Sialorrhea — Therapeutic Drug Options

2002 ◽  
Vol 36 (11) ◽  
pp. 1785-1790 ◽  
Author(s):  
Dorothy Z Tscheng
Keyword(s):  
Small Sample Size ◽  
Symptom Relief ◽  
Small Sample ◽  
The Other ◽  
Therapeutic Drug ◽  
Efficacy And Safety ◽  
Drug Induced ◽  
Data Synthesis ◽  
Search Terms ◽  
Drug Treatments

OBJECTIVE: To review the efficacy and safety of various drug treatments for sialorrhea. Pharmacotherapy for drug-induced sialorrhea is not addressed. DATA SOURCES: Clinical studies were identified using PubMed (1966–October 2001). Key search terms included sialorrhea and drug therapy. DATA SYNTHESIS: Sialorrhea is a social and physical detriment to patients. Drug treatment, although not necessarily the treatment of choice for all patients, can offer some symptom relief. CONCLUSIONS: Literature has documented that benztropine, glycopyrrolate, and scopolamine can reduce the incidence of sialorrhea. Although the literature evaluating the therapeutic options has limitations (e.g., small sample size, inconsistent outcome measurements), glycopyrrolate may have an advantage over the other agents due to fewer adverse effects.

Review of Serum Voriconazole Concentrations and Correlations with Adverse Events and Efficacy

2009 ◽  
Vol 25 (3) ◽  
pp. 183-189
Author(s):  
Michael J Latran
Keyword(s):  
Adverse Events ◽  
Fungal Infections ◽  
Case Reports ◽  
Elevated Serum ◽  
Therapeutic Drug ◽  
Serum Concentrations ◽  
Efficacy And Safety ◽  
Data Synthesis ◽  
Additional Information ◽  
Search Terms

Objective: To review the available evidence regarding the monitoring of serum voriconazole concentrations in terms of efficacy and safety. Data Sources: A literature search of MEDLINE was conducted (1950–February 2009), with combinations of the following search terms: voriconazole, therapeutic drug monitoring, voriconazole serum concentrations, voriconazole levels, trough, and adverse events. Data Collection: All studies and case reports that evaluated serum voriconazole concentrations in adults were reviewed and considered for inclusion. Citations in identified articles were searched for additional information. Data Synthesis: Ten studies and case reports that evaluated serum voriconazole concentrations in terms of efficacy and safety in adults were identified and included in this review. Results from efficacy studies show an association between low serum voriconazole concentrations and disease progression. One study found that a lack of response occurred more often in patients with a serum voriconazole trough of 1 μg/mL or less (p = 0.02). Another study found that patients were more likely to fail voriconazole therapy for invasive fungal infections when serum concentrations were less than or equal to 2 μg/mL. In terms of safety, 6 studies showed an association between elevated serum voriconazole concentrations and adverse events. Conclusions: Available data suggest that serum voriconazole concentrations of 1 μg/mL or less are associated with therapeutic failures, whereas serum voriconazole concentrations of 6 μg/mL or more are associated with adverse events. Studies show that monitoring serum voriconazole concentrations may decrease the incidence of adverse events while increasing efficacy.

Use of antipsychotics and antidepressants in patients with HIV

2016 ◽  
Vol 33 (S1) ◽  
pp. S150-S151 ◽  
Author(s):  
P. Muñoz-Calero ◽  
F. García Sánchez ◽  
N. Rodriguez Criado ◽  
R. Martín Aragón ◽  
J.F. Cruz Fourcade ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Hiv Infection ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Small Sample Size ◽  
Small Sample ◽  
Psychotic Symptoms ◽  
Efficacy And Safety ◽  
Search Terms ◽  
Pharmacological Interactions ◽  
Competing Interest

