Article No. 10612
Abstract

In diabetes mellitus, adverse events associated with oral antidiabetics agents may interfere with the patients’ health. This paper presents a study to design and validate a questionnaire to identify adverse events associated with oral antidiabetic agents in primary health care units. After design and field testing of the questionnaire, a cross-sectional observational study was conducted by applying the questionnaire through interview to 357 type 2 diabetics in six primary health care units of the central region of Portugal, between January and December 2013. Descriptive and inferential statistics analysis after checking for the normality of the data was performed. Internal consistency was explored using Cronbach's alpha coefficient; the construct validity was assessed through factor analysis after the Kaiser-Meyer-Olkin test (KMO) and Bartlett's test of sphericity. The accepted level of significance was of р <0.05. The questionnaire included 22 adverse events, a KMO value of 0.649, Bartlett test: p <0.000 and Cronbach's alpha= 0.691. Fifty-five percent (55.2%) of diabetics enrolled in the study (mean age of 67.5 ± 9.5 years) were women. The average development time from onset of disease was 9.1 ± 7.2 years. The most widely used oral antidiabetic drugs are biguanides (62.5%) and metformin+vildagliptin (16.8%), as monotherapy and combination therapy, respectively. The most adverse events pointed out by patients were "Arthralgia" (16.8%), "Paresthesia’s" (4.5%), "Flatulence" (3.9%) and "Peripheral edema" (2.8%). Testing of the questionnaire revealed good patient’s acceptability and comprehensibility, showed acceptable reliability, and that it is easy to apply in primary health care units.

