The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance

B Darpo - British journal of pharmacology, 2010 - Wiley Online Library
The ICH E14 guidance on how to clinically assess a new drug's liability to prolong the QT
interval was adopted in May 2005. A centre‐piece of the guidance was the establishment of …

Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects

…, AA Fossa, J Zhang, F Badilini, J Li, B Darpö… - American heart …, 2012 - Elsevier
… Therefore, the different correction methods gave conflicting results of drug effect (Figure 1B).
QTcI fixed inaccurately excluded a significant effect because the uppers of 2-sided 90% CIs …

The IQ‐CSRC prospective clinical phase 1 study:“Can early QT assessment using exposure response analysis replace the thorough QT study?”

B Darpo, N Sarapa, C Garnett, C Benson… - Annals of …, 2014 - Wiley Online Library
A collaboration between the Consortium for Innovation and Quality in Pharmaceutical
Development and the Cardiac Safety Research Consortium has been formed to design a clinical …

Reduction in sympathetic activity after long-term CPAP treatment in sleep apnoea: cardiovascular implications

J Hedner, B Darpo, H Ejnell, J Carlson… - European Respiratory …, 1995 - Eur Respiratory Soc
Twelve patients with severe obstructive sleep apnoea were included in an open, long-term,
prospective, follow-up study addressing the effects of nasal continuous positive airway …

Spectrum of drugs prolonging QT interval and the incidence of torsades de pointes

B Darpö - European Heart Journal Supplements, 2001 - academic.oup.com
The incidence of drug-induced proarrhythmias in the general population is largely unknown.
Knowledge regarding incidence and risk factors is mainly derived from studies during …

Results from the IQ‐CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase

B Darpo, C Benson, C Dota, G Ferber… - Clinical …, 2015 - Wiley Online Library
The QT effects of five “QT‐positive” and one negative drug were tested to evaluate whether
exposure–response analysis can detect QT effects in a small study with healthy subjects. …

An exploratory double‐blind, randomized clinical trial with selisistat, a SirT1 inhibitor, in patients with H untington's disease

…, G Pollio, R Andre, SJ Tabrizi, B Darpo… - British journal of …, 2015 - Wiley Online Library
… and/or confusional states, with clinically significant laboratory or ECG abnormalities,
haematological, hepatic, cardiac, or renal diseases or a history of infections with HIV or hepatitis B

Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical …

B Darpo, T Nebout, PT Sager - The Journal of Clinical …, 2006 - Wiley Online Library
B, exposure after multiple doses of twice normal dose. The exposure is increased in parallel
for both moieties. C, multiple doses of normal dose, concomitantly with metabolic inhibitor, …

Electrocardiographic and clinical predictors of torsades de pointes induced by almokalant infusion in patients with chronic atrial fibrillation or flutter: a prospective …

B Houltz, B Darpö, N Edvardsson… - Pacing and clinical …, 1998 - Wiley Online Library
The aim of this study was to identify predictors of torsades de pointes (TdP) in patients with
atrial fibrillation (AF) or flutter exposed to the Class III antiarrhythmic drug almokalant. TdP …

Prospective study of left ventricular function after radiofrequency ablation of atrioventricular junction in patients with atrial fibrillation.

M Edner, K Caidahl, L Bergfeldt, B Darpö… - Heart, 1995 - heart.bmj.com
… The left atrial diameter was unchanged, but the area decreased in group B after the ablation …
in group B than in group A (P < 0 05). In group A no change was observed, but in group B a …