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At least 19 recordsLinked to original sources
PubMed2000

Interventions for nausea and vomiting in early pregnancy.

BACKGROUND: Nausea and vomiting are the most common symptoms experienced in early pregnancy, with nausea affecting between 70 and 85% of women. About half of pregnant women experience vomiting. OBJECTIVES: The objective of this review was to assess the effects of different methods of treating nausea and vomiting in early pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. SELECTION CRITERIA: Randomised trials of any treatment for nausea and/or vomiting in early pregnancy. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. MAIN RESULTS: Twenty trials were included. These trials were of variable quality. Nausea treatments were different anti-histamine medications, vitamin B6 (pyridoxine), the combination tablet Debendox (Bendectin) and P6 acupressure. For hyperemesis gravidarum two trials were identified using treatments with ginger root and ACTH (adrenocorticotropic hormone) injections. Based on 13 trials, there was an overall reduction in nausea from anti-emetic medication (odds ratio 0.17, 95% confidence interval 0. 13 to 0.21). REVIEWER'S CONCLUSIONS: Anti-emetic medication appears to reduce the frequency of nausea in early pregnancy. There is some evidence of adverse effects, but there is very little information on effects on fetal outcomes. Of newer treatments, pyridoxine (vitamin B6) appears to be more effective in reducing the severity of nausea. The results from trials of P6 acupressure are equivocal. The results of the trial using adrenocorticotropic hormone to treat hyperemesis gravidarum show no evidence of benefit. Ginger may be of benefit, but the evidence so far is weak.

Antiemetics↗
PubMed1997

A new nausea model in humans produces mild nausea without electrogastrogram and vasopressin changes.

UNLABELLED: The standard human vection model utilized for nausea has been an optokinetic drum. This model may be difficult to extrapolate to the usual clinical setting. Our goals were to develop an experimental model which could induce low grade nausea in humans and to determine the relationship between mild nausea and changes in the electrogastrogram and plasma vasopressin concentrations. METHODS: Twenty-one volunteers (11 males, mean age: 37 years) participated. At baseline and throughout the study the electrogastrogram was monitored, blood was drawn for vasopressin assay and symptoms of nausea, dizziness and headache were rated on a 0-10-point scale. Subjects were semireclined in a darkened room while viewing moving bars of light rotating at a rate of 85 degrees s-1. Subjects were asked to rate their proneness to motion sickness and their current level of anxiety at baseline. RESULTS: Eight subjects developed mild to moderate (mean: 3.6) nausea during vection. Symptoms of nausea were correlated with a reported history of motion sickness (r = 0.49, P < 0.05) but not with anxiety (r = 0.14, P = 0.54). Degrees of nausea correlated with degrees of dizziness (r = 0.47, P < 0.05) but not with headache (r = 0.29, P = 0.14). Subjects who developed mild nausea were not significantly more likely to exhibit altered electrogastrogram or vasopressin than subjects who did not report nausea. Vasopressin levels during baseline and experimental conditions were highly correlated (r = 0.66, P < 0.005 and r = 0.55 P < 0.005, respectively) with reported baseline anxiety. CONCLUSIONS: (1) This new model in humans induced mild nausea that was unrelated to electrogastrogram and vasopressin abnormalities, (2) high correlation between anxiety and vasopressin suggests that vasopressin may not be directly related to nausea, and (3) these data indicate that onset of nausea mediated centrally can occur without associated electrogastrogram changes.

Adult↗
PubMed1996

Assessment of the multiple dimensions of nausea: the Nausea Profile (NP).

Nausea, unlike emesis, is a subjective experience that is difficult to describe to others, be they clinicians or researchers. Previous research has been limited to examining the frequency, severity, and duration of nausea. The goal of this study was to design a questionnaire that would allow for the evaluation of the characteristics of nausea across individuals and situations. This study consisted of 4 stages: descriptors were generated, categorized into 3 dimensions, and reevaluated to verify their reliability; in the final stage, the developed checklist was compared to a visual-analogue-scale (VAS) report of nausea in subjects exposed to a rotating optokinetic drum to stimulate nausea. The overall nausea checklist score and the VAS score were highly correlated (r = 0.71, p < 0.01). The development and use of the nausea checklist are discussed.

Adult↗
PubMed1988

Defining anticipatory nausea and vomiting: differences among cancer chemotherapy patients who report pretreatment nausea.