Key Words   
Psychometric properties; validity; questionnaire; adverse drugs events
Copyright
References
  1. International Diabetes Federation. The Diabetes Atlas. Sixth edition. Update. Brussels; 2014.
  2. Chen L, Magliano DJ, Zimmet PZ. The worldwide epidemiology of type 2 diabetes mellitus--present and future perspectives. Nat Rev Endocrinol. Nature Publishing Group; 2012 Apr;8(4):228–36.
  3. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193–203.
  4. Daly JM, Hartz AJ, Xu Y, Levy BT, James P a, Merchant ML, et al. An assessment of attitudes, behaviors, and outcomes of patients with type 2 diabetes. J Am Board Fam Med. 2009;22(3):280–90.
  5. Carter P, Gray LJ, Troughton J, Khunti K, Davies MJ. Fruit and vegetable intake and incidence of type 2 diabetes mellitus: systematic review and meta-analysis. Bmj. 2010 Aug;341(aug18 4):c4229–c4229.
  6. Chao J, Nau DP, Aikens JE. Patient-reported perceptions of side effects of antihyperglycemic medication and adherence to medication regimens in persons with diabetes mellitus. Clin Ther. 2007 Jan ;29(1):177–80.
  7. Pollack MF, Purayidathil FW, Bolge SC, Williams SA. Patient-reported tolerability issues with oral antidiabetic agents: Associations with adherence; treatment satisfaction and health-related quality of life. Diabetes Res Clin Pract. 2010 Feb;87(2):204–10.
  8. Asche C V, McAdam-Marx C, Shane-McWhorter L, Sheng X, Plauschinat C a. Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Aug;10(8):638–45.
  9. Cheng AYY, Fantus IG. Oral antihyperglycemic therapy for type 2 diabetes mellitus. Can Med Assoc J. 2005;172(2):213–26.
  10. Chacra AR, Tan GH, Ravichandran S, List J, Chen R. Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks. Diab Vasc Dis Res. 2011 Apr;8(2):150–9.
  11. Stein SA, Lamos EM, Davis SN. A review of the efficacy and safety of oral antidiabetic drugs. Expert Opin Drug Saf. 2013;12(2):153–75.
  12. Mathieu C, Barnett a H, Brath H, Conget I, de Castro JJ, Göke R, et al. Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: a real-life worldwide observational study (EDGE). Int J Clin Pract. 2013 Oct;67(10):947–56.
  13. Margraff F, Bertram D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug Saf. 2014 Jun;37(6):409–19.
  14. Hill MM, Hill A. Capítulo 5-As respostas: escalas de medida. Investigação por Questionário. 1a Edição. Lisboa: Edições Silabo; 2000. p. 106–18.
  15. Bryman A&, Cramer D. Constructing Variables. M Hardy & A Bryman (Eds); Handbook of Data Analysis. London; England: SAGE Publications Ltd; 2004. p. 18–35.
  16. Costello AB, Osborne JW. Best Practices in Exploratory Factor Analysis: Four Recommendations for Getting the Most From Your Analysis. Pract Assessment, Res Eval. 2005;
  17. Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan; 60(1):34–42.
  18. Tabachnick BG, Fidell LS. Using Multivariate Statistics. 5th ed. Bacon P&, editor. Pearson/Allyn & Bacon. Boston; 2007.
  19. Hair JF, Black WC, Babin BJ, Anderson RE, Tatham RL. Multivariate data analysis. 6th Editio. Pearson-Prentice Hall, Upper Saddle River, NJ.; 2006. 100-128 p.
  20. American Diabetes Association. Standards of Medical Care in Diabetes—2015 Abridged for Primary Care Providers. Diabetes Care. 2015;33(2):97–111.
  21. Williams B, Brown T, Onsman A. Exploratory factor analysis : A five-step guide for novices. J Emerg Prim Heal Care. 2012;8(3):1–13.
  22. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Medical Dictionary for Regulatory Activities (MedDRA). 2014. MedDRA Version 17.1 p.
  23. Rosenstock J, Rood J, Cobitz a, Biswas N, Chou H, Garber a. Initial treatment with rosiglitazone/metformin fixed-dose combination therapy compared with monotherapy with either rosiglitazone or metformin in patients with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2006 Nov;8(6):650–60.
  24. Seufert J, Urquhart R. 2-Year Effects of Pioglitazone Add-on To Sulfonylurea or Metformin on Oral Glucose Tolerance in Patients With Type 2 Diabetes. Diabetes Res Clin Pract. 2008 Mar; 79(3):453–60.
  25. Rosenstock, Aguilar-Salinas C, Klein E, Nepal S, List J, Chen R. Effect of saxagliptin monotherapy in treatment-naïve patients with type 2 diabetes. Curr Med Res Opin. 2009; 25(10):2401–11.
  26. Vilar L, Canadas V, Arruda MJ, Arahata C, Agra R, Pontes L, et al. Comparison of metformin, gliclazide MR and rosiglitazone in monotherapy and in combination for type 2 diabetes. Arq Bras Endocrinol Metabol. 2010;
  27. Dharmalingam M. Efficacy and tolerability of GLP-1 agonists in patients with type 2 diabetes mellitus: an Indian perspective. Ther Adv Endocrinol Metab. 2014; 5(6):159–65.
  28. Ortiz LGC, Cabriales ECG, González JGG, Meza MVG. Condutas de autocuidado e indicadores de saúde em adultos com diabetes tipo 2. Rev Latino-Am Enferm. 2010; 18(4).
  29. Tranqueiro MT de O. A gestão do autocuidado nos idosos com diabetes : revisão sistemática da literatura. Rev Enferm Ref. 2013;9(III Série):151–60.
  30. Cardoso AF, Queirós P, Ribeiro CF. Intervenções para a aquisição do autocuidado terapêutico da pessoa com diabetes mellitus: revisão sistemática da literatura. Rev Port Saúde Pública. 2015;(JANUARY).

 

To cite this article

Rui Santos Cruz, Margarida Tenente Pocinho, Luiz Miguel Santiago, Carlos Fontes Ribeiro , " A New Tool For Detecting Adverse Events Associated With Oralantidiabetic Agents ", International Journal of Latest Research in Science and Technology . Vol. 5, Issue 1, pp 61-65 , 2016

Responsive image

MNK Publication was founded in 2012 to upholder revolutionary ideas that would advance the research and practice of business and management. Today, we comply with to advance fresh thinking in latest scientific fields where we think we can make a real difference and growth now also including medical and social care, education,management and engineering.

Responsive image

We offers several opportunities for partnership and tie-up with individual, corporate and organizational level. We are working on the open access platform. Editors, authors, readers, librarians and conference organizer can work together. We are giving open opportunities to all. Our team is always willing to work and collaborate to promote open access publication.

Responsive image

Our Journals provide one of the strongest International open access platform for research communities. Our conference proceeding services provide conference organizers a privileged platform for publishing extended conference papers as journal publications. It is deliberated to disseminate scientific research and to establish long term International collaborations and partnerships with academic communities and conference organizers.