Preview

Diabetes mellitus

Advanced search

IMPROVE observational program: safety and effectiveness of biphasic insulin aspart 30 in routine clinical practice. Overview of starting characteristics of the Russian patient cohort

https://doi.org/10.14341/2072-0351-5713

Abstract

AIM: To analyse starting characteristics of the Russian patient cohort included in the IMPROVE observational program with reference to its demographiccomposition and clinical features of the disease in patients allocated to different groups depending on previous treatment, reason for prescribing DiAsp 30 (NovoMix 30) therapy, and its initial dosage regime.


METHODS: The analysis covered the cohort of Russian patients included in the IMPROVE global program, an open non-randomizedobservational multicentre study of safety and effectiveness of insulin DiAsp for patients with DM2 during 26 weeks of routine clinical practice. In thepreceding period, the patients (n=4869) received either oral hypoglycemic agents (OHAs) (n=2430) or insulin +/- OHAs (n=2343); the controlgroup was comprised of 95 patients given no previous antidiabetic treatment.


RESULTS: Most patients had inadequate glycemic control prior to DiAsp therapy with the mean HbA1c level of 9,2%. Those given no previous antidiabetictreatment showed the highest HbA1c level (9,9%) and higher frequency of microvascular vs macrovascular complications (91 and 51% respectively).Patients that used the largest amount of antidiabetic agents developed the highest number of complications; this situation reflects therelationship between poor glycemic control and the risk of complications.


CONCLUSIONS: The Russian patient cohort is one of the three largest ones in the IMPROVE? global program. They reside in different geographic regions,have different history of antidiabetic treatment and far-from-normal HbA1c levels as a result of altogether poor glycemic control in Russian patientswith DM2. The cohort at large exhibits a suboptimal HbA1c level even though the majority of the patient have an access to antidiabetic therapy. Mostphysicians participating in the study refer to improved glycemic control in their DM2 patients (lowered HbA1c, fasting and postprandial glucose levels)as the main reason for the initiation of therapy with DiAsp 30 (NovoMix 30).

About the Authors

Marina Vladimirovna Shestakova
Endocrinology Research Centre, Moscow


Akill Ballan
Novo Nordisk, Russia


References

1. American Diabetes Association. //Diabetes Care. - 2007. - 30 Suppl. 1. - S4-S41.

2. Global Guideline for Type 2 Diabetes; IDF, 2005.

3. UKPDS Group. Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33) // Lancet. - 1998. - 352. - Р.837-853.

4. American Diabetes Association. Implications of the United Kingdom Prospective Diabetes Study // Diabetes Care. - 2003. - 26 (Suppl.1). - S28-S32.

5. American Diabetes Association. Standards of medical care in diabetes // Diabetes Care. - 2004. - 27 (Suppl. 1). - S15-S35.

6. American Association of Clinical Endocrinologists. Medical guidelines for the anagement of diabetes mellitus: the AACE system of intensive diabetes selfmanagement- 2002 update // Endocr. Pract. - 2002. - 8 (Suppl. 1). - Р.40- 83.

7. Алгоритмы специализированной медицинской помощи больным сахар- ным диабетом / Под ред. акад. Дедова И.И. и проф. Шестаковой М.В. - Издание 4-е. - М.: 2009.

8. Global Guidelines for Type 2 Diabetes, IDF, 2005

9. American Association of Clinical Endocrinologists (AACE) website. Diabetes Guidelines. http://www.aace.com/clin/guidelines/diabetes_2002.pdf.

10. Selvin E., Marinopoulos S., Berkenblit G. et al. Metaanalysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus // Р.Ann. Intern. Med. - 2004. - 141. - Р.421-431.

11. Marre M. Before oral agents fail: the case for starting insulin early // Int. J. Obes. - 2002. - 26 (Suppl. 3). - S25-S30.

12. Mari'lle J.P. van Avendonk and Guy E.H.M. Rutten. Insulin therapy in type 2 diabetes: what is the evidence? // Diabetes, Obesity and Metabolism. - 2009.

13. Lebovitz. Diabetes Reviews. 1999. - 7: 139-53 (data are from the UKPDS population: UKPDS 16 // Diabetes. - 1995. - 44. - Р.1249-1258.

14. Nathan D.M. Finding new treatments for diabetes - how many, how fast… how good? // N. Engl. J. Med. - 2007. - 356. - Р.437-40.

15. Wright A., Burden A.C., Paisey R.B., Cull C.A., Holman R.R. Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57) // Diabetes Care. - 2002.

16. Michael E. Cobble. Initiating and Intensifying Insulin Therapy for Type 2 Diabetes: Why, When, and How // Am. J. Ther. - 2009. - 16. - Р.56-64.

17. Ligthelm R., Davidson J. Initiating insulin in primary care - The role of modern premixed formulations // Diabetes Primary Care. - 2008. - 2. - Р.9-16.

18. Khutsoane D., Sharma S.K., Almustafa M. et al. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study // Diabetes. Obes. Metab. - 2008. - 10. - Р.212-222.

19. Raskin P., Allen E., Hollander P. et al. For the INITIATE study group. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs // Diabetes Care. - 2005. - 28. - Р260-265.

20. Garber A., Wahlen J., Wahl T. et al. For the 1-2-3 study group. Attainment of glycaemic goals in type 2 diabetes with once-, twice, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study) // Diabetes. Obes. Metab. - 2006. - 8. - 58-66.

21. Khutsoane D., Sharma S.K., Almustafa M. et al. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study. //Diabetes. Obes. Metab. - 2008. - 10. - Р.212-222.

22. Ligthelm R.J., Borzi V., Gumprecht J., Kawamori R., Wenying Y., Valensi P. Importance of observational studies in clinical practice // Clin. Ther. 2007; 29: 1284-92.

23. Shaban J., Hansen J.B. and Wenying Y. NovoMix® 30 (BIAsp 30) Improves Glycemic Control in Type 2 Diabetes: Results from the IMPROVE™ Study // Diabetes Care. - 2008. - 31(suppl. 1). - S12-S54.

24. Valensi P., Benroubbi M., Borzi V., et al. The IMPROVE ™ Study - a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts // Int. J. Clin. Pract. - 2008. - 62. - Р.1809-1819.

25. Siddharth Shah A.K. Das Ajay Kumar et al. Baseline Characteristics of the Indian Cohort from the IMPROVE™ Study: a Multinational, Observational Study of Biphasic Insulin Aspart 30 Treatment for Type 2 Diabetes // Adv. Ther. 2009; 26 (3).

26. Ilkova H., Glaser B., Tunзkale A., Bagriaзik N., Cerasi E. Induction of longterm glycaemic сontrol in newly diagnosed type 2 diabetic patients by transient intensive insulin treatment // Diabetes Care. 1997; 20:1.


Review

For citations:


Shestakova M.V., Ballan A. IMPROVE observational program: safety and effectiveness of biphasic insulin aspart 30 in routine clinical practice. Overview of starting characteristics of the Russian patient cohort. Diabetes mellitus. 2009;12(4):93-97. (In Russ.) https://doi.org/10.14341/2072-0351-5713

Views: 688


ISSN 2072-0351 (Print)
ISSN 2072-0378 (Online)