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Časopis Internal medicine – Článok The effectiveness and safety of adding prandial insulin glulisine to patients with insufficiently together with or without oral antidiabetic drugs.

Internal medicine

Peer - Reviewed Postgraduate Medical Journal.
Period 11x per year (july - august double issue)
1335-8359
The journal is indexed in the Slovak National Bibliography, Bibliographiia Medica Slovaca (BMS) and listed to citation database CiBaMed. All articles are reviewed. The publisher does not bear any responsibility for data and opinions of particular authors of the articles or advertisements. The articles on grey pages are company promotions or non reviewed information, an author is responsible for the content. Any reproduction of the content is allowed only with direct consent of the editorial office.
Predplatné
Internal medicine
Internal medicine
Peer - Reviewed Postgraduate Medical Journal.
Period 11x per year (july - august double issue)
Predplatné
Téma: 

The effectiveness and safety of adding prandial insulin glulisine to patients with insufficiently together with or without oral antidiabetic drugs.

Emil Martinka

Observation objectives. The purpose of the presented non-interventional clinical monitoring FUTURE was to evaluate, under the conditions of normal clinical practice, the efficacy and safety of adding of prandial insulin analogue glulisine to patients with type 2 diabetes mellitus (DM-2) with unsatisfactory glycaemic control (HbA1c > 7 %) when treated with basal insulin glargine (with or without oral antidiabetic agents). The frequency of administration and dosage of insulin glulisine was determined by a physician based on individual needs of the patient. Research Design and Methods. It was a short-term (6 months), multicentric (58 centres) clinical trial under normal conditions of outpatient care, which included the participation of 487 patients with DM-2 and meeting the criteria for inclusion (DM-2 subjects with poor glycaemic control (HbA1c > 7%) when treated only by the basal analogue glargine or together with OAD. Results. 6-months after adding insulin glulisine a significant decrease in HbA1c (from 8.7 ± 1.22 to 7.4 ± 1.0 %, p < 0.01) was reached. The percentage of patients with HbA1c < 7 % increased from 0 % to 30.4 %, and conversely, the proportion of patients with HbA1c > 8.0 % decreased from 70.7 % to 23.2 %. In the glycaemic profiles, glucose levels significantly decreased at all measured times of the day (p < 0.01). Body weight as well as BMI between the beginning and the end of monitoring did not change. The overall incidence of reported symptomatic hypoglycaemia was 99 episodes in 72 patients (14.8 %), representing 0.41 episodes per patient per year. None of hypoglycaemia episodes was assessed as severe hypoglycaemia. The average daily dose of insulin glargine at the end of the period remained unchanged compared to the baseline dose (0.27 ± 0.12 U/kg versus 0.28 ± 0.11 U/kg, NS). The daily dose of insulin glulisine at the end of the reporting period, compared with the initial dose, was increased from 26.4 ± 11.3 U/day to 30.1 ± 12.1 U/day , p < 0.01). Mostly (92.2 %) insulin glulisine was applied in three doses; each individual dose was relatively balanced (on average about 10.4 U per application) with a slightly higher dose when applied in the morning (11.2 U). Metformin was the most commonly used OAD at the baseline, used by approximately 95 % of patients (40 % as only OAD, 53 % in combination with another OAD). At the end of the monitoring the percentage of patients on metformin slightly increased (approx. 98 % of all subjects, 95 % of subjects as only OAD). Conversely, the percentage of patients taking sulphonylurea decreased from initial values of 57.3 % to 4.5 %. In the course of the trial no serious adverse events were reported. Less than 1% of patients reported non-serious adverse events which were not attributed to the treatment with insulin and thus they were not a reason for termination or interruption of the treatment. Summary. Adding prandial analogue insulin glulisine in DM-2 patients with unsatisfactory glycaemic control (HbA1c > 7.0 %) when treated with basal insulin glargine (with or without oral antidiabetic agents) resulted in significant improvement in glycaemic control, whether according HbA1c or according to the glucose in glycaemic profiles. This improvement did not lead to weight gain, or changes in the distribution of BMI, and did not result in the rise of significant incidence of symptomatic hypoglycaemia. Insulin doses, thanks to which these results were achieved, reflected the standard clinical practice.

Intensification of insulin therapy, insulin glargine, insulin glulisine, type 2 diabetes mellitus, current clinical practice
Interná med. 2013; 13 (9): 411-417

Ročník 2013  Témy časopisu Internal medicine 9 / 2013

Overview works

Štefan Sotak, Ivica Lazúrová
Peter Bánovčin jr., Juraj Halička, Rudolf Hyrdel
Miroslav Šimek
Ivan Varga, Eva Gonçalvesová

Clinical pharmacology

Ján Murín
Daša Skripová

Emil Martinka
Nie sú dostupné žiadne voľne dostupné články
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prof. MUDr. Peter Mitro, PhD.
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2. Stenestrand U, Wallentin L. Swedish Register of Cardiac Intensive Care (RIKS-HIA): Early statin treatment following acute myocardial infarction and 1-year survival. JAMA 2001; 285(4): 430-436.
3. LIPID Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998; 339: 1349-1357.
4. Jurkovičová O, Spitzerová H, Cagáň S. Komorové arytmie a náhla srdcová smrť pri akútnom infarkte myokardu. Bratisl Lek Listy 1997; 98: 379-389.
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Period 11x per year (july - august double issue)
1335-8359
The journal is indexed in the Slovak National Bibliography, Bibliographiia Medica Slovaca (BMS) and listed to citation database CiBaMed. All articles are reviewed. The publisher does not bear any responsibility for data and opinions of particular authors of the articles or advertisements. The articles on grey pages are company promotions or non reviewed information, an author is responsible for the content. Any reproduction of the content is allowed only with direct consent of the editorial office.
Predplatné
Internal medicine
Internal medicine
Peer - Reviewed Postgraduate Medical Journal.
Period 11x per year (july - august double issue)
Predplatné