Lessons learned from 15 years of KIMS and 5 years of ACROSTUDY

TY - JOUR

T1 - Lessons learned from 15 years of KIMS and 5 years of ACROSTUDY

AU - Luger, Anton

AU - Feldt-Rasmussen, Ulla

AU - Abs, Roger

AU - Gaillard, Rolf C

AU - Buchfelder, Michael

AU - Trainer, Peter

AU - Brue, Thierry

N1 - Copyright © 2011 S. Karger AG, Basel.

PY - 2011/7

Y1 - 2011/7

N2 - BACKGROUND: Pharmacoepidemiological surveys provide a valuable contribution to the continued monitoring of drug-related effects in patients with rare disorders. One of the earliest examples of this type of survey is KIGS (Pfizer International Growth Study Database), which has monitored the safety and effectiveness of growth hormone (GH) therapy in GH-deficient children since its inception in 1987. Following closely in the footsteps of KIGS is KIMS (Pfizer International Metabolic Database). As of 2009, KIMS has been collecting data on the long-term safety and clinical outcomes of GH replacement in GH-deficient adults for 15 years. Approximately 5 years ago, the ACROSTUDY database was established to monitor the long-term safety and effectiveness of pegvisomant in patients with acromegaly. CONCLUSIONS: By collecting data on the treatment of relatively rare conditions in routine clinical practice, pharmacoepidemiological surveys such as KIMS and ACROSTUDY provide valuable information on the safety and effectiveness of treatment with GH replacement and pegvisomant in the real world.

AB - BACKGROUND: Pharmacoepidemiological surveys provide a valuable contribution to the continued monitoring of drug-related effects in patients with rare disorders. One of the earliest examples of this type of survey is KIGS (Pfizer International Growth Study Database), which has monitored the safety and effectiveness of growth hormone (GH) therapy in GH-deficient children since its inception in 1987. Following closely in the footsteps of KIGS is KIMS (Pfizer International Metabolic Database). As of 2009, KIMS has been collecting data on the long-term safety and clinical outcomes of GH replacement in GH-deficient adults for 15 years. Approximately 5 years ago, the ACROSTUDY database was established to monitor the long-term safety and effectiveness of pegvisomant in patients with acromegaly. CONCLUSIONS: By collecting data on the treatment of relatively rare conditions in routine clinical practice, pharmacoepidemiological surveys such as KIMS and ACROSTUDY provide valuable information on the safety and effectiveness of treatment with GH replacement and pegvisomant in the real world.

U2 - http://dx.doi.org/10.1159/000329156

DO - http://dx.doi.org/10.1159/000329156

M3 - Journal article

SN - 1663-2818

VL - 76 Suppl 1

SP - 33

EP - 38

JO - Hormone Research in Paediatrics

JF - Hormone Research in Paediatrics

ER -