title: [Annual monitoring of side effects of administering sitagliptin in patients with type 2 diabetes mellitus].
abstract: We present the results of an independent, drug company-unsupported follow-up of patients with type 2 diabetes mellitus (T2DM) treated with the dipeptidyl peptidase 4 inhibitor sitagliptin. 29 patients (16 men, 13 women) used sitagliptin 100 mg daily for one year as an add-on to their chronic antidiabetic therapy. 16 type diabetic patients formed a control group - they used their chronic antidiabetic therapy without sitagliptin. 10 additional patients (6 men and 4 women) were enrolled in the study and treated with sitagliptin for one month. Body weight, BMI, glycaemia, glycated hemoglobin (HbA1c), cholesterolemia, triacylglycerolemia and serum amylases were determined and abdominal ultrasonography was performed. Because significant changes in immunological tests had been found especially after one month of treatment, 10 additional patients (6 men and 4 women) were enrolled in the study and treated with sitagliptin for one month. Sitagliptin treatment led to a significant body weight loss of 1 kg per year. In the control group, no significant change was observed. Similar results were noticed in HbA1c level and fasting glycaemia - mild but statisticaly significant reduction in the sitagliptin group both after one month and one year (not in HbA1c), no difference in the control group. There was no change in cholesterolemia, or in triacylglycerolemia. In 33% of patients in the sitagliptin group, the level of liver steatosis decreased by ultrasonographic evaluation. This was not found in any of the patients case in the control group. The serum amylase levels increased slightly over the upper limit in two sitagliptin treated patients. In the other sitagliptin treated patients serum amylase remained within the laboratory limits, but slight, statistically significant elevation of serum amylases was observed in the intervened group. This result was not found in the control group. There were not differences in the frequency between occurence of mild respiratory infections in the sitagliptin and control group. Marginally significant decrease was observed in the intervened group.
  
  
  
  sitagliptin - type 2 diabetes mellitus - side effects.
authors.affiliation: Diabetologické a nutriční centrum 3. LF UK a FN Královské Vinohrady, Praha, Centrum výzkumu diabetu, metabolizmu a výživy 3. LF UK v Praze
authors.forename: Michal
authors.initials: M
authors.lastname: Andel
authors.affiliation: Diabetologické a nutriční centrum 3. LF UK a FN Královské Vinohrady, Praha, Centrum výzkumu diabetu, metabolizmu a výživy 3. LF UK v Praze
authors.forename: Pavel
authors.initials: P
authors.lastname: Skrha
authors.affiliation: Diabetologické a nutriční centrum 3. LF UK a FN Královské Vinohrady, Praha, Centrum výzkumu diabetu, metabolizmu a výživy 3. LF UK v Praze
authors.forename: Pavel
authors.initials: P
authors.lastname: Kraml
authors.affiliation: Diabetologické a nutriční centrum 3. LF UK a FN Královské Vinohrady, Praha, Centrum výzkumu diabetu, metabolizmu a výživy 3. LF UK v Praze
authors.forename: Jana
authors.initials: J
authors.lastname: Potockova
authors.affiliation: Diabetologické a nutriční centrum 3. LF UK a FN Královské Vinohrady, Praha, Centrum výzkumu diabetu, metabolizmu a výživy 3. LF UK v Praze
authors.forename: Iva
authors.initials: I
authors.lastname: Hoffmanova
authors.affiliation: Diabetologické a nutriční centrum 3. LF UK a FN Královské Vinohrady, Praha, Centrum výzkumu diabetu, metabolizmu a výživy 3. LF UK v Praze
authors.forename: Elena
authors.initials: E
authors.lastname: Silhova
authors.affiliation: Diabetologické a nutriční centrum 3. LF UK a FN Královské Vinohrady, Praha, Centrum výzkumu diabetu, metabolizmu a výživy 3. LF UK v Praze
authors.forename: Josef
authors.initials: J
authors.lastname: Fontana
authors.affiliation: Diabetologická ambulance, Praha 8
authors.forename: Anna
authors.initials: A
authors.lastname: Richterova
authors.affiliation: Diabetologická ambulance, Praha 5
authors.forename: Martin
authors.initials: M
authors.lastname: Gadiredi
authors.affiliation: Ústav biochemie a experimentální onkologie 1. LF UK v Praze
authors.forename: Petr
authors.initials: P
authors.lastname: Busek
authors.affiliation: Ústav biochemie a experimentální onkologie 1. LF UK v Praze
authors.forename: Lucie
authors.initials: L
authors.lastname: Sromova
authors.affiliation: Ústav biochemie a experimentální onkologie 1. LF UK v Praze
authors.forename: Aleksi
authors.initials: A
authors.lastname: Šedo
mesh_terms: D015992:Body Mass Index; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D008297:Male; D000068900:Sitagliptin Phosphate / Q000009:adverse effects*
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D007004:Hypoglycemic Agents; D000068900:Sitagliptin Phosphate