Literature DB >> 12728289

Tailored pharmacokinetic dosing allows self-administration and reduces the cost of IV augmentation therapy with human alpha(1)-antitrypsin.

Eeva Piitulainen1, Elisabeth Bernspång, Sven Björkman, Erik Berntorp.   

Abstract

OBJECTIVE: Severe alpha(1)-Antitrypsin (AAT) deficiency (PiZZ) predisposes to the development of emphysema. Intravenous augmentation therapy with purified human AAT has been available since 1988. The dosage has varied from 60 mg/kg body weight once weekly to 250 mg/kg once monthly. We have found the dosage of 120 mg/kg every 2 weeks to be the most convenient for the patients. The treatment is very expensive. The objective of this investigation was to study whether tailored pharmacokinetic dosing of human AAT allows self-administration and reduces the total annual dose and cost of intravenous augmentation therapy.
METHODS: Five PiZZ individuals receiving purified human AAT at a dose of 120 mg/kg every 2 weeks were included in the study. Three patients had a percutaneous and one patient had a subcutaneous intravenous injection port system. After a 4-week interruption of the treatment an ordinary dose of 120 mg/kg human AAT was infused. Plasma AAT levels were determined preinfusion, postinfusion, and once daily for 10-14 days. The pharmacokinetic parameters of exogenous AAT were calculated for each patient. Based on these, individual dosage schemes were designed by computer simulation. The patients were treated with the new dose twice weekly for 4 weeks, and plasma AAT was determined immediately before the last two infusions.
RESULTS: At a dose of 1 or 2 g twice weekly the median annual consumption of human AAT was reduced from 286 to 156 g/patient. The trough plasma AAT level was maintained above 0.70 g/l, which is considered as protective. The three patients who had an implanted percutaneous venous port system learned to administer the treatment by themselves at home. The other two patients were treated at home by the district nurse.
CONCLUSIONS: The results of our study indicate that tailored pharmacokinetic dosing of human AAT reduces the total annual dose and cost of IV augmentation therapy. In addition, this dosing facilitates self-administration of AAT and allows treatment at home.

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Year:  2003        PMID: 12728289     DOI: 10.1007/s00228-003-0589-z

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   2.953


  19 in total

1.  Pharmacokinetic study of alpha1-antitrypsin infusion in alpha1-antitrypsin deficiency.

Authors:  A F Barker; I Iwata-Morgan; L Oveson; R Roussel
Journal:  Chest       Date:  1997-09       Impact factor: 9.410

2.  The direct medical costs of alpha(1)-antitrypsin deficiency.

Authors:  C D Mullins; X Huang; S Merchant; J K Stoller
Journal:  Chest       Date:  2001-03       Impact factor: 9.410

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Authors:  E Berntorp; E Piitulainen; S Lethagen; E Mattson; L Tengborn; T Mätzsch
Journal:  Haemophilia       Date:  2003-03       Impact factor: 4.287

Review 6.  Elastases and emphysema. Current assessment of the protease-antiprotease hypothesis.

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Journal:  Am Rev Respir Dis       Date:  1985-08

7.  Port-A-Cath usage in children with haemophilia: experience of 53 cases.

Authors:  R Ljung; M van den Berg; P Petrini; L Tengborn; E Scheibel; R Kekomäki; W Effenberger
Journal:  Acta Paediatr       Date:  1998-10       Impact factor: 2.299

8.  Multidose pharmacokinetics of factor IX: implications for dosing in prophylaxis.

Authors:  M Carlsson; S Björkman; E Berntorp
Journal:  Haemophilia       Date:  1998-03       Impact factor: 4.287

9.  Biochemical efficacy and safety of a new pooled human plasma alpha(1)-antitrypsin, Respitin.

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Journal:  Chest       Date:  2002-07       Impact factor: 9.410

10.  Pharmacokinetic dosing in prophylactic treatment of hemophilia A.

Authors:  M Carlsson; E Berntorp; S Björkman; K Lindvall
Journal:  Eur J Haematol       Date:  1993-10       Impact factor: 2.997

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  7 in total

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Authors:  J Stolk
Journal:  Thorax       Date:  2006-12       Impact factor: 9.139

2.  Alpha-1-antitrypsin deficiency: optimal therapeutic regimen based on population pharmacokinetics.

Authors:  D Soy; C de la Roza; B Lara; C Esquinas; A Torres; M Miravitlles
Journal:  Thorax       Date:  2006-08-23       Impact factor: 9.139

3.  Exogenous alpha 1-antitrypsin down-regulates SERPINA1 expression.

Authors:  Ahmad Karadagi; Helene Johansson; Helen Zemack; Sandeep Salipalli; Lisa-Mari Mörk; Kristina Kannisto; Carl Jorns; Roberto Gramignoli; Stephen Strom; Knut Stokkeland; Bo-Göran Ericzon; Danny Jonigk; Sabina Janciauskiene; Greg Nowak; Ewa C S Ellis
Journal:  PLoS One       Date:  2017-05-09       Impact factor: 3.240

4.  Diagnosis and management of α1-antitrypsin deficiency in Europe: an expert survey.

Authors:  Ildikó Horváth; Maria Canotilho; Jan Chlumský; Joanna Chorostowska-Wynimko; Luciano Corda; Eric Derom; Joachim H Ficker; Meinhard Kneussl; Marc Miravitlles; Maria Sucena; Gabriel Thabut; Alice M Turner; Emily van 't Wout; N Gerard McElvaney
Journal:  ERJ Open Res       Date:  2019-03-11

5.  Systemic modified messenger RNA for replacement therapy in alpha 1-antitrypsin deficiency.

Authors:  Ahmad Karadagi; Alex G Cavedon; Helen Zemack; Greg Nowak; Marianne E Eybye; Xuling Zhu; Eleonora Guadagnin; Rebecca A White; Lisa M Rice; Andrea L Frassetto; Stephen Strom; Carl Jorns; Paolo G V Martini; Ewa Ellis
Journal:  Sci Rep       Date:  2020-04-27       Impact factor: 4.379

Review 6.  New Patient-Centric Approaches to the Management of Alpha-1 Antitrypsin Deficiency.

Authors:  Joanna Chorostowska-Wynimko; Miriam Barrecheguren; Ilaria Ferrarotti; Timm Greulich; Robert A Sandhaus; Michael Campos
Journal:  Int J Chron Obstruct Pulmon Dis       Date:  2020-02-12

7.  Safety and efficacy of alpha-1-antitrypsin augmentation therapy in the treatment of patients with alpha-1-antitrypsin deficiency.

Authors:  Irina Petrache; Joud Hajjar; Michael Campos
Journal:  Biologics       Date:  2009-07-13
  7 in total

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