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Hospital Pharmacy Apr 2015Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The...
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The April 2015 monograph topics are edoxaban, diclofenac sodium injectable, olaparib, antihemophilic factor porcine, and blinatumomab. The Safety MUE is on edoxaban.
PubMed: 26448661
DOI: 10.1310/hpj5004-310 -
PloS One 2016Previous randomized controlled trials have reported conflicting findings on the superiority of palonosetron over ramosetron for preventing postoperative nausea and... (Comparative Study)
Comparative Study Meta-Analysis Review
Previous randomized controlled trials have reported conflicting findings on the superiority of palonosetron over ramosetron for preventing postoperative nausea and vomiting (PONV). Therefore, the present systematic review was registered in PROSPERO (CRD42016038120) and performed to compare the efficacy of perioperative administration of palonosetron to that of ramosetron for preventing PONV. We searched MEDLINE, EMBASE, and CENTRAL to identify all randomized controlled trials that compared the effectiveness of perioperative administration of palonosetron to that of ramosetron. The primary endpoints were defined as the incidence of postoperative nausea (PON), postoperative vomiting (POV), and PONV. A total of 695 patients were included in the final analysis. Subgroup analysis was performed through administration times which were divided into two phases: the early phase of surgery and the end of surgery. Combined analysis did not show differences between palonosetron and ramosetron in the overall incidence of PON, POV or PONV. Palonosetron was more effective than ramosetron, when the administration time for the 5-HT3 receptor antagonist was during the early phase of the operation. Otherwise, ramosetron was more effective than palonosetron, when the administration time was at the end of surgery. However, the quality of evidence for each outcome was low or very low and number of included studies was small, limiting our confidence in findings.
Topics: Benzimidazoles; Female; Humans; Isoquinolines; Male; Palonosetron; Postoperative Nausea and Vomiting; Quinuclidines; Randomized Controlled Trials as Topic
PubMed: 27992509
DOI: 10.1371/journal.pone.0168509 -
Current Cancer Drug Targets 2022Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event associated with many anticancer therapies and can negatively impact patients' quality of life... (Review)
Review
Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event associated with many anticancer therapies and can negatively impact patients' quality of life and potentially limit the effectiveness of chemotherapy. Currently, CINV can be prevented in most patients with guideline-recommended antiemetic regimens. However, clinicians do not always follow guidelines, and patients often face difficulties adhering to their prescribed treatments. Therefore, approaches to increase guideline adherence need to be implemented. NEPA is the first and only fixed combination antiemetic, composed of netupitant (oral)/fosnetupitant (intravenous) and palonosetron, which, together with dexamethasone, constitute a triple antiemetic combination recommended for the prevention of CINV for patients receiving highly emetogenic chemotherapy and for certain patients receiving moderately emetogenic chemotherapy. Thus, NEPA offers a convenient and straightforward antiemetic treatment that could improve adherence to guidelines. This review provides an overview of CINV, evaluates the accumulated evidence of NEPA's antiemetic activity and safety from clinical trials and real-world practice, and examines the preliminary evidence of antiemetic control with NEPA in daily clinical settings beyond those described in pivotal trials. Moreover, we review the utility of NEPA in controlling nausea and preserving patients' quality of life during chemotherapy, two major concerns in managing patients with cancer.
Topics: Antiemetics; Antineoplastic Agents; Benzeneacetamides; Dexamethasone; Humans; Nausea; Palonosetron; Piperazines; Pyridines; Quality of Life; Vomiting
PubMed: 35570542
DOI: 10.2174/1568009622666220513094352 -
Medicine Oct 2023To investigate the efficacy and safety of dexamethasone + palonosetron in the prevention of post-embolization syndrome after drug-eluting beads transcatheter...
