Hospital Pharmacy - December 2017 - 734

734
** Mean change in ALSFRS-R score: −5.7 with edaravone, compared with −6.35 with placebo (intergroup
difference in adjusted mean change, 0.65; 95% CI,
−0.9 to 2.19; P = .411). Changes in the ALSFRS-R
scores according to diagnostic category were as
follows:
** Definite ALS (n = 49): −6.7 with edaravone and −8.7
with placebo (intergroup difference in adjusted mean
change, 2; P = .33)
** Probable ALS (n = 102): −5.2 with edaravone and
−6.1 with placebo (intergroup difference in adjusted
mean change, 0.9; P = .374)
** Probable laboratory-supported ALS (n = 47): −3.6
with edaravone and −4 with placebo (intergroup difference in adjusted mean change, 0.4; P = .702)
Secondary End Point(s):
** Mean change in FVC: −14.57 with edaravone and
−17.49 with placebo (intergroup difference in adjusted
mean change, 2.92; 95% CI, −1.49 to 7.33; P = .193).
** Mean change in grip strength (left and right side):
−4.81 with edaravone compared with −5.71 with placebo (intergroup difference in adjusted mean change,
0.89; 95% CI, −0.37 to 2.16; P = .165).
** Mean change in pinch strength (left and right side):
−0.83 with edaravone and −1.03 with placebo (intergroup difference in adjusted mean change, 0.2; 95%
CI, −0.08 to 0.48; P = .165). For the repeated measures analysis, the intergroup difference for pinch
strength was 0.21 (P = .038).
** Mean change in Modified Norris Scale score: −14.12
with edaravone compared with −16.15 with placebo
(intergroup difference in adjusted mean change, 2.03;
95% CI, −1.69 to 5.75; P = .284).
** Mean change in ALS Assessment Questionnaire
(ALSAQ-40): 19.6 with edaravone and 19.13 with
placebo (intergroup difference in adjusted mean
change, 0.48; 95% CI, −6.44 to 7.39; P = .892).
** Proportion of patients with disease progression or
death: A greater proportion of patients in the edaravone group had disease progression or death (31% in
the edaravone group compared with 26% receiving
placebo).
Comments: This was a multicenter study conducted in
Japan, with patients enrolled in a 2-phase trial (12 weeks
preobservation followed by 24 weeks of treatment).
Patients were stratified by change in ALSFRS-R score
during the preobservation phase (−4, −3 or −2, −1), initial symptom presentation (predominantly bulbar or limb
involvement), and use of riluzole (yes or no). The estimated sample size was 200 (100 patients per arm) randomized 1:1 to edaravone or placebo, to achieve 85%
power for a difference of 2.2 in the change in ALSFRS-R
score. Changes in ALSFRS-R score were assessed at

Hospital Pharmacy 52(11)
baseline (before treatment), and then at the beginning of
each treatment cycle, until 2 weeks after the last dose of
medication. Efficacy analyses were performed in the full
analysis set, which excluded 1 patient (diagnosed with a
different disease [unspecified]). Two methods were used
to handle missing data: for patients with 1 or more events,
survival time was based on the onset date for the first
event, and the end date of observation was used as the
cutoff date for censored cases; for patients with missing
data at 24 weeks after starting treatment, last observation
carried forward was used to impute missing values. There
was no significant difference in the change in ALSFRS-R
score for patients receiving edaravone compared with
placebo, but subgroup analyses showed that change in
ALSFRS-R score was greater in patients with a definite
diagnosis for ALS. In addition, with the exception of a
slight difference in pinch strength, patients did not see
benefit in terms of FVC, motor symptoms, or grip
strength compared with placebo. Common adverse
effects of edaravone included nasopharyngitis, gait disturbance, dysphagia, muscle weakness, contusion,
insomnia, and headache.
Limitations: The study enrolled Japanese patients with
probable or definite ALS and disease duration of up to 3
years. The clinical application of the data may be limited
to Asian patients with early disease. In addition, the relatively short study duration may not appropriately capture
patient response for this disease state.

Contraindications, Warnings, and
Precautions
Contraindications
Edaravone is contraindicated in patients with hypersensitivity to the medication or to any of its excipients (L-cysteine
hydrochloride hydrate, sodium bisulfate, sodium chloride,
phosphoric acid, and sodium hydroxide).1

Warnings and Precautions
Hypersensitivity reactions (redness, wheals, erythema multiforme) and anaphylaxis (urticaria, decreased blood pressure, dyspnea) are potential severe adverse events in
patients taking edaravone. Patients should be monitored for
signs and symptoms of hypersensitivity reactions and edaravone should be discontinued if a hypersensitivity reaction
occurs.1
Edaravone contains sodium bisulfite, a sulfite that may
potentiate allergic-type (anaphylactic) reactions, especially
in patients with sulfite sensitivity. Patients with asthma may
be especially predisposed to sulfite sensitivity.1
The carcinogenic potential of edaravone has not been
fully assessed, and assays were negative for mutagenicity.1
There are currently no clinical data regarding developmental risk associated with edaravone use in pregnancy.



