Застосування інсуліну гларгін (Лантус®) у повсякденній клінічній практиці: результати обсерваційного перехресного ретроспективного спостереження IDEAL

Автор(и)

  • О. С. Ларін Український науково-практичний центр ендокринної хірургії, трансплантації ендокринних органів і тканин МОЗ України, Київ, Ukraine https://orcid.org/0000-0002-5090-5110

DOI:

https://doi.org/10.24026/1818-1384.4(45).2013.78395

Ключові слова:

insulin therapy, glargine (Lantus®), efficacy safety

Анотація

Diabetes mellitus (DM) type 2 is one of the most important problems of present-day medicine. The main reasons for limiting the use of insulin therapy are: the risk of hypoglycemia, body weight increase, a peak of the insulin activity, starting treatment with sub-optimal dose of insulin and its inadequate titration. Insulin glargine (Lantus®) is the first long-acting insulin analogue, characterized by the peak of activity miss and less interindividual variability compared with insulin neutral protamine Hagedorn (NPH) or ultralente. Objectives – evaluate the efficacy and safety of insulin glargine (Lantus®), and NPH insulin in patients with DM type 2 in daily clinical practice. In a observational retrospective cross follow study included 216 patients treated with Lantus® for 4-9 months (active group) and 133 patients treated with NPH insulin for more than 12 months (control group). Efficacy was assessed by the level of glycosylated hemoglobin (HbA1c) and fasting glucose. Safety was assessed by evaluating the frequency of documented symptomatic hypoglycemia. The groups were homogeneous by sex and age. The reasons for changing to Lantus® were decompensation or labile for DM (48.03%), allergy or intolerance to NPH insulin (1.18%), comorbidity (1.18%). By the end of the study among patients treated with Lantus®, the number of patients with a value of HbA1c more than 7.5% decreased by 47.1%, whereas in the NPH insulin group – by 10.3%. The number of patients with a fasting glucose level of more than 7 mmol/l Lantus® group decreased by 42.1% and in the group of NPH insulin – by 15.5%. The mean daily insulin dose in patients treated with Lantus® was lower than average daily dose in control group for 22.2%. Symptomatic hypoglycemia during the last month of observation occurred significantly more often in the control group (62.05%), whereas in the main group – 37.96% (p<0.05). Lantus® versus NPH insulin allows a better compensation of DM 2 and requires a smaller daily dose of insulin. 

Біографія автора

О. С. Ларін, Український науково-практичний центр ендокринної хірургії, трансплантації ендокринних органів і тканин МОЗ України, Київ

(від групи дослідників)

Посилання

Turner R., Cull C., Frighi V., Holmann R. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49): UK Prospective Diabetes Study (UKPDS) Group // JAMA. – 1999. – Vol. 281. – P. 2005-2012. https://doi.org/10.1001/jama.281.21.2005

Korytkowski M. When oral agents fail: practical barriers to starting insulin // Int. J. Obes. Relat. Metab. Disord. – 2002. – Vol. 26. – P. S18-S24. https://doi.org/10.1038/sj.ijo.0802173

Bolli G.B. The pharmacokinetic basis of insulin therapy in diabetes mellitus // Diabetes Res. Clin. Pract. – 1989. – Vol. 6. – P. S3-S16. https://doi.org/10.1016/0168-8227(89)90073-9

Binder C., Lauritzen T., Faber O., Pramming S. Insulin pharmacokinetics // Diabetes Care. – 1984. – Vol. 7. – P. 188-199. https://doi.org/10.2337/diacare.7.2.188

Lepore M., Pampanelli S., Fanelli C., Porcellati F., Bartocci L., Di Vincenzo A., Cordoni C., Costa E., Brunetti P., Bolli G.B. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro // Diabetes. – 2000. – Vol. 49. – P. 2142-2148. https://doi.org/10.2337/diabetes.49.12.2142

Riddle M., Rosenstock J., Gerich J., Investigators IGS. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetes patients // Diabetes Care. – 2003. – Vol. 26. – P. 3080-3086. https://doi.org/10.2337/diacare.26.11.3080

Rosenstock J., Massi Benedetti M., Haring H.U., Lin Z., Salzman A. Confirmed lower risk of hypoglycemia with insulin glargine versus NPH insulin: a meta-analysis of 2304 patients with type 2 diabetes // Diabetologia. – 2003. – Vol. 46. – P. A304.

