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naive or receiving 1 dopamine agonist (at a stable dose for
at least 4 weeks) were eligible; 60.5% of patients were
receiving a dopamine agonist. Patients were excluded if
they had a history of alcohol or drug abuse, any motor
fluctuations, present or past mental illness, Mini-Mental
State Examination (MMSE) score of less than 24, Hamilton
Depression Scale (HAMD) score of more than 17, or laboratory values outside of normal limits by more than 50%.
Intervention: Patients were randomized 1:1:1 to receive
safinamide 0.5 mg/kg (n = 55), safinamide 1 mg/kg (n =
56), or placebo (n = 56) once daily after being weighed.
All patients received 5 identical capsules each day at 8:00
am for 12 weeks. The dopamine agonist dose was maintained at the preenrollment dose or, if necessary, was
decreased during treatment.
Results
Primary End Point(s)
** Percentage of patients with at least 30% improvement
in Unified Parkinson Disease Rating Scale (UPDRS)
part III (motor examination) scores was 30.9% in the
0.5 mg/kg group, 37.5% in the 1 mg/kg group, and
21.4% in the placebo group.
End Point(s)
** Percentage of patients with at least 30% improvement
in UPDRS part III in the subpopulation taking safinamide and a dopamine agonist (n = 101): 36.4% in the
0.5 mg/kg group, 47.1% in the 1 mg/kg group, and
20.6% in the placebo group.
Comments: The average safinamide dose was 40 mg
(range, 20-40 mg) for the 0.5 mg/kg group and 70 mg
(range, 40-90 mg) for the 1 mg/kg group. The combination of safinamide and a dopamine agonist resulted in
increased benefit. There were no tolerability issues with
the highest dose of safinamide, which allows for the use
of higher doses in future studies.
Limitations: The purpose of this study was to determine
whether safinamide improves Parkinson disease symptoms. The sample size was not powered for any end point.
It is unclear in which countries this study was conducted.
Reference: Stocchi F, et al, 2012 (Study 015)8
Study Design: Randomized, double-blind, placebo-controlled, parallel-group, multicenter study
Study Funding: Newron Pharmaceuticals, Merck Serono
Patients: 269 patients with idiopathic Parkinson disease
(Hoehn and Yahr stage I to III) for less than 5 years.
Patients were required to be on a stable dose of a single
dopamine agonist for at least 4 weeks before screening. At
baseline, average patient age was 57.4 years; 63% were
Hospital Pharmacy 52(8)
male; 59% were white and 37% Asian; and average duration of Parkinson disease was 2.5 years. Clinical Global
Impression-Severity of Illness (CGI-S) score was approximately 3.1, UPDRS part III (motor examination) score
was 20.7, MMSE score was approximately 28.5, and
HAMD score was approximately 4.2, with no meaningful
differences among treatment groups. The majority of
dopamine agonist use included ropinirole (45% to 48%),
pramipexole (23% to 30%), bromocriptine (11% to 22%),
and cabergoline (3%-10%). Exclusion criteria were endof-dose "wearing off," "on/off" phenomena, disabling
dysmnesia, or wide fluctuations; severe postural hypotension; concomitant use of monoamine oxidase inhibitors
(MAOIs); or use of other Parkinson disease medications
other than the single dopamine agonist.
Intervention: Patients were randomized 1:1:1 to receive
safinamide 100 mg (n = 90), safinamide 200 mg (n = 89),
or placebo (n = 90) once daily with breakfast for 24
weeks. All patients were maintained on their preenrollment dose of dopamine agonist throughout the study;
however, for patients receiving the maximum dose of
study medication and whose motor symptoms were worsening, the dopamine agonist dose could be increased or
other Parkinson disease medications added.
Results
Primary End Point(s)
** Average difference from baseline to week 24 in
UPDRS part III scores in the intention-to-treat (ITT)
population (eg, all patients who received at least 1
dose), without imputation for missing data, was −6
with safinamide 100 mg (−1.9 point estimate vs placebo [95% confidence interval, CI, −3.7 to −0.1; P =
.0419]), −3.9 with safinamide 200 mg (−0.4 point estimate vs placebo [95% CI, −2.3 to 1.4; P = .65]), and
−3.6 with placebo.
Secondary End Point(s)
** Percentage of patients with response at week 24:
|| Clinical
Global Impression-Change (CGI-C)
score (response defined as a score between 1 and
3): approximately 61% in the safinamide 100 mg
group (P = .18 vs placebo), approximately 59% in
the safinamide 200 mg group (P = .08 vs placebo),
and approximately 49% in the placebo group.
|| UPDRS part III score (response defined as having
at least 30% improvement with no deterioration
in part II [activities of daily living] and part IV
[complications of therapy] scores): approximately
38% with 100 mg (P = .05), approximately 36%
with 200 mg (P = .08), and approximately 24%
with placebo.