IntroductionPsychological distress appears in the majority of people infected with HIV. Depression is the most important affection, the prevalence in comparison with general population arises to 37%. Psychotic symptoms in patients with HIV are a very frequent entity, in some cases, these symptoms are pre-existent in others the evolution of the infection or a medical cause related with the infection can cause its apparition. Psychosis and depression in patients with HIV have some clinical and therapeutical considerations. Antidepressants and antipsychotics have many pharmacological interactions with antiretroviral therapy.ObjectivesReview the efficacy and safety of antidepressants and antipsychotics in patients with HIV infection.MethodsPubMed was searched for articles published between 1966 and January 1, 2015, using the search terms HIV, AIDS, depression, phycosis, antipsychotics, antidepressants, antiretrovirals. We selected randomized placebo controlled or active comparator control trials.ResultsTwelve studies for depression treatment and 2 studies for psychosis treatment in patients with HIV infection. Selective serotonin reuptake inhibitors (SSRI) especially fluoxetine and tryciclic antidepressants are effective in treating depressive symptoms in patients with HIV infection. Testosterone and stimulants have been used in patients with mild depressive symptoms, however studies with these agents had a small sample size. Haloperidol and chlorpromazine were effective for AIDS delirium, there are not controlled trials with other antipsychotics.ConclusionsPsychiatrists must be concern about the clinical particularities of patients with HIV and depression or psychotic symptoms. The election of antidepressant or antipsychotic has to be made very carefully because of their side effects and interactions.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Efficacy and safety of colistin loading dose: a meta-analysis

2020 ◽  
Vol 75 (7) ◽  
pp. 1689-1698
Author(s):  
Ioannis Bellos ◽  
Vasilios Pergialiotis ◽  
Maximos Frountzas ◽  
Konstantinos Kontzoglou ◽  
Georgios Daskalakis ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Meta Analysis ◽  
Treatment Success ◽  
Small Sample ◽  
High Dose ◽  
Loading Dose ◽  
Efficacy And Safety ◽  
Optimal Dosing ◽  
Retrospective Cohort Studies ◽  
Dosing Strategy

Abstract Objectives Colistin represents a polypeptide used for the treatment of MDR microorganisms, although the optimal dosing strategy is under investigation. The present meta-analysis aims to determine whether the administration of a colistin loading dose in patients receiving high-dose maintenance regimens changes the rates of treatment success and the risk of nephrotoxicity. Methods Medline, Scopus, CENTRAL, Clinicaltrials.gov and Google Scholar were systematically searched from inception to 18 November 2019. Studies were considered eligible if they reported clinical outcomes among patients receiving high-dose colistin therapy with and without the administration of a loading dose. Meta-analysis was performed by fitting a random-effects model. Results Eight (three prospective and five retrospective cohort) studies were included, comprising 1115 patients. The administration of a colistin loading dose was associated with significantly higher microbiological [risk ratio (RR) = 1.23, 95% CI = 1.10–1.39] but not clinical (RR = 1.04, 95% CI = 0.87–1.24) success. No significant associations were calculated for nephrotoxicity (RR = 1.31, 95% CI = 0.90–1.91) and mortality (RR = 1.03, 95% CI = 0.82–1.29) risk. The results remained stable after adjustments for small sample size, credibility ceilings, publication bias and risk of bias. Conclusions Observational evidence suggests that the administration of a colistin loading dose in patients receiving high maintenance dosage regimens is significantly associated with higher rates of microbiological response, but does not change clinical cure, mortality or nephrotoxicity risk. The dosing regimen that would provide the optimal balance between treatment efficacy and safety needs to be determined by future randomized controlled trials.

Therapeutic Drug Monitoring of Lamotrigine

2002 ◽  
Vol 36 (5) ◽  
pp. 917-920 ◽  
Author(s):  
Elaine Chong ◽  
L Lee Dupuis
Keyword(s):  
Decision Making ◽  
Dose Adjustment ◽  
Clinical Evidence ◽  
Therapeutic Drug ◽  
Data Synthesis ◽  
Search Terms ◽  
Pharmacologic Response ◽  
Routine Monitoring ◽  
Data Source ◽  
Lamotrigine Concentration

OBJECTIVE: To evaluate the usefulness of routine monitoring of serum lamotrigine concentration. DATA SOURCE: Literature was accessed through MEDLINE (1990–January 2001). Key search terms included lamotrigine, pharmacokinetics, and epilepsy. DATA SYNTHESIS: A decision-making algorithm was used to evaluate the clinical evidence to support or refute the routine use of serum lamotrigine concentrations to adjust doses. The value of serum lamotrigine concentration monitoring remains controversial, primarily because clear relationships between concentration and pharmacologic response (either efficacy or toxicity) have not been demonstrated. CONCLUSIONS: Serum concentration monitoring of lamotrigine is not recommended as a tool for routine dose adjustment.

