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A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary hypertension.
Clin Pharmacokinet. 2008; 47(9):611-8.CP

Abstract

BACKGROUND AND OBJECTIVE

Subcutaneous treprostinil is an effective treatment for pulmonary arterial hypertension (PAH). A previous pivotal study indicated that infusion site pain was dose dependent and resulted in suboptimal dose escalation by week 12 and a reduced clinical benefit. We hypothesized that a rapid-escalation treprostinil dosing regimen would be as safe and effective as a slow-escalation dosing regimen.

METHODS

Twenty-three patients received treprostinil to treat PH of various aetiologies and were randomized into two groups. Group 1 (11 patients: seven females and four males, aged 51.7 +/- 15.4 years) received a slow-escalation regimen, and group 2 (12 patients: ten females and two males, aged 51.3 +/- 16.7 years) were exposed to rapid dose escalation. The dose escalation, exercise capacity (a 6-minute walk test [6WT] or a shuttle walk test [SWT]), WHO classification, blood pressure, heart rate, respiration rate, baseline haemodynamics and adverse events were followed up for 12 weeks.

RESULTS

Baseline haemodynamics did not differ significantly between the treatment groups. At follow-up, the treprostinil dose reached 12.9 +/- 2.7 ng/kg/min in group 1 and 20.3 +/- 5.8 ng/kg/min in group 2 (p < 0.01). The patients' WHO classification improved significantly (p < 0.05), with no difference between the groups. Improvement of exercise capacity was greater in group 2 (6WT and SWT, p < 0.05). Infusion site pain occurred in 81.8% of group 1 and in 58.3% of group 2 (p < 0.05) patients. Other adverse events and changes in the heart rate, respiration rate and blood pressure were similar in both groups.

CONCLUSION

The rapid-dosing regimen is as safe and effective as the slow-escalation regimen and may be associated with even better clinical outcomes. Infusion site pain is not dose dependent.

Authors+Show Affiliations

Department of Internal Medicine II, Division of Cardiology, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18698881

Citation

Skoro-Sajer, Nika, et al. "A Clinical Comparison of Slow- and Rapid-escalation Treprostinil Dosing Regimens in Patients With Pulmonary Hypertension." Clinical Pharmacokinetics, vol. 47, no. 9, 2008, pp. 611-8.
Skoro-Sajer N, Lang IM, Harja E, et al. A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary hypertension. Clin Pharmacokinet. 2008;47(9):611-8.
Skoro-Sajer, N., Lang, I. M., Harja, E., Kneussl, M. P., Sing, W. G., & Gibbs, S. J. (2008). A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary hypertension. Clinical Pharmacokinetics, 47(9), 611-8.
Skoro-Sajer N, et al. A Clinical Comparison of Slow- and Rapid-escalation Treprostinil Dosing Regimens in Patients With Pulmonary Hypertension. Clin Pharmacokinet. 2008;47(9):611-8. PubMed PMID: 18698881.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary hypertension. AU - Skoro-Sajer,Nika, AU - Lang,Irene M, AU - Harja,Evis, AU - Kneussl,Meinhard P, AU - Sing,Wendy Gin, AU - Gibbs,Simon J R, PY - 2008/8/14/pubmed PY - 2008/12/19/medline PY - 2008/8/14/entrez SP - 611 EP - 8 JF - Clinical pharmacokinetics JO - Clin Pharmacokinet VL - 47 IS - 9 N2 - BACKGROUND AND OBJECTIVE: Subcutaneous treprostinil is an effective treatment for pulmonary arterial hypertension (PAH). A previous pivotal study indicated that infusion site pain was dose dependent and resulted in suboptimal dose escalation by week 12 and a reduced clinical benefit. We hypothesized that a rapid-escalation treprostinil dosing regimen would be as safe and effective as a slow-escalation dosing regimen. METHODS: Twenty-three patients received treprostinil to treat PH of various aetiologies and were randomized into two groups. Group 1 (11 patients: seven females and four males, aged 51.7 +/- 15.4 years) received a slow-escalation regimen, and group 2 (12 patients: ten females and two males, aged 51.3 +/- 16.7 years) were exposed to rapid dose escalation. The dose escalation, exercise capacity (a 6-minute walk test [6WT] or a shuttle walk test [SWT]), WHO classification, blood pressure, heart rate, respiration rate, baseline haemodynamics and adverse events were followed up for 12 weeks. RESULTS: Baseline haemodynamics did not differ significantly between the treatment groups. At follow-up, the treprostinil dose reached 12.9 +/- 2.7 ng/kg/min in group 1 and 20.3 +/- 5.8 ng/kg/min in group 2 (p < 0.01). The patients' WHO classification improved significantly (p < 0.05), with no difference between the groups. Improvement of exercise capacity was greater in group 2 (6WT and SWT, p < 0.05). Infusion site pain occurred in 81.8% of group 1 and in 58.3% of group 2 (p < 0.05) patients. Other adverse events and changes in the heart rate, respiration rate and blood pressure were similar in both groups. CONCLUSION: The rapid-dosing regimen is as safe and effective as the slow-escalation regimen and may be associated with even better clinical outcomes. Infusion site pain is not dose dependent. SN - 0312-5963 UR - https://www.unboundmedicine.com/medline/citation/18698881/A_clinical_comparison_of_slow__and_rapid_escalation_treprostinil_dosing_regimens_in_patients_with_pulmonary_hypertension_ L2 - https://dx.doi.org/10.2165/00003088-200847090-00004 DB - PRIME DP - Unbound Medicine ER -