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pelvic floor dysfunction; pseudo-obstruction; active infectious
gastritis; diverticulitis; anal fissures or disease/condition that
can affect GI motility or defecation or that is associated with
abdominal pain; unexplained GI bleeding, iron deficiency
anemia, weight loss, or systemic signs of infection or colitis;
and participation in a previous plecanatide clinical trial.
Intervention: Patients were randomized (1:1:1) to receive
placebo or plecanatide 3 mg or 6 mg once daily for 12 treatment weeks.
Results
Primary End Point(s)
** Proportion of durable overall responders, defined as
patients who were weekly responders (3 or more CSBMs
and an increase of 1 or more CSBM from baseline) for at
least 9 of 12 treatment weeks, including 3 of the last 4
weeks, was 10.2% with placebo, 21% with plecanatide 3
mg, and 19.5% with plecanatide 6 mg (P < .001 vs
placebo for both). The NNT for durable overall CSBM
response over 12 weeks of therapy was 9.3 with plecanatide 3 mg and 10.8 with plecanatide 6 mg.
Secondary End Point(s)
** Changes in the frequency of SBMs and CSBMs per
week from baseline occurred within the first week and
were maintained through week 12. SBMs increased
from baseline at week 12 by 1.4 with placebo, 3.3
with plecanatide 3 mg, and 3.2 with plecanatide 6 mg
(P < .001 vs placebo for both). CSBMs increased
from baseline by 1.2 per week with placebo, by 2.5
per week with plecanatide 3 mg, and by 2.2 per week
with plecanatide 6 mg (P < .001 vs placebo for both).
Comments: This phase 3 study was designed to assess
the efficacy and safety of plecanatide in the treatment of
CIC. Electronic diaries were used to track SBMs, CSBMs,
and symptoms. The study used an mITT population for analysis and was conducted in the United States and Canada.
Limitations: Study results are only available as a published abstract.
Reference: Miner PB, et al, 2016 (Study-03)21,22
Study Design: Randomized, double-blind, multicenter
study
Study Funding: Synergy Pharmaceuticals
Patients: 1337 adults with CIC. Patients had to meet
modified Rome III criteria for CIC diagnosis and had to have
experienced symptoms for at least 3 months, with symptom
onset at least 6 months prior to diagnosis.
Intervention: Patients were randomized (1:1:1) to receive
placebo or plecanatide 3 mg or 6 mg once daily for 12 treatment weeks.
Hospital Pharmacy 52(6)
Results
Primary End Point(s)
** Proportion of durable overall responders, defined as
patients who were weekly responders (3 or more CSBMs
and an increase of 1 or more CSBM from baseline) for at
least 9 of 12 treatment weeks, including 3 of the last 4
weeks, increased by 12.8% with placebo, 20.1% with
plecanatide 3 mg, and 20% with plecanatide 6 mg (P =
.004 vs placebo for both). The NNT for durable overall
CSBM response over 12 weeks of therapy was 13.7 with
plecanatide 3 mg and 13.9 with plecanatide 6 mg.
Secondary End Point(s)
** Changes in the frequency of SBMs and CSBMs per
week from baseline occurred within the first week and
were maintained through week 12. SBMs increased
from baseline at week 12 by 1.8 with placebo, 3.2
with plecanatide 3 mg, and 3.2 with plecanatide 6 mg
(P < .001 vs placebo for both). CSBMs increased
from baseline by 1.4 per week with placebo, by 2.3
per week with plecanatide 3 mg, and by 2.2 per week
with plecanatide 6 mg (P < .001 vs placebo for both).
Comments: This study used the same design as Study-00
and was conducted only in the United States.19,22 Pooled
analysis of Study-00 and Study-03 demonstrated improvements in Bristol Stool Form Scale scores, Patient Global
Assessments of constipation severity, treatment satisfaction
scores, and treatment continuation scores with both doses of
plecanatide compared with placebo.23,24 Patients from these
2 studies were eligible to enroll in a multicenter, open-label,
52-week safety and tolerability study of plecanatide.25
Limitations: Study results are only available as a published abstract.