scholarly journals Efficacy and safety of darolutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a sub-group analysis of the phase III ARAMIS trial

2020 ◽  
Author(s):  
Hiroji Uemura ◽  
Hisashi Matsushima ◽  
Kazuki Kobayashi ◽  
Hiroya Mizusawa ◽  
Hiroaki Nishimatsu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Small Sample Size ◽  
Group Analysis ◽  
Specific Antigen ◽  
Japanese Patients ◽  
Small Sample ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

Abstract Background Darolutamide, an oral androgen receptor inhibitor, has been approved for treating nonmetastatic castration-resistant prostate cancer (nmCRPC), based on significant improvements in metastasis-free survival (MFS) in the ARAMIS clinical trial. Efficacy and safety of darolutamide in Japanese patients are reported here. Methods In this randomized, double-blind, placebo-controlled phase III trial, 1509 patients with nmCRPC and prostate-specific antigen (PSA) doubling time ≤ 10 months were randomized 2:1 to darolutamide 600 mg twice daily or matched placebo while continuing androgen deprivation therapy. The primary endpoint was MFS. Results In Japan, 95 patients were enrolled and randomized to darolutamide (n = 62) or placebo (n = 33). At the primary analysis (cut-off date: September 3, 2018), after 20 primary end-point events had occurred, median MFS was not reached with darolutamide vs. 18.2 months with placebo (HR 0.28, 95% CI 0.11–0.70). Median OS was not reached due to limited numbers of events in both groups but favored darolutamide in the Japanese subgroup. Time to pain progression, time to PSA progression, and PSA response also favored darolutamide. Among Japanese patients randomized to darolutamide vs. placebo, incidences of treatment-emergent adverse events (TEAEs) were 85.5 vs. 63.6%, and incidences of treatment discontinuation due to TEAEs were 8.1 vs. 6.1%. Conclusions Efficacy outcomes favored darolutamide in Japanese patients with nmCRPC, supporting the clinical benefit of darolutamide in this patient population. Darolutamide was well tolerated; however, due to the small sample size, it is impossible to conclude with certainty whether differences in the safety profile exist between Japanese and overall ARAMIS populations.

Drug-Induced Yawning—A Review

2011 ◽  
Vol 45 (10) ◽  
pp. 1297-1301 ◽  
Author(s):  
Edna Patatanian ◽  
Nancy Toedter Williams
Keyword(s):  
Case Reports ◽  
Data Extraction ◽  
Background Information ◽  
Drug Induced ◽  
Data Synthesis ◽  
Search Terms ◽  
Dopaminergic Agents ◽  
Study Selection ◽  
Physiologic Function ◽  
Induction Agents

Objective: To review the current literature on drug-induced yawning. Data Sources: Literature was accessed through MEDLINE/PubMed (1996-July 2011), International Pharmaceutical Abstracts (1997-July 2011), and EMBASE, using the search terms yawning, drug-induced yawning, and adverse drug reactions. Study Selection and Data Extraction: Relevant clinical trials and case reports were selected and included to present background information. Bibliographies of all relevant articles were reviewed for additional citations. Data Synthesis: Yawning is a common stereotype behavior with unknown physiologic function that occurs in most vertebrates and humans as early as 15 weeks of intrauterine life. Yawning Is under the control of several neurotransmitters and neuropeptides, Including dopamine, serotonin, oxytocin, and acetylcholine. Among drugs, antidepressants, opioids, dopaminergic agents, benzodiazepines, and induction agents are the main pharmacologic classes associated with yawning. Conclusions: Yawning is rarely a serious adverse reaction and is not frequently listed in the drug summary. Most available data are based on case reports, small studies, and older literature. Clinicians should be aware of the agents commonly triggering this behavior.