Table of Contents for the Digital Edition of Hospital Pharmacy - September 2017
Pharmacy Transitions of Care and Culture
Bivalirudin Medication Use Evaluation and Cost Savings Initiative
Navigating the New Antimicrobial Stewardship Regulations
Safinamide
Biosimilar Substitution Laws
Evaluation of Corticosteroid Dose in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Hazardous Drug Contamination of Drug Preparation Devices and Staff: A Contamination Study Simulating the Use of Chemotherapy Drugs in a Clinical Setting
A Case of Metronidazole Injection Infiltration Without Sequelae
Doubling Pharmacist Coverage in the Intensive Care Unit: Impact on the Pharmacists’ Clinical Activities and Team Members’ Satisfaction
Extended Stability of Epinephrine Hydrochloride Injection in Polyvinyl Chloride Bags Stored in Amber Ultraviolet Light–Blocking Bags
Formation of a Citywide Pharmacy Residents’ Collaborative Committee
Hospital Pharmacy - September 2017 - 513
Hospital Pharmacy - September 2017 - 514
Hospital Pharmacy - September 2017 - 515
Hospital Pharmacy - September 2017 - 516
Hospital Pharmacy - September 2017 - 517
Hospital Pharmacy - September 2017 - 518
Hospital Pharmacy - September 2017 - 519
Hospital Pharmacy - September 2017 - Pharmacy Transitions of Care and Culture
Hospital Pharmacy - September 2017 - 521
Hospital Pharmacy - September 2017 - Bivalirudin Medication Use Evaluation and Cost Savings Initiative
Hospital Pharmacy - September 2017 - 523
Hospital Pharmacy - September 2017 - 524
Hospital Pharmacy - September 2017 - 525
Hospital Pharmacy - September 2017 - 526
Hospital Pharmacy - September 2017 - Navigating the New Antimicrobial Stewardship Regulations
Hospital Pharmacy - September 2017 - 528
Hospital Pharmacy - September 2017 - 529
Hospital Pharmacy - September 2017 - 530
Hospital Pharmacy - September 2017 - 531
Hospital Pharmacy - September 2017 - Safinamide
Hospital Pharmacy - September 2017 - 533
Hospital Pharmacy - September 2017 - 534
Hospital Pharmacy - September 2017 - 535
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Hospital Pharmacy - September 2017 - 542
Hospital Pharmacy - September 2017 - 543
Hospital Pharmacy - September 2017 - Biosimilar Substitution Laws
Hospital Pharmacy - September 2017 - 545
Hospital Pharmacy - September 2017 - Evaluation of Corticosteroid Dose in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Hospital Pharmacy - September 2017 - 547
Hospital Pharmacy - September 2017 - 548
Hospital Pharmacy - September 2017 - 549
Hospital Pharmacy - September 2017 - 550
Hospital Pharmacy - September 2017 - Hazardous Drug Contamination of Drug Preparation Devices and Staff: A Contamination Study Simulating the Use of Chemotherapy Drugs in a Clinical Setting
Hospital Pharmacy - September 2017 - 552
Hospital Pharmacy - September 2017 - 553
Hospital Pharmacy - September 2017 - 554
Hospital Pharmacy - September 2017 - 555
Hospital Pharmacy - September 2017 - 556
Hospital Pharmacy - September 2017 - 557
Hospital Pharmacy - September 2017 - 558
Hospital Pharmacy - September 2017 - A Case of Metronidazole Injection Infiltration Without Sequelae
Hospital Pharmacy - September 2017 - 560
Hospital Pharmacy - September 2017 - 561
Hospital Pharmacy - September 2017 - 562
Hospital Pharmacy - September 2017 - 563
Hospital Pharmacy - September 2017 - Doubling Pharmacist Coverage in the Intensive Care Unit: Impact on the Pharmacists’ Clinical Activities and Team Members’ Satisfaction
Hospital Pharmacy - September 2017 - 565
Hospital Pharmacy - September 2017 - 566
Hospital Pharmacy - September 2017 - 567
Hospital Pharmacy - September 2017 - 568
Hospital Pharmacy - September 2017 - 569
Hospital Pharmacy - September 2017 - Extended Stability of Epinephrine Hydrochloride Injection in Polyvinyl Chloride Bags Stored in Amber Ultraviolet Light–Blocking Bags
Hospital Pharmacy - September 2017 - 571
Hospital Pharmacy - September 2017 - 572
Hospital Pharmacy - September 2017 - 573
Hospital Pharmacy - September 2017 - Formation of a Citywide Pharmacy Residents’ Collaborative Committee
Hospital Pharmacy - September 2017 - 575
Hospital Pharmacy - September 2017 - 576
Hospital Pharmacy - September 2017 - 577
Hospital Pharmacy - September 2017 - 578
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Hospital Pharmacy - September 2017 - 580
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