References

problendo

Проблемы Эндокринологии

Problems of Endocrinology

0375-96602308-1430

Endocrinology Research Centre

10.14341/probl201359525-31

problendo-6486

Research Article

Статьи

Articles

LOTUS2: Наблюдательное исследование эффективности и безопасности терапии инсулином гларгин (лантус) в повседневной клинической практике у пациентов с сахарным диабетом 2-го типа, не достигших целевого гликемического контроля на терапии инсулином детемир

LOTUS2: The observational study of the effectiveness and safety of insulin glargine (lantus) in the routine clinical practice for the patients with type 2 diabetes mellitus failing to achieve the targeted glycemic control using insulin detemir

Glinkina

I V

2013

15102013

595

ТОМ 59, №5 (2013)

2531

2013

Glinkina I.V.

Данная работа распространяется под лицензией Creative Commons Attribution 4.0.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.probl-endojournals.ru/jour/article/view/6486

Пациенты с сахарным диабетом 2-го типа (СД2) длительностью не более 10 лет при уровне HbA1c ≥7,0 и <10,0% на терапии инсулином детемир (вводимым 1 или 2 раза в сутки) в сочетании с ПССП, были переведены на терапию инсулином гларгин (лантус солостар), который вводился 1 раз в сутки. Пациентам рекомендовали титровать дозу инсулина гларгин до достижения целевого уровня глюкозы плазмы натощак (ГПН) <5,6 ммоль/л. Через 3 и 6 мес после включения в исследование оценивались уровни HbA1c и ГПН, дозы инсулина, масса тела, частота гипогликемий и нежелательных явлений, удовлетворенность врачей и пациентов проводимой терапией. В исследование были включены 915 пациентов (средний возраст 57,9±9,2 года, средняя длительность СД 5,9±2,3 года, средний ИМТ 31,0±5,1 кг/м2). После перевода пациентов на терапию инсулином гларгин средний уровень HbA1с снизился с 8,6±0,7 до 7,7±0,7% к 3-му и до 7,1±0,6% к 6-му месяцу терапии (р<0,001). Доля пациентов с уровнем HbA1с <7% через 6 мес составила 46,5%. Отмечено уменьшение доли пациентов, которые испытали симптоматические или ночные гипогликемии. Тяжелых гипогликемий зарегистрировано не было. К 6-му месяцу также отмечено некоторое снижение массы тела на 0,9±2,9 кг (р<0,001). Большинство пациентов и врачей дали проводимой терапии оценку "хорошо" или "очень хорошо". Таким образом, в ежедневной клинической практике замена инсулина детемир на инсулин гларгин у пациентов с СД2 и неудовлетворительным гликемическим контролем на терапии ПССП в сочетании с инсулином детемир может привести к улучшению гликемического контроля без увеличения массы тела и с низкой частотой гипогликемий.

The present study included patients presenting with type 2 diabetes mellitus (DM2) of less than 10 years in duration having the HbA1c levels between 7.0% and 10.0%. They were treated with insulin detemir (once or twice daily) in combination with oral hypoglycemic agents (OHGA) and transferred thereafter to therapy with insulin glargine (Lantus, SoloSTAR) administered once daily. The patients were advised to adjust the dose of insulin glargine in order to achieve the desired fasting blood glucose level (FBGL) below 5.6 mmol/l. The HbA1c levels and FBGL, insulin doses, body weight, frequency of hypoglycemic episodes and adverse reactions were measured within 3 and 6 months after inclusion in the study; simultaneously, the patients and doctors' satisfaction with the treatment was estimated. A total of 915 patients were available for the examination (mean age 57.9±9.2 years, mean duration of DM2 5.9±2.3 years, average BMI 31.0±5.1 kg/m2). The number of the patients presenting with the HbA1c levels below 7% within 6 months after the onset of therapy amounted to 46.5% of the total. During the same period, percentage of the patients experiencing nocturnal and daytime glycemic episodes decreased. No cases of severe hypoglycemia were documented. Moreover, the body weight of the patients somewhat decreased (by 0.9±2.9 kg; p<0.001) by the 6 month. The majority of the patients and their doctors reported the effects of described therapy as "good" or "very good". It is concluded that the substitution of the treatment with insulin detemir in combination with OHGA by therapy with insulin glargine in the patients with DM2 and suboptimal glycemic control under conditions of the routine clinical practice may improve the quality of glycemic control without a substantial body weight gain and with the low frequency of hypoglycemic episodes.