To investigate the efficacy and safety of dexamethasone + palonosetron in the prevention of post-embolization syndrome after drug-eluting beads transcatheter arterial chemoembolization (D-TACE). The data of 278 patients who received D-TACE from January 2018 to December 2021 were collected and divided into 2 groups: D-TACE group (N = 145) and D-TACE + dexamethasone + palonosetron group (N = 133). The incidence of post-embolization syndrome and infection after D-TACE was assessed in both groups. Incidence of abdominal pain: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 56.6% versus 40.6%, P = .008; incidence of fever: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 40.0% versus 14.3%, P = .000; incidence of nausea: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 61.4% versus 39.8%, P = .001; incidence of vomiting: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 48.3% versus 21.1%, P = .000; incidence of infection: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 1.4% versus 1.5%, P = .931. The combined use of dexamethasone and palonosetron before D-TACE can effectively reduce the incidence of post-embolization syndrome and reduce the degree of side effects, but it will not increase the risk of infection.
Topics: Humans; Palonosetron; Antiemetics; Retrospective Studies; Dexamethasone; Carcinoma, Hepatocellular; Liver Neoplasms; Chemoembolization, Therapeutic; Vomiting
PubMed: 37800841
DOI: 10.1097/MD.0000000000035433 -
Current Therapeutic Research, Clinical... 2022Spinal surgery is associated with severe pain within the first few days after surgery. Opioids are commonly used to control postoperative pain, but these can lead to... (Review)
Review
BACKGROUND
Spinal surgery is associated with severe pain within the first few days after surgery. Opioids are commonly used to control postoperative pain, but these can lead to postoperative nausea and vomiting (PONV). Therefore, use of more effective and better-tolerated agents would be beneficial for these patients. Serotonin receptor antagonists, such as ramosetron, have been used to reduce PONV in patients receiving anesthesia.
OBJECTIVE
We conducted a meta-analysis of published randomized controlled trials (RCTs) to compare the efficacy and tolerance of ramosetron to prevent PONV after spinal surgery.
METHODS
Medline, Embase, Cochrane Library, and Science Citation Index databases were systematically searched for relevant RCT articles published between January 1979 and November 2020. Full text articles restricted to English language that described RCTs comparing the use of ramosetron with other serotonin antagonists to treat PONV following spinal surgery in adult patients were considered for meta-analysis. Two reviewers independently performed study selection, quality assessment, and data extraction of all articles. Differences were resolved by a third reviewer.
RESULTS
The search identified 88 potentially relevant articles, of which only 3 met our selection criteria. Study drugs were administered at the end of spinal surgery in all 3 included articles. The meta-analysis revealed that ramosetron (0.3 mg) reduced the pain score (mean difference = -0.66; 95% CI -1.02 to -0.30), lowered the risk of PONV (risk ratio = 0.86; 95% CI, 0.76-0.97), and postoperative vomiting (risk ratio = 0.32; 95% CI, 0.17-0.60), and limited the use of rescue antiemetics (risk ratio = 0.66; 95% CI, 0.45-0.96) after spinal surgery. However, there were no significant differences in the incidence of postoperative nausea, the use of rescue pain medications, the number of rescue analgesics required, and the risk of discontinuation of patient-controlled analgesia between ramosetron and palonosetron (0.075 mg) or ondansetron (4 mg). There were no statistically significant differences in the risk of adverse events among the 3 medications.
CONCLUSIONS
This meta-analysis of 3 RCTs showed that ramosetron reduced the risk of PONV and POV, limited the use of rescue antiemetics, reduced the postoperative pain score, and did not increase the risk of discontinuing patient-controlled analgesia compared with palonosetron or ondansetron after spinal surgery in 3 RCTs. Therefore, this meta-analysis indicates that ramosetron is an effective and well tolerated antiemetic that can be used to prevent PONV following spinal surgery in adult patients. PROSPERO identifier: CRD42020223596 (. 2022; 83:XXX-XXX)© 2022 Elsevier HS Journals, Inc.