Topical Tacrolimus in the Treatment of Atopic Dermatitis

2001 ◽  
Vol 35 (7-8) ◽  
pp. 943-946 ◽  
Author(s):  
Laura M Gianni ◽  
Maria Marzella Sulli
Keyword(s):  
Atopic Dermatitis ◽  
Skin Penetration ◽  
Data Sources ◽  
Cell Mediated Immunity ◽  
Efficacy And Safety ◽  
Data Synthesis ◽  
Topical Tacrolimus ◽  
Duration Of Therapy ◽  
Search Terms ◽  
Optimal Duration

OBJECTIVE: To review the efficacy of topical tacrolimus in the treatment of atopic dermatitis (AD). DATA SOURCES: Searches of MEDLINE (1966–October 2000), International Pharmaceutical Abstracts (1970–October 2000), and ScienceDirect (1994–October 2000) were performed using the key search terms tacrolimus, FK506, and atopic dermatitis. DATA SYNTHESIS: Since patients with AD have defects in cell-mediated immunity, the immunosuppressant properties of the macrolides (cyclosporine and tacrolimus) may prove to be beneficial in the treatment of AD. Topical tacrolimus has been frequently studied in the treatment of AD because it was found to have better skin penetration and higher potentency than topically applied cyclosporine. Studies evaluating the use of topical tacrolimus are presented and provide evidence that topical tacrolimus is effective in the treatment of AD with no evidence thus far of systemic adverse effects. CONCLUSIONS: There is a fair amount of documentation of the efficacy and safety of topical tacrolimus. Further trials are needed to determine the optimal duration of therapy and its efficacy and safety in children less than seven years of age.

scholarly journals Fish mislabelling in France: substitution rates and retail types

2014 ◽  
Author(s):  
Julien Bénard-Capelle ◽  
Victoire Guillonneau ◽  
Claire Nouvian ◽  
Nicolas Fournier ◽  
Karine Le Loët ◽  
...  
Keyword(s):  
Natural Resources ◽  
Sample Size ◽  
Citizen Science ◽  
Substitution Rate ◽  
Small Sample Size ◽  
Bluefin Tuna ◽  
Small Sample ◽  
The Other ◽  
Species Substitution ◽  
Scientific Expertise

The development of citizen science has brought together scientific expertise and volunteer involvement to answer both scientific and societal questions. In this study, a consortium of citizens, journalist, scientists and non governmental organisations reports the first measure of the market-wide rate of fish mislabelling in France.We collected in fishmonger shops, supermarkets and restaurants and sequenced 390 samples of fish either in fillets or prepared meals, which is the largest dataset assembled to date in an European country.The overall substitution rate is one of the lowest observed for comparable surveys with large sampling in Europe. Remarkably, we detected no case of species mislabelling among the frozen fillets or in industrially prepared meals. We also investigated most of the mislabelling cases detected directly from the sellers. A number of them admitted that the substitution took place at the end of the supply chain.The rate of mislabelling does not differ between species (3.7 %, ci 2.2-6.4%), except for bluefin tuna. Despite a very small sample size (n=6), this species stands in sharp contrast with the low substitution rate observed for the other species (rate between 36 and 99%). This study shows that even in countries where species substitution rate is low, citizen science can enhance the management of natural resources and provide important insights for regulation policies.

scholarly journals 1537. Multicenter Study with Therapeutic Drug Monitoring (TDM) of Voriconazole (VRCZ) in Japanese Patients

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S560-S560
Author(s):  
Takashi Ueda ◽  
Yoshio Takesue ◽  
Yukihiro Hamada ◽  
Keiko Fukunaga ◽  
Kazuhiro Ikegame ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Japanese Patients ◽  
Small Sample ◽  
Therapeutic Drug ◽  
Optimal Timing ◽  
Loading Dose ◽  
Visual Symptoms ◽  
Low Performance ◽  
Adequate Dosage ◽  
Asian People

