The immunogenicity of Polhumin® insulin - The results of a six-month comparative, multicenter, randomized, controlled clinical trial conducted in the double-blind conditions [Immunogenność insulin Polhumin® - Wyniki sześciomiesiȩcznego wieloośrodkowego, porównawczego, kontrolowanego, randomizowanego badania klinicznego prowadzonego w warunkach podwójnie ślepej próby]
Mrozikiewicz P.,University Medyczny znaniu |
Strojek K.,Slaski University Medyczny brzu |
Opiela J.,Centrum Medyczne OMEDICA |
Kaminski J.,GP PHARM Medical
Diabetologia Kliniczna | Year: 2014
Background. Long-term use of insulin leads to a number of side effects, including the formation of specific insulin antibodies which can give immunological complications. Aim. Randomized, double-blind, multicenter phase IV clinical trial comparing the immunogenicity of two formulations of human insulin: Polhumin® (Tarchominskie Pharmaceutical Plant "POLFA" S.A.) and Humulin® (Lilly France S.A.) used in the treatment of diabetes. Material and methods. After initial screening in the group of 751 subjects, 502 patient were qualified to the study who were treated for 28 weeks with recombinant human insulin (Polhumin®) or reference (Humulin®). The main inclusion criteria were diabetes type 1 or 2 for at least 6 months not treated with either Polhumin® or Humulin® preparations and the absence of anti-insulin antibodies. Results. The proportion of patients with new anti-insulin antibodies were 15% in the test group and 14% in the reference group. There were no statistically significant differences in the number of newly established insulin antibodies between the groups receiving the study drug and a reference drug. The percentage of glycated hemoglobin (HbA1c) decreased in the group treated with Polhumin® from 7.8 ± 1.5% to 7.1 ± 1.2% (p < 0.001) and in the group treated with Humulin® from 7.7 ± 1.5% to 7.0 ± 1.0% (p < 0.001). The body weight remained comparable between both treatment groups for the entire duration of treatment: 84 ± 14 kg in the test group vs. 85 ± 12 kg in the reference group at screening; 84.0 ± 15 kg in the test group vs. 85 ± 12 kg in the reference group after 28 weeks of treatment. The total number of 155 patients reported 276 adverse events. There were no differences in the frequency of adverse events between the two groups. Conclusions. Polhumin® is comparable to the reference product - Humulin® regarding its immunogenicity and clinical efficacy. Copyright © 2014 Via Medica.
Kostka-Jeziorny K.,Katedra I Klinika Hipertensjologii |
Tykarski A.,Katedra I Klinika Hipertensjologii |
Dzida G.,Medical University of Lublin |
Filipiak K.J.,Medical University of Warsaw |
And 3 more authors.
Nadcisnienie Tetnicze | Year: 2012
Calcium channel blockers (CCBs) are widely prescribed for the treatment of arterial hypertension. Lercanidipine is a dihydropyridine with an intrinsic long-acting hypertensive effect with high vascular selectivity. Drug is effective in reducing blood pressure over 24-h period.Lercanidipine has a weak cardiodepressant (nagative inotropic) acivity and high lipophilicity. No significant differences in antihypertensive efficacy were found between lercanidipine and nifedipine GITS, losartan, captopril and amlodipine in trials lasting 4-16 weeks. Lercanidipine is effective in elderly hypertensive patients and particularly in elderly patients with isolated hypertension. This drug does not seem to be associated with an adverse effect on glycaemic parameters in patients with type 2 diabetes. Lercanidipineis associated with less peripheral oedema than some other CCBs at equivalent antihypertensive doses. Copyright © 2012 Via Medica.