PubMed: 35464291
DOI: 10.1016/j.curtheres.2022.100666 -
Biological & Pharmaceutical Bulletin 2024Although carboplatin (CBDCA) is classified as a moderately emetogenic agent, the majority of guidelines recommend the use of a neurokinin-1 receptor antagonist in...
Although carboplatin (CBDCA) is classified as a moderately emetogenic agent, the majority of guidelines recommend the use of a neurokinin-1 receptor antagonist in addition to a 5-hydroxytryptamine type 3 receptor antagonist with dexamethasone (DEX) for CBDCA-containing chemotherapy because of its higher emetogenic risk. However, the additional efficacy of aprepitant (APR) in CBDCA-containing treatment remains controversial, and data on multiple-day treatments are limited. Etoposide (ETP) was administered on days 1-3 in the CBDCA + ETP regimen, and it is important to evaluate suitable antiemetic therapy for the regimen. Therefore, we evaluated the efficacy of additional APR in CBDCA + ETP. Patients were divided into two groups and retrospectively evaluated. One was the control group, which was prophylactically administered palonosetron (PALO) and DEX, and the other was the APR group, which received APR orally with PALO and DEX. The primary endpoint was complete response (CR) between the groups. The overall CR rates were 75.0 and 76.4% in the control and APR groups, respectively, with no significant difference (p = 1.00). In the acute phase, it was 88.9 and 97.2%, respectively, and 86.1 and 79.2% in the delayed phase, respectively, without significant differences (p = 0.10 and 0.38, respectively). The incidence and severity of nausea, vomiting, and anorexia were not significantly different between the two groups in the acute and delayed phases. Our findings suggest that combining APR with PALO and DEX does not improve the CR rate in CBDCA + ETP therapy.
Topics: Aprepitant; Carboplatin; Humans; Dexamethasone; Palonosetron; Male; Etoposide; Antiemetics; Female; Middle Aged; Vomiting; Aged; Nausea; Retrospective Studies; Adult; Drug Therapy, Combination; Antineoplastic Combined Chemotherapy Protocols; Quinuclidines; Morpholines; Antineoplastic Agents; Isoquinolines; Treatment Outcome
PubMed: 38897969
DOI: 10.1248/bpb.b24-00046 -
Anesthesia, Essays and Researches 2022Postoperative nausea and vomiting (PONV) are one of the common distressing conditions after anesthesia. The PONV are related to several potential risk factors are...
Comparison of Palonosetron Versus Palonosetron and Dexamethasone for Prevention of Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Study.
BACKGROUND
Postoperative nausea and vomiting (PONV) are one of the common distressing conditions after anesthesia. The PONV are related to several potential risk factors are patient related, anesthesia related, and surgery related. In surgery-related risk, middle ear surgery is associated with a high incidence of PONV.
AIMS
This study aimed to compare the efficiency of palonosetron versus palonosetron with dexamethasone in the prevention of PONV in middle ear surgeries.
SETTINGS AND DESIGN
This was a prospective, randomized, double-blind study.
STATISTICAL ANALYSIS
The data were presented as descriptive statistics for continuous variables and percentages for categorical variables and were subjected to Z-test/Chi-square test/Fisher's exact test. The value of < 0.05 was considered statistically significant.
RESULTS
Demographic parts in comparison to age, duration of surgery, and duration of anesthesia were similar in both the groups. Our study showed that the incidence of PONV during 0-6 h was 38% ( = 19) in Group A and 12% ( = 6) in Group B and the incidence during 6-12 h postoperatively was 14% ( = 7) in Group A and 8% ( = 4) in Group B. During 12-24 h, the incidence was 8% ( = 4) and 6% ( = 3) in Group A and B, respectively. Hence, the difference of total early PONV in Group A was 60% ( = 30) and in Group B, it was 26% ( = 13) which was statistically significant ( < 0.03).
CONCLUSIONS
The above result proves that palonosetron and dexamethasone group is superior in the prevention of PONV in middle ear surgery.
