Hospital Pharmacy - December 2017 - 733

Ali and Baker
ALS, offers modest benefit, but is recommended to slow
disease progression in patients with ALS.16 Supportive
care is recommended for management of symptoms such
as sialorrhea, spasticity, cramps, pseudobulbar affect,
fatigue, depression, anxiety, and insomnia. Pharmacologic
options for sialorrhea include amitriptyline, botulinum
toxin A, and botulinum toxin B, the latter being the preferred agent after the patient has tried anticholinergics.
Pseudobulbar affect may be managed with dextromethorphan/quinidine combination therapy, but benefits must
be weighed against the adverse effects of these medications. There are insufficient data to support or refute the
use of medications to manage fatigue, spasticity,
cramps, depression, anxiety, and insomnia.17 Respiratory
therapies (noninvasive ventilation or tracheostomy invasive ventilation) and nutritional care are recommended as
palliative measures.16,17 Edaravone is not discussed in the
guidelines.
Studies
Drug: Edaravone vs Placebo
Reference: Abe K, et al, 20171,18-20
Study Design: Randomized, double-blind, placebo-controlled, parallel-group, multicenter phase 3 study trial
Study Funding: Mitsubishi Tanabe Pharma Corporation
Patients: 137 patients (20 to 75 years of age) with definite or probable ALS (per revised El Escorial criteria).
Patients had Japanese ALS Severity Classification grade
1 or 2 (scale of 1 to 5, with lower scores indicating early
disease), Revised ALS Functional Rating Scale
(ALSFRS-R) score of at least 2 on all 12 items, forced
vital capacity (FVC) of 80% or more, and disease duration of 2 years or less. Exclusion criteria included
Parkinson disease, schizophrenia, dementia, renal failure,
or other severe complication; hypersensitivity to edaravone; pregnancy (or plan to become pregnant) or breastfeeding; or current or recent (within 12 weeks before
consent) participation in other clinical trials.
Intervention: Patients were randomized 1:1 to receive IV
edaravone 60 mg or matching placebo for 24 weeks (28day cycles). For the first cycle, patients received study
medication once daily for 14 days, followed by a 14-day
observation period; for subsequent cycles, study medication was administered for 10 of the 14 days, followed by
a 2-week drug-free period. Riluzole was used by more
than 90% of patients in both treatment groups.
Results:
Primary End Point(s):
** Least squares mean change in ALSFRS-R score from
baseline to week 24: −5.01 with edaravone compared
with −7.5 with placebo (intergroup difference in
adjusted mean change, 2.49; 95% confidence interval
[CI], 0.99 to 3.98; P = .001).

733
Comments: Patients treated with edaravone had slower
progression, as measured by change in ALSFRS-R
score from baseline to 24 weeks. Treatment-emergent
adverse reactions were reported in 84% of both groups,
and serious adverse reactions (eg, dysphagia, respiratory disorder, speech disorder) occurred in 16% of
patients receiving edaravone compared with 24% in the
placebo group.
Limitations: The study had a relatively small sample
size and was conducted only in Japanese patients with
early-stage ALS (Japanese ALS Severity Classification
grade 1 or 2) who were living independently and met
enrollment criteria. The 24-week study duration may not
appropriately capture patient response for this disease
state.1
Reference: Abe K, et al, 20143
Study Design: Randomized, double-blind, placebo-controlled, multicenter phase 3 study
Study Funding: Mitsubishi Tanabe Pharma Corporation
Patients: 206 patients (20 to 75 years of age) with diagnosis of definite, probable, or probable laboratory-supported ALS (per the revised Airlie House diagnostic
criteria). Patients were required to have FVC of 70% or
more; disease duration of 3 years or less; change in
ALSFRS-R score during the 12-week preobservation
period of −1 to −4 points; and Japanese ALS Severity
Classification of grade 1 or 2. Patients were excluded if
they had reduced respiratory function and complaints of
dyspnea; comorbidities that would impact evaluation of
drug efficacy, such as Parkinson disease, schizophrenia,
or dementia; complications that require hospitalization,
including liver, cardiac, and renal disease; creatinine
clearance of 50 mL/min or less 28 days prior to treatment initiation; or were undergoing treatment for cancer.
Patient demographic characteristics at baseline were
well balanced between the treatment groups. The majority of the study population was male (64%) with probable (52%) or definite (24%) ALS, Japanese ALS Severity
Classification grade 2 disease (63%), and ALSFRS-R
change of −2 or −1 in the preobservation phase (70%).
The majority of patients (89%) were taking riluzole.
Intervention: Patients were randomized 1:1 to receive
either edaravone 600 mg or matching placebo (28-day
cycles). For the first cycle, edaravone was administered
once daily for 14 days, followed by a 14-day observation
period; for subsequent cycles, patients received study
medication for 10 of the 14 days. Patients received study
medications for 24 weeks of the 36-week study period
and were assessed during the 12-week preobservation
period, before the start of the first treatment cycle, and at
the end of each treatment cycle (after the 14-day observation period and before the first dosage of the next cycle).
Results:
Primary End Point(s):



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
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2020
https://www.nxtbook.com/nxtbooks/sage/psychologicalscience_demo
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https://www.nxtbook.com/nxtbooks/sage/fai_202009
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_august2020
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https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2019
https://www.nxtbook.com/nxtbooks/sage/fai_201909
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_july2019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2019
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https://www.nxtbook.com/nxtbooks/sage/tec_20180810
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2018
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_julyaugust2018
https://www.nxtbook.com/nxtbooks/sage/fai_201807
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2018
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2018
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