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Case reports

Hyperhomocysteinemia, low folate status, homozygous
C₆₇₇T mutation of the methylene tetrahydrofolate reductase and renal arterial thrombosis

G. Queffeulou, C. Michel, F.Vrtovsnik, J.-B. Philit, E. Dupuis and F. Mignon

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Volume 57 (2002) p. 158 - 162

Original

Erdosteine affects eicosanoid production in COPD

R.W. Dal Negro, M. Visconti, S. Tognella and C. Micheletto

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42.00 $

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42.00 $

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Volume 49 p. 41 - 45

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 49 – No. 1/2011 (41-45)

Erdosteine affects eicosanoid production in COPD

R.W. Dal Negro, M. Visconti, S. Tognella and C. Micheletto

Lung Department, Orlandi General Hospital, Bussolengo, Verona, Italy
Oxidant-antioxidant imbalance and lipid peroxidation are known to activate the 5-LO pathway with increased expression of inflammatory eicosanoids. Erdosteine has recently shown important anti-oxidant properties, including the ability to reduce 8-isoprostane in COPD patients. Aim: To assess the effects of erdosteine (E) on eicosanoids, and to compare the time-course of effect with that of E anti-oxidant activity. Methods: 12 moderate COPD patients (9 males, 60 – 78 y) randomly received E 300 mg b.i.d. or placebo (P) for 10 days in a double-blind, controlled design. Blood ROS (Fort/Units); serum LTB₄ and urine LTE₄ (pg/ml) were measured at baseline and after 1, 3, 5 and 10 days of treatment. Analysis of covariance (ANCOVA) was performed. Results: In COPD patients, both LTB₄ and LTE₄ dropped significantly during the 10-day treatment with E: s-LTB₄ from 136.0 ± 35.4 SD to 54.5 ± 31.2 SD; u-LTE₄ from 267.0 ± 91.5 SD to 84.0 ± 64.7 SD, p < 0.001 vs. p from Days 5 and 3, respectively. Moreover, a significant decrease of blood ROS was confirmed in patients using E. FEV₁ values slightly increased during erdosteine treatment, whereas a trend to decrease was observed in the placebo group, with a significant difference in favor of erdosteine after 10 days of treatment (p = 0.0088). Conclusions: 1) The scavenging and anti-inflammatory effects of Erdosteine were both confirmed; 2) erdosteine proved to affect eicosanoids significantly; 3) this novel effect underlines the important anti-inflammatory potentialities of the drug in COPD; 4) further investigation is needed in order to assess the capability of Erdosteine in controlling ongoing inflammation in chronic respiratory diseases.Correspondence to:
R.W. Dal Negro
Orlandi General Hospital
Via Ospedale, 37012 Bussolengo, Italy
Email: [email protected]

Original Research

A novel 6-mercaptopurine oral liquid formulation for pediatric acute lymphoblastic leukemia patients – results of a randomized clinical trial

Lidwien M. Hanff, Ron A.A. Mathot, Oscar Smeets, Doerine J. Postma, Satianand Ramnarain, Andras Vermes, Rob Pieters, and C. Michel Zwaan

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42.00 $

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42.00 $

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Volume 52 p. 653 - 662

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 8/2014 (653-662)

A novel 6-mercaptopurine oral liquid formulation for pediatric acute lymphoblastic leukemia patients – results of a randomized clinical trial

Lidwien M. Hanff¹, Ron A.A. Mathot², Oscar Smeets³, Doerine J. Postma³, Satianand Ramnarain⁴, Andras Vermes¹, Rob Pieters⁴, and C. Michel Zwaan⁴

¹Department of Hospital Pharmacy, Erasmus MC, Rotterdam, ²Department of Hospital Pharmacy, Academic Medical Center, Amsterdam, ³Laboratory of Dutch Pharmacists, Royal Dutch Pharmacists Association, Den Haag, and ⁴Department of Pediatric Oncology, Erasmus MC – Sophia Children’s Hospital, Rotterdam, The Netherlands
Objective: Pediatric patients with acute lymphoblastic leukemia (ALL) are treated with oral 6-mercaptopurine (6MP) for nearly 2 years, but no pediatric formulation has been available. In this study, an oral 6MP liquid suitable for pediatric use was developed and tested in the target population. Method: A randomized cross-over study was performed in 20 pediatric ALL patients (age 1.9 – 14.6 years), comparing pharmacokinetics and pharmacodynamics of a newly developed 6MP liquid formulation to 6MP capsules, both taken orally for 4 weeks. Results: Based upon trough levels of the principal active metabolite,6-thioguanine nucleotides (6-TGN),a relative bioavailability of the liquid vs. capsulesof 1.01 was found (90% CI 0.86 – 1.20), demonstrating bioequivalence. This was supported by the similarly observed 6MP dosages needed for leucocyte depletion, for both formulations (35 mg/day (range 10 – 115 mg)). 75% of the parents/patients (p = 0.005) preferred the oral liquid over the capsules because of the ease of administration. Conclusion: We conclude that the novel 6MP liquid is a promising treatment for ALL.Correspondence to:
L.M.Hanff, PharmD, PhD
Department of Hospital Pharmacy Erasmus MC
PO Box 2040, 3000 CA Rotterdam, The Netherlands
Email: [email protected]

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