PubMed: 36249139
DOI: 10.4103/aer.aer_131_21 -
The Journal of International Medical... Jan 2018Background This meta-analysis was performed to evaluate the efficacy and safety of palonosetron and ondansetron in preventing postoperative nausea and vomiting (PONV) in... (Meta-Analysis)
Meta-Analysis
Background This meta-analysis was performed to evaluate the efficacy and safety of palonosetron and ondansetron in preventing postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic surgery with general anesthesia. Methods We searched for randomized controlled clinical trials in PubMed, Embase, and The Cochrane Library. Results Nine studies were enrolled in this meta-analysis and showed no statistically significant difference between palonosetron and ondansetron in the prevention of PONV in the first 24 hours after surgery (relative risk [RR], 0.62; 95% confidence interval [CI], 0.35-1.10). Palonosetron more effectively prevented vomiting at various time intervals during the first 24 hours postoperatively than did ondansetron: 0-2 hours (RR, 0.45; 95% CI, 0.26-0.78), 2-6 hours (RR, 0.74; 95% CI, 0.39-1.40), and 6-24 hours (RR, 1.20; 95% CI, 0.55-2.64). No significant differences in side effects were found between palonosetron and ondansetron (RR, 0.67; 95% CI, 0.40-1.14). Conclusion This meta-analysis demonstrated that palonosetron is not more efficacious than ondansetron in the prevention of early PONV. However, palonosetron was more efficacious than ondansetron in the prevention of vomiting after laparoscopic surgery.
Topics: Anesthesia, General; Antiemetics; Humans; Isoquinolines; Laparoscopy; Ondansetron; Palonosetron; Postoperative Nausea and Vomiting; Quinuclidines; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 28718727
DOI: 10.1177/0300060517715374 -
Annals of Oncology : Official Journal... Jul 2014
Topics: Antiemetics; Antineoplastic Agents; Drug Therapy, Combination; Humans; Isoquinolines; Nausea; Palonosetron; Pyridines; Quinuclidines; Vomiting
PubMed: 24942276
DOI: 10.1093/annonc/mdu190 -
Therapeutics and Clinical Risk... 2016The purpose of this review is to summarize and discuss the recently published data (both original studies and reviews) on the oral medication NEPA, consisting of... (Review)
Review
PURPOSE
The purpose of this review is to summarize and discuss the recently published data (both original studies and reviews) on the oral medication NEPA, consisting of netupitant (a neurokinin-1 receptor antagonist [NK1RA], 300 mg dose) and palonosetron (5-hydroxytryptamine [serotonin or 5HT] type 3 receptor antagonist [5HT3RA], 0.5 mg dose), in the prevention of the acute and delayed nausea and vomiting in patients receiving highly or moderately emetogenic chemotherapy.
METHODS
This review was based on the very limited number of available published trials consisting of two Phase III studies and one Phase II dose-selecting trial.
RESULTS
These studies demonstrated some therapeutic benefits of NEPA over related chemotherapy-induced nausea and vomiting (CINV) prophylaxis management, as well as its beneficial safety profile. In particular, compared with single-dose 0.5 mg palonosetron, the complete response rates for all phases of CINV for the first cycle of highly emetogenic chemotherapy (with cisplatin), as well as anthracycline-cyclophosphamide-based moderately emetogenic chemotherapy, were significantly higher for single-dose NEPA. The high efficacy of NEPA in terms of prevention of CINV continued throughout repeated cycles of highly and moderately emetogenic therapies.
CONCLUSION
It is currently recommended that patients who are administered highly emetogenic chemotherapy regimens should obtain a three-drug combination consisting of NK1RA, 5HT3RA, and dexamethasone. The recently available oral combination of NEPA plus dexamethasone provides an additional pharmacological management option that could be considered in this scenario.
PubMed: 27194913
DOI: 10.2147/TCRM.S81126