сахарный диабет 2-го типаинсулин гларгин

type 2 diabetes mellitusinsilin glargineLOTUS2LOTUS2.

References1

Nathan D.M., Buse J.B., Davidson M.B., Ferrannini E., Holman R.R., Sherwin R., Zinman B. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2009; 52: 17-30.

U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes 1995; 44: 11: 1249-1258.

Holman R.R., Farmer A.J., Davies M.J., Levy J.C., Darbyshire J.L., Keenan J.F., Paul S.K. 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med 2009; 361: 1736-1747.

Riddle M.C., Umpierrez G., Digenio A., Zhou R., Rosenstock J. Challenging the "Monnier Concept": High Basal (not Postprandial) Glucose Dominates Hyperglycemic Exposure over a Wide Range of A1C on Oral Therapy, and Contributes Significantly Even after Addition of Basal Insulin. Diabetes 2010; 59: Suppl 1: Abstract: 626.

Freemantle N., Balkau B., Danchin N., Admane K., Marre M., Home Ph., Blonde L. Cardiovascular (CV) Risk Evaluation in People with Type 2 Diabetes (T2D) on Insulin Therapy (CREDIT) Study - CV Disease and CV Risk at Baseline. Diabetes 2009; 58: Suppl 1: Abstract: 474.

DeVries J.H., Meneghini L.F., Barnett A.H., Reid T., Dain M.P., Landgraf W., Vlajnic A., Traylor L., Bergenstal R.M. Pooled Hypoglycemia Event Rates With Insulin Glargine Added to Metformin from Treat-To-Target Type 2 Diabetes Mellitus (T2DM) Trials. Diabetes 2012; 61: Suppl 1: А 552-553: Abstract: 2172-PO.

Home P.D., Fritsche A., Schinzel S., Massi-Benedetti M. Metaanalysis of individual patient data to assess the risk of hypoglycaemia in people with type 2 diabetes using NPH insulin or insulin glargine. Diabetes Obes Metabol 2010; 12: 772-779.

Mullins P., Sharplin P., Yki-Jarvinen H., Riddle M.C., Haring H.U. Negative binomial meta-regression analysis of combined glycosylated hemoglobin and hypoglycemia outcomes across eleven Phase III and IV studies of insulin glargine compared with neutral protamine Hagedorn insulin in type 1 and type 2 diabetes mellitus. Clin Ther 2007; 29: 1607-1619.

Swinnen S.G., Simon A.C., Holleman F., Hoekstra J.B., Devries J.H. Insulin detemir versus insulin glargine for type 2 diabetes mellitus. Cochrane Database Syst Rev 2011; 7: CD006383.

Meneghini L., Kesavadev J., Demissie M., Nazeri A., Hollander P. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Diabetes Obes Metabol 2013; 15: 8: 729-736.

Ligthelm R.J., Borzi V., Gumprecht J., Kawamori R., Wenying Y., Valensi P. Importance of observational studies in clinical practice. Clin Ther 2007; 29: 1284-1292 (Special Nomer).

Dixon S., Peters J.R. Evaluating the 'real' costeffectiveness of health technology: reconciling the public interest with patients' interests. Curr Med Res Opin 2007; 23: Suppl 1: S1-S6.

Hajos T.R., Pouwer F., de Grooth R., Holleman F., Twisk J.W., Diamant M., Snoek F.J. The longitudinal association between glycaemic control and health-related quality of life following insulin therapy optimisation in type 2 diabetes patients. A prospective observational study in secondary care. Qual Life Res 2012; 21: 8: 1359-1365.

Meneghini L., Koenen C., Weng W., Selam J.L. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes-results of the randomized, controlled PREDICTIVE 303 study. Diabet Obes Metabol 2007; 9: 902-913.

Lieverse L. et al. Improved glycaemic control with once-daily insulin glargine in people with type 2 diabetes inadequately controlled on insulin detemir/OAD combination therapy (RESOLUTE). Diabetologia 2012; 55: Suppl. 1: Abstract 947.

Veneman T.F., Storms F.E.M.G., Eland I.A., Bouter P.K.P. From insulin detemir to glargine: Effect on glycemic control and psychological wellbeing in patients with diabetes mellitus type 2 in daily practice. J Diabetes Mellitus 2012; 2: 101-108.

The authors declare that there are no conflicts of interest present.