Reduction of painful vaso-occlusive crisis of sickle cell anaemia by tinzaparin in a double-blind randomized trial

Mohamad Hasan Qari; Soad Khalil Aljaouni; Mohamad Salleh Alardawi; Huda Fatani; Fatin Mohamad Alsayes; Panagiotis Zografos; Mohamad Alsaigh; Adnan Alalfi; Mohamad Alamin; Abdulilah Gadi; Shaker A. Mousa

doi:10.1160/Th06-12-0718

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2007; 98(02): 392-396
DOI: 10.1160/Th06-12-0718

Platelets and Blood Cells

Schattauer GmbH

Reduction of painful vaso-occlusive crisis of sickle cell anaemia by tinzaparin in a double-blind randomized trial

Mohamad Hasan Qari

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Soad Khalil Aljaouni

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Mohamad Salleh Alardawi

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Huda Fatani

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Fatin Mohamad Alsayes

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Panagiotis Zografos

²Leo Pharmaceutical Products, Athens, Greece

,

Mohamad Alsaigh

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Adnan Alalfi

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Mohamad Alamin

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Abdulilah Gadi

¹College of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia

,

Shaker A. Mousa

³The Pharmaceutical Research Institute at Albany, Albany, New York, USA

› Institutsangaben

Abstract

Summary

A randomized double-blind clinical trial was performed to test the safety and efficacy of a low-molecular-weight heparin, tinzaparin (Innohep^®), for the management of acute painful vasoocclusive crisis characteristic of sickle cell anemia (SCA). We studied 253 patients with acute painful crisis but with no other complications of SCA, randomized to treatment or control groups. In the treatment group, 127 patients received tinzaparin at 175 IU/kg, subcutaneous once daily, along with supportive care including morphine analgesia; in the control group, 126 patients received placebo and the same supportive care.The maxi- mal experimental treatment period was seven days. Analysis revealed a statistically significant reduction in number of days with the severest pain score, overall duration of painful crisis, and duration of hospitalization (p <0.05 for each comparison of tinzaparin vs. placebo).The decline in pain intensity was sharper for tinzaparin-treated patients, and complications consisted of two minor bleeding events that were reported and treated by cessation of tinzaparin.This investigation demonstrated that tinzaparin, administered at its approved treatment regimen, reduced the severity and duration of acute crisis of SCA.

Keywords

Sickle cell anemia - tinzaparin - heparin - pain - genetic disease

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