Contraindications, Warnings, and
Precautions
Contraindications
Plecanatide is contraindicated in patients younger than 6
years due to the risk of serious dehydration, and in patients
with known or suspected mechanical GI obstruction.2
Linaclotide has similar contraindications.8
Although not stated in the prescribing information, a
potential contraindication is hypersensitivity to plecanatide
or any of its inactive ingredients (magnesium stearate and
microcrystalline cellulose).2
Warnings and Precautions
According to the boxed warning for plecanatide, use in children 6 years to younger than 18 years is not recommended;
Table of Contents for the Digital Edition of Hospital Pharmacy - June 2017
Formal Leadership: Thrilling (and Scary) Like a Roller Coaster Ride
ISMP Medication Error Report Analysis
Cancer Chemotherapy Update: Bevacizumab, Etoposide, and Cisplatin Regimen for Refractory Brain Metastases
Formulary Drug Reviews: Plecanatide
Calcitonin Gene-Related Peptide Receptor Antagonists for Migraine Prophylaxis: A Review of a Drug Class or Therapeutic Class in a Late Stage of Clinical Development
Highly Probable Drug Reaction With Eosinophilia and Systemic Symptoms Syndrome Associated With Lenalidomide
Significant Published Articles for Pharmacy Nutrition Support Practice in 2016
Financial Effect of a Drug Distribution Model Change on a Health System
Limited Influence of Excipients in Extemporaneous Compounded Suspensions
Improved Outcomes and Cost Savings Associated With Pharmacist Presence in the Emergency Department
Patients Given Take Home Medications Instead of Paper Prescriptions Are More Likely to Return to Emergency Department
Hospital Pharmacy - June 2017 - 381
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Hospital Pharmacy - June 2017 - 386
Hospital Pharmacy - June 2017 - 387
Hospital Pharmacy - June 2017 - Formal Leadership: Thrilling (and Scary) Like a Roller Coaster Ride
Hospital Pharmacy - June 2017 - 389
Hospital Pharmacy - June 2017 - ISMP Medication Error Report Analysis
Hospital Pharmacy - June 2017 - 391
Hospital Pharmacy - June 2017 - 392
Hospital Pharmacy - June 2017 - 393
Hospital Pharmacy - June 2017 - Cancer Chemotherapy Update: Bevacizumab, Etoposide, and Cisplatin Regimen for Refractory Brain Metastases
Hospital Pharmacy - June 2017 - 395
Hospital Pharmacy - June 2017 - 396
Hospital Pharmacy - June 2017 - 397
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Hospital Pharmacy - June 2017 - Formulary Drug Reviews: Plecanatide
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Hospital Pharmacy - June 2017 - 402
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Hospital Pharmacy - June 2017 - 404
Hospital Pharmacy - June 2017 - 405
Hospital Pharmacy - June 2017 - Calcitonin Gene-Related Peptide Receptor Antagonists for Migraine Prophylaxis: A Review of a Drug Class or Therapeutic Class in a Late Stage of Clinical Development
Hospital Pharmacy - June 2017 - 407
Hospital Pharmacy - June 2017 - Highly Probable Drug Reaction With Eosinophilia and Systemic Symptoms Syndrome Associated With Lenalidomide
Hospital Pharmacy - June 2017 - 409
Hospital Pharmacy - June 2017 - 410
Hospital Pharmacy - June 2017 - 411
Hospital Pharmacy - June 2017 - Significant Published Articles for Pharmacy Nutrition Support Practice in 2016
Hospital Pharmacy - June 2017 - 413
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Hospital Pharmacy - June 2017 - 416
Hospital Pharmacy - June 2017 - 417
Hospital Pharmacy - June 2017 - 418
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Hospital Pharmacy - June 2017 - 420
Hospital Pharmacy - June 2017 - 421
Hospital Pharmacy - June 2017 - Financial Effect of a Drug Distribution Model Change on a Health System
Hospital Pharmacy - June 2017 - 423
Hospital Pharmacy - June 2017 - 424
Hospital Pharmacy - June 2017 - 425
Hospital Pharmacy - June 2017 - 426
Hospital Pharmacy - June 2017 - 427
Hospital Pharmacy - June 2017 - Limited Influence of Excipients in Extemporaneous Compounded Suspensions
Hospital Pharmacy - June 2017 - 429
Hospital Pharmacy - June 2017 - 430
Hospital Pharmacy - June 2017 - 431
Hospital Pharmacy - June 2017 - 432
Hospital Pharmacy - June 2017 - Improved Outcomes and Cost Savings Associated With Pharmacist Presence in the Emergency Department
Hospital Pharmacy - June 2017 - 434
Hospital Pharmacy - June 2017 - 435
Hospital Pharmacy - June 2017 - 436
Hospital Pharmacy - June 2017 - 437
Hospital Pharmacy - June 2017 - Patients Given Take Home Medications Instead of Paper Prescriptions Are More Likely to Return to Emergency Department
Hospital Pharmacy - June 2017 - 439
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Hospital Pharmacy - June 2017 - 441
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