Yki-Jarvinen H., Dressler A., Ziemen M. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes: HOE 901/3002 Study Group // Diabetes Care. – 2000. – Vol. 23. – P. 1130-1136. https://doi.org/10.2337/diacare.23.8.1130

American Diabetes Association: Clinical Practice Recommendations 2003 // Diabetes Care. – 2003. – Vol. 26 (suppl. 1). – P. S1-S156. http://care.diabetesjournals.org/content/26/suppl_1

Davies M., Storms F., Shutler S., Bianchi-Biscay M., Gomis R. Insulin glargine in type 2 patients with suboptimal glycemic control on twice-daily premix insulin: AT.LANTUS Trial Results study // Diabetes. – 2004. – Vol, 53 (suppl. 2). – P. A473.

Lavalle-Gonzalez F., Storms F., Shutler S., Bianchi-Biscay M., Gomis R. Effect of basal insulin glargine therapy in type 2 patients inadequately controlled on oral antidiabetic agents: AT.LANTUS trial results. Abstract presented at the American Diabetes Association 64th Scientific Sessions, 4-8 June 2004, The Orange County Convention Center, Orlando, Florida: 12-LB (late breaking). – 2004.

Fulcher G., Storms F., Shutler S., Leperlier C., Gomis R., Davies M. Initiation of insulin glargine in patients with type 2 diabetes suboptimally controlled on once- or twice-daily NPH insulin: results from the AT.LANTUS trial // Diabetologia. – 2004. – Vol. 47. – P. A272.

Lavalle-Gonzalez F., Storms F., Shutler S., Bianchi-Biscay M., Gomis R., Davies M. Initiation of basal insulin glargine therapy in type 2 patients inadequately controlled on oral antidiabetic agents: results from the AT.LANTUS Trial // Diabetologia. 2004. – Vol. 47. – Abstract 751.

Storms F., Shutler S., Rodriguez J., Gomis R., Davies M. The AT.LANTUS trial investigating treatment algorithms for insulin glargine (LANTUS) therapy: results in subjects with type 1 and type 2 diabetes // Diabetologia. – 2004. – Vol. 47. – Abstract 910.

Davies M., Storms F., Shutler S., Bianchi-Biscay M., Gomis R. Initiation of insulin glargine in type 2 patients with suboptimal glycaemic control on twice-daily premix insulin: results from the AT.LANTUS trial // Diabetologia. – 2004. – Vol. 47. – Abstract 146.

Gerstein H.C., Yale J.-F., Harris S.B. et al. A Randomized Trial of Early Glargine Use to Achieve Optimal A1c Levels in Insulin Naive people with Type 2 Diabetes. Presented at the 65th Annual Scientific Sessions of the American Diabetes Association, San Diego, California, USA. – 2005.

Fritsche H. et al. Glimepiride combined with morning insulin glargin, bedtime NPH insulin, or bedtime insulin glargine in patients with type 2 diabetes mellitus. A randomized control trial // Ann. Intern. Med. – 2003. – Vol. 138. – P. 952-959. https://doi.org/10.7326/0003-4819-138-12-200306170-00006

Schreiber S., Russman A. Improved metabolic control with a favorable weight profile in patients with type 2 diabetes treated with insulin glargin in clinical practice // Diabetes. – 2002. – Vol. 51 (suppl. 2). – P. A114. – Abstract 464-P.

##submission.downloads##

Опубліковано

2013-11-26

Номер

Розділ

Статті