Table of Contents for the Digital Edition of Hospital Pharmacy - December 2017

Knowing What Is Coming: The Importance of Monitoring the Pharmaceutical Pipeline
In Reply to “Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital”
Letter to the Editor on “Enzyme Replacement or Substrate Reduction? A Review of Gaucher Disease Treatment Options”
Response to Letter to the Editor on “Enzyme Replacement or Substrate Reduction? A Review of Gaucher Disease Treatment Options”
Commentary: Exploring Novel Approaches to Staff Rewards and Recognition
Edaravone
Pharmaceutical Pipeline Update
BACE Inhibitors and Tau Protein Targeting Drugs in Prevention of Alzheimer’s Disease
Direct and Indirect Remuneration Fees: The Controversy Continues
Factors Associated With Burnout Among US Hospital Clinical Pharmacy Practitioners: Results of a Nationwide Pilot Survey
In Vitro Evaluation of Eslicarbazepine Delivery via Enteral Feeding Tubes
Evaluation of Insulin Use and Hypoglycemia in Hospitalized Elderly Patients
Production Standard and Stability of Compounded del Nido Cardioplegia Solution
Lumbar Spine Surgeries and Medication Usage During Hospital Stay: One-Center Perspective
Hospital Pharmacy - December 2017 - 713
Hospital Pharmacy - December 2017 - 714
Hospital Pharmacy - December 2017 - 715
Hospital Pharmacy - December 2017 - 716
Hospital Pharmacy - December 2017 - 717
Hospital Pharmacy - December 2017 - 718
Hospital Pharmacy - December 2017 - 719
Hospital Pharmacy - December 2017 - 720
Hospital Pharmacy - December 2017 - Knowing What Is Coming: The Importance of Monitoring the Pharmaceutical Pipeline
Hospital Pharmacy - December 2017 - 722
Hospital Pharmacy - December 2017 - In Reply to “Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital”
Hospital Pharmacy - December 2017 - 724
Hospital Pharmacy - December 2017 - Letter to the Editor on “Enzyme Replacement or Substrate Reduction? A Review of Gaucher Disease Treatment Options”
Hospital Pharmacy - December 2017 - 726
Hospital Pharmacy - December 2017 - Response to Letter to the Editor on “Enzyme Replacement or Substrate Reduction? A Review of Gaucher Disease Treatment Options”
Hospital Pharmacy - December 2017 - 728
Hospital Pharmacy - December 2017 - Commentary: Exploring Novel Approaches to Staff Rewards and Recognition
Hospital Pharmacy - December 2017 - 730
Hospital Pharmacy - December 2017 - 731
Hospital Pharmacy - December 2017 - Edaravone
Hospital Pharmacy - December 2017 - 733
Hospital Pharmacy - December 2017 - 734
Hospital Pharmacy - December 2017 - 735
Hospital Pharmacy - December 2017 - 736
Hospital Pharmacy - December 2017 - BACE Inhibitors and Tau Protein Targeting Drugs in Prevention of Alzheimer’s Disease
Hospital Pharmacy - December 2017 - 738
Hospital Pharmacy - December 2017 - 739
Hospital Pharmacy - December 2017 - Direct and Indirect Remuneration Fees: The Controversy Continues
Hospital Pharmacy - December 2017 - 741
Hospital Pharmacy - December 2017 - Factors Associated With Burnout Among US Hospital Clinical Pharmacy Practitioners: Results of a Nationwide Pilot Survey
Hospital Pharmacy - December 2017 - 743
Hospital Pharmacy - December 2017 - 744
Hospital Pharmacy - December 2017 - 745
Hospital Pharmacy - December 2017 - 746
Hospital Pharmacy - December 2017 - 747
Hospital Pharmacy - December 2017 - 748
Hospital Pharmacy - December 2017 - 749
Hospital Pharmacy - December 2017 - 750
Hospital Pharmacy - December 2017 - 751
Hospital Pharmacy - December 2017 - In Vitro Evaluation of Eslicarbazepine Delivery via Enteral Feeding Tubes
Hospital Pharmacy - December 2017 - 753
Hospital Pharmacy - December 2017 - 754
Hospital Pharmacy - December 2017 - 755
Hospital Pharmacy - December 2017 - 756
Hospital Pharmacy - December 2017 - 757
Hospital Pharmacy - December 2017 - 758
Hospital Pharmacy - December 2017 - 759
Hospital Pharmacy - December 2017 - 760
Hospital Pharmacy - December 2017 - Evaluation of Insulin Use and Hypoglycemia in Hospitalized Elderly Patients
Hospital Pharmacy - December 2017 - 762
Hospital Pharmacy - December 2017 - 763
Hospital Pharmacy - December 2017 - 764
Hospital Pharmacy - December 2017 - 765
Hospital Pharmacy - December 2017 - Production Standard and Stability of Compounded del Nido Cardioplegia Solution
Hospital Pharmacy - December 2017 - 767
Hospital Pharmacy - December 2017 - 768
Hospital Pharmacy - December 2017 - 769
Hospital Pharmacy - December 2017 - 770
Hospital Pharmacy - December 2017 - 771
Hospital Pharmacy - December 2017 - 772
Hospital Pharmacy - December 2017 - 773
Hospital Pharmacy - December 2017 - Lumbar Spine Surgeries and Medication Usage During Hospital Stay: One-Center Perspective
Hospital Pharmacy - December 2017 - 775
Hospital Pharmacy - December 2017 - 776
Hospital Pharmacy - December 2017 - 777
Hospital Pharmacy - December 2017 - 778
Hospital Pharmacy - December 2017 - 779
Hospital Pharmacy - December 2017 - 780
Hospital Pharmacy - December 2017 - 781
Hospital Pharmacy - December 2017 - 782
Hospital Pharmacy - December 2017 - 783
Hospital Pharmacy - December 2017 - 784
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