Abstract Background TDM of VRCZ might be useful, especially in Asian people because of CYP2C19 genetic polymorphisms. However, limited data are available because of the small sample size. Methods Patients who received VRCZ and had TDM were reviewed retrospectively at five institutions. Adequate VRCZ dosage was defined as a loading dose of 5–6 ± 0.5 mg/kg twice daily followed by a maintenance dose of 3–4 ± 0.5 mg/kg twice daily. For prophylaxis, the loading dose was left to the physician’s discretion. Optimal timing of TDM was defined as 4–7 days after starting therapy. Patients with adequate dosing and optimal timing of TDM were evaluated for analysis of trough levels (Cmin). Target Cmin was set at 1–5 µg/mL. Results The study included 584 patients (treatment: 402; prophylaxis: 182). TDM was conducted on days 4–7 in 66.5% of patients (>7, 30.2%). A low adequate dosage (44.5%) was observed for treatment mainly because of a low performance of the loading dose (46.8%). Achievement of target Cmin was obtained in 62.7% (>5 µg/mL, 32.2%) in the treatment group and in 67.6% (11.0%) in the prophylaxis group. Seventy-one of 81 (81.7%) patients who required a dose reduction reached target Cmin by the second TDM. In 38 patients whose dose was not altered at oral switching, Cmin was significantly reduced from 2.5 ± 1.6 to 1.2 ± 1.3 μg/mL (P = 0.002), which indicated the necessity of TDM after oral switching. Hepatotoxicity occurred in 4.6% and visual symptoms in 7.9% of patients. Visual symptoms resolved without discontinuation of VRCZ in 73.9% of patients. Because of dosage adjustment based on TDM, high Cmin did not cause hepatotoxicity. However, the incidence of visual symptoms was significantly higher in patients with a high Cmin (12.7% vs. 5.4%, P = 0.002). Conclusion One-third of Japanese patients who underwent VRCZ treatment with a loading dose showed high Cmin. Occurrence of hepatotoxicity was prevented with alteration of dosage in these patients (AMED, JP18fk0108045). Disclosures All authors: No reported disclosures.

An open-label, multicenter, phase II study of ceritinib in patients with advanced ALK+ non-lung solid tumors and hematological malignancies (ASCEND-10).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3520-3520
Author(s):  
Victor Moreno ◽  
Tae Min Kim ◽  
Sun Young Rha ◽  
Federico Longo ◽  
Sith Sathornsumetee ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Solid Tumors ◽  
Hematological Malignancies ◽  
Small Sample Size ◽  
Stage Iv ◽  
Small Sample ◽  
Gamma Glutamyl Transferase ◽  
Efficacy And Safety ◽  
Open Label ◽  
Glutamyl Transferase

3520 Background: Prior studies have confirmed the efficacy and safety of ceritinib in patients (pts) with advanced ALK+ non-small cell lung cancer (Soria, et al, Lancet 2017; Shaw et al, Lancet Oncol 2017; Cho et al, JTO 2019). Ceritinib also demonstrated antitumor activity in pediatric pts with ALK+ inflammatory myofibroblastic tumor (IMT) and ALCL (Georger et al, ASCO 2015 [abstract#10005]). Long-term clinical benefits of ceritinib treatment were shown in pts with anaplastic large cell lymphoma (ALCL) (Richly et al, Blood 2015). The aim of the current study was to examine ceritinib efficacy and safety in pts with advanced ALK+ non-lung solid tumors and hematological malignancies. Methods: In this open-label, multi-arm, phase 2 (NCT02465528) trial, adult pts with ALK gene abnormalities who had received ≥1 prior systemic therapy were administered oral ceritinib 750 mg/day, under fasted conditions. Primary endpoint: investigator assessed disease control rate (DCR); secondary endpoints: investigator assessed overall response rate (ORR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and safety. Results: Overall, 22 pts (ALCL [n = 1], IMT [n = 4], glioblastoma multiforme [GBM, n = 12] and others [n = 5]) were enrolled; median (m) age: 52.5 years; male: 50%; Stage ≥IV: 95.4%. Key efficacy results are shown in the Table. mTTR in pts with confirmed complete response (CR) or partial response (PR) [n = 4] was 7.4 (range, 6–25) weeks. mDOR was not reached. mPFS (95% CI) was 2.6 (1.6, 3.7) weeks. Most common adverse events (AEs; ≥30%) were: diarrhea and nausea (59.1% each), vomiting (50.0%) and increased alanine aminotransferase (31.8%). Most common grade ≥3 AEs (≥10%): hyperglycemia (18.2%), increased gamma-glutamyl transferase, thrombocytopenia, and anemia (13.6% each). Clinical trial information: NCT02465528 . Conclusions: Ceritinib 750 mg/day under fasted conditions showed antitumor activity in pts with ALK+ ALCL and IMT; however, data interpretation is limited due to the small sample size. Safety findings were consistent with the known ceritinib safety profile. [Table: see text]

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