PDSA E-News: January 31, 2014


Clinical TrialSwitching TPOs Found Helpful for Chronic ITP Patients

Both romiplostim (Nplate®) and eltrombopag (Promacta/Revolade®), two thrombopoietic receptor-agonists (TPOs) with efficacy against ITP in controlled studies, have been authorized in most countries for adult patients with chronic ITP. Previously data was not available comparing outcomes of switching from romiplostim to eltrombopag or vice versa. In this study 46 patients sequentially received both drugs, switching from one to the other. Reasons given for switching included: lack of efficacy for 23 of the patients, platelet-count fluctuations for 11 patients, side effects for 4 patients, and patient preference for 8 patients.

The study found that for 50-80% of the patients, switching from one TPO to the other had a positive impact on platelet count, with fluctuations disappearing in 54%. Side effects resolved in 100%. Both TPOs achieved similar response patterns in 80% of the patients. The results confirmed that switching from one TPO to the other could benefit patients with severe chronic ITP who had failed to respond or had experienced serious side effects to the first one.

Khellaf M, Viallard JF, Hamidou M, et al., "A retrospective pilot evaluation of switching thrombopoietic receptor-agonists in immune thrombocytopenia." Haematologica 2013 Jun; 98(6): 881-7.


StudyRomiplostim Raises Platelets for Half of Chronic ITP Children

In a small French study (2009 to 2012), 10 children (ages 1 - 18) with non-responsive or refractory chronic immune thrombocytopenia (ITP) were treated with romiplostim (Nplate®). The average duration of thrombocytopenia in the children was 9 years. Average time of the romiplostim treatment in the study was 9 months (range of 3 - 36 months).

Patients received a weekly romiplostim treatment, at an initial dose of 1 μg/kg/week; this could be increased weekly up to 10 μg/kg according to clinical response and platelet count. Half (5/10) of the children responded to the treatment, one completely (platelet count higher than 100,000) and four partially (count of 30,000 to 100,000 and no bleeding). Five had no clinical response to romiplostim. Two patients required IVIg and/or steroid rescue therapy. No serious side effects were noted. There were no signs of marrow dysfunction.

Pasquet M, Aladjidi N, Guiton C, et al., "Romiplostim in children with chronic immune thrombocytopenia (ITP): the French Experience." Br J Haematol. 2014 Jan; 164(2): 266-71.



DoctorFDA Asks Doctors to Limit Combination Prescription Pain Killers

ITP patients who need pain relief for aches and pains are told to take acetaminophen, rather than aspirin or ibuprofen products that can affect their platelets.

Here's something new to be aware of. Healthcare professionals are being asked by the U.S. Food and Drug Administration (FDA) to stop prescribing combination pain medications containing more than 325 mg of acetaminophen per tablet, capsule, or other dosage unit. FDA's concern is the risk for liver damage from higher doses of acetaminophen (i.e., name brand Tylenol®).Their concern is for prescription pain relievers that contain acetaminophen and ingredients such as codeine, oxycodone, or hydrocodone. Some combinations contain up to 750 mg of acetaminophen per dose. FDA says there is no evidence that more than 325 mg of acetaminophen per dosage unit offers additional benefit to outweigh the risk for liver injury. A boxed warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.

In January 2011 FDA asked pharmaceutical manufacturers of prescription meds to limit acetaminophen to no more than 325 mg per combination tablet, capsule, or dose by January 14, 2014. So far more than half have complied. In the future FDA will be withdrawing approval for products containing more than 325 mg. FDA said it will address over-the-counter (OTC) pain relievers and cold and sinus meds that contain acetaminophen in a separate regulatory action.

Brooks, M., "FDA Asks Docs to Limit Acetaminophen in Prescription Meds." Medscape.com, Jan. 15, 2014. http://www.medscape.com/viewarticle/819216 http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm



MeditationMeditation Changes Gene Expression in Humans

An international research team (U.S., Spain and France) reported the first evidence of molecular changes in the body after mindfulness meditation. Their study investigated effects of a day of intensive mindfulness practice in a group of experienced meditators who were compared to a group of untrained control subjects who carried out quiet, non-meditative activities. Following 8 hours of mindfulness practice, meditators showed a range of genetic and molecular differences. Changes included altered levels of gene-regulating machinery as well as reduced levels of pro-inflammatory genes. These in turn related to faster recovery from a stressful situation.

There were no differences in tested genes between the two subject groups at the start of the study. Effects were seen only in the meditators after following mindfulness practice. The researchers state this appears to be the first paper that shows rapid alteration in gene expression in subjects doing mindfulness meditation. Study author, Richard Davidson, said, "Our genes are quite dynamic and these results suggest that the calmness of our mind can actually have a potential influence on their expression." The study, which was conducted at the University of Wisconsin-Madison, received funding from the National Center for Complementary and Alternative Medicine and several other donor organizations. Results will be published February 2014 in the journal Psychoneuroendocrinology.

Sakai, J. "Study reveals gene expression changes with meditation." University of Wisconsin System, Dec. 4, 2013. http://investigatinghealthyminds.org/cihmDrDavidson.html



back to top

BBB Cleveland logo GuideStar Seal NORD Member Badge 2018THSNA logo