It is important to distinguish patients whose reports of pretreatment nausea and vomiting reflect classically conditioned anticipatory nausea and vomiting (ANV) from those whose reports reflect the influence of other pharmacological and psychological factors. Therefore, Andrykowski (J. Behav. Med. 9: 33-41, 1986) has suggested that only patients who report pretreatment nausea on Day 1 of a chemotherapy cycle be considered to have developed ANV. As part of a prospective, longitudinal investigation of side effects associated with cancer chemotherapy, three groups of patients were identified: those who (a) never reported pretreatment nausea (noPTN), (b) reported pretreatment nausea but never prior to a Day 1 infusion (PTN), and (c) reported pretreatment nausea prior to a Day 1 infusion (PTND1). Discriminant analysis revealed that the PTN and noPTN groups did not differ, while both differed from the PTND1 group, particularly with respect to factors presumed to facilitate classical conditioning. The results justify excluding PTN patients from the criterion group of patients considered to have developed ANV.

Adult↗
PubMed2002

Motherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy.

OBJECTIVE: The morbidity of nausea and vomiting of pregnancy varies substantially. In addition to the physical symptoms, the emotional and psychosocial stress must be considered. The method available today to measure the severity of nausea and vomiting of pregnancy stems from chemotherapy-induced symptoms and is too complicated to use clinically. We sought to establish a simple and clinically relevant method for evaluation of the severity of nausea and vomiting of pregnancy that can be used for both clinical practice and research. METHODS: Women with nausea and vomiting of pregnancy were scored by use of the "gold standard" Rhodes' score, which includes 8 items. The Rhodes' score was compared with several short versions of 3 to 4 items. Patients were subsequently followed up a week later to monitor changes in scores. Changes in the Rhodes' scores were correlated with changes in the simplified scores. RESULTS: There was a very tight correlation between the Rhodes' score and the new pregnancy-unique quantification of emesis and nausea (PUQE) scoring system, which was based on the 3 items that included the number of daily vomiting episodes, the length of nausea per day in hours, and the number of retching episodes (r = 0.904; P <.0001). The distribution of severity of cases (between none, mild, moderate, and severe) did not differ between the Rhodes' and the PUQE. Comparing the changes in Rhodes' scores after a week of follow-up versus changes in the new PUQE score, there was a very high agreement (r = 0.95;P <.0001). CONCLUSION: The new PUQE score yields similar results to the gold standard, but more cumbersome, Rhode's score. Clinicians and researchers can easily use PUQE.

Female↗
PubMed2000

Nausea and vomiting remain a significant clinical problem: trends over time in controlling chemotherapy-induced nausea and vomiting in 1413 patients treated in community clinical practices.

Data from 1413 outpatients in community-based clinical practices were collected in order to characterize the use and effectiveness of 5-HT(3) receptor antagonists for control of chemotherapy-induced nausea and vomiting (NV). Patients were divided by treatment starting date into six cohorts for trend analysis. In addition, NV symptoms were compared in 252 patients treated prior to the commercial introduction of the 5-HT(3) receptor antagonist antiemetics, and an equal number of patients treated after their introduction. A comparison of cohorts revealed a significant (P = 0. 027) downward trend over time for the frequency of post-treatment vomiting episodes, but not for frequency of post-treatment nausea (P = 0.69). The average duration of nausea following treatment increased significantly over time (P = 0.003). Although the introduction of 5-HT(3) receptor antagonist antiemetics has apparently led to a significant reduction in the frequency of post-treatment vomiting, there has been an accompanying increase in the duration of post-treatment nausea.

Adolescent↗
PubMed1999

The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting.

PURPOSE/OBJECTIVES: To determine the reliability of the Index of Nausea, Vomiting, and Retching (INVR), a new format of the Rhodes Index of Nausea and Vomiting Form 2 (INV-2). DESIGN AND SETTING: A parallel form study was conducted at a large, Midwestern teaching hospital and a cancer center. SAMPLE: Convenience sample of 159 subjects: 40 obstetrical, 60 oncological, 59 medical/surgical. METHODS: Two instruments, the INVR and the INV-2, were administered approximately 30-60 minutes apart. One-half of the subjects completed the INVR first, and the other half completed the INV-2 first. MAIN OUTCOME MEASURES: Equivalency measures of reliability correlation coefficients for both instruments. FINDINGS: A high rate of agreement was found in the responses between the two forms. In cases of clear disagreement, the responses to the INVR were more frequently consistent than the responses to the original form. CONCLUSIONS: INVR has tested reliability and is more user friendly for the patient and the healthcare provider. IMPLICATIONS FOR NURSING PRACTICE: Nurses have a focal role in managing symptoms. Managing nausea, vomiting, and retching requires excellent assessment skills of the patient's personal symptom experience and knowledge of pharmacology. Efficient, cost-saving assessments require accurate self-report instruments that permit patients to quantify their symptom experiences. The INVR can provide a scientific base from which to prescribe and teach patients and may improve their quality of life. Reliable and valid self-reporting instruments are essential for managing these adverse symptoms.

Adolescent↗
PubMed1990

[Nausea in cancer patients. An analysis of its frequency and an evaluation of the treatment of nausea].

Frequency of nausea was investigated during the last six months of life of 342 patients who died from cancer in 1987. 44% received antiemetic treatment, but only 2% obtained complete relief. There was a close connection between opiate treatment, cytostatic treatment and nausea. The highest frequency of nausea was found among patients with gastrointestinal and ovarian cancer, whilst the lowest frequency was found in the prostate cancer group. We discuss antiemetic treatments in this connection.

Antiemetics↗
PubMed1998

Patients' pretreatment expectations of chemotherapy-related nausea are an independent predictor of anticipatory nausea.

Based on extensive research with animals, classical conditioning theorists have come to regard contingency as the primary factor in the development of conditioned responses. However, recent experimental work with humans has suggested the possibility that participant expectations may also directly contribute to the development of conditioned responses. To date, this phenomenon has not been investigated in clinical settings. Anticipatory nausea (AN) in chemotherapy patients, widely viewed as the best established example of classical conditioning in clinical medicine, provides an opportunity to examine the contributions of patient expectations to the development of a conditioned response outside the laboratory. The present study of 59 breast cancer patients supported the hypothesis that pretreatment patient expectations make a significant (p < .03) contribution to the development of AN after statistically controlling for the strongest conditioning predictor, contingency. These data imply that patient expectations should be considered when evaluating conditioned responses to aversive medical treatments.

Adult↗
PubMed2002

[Dexamethasone enhances the effect of tropisetron and ondansetron against nausea and vomiting against nausea and vomiting after patient-controlled analgesia].

OBJECTIVE: To study the enhancement by dexamethasone of the effect of ondansetron and tropiesetron against postoperative nausea and vomiting (PONV) in patients receiving patient-controlled analgesia (PCA) and observe the effect of dexamethasone on wound healing. METHODS: One hundred and twenty elective surgical patients receiving PCA were divided into 4 groups, including 2 control groups with the prescription of ondansetron (8 mg) and tropiesetron (3 mg) respectively (control A and B) and 2 observation groups in which the patients were given ondansetron (8 mg) plus dexamethasone (10 mg) and tropiesetron (3 mg) plus dexamethasone (10 mg) respectively (observation groups C and D). The incidence and severity of PONV was observed at 4, 8, 2, 24 h and 2, 3 d postoperatively, and the time and grade of healing of the wound evaluated. RESULTS: Significant difference in PONV between group A and group B was observed (P<0.01), and in the observation groups, PONV was markedly reduced compared with the control groups (C vs A, P<0.01; D vs B, P<0.05). In light of the time and grade of wound healing, the observation groups differed little from the control groups. CONCLUSION: Dexamethasone (10 mg) can greatly enhance the effect of ondansetron and tropiesetron against PONV in patients receiving PCA without interfering the healing of the wound.

Analgesia, Patient-Controlled↗
PubMed2004

Incidence and duration of antidepressant-induced nausea: duloxetine compared with paroxetine and fluoxetine.

OBJECTIVE: This analysis assessed the incidence, severity, onset, and duration of nausea among patients with major depressive disorder (MDD) treated with the new antidepressant duloxetine. METHODS: Data were pooled from 8 double-blind, randomized, placebo- and active comparator-controlled trials employing patients with MDD that were submitted to the US Food and Drug Administration to support duloxetine's new drug application for treatment of MDD. RESULTS: The numbers of patients receiving each regimen were as follows: placebo, n = 777; duloxetine 40 mg/d, n = 177; duloxetine 60 mg/d, n = 251; duloxetine 80 mg/d, n = 363; duloxetine 120 mg/d, n = 348; paroxetine 20 mg/d, n = 359; and fluoxetine 20 mg/d, n = 70. In acute placebo-controlled trials of duloxetine 40 to 120 mg/d, treatment-emergent nausea was reported by more duloxetine-treated patients than those receiving placebo (19.9% [227/1139] vs 6.9% [154/777], respectively; P <0.001). Among duloxetine-treated patients, the median time to onset of nausea was 1 day, and the median duration of nausea was 7 days. The incidence of nausea was similar to placebo rates after 1 week. In paroxetine-controlled studies, the incidence of treatment-emergent nausea in patients receiving duloxetine did not differ significantly from paroxetine (14.4% vs 12.0%, respectively). In head-to-head studies, the incidence of treatment-emergent nausea with duloxetine did not differ significantly from that with fluoxetine (17.1% vs 15.7%, respectively). Most duloxetine-treated patients reported nausea to be mild (52.9%) or moderate (41.4%). Treatment discontinuation secondary to nausea occurred in more duloxetine-treated patients than those receiving placebo (1.4% [16/1139] vs 0.1% [1/777], respectively; P = 0.002). Following abrupt discontinuation after acute treatment, 5.9% of duloxetine-treated patients exhibited nausea compared with 0.3% of patients receiving placebo (P < 0.001). The incidence of treatment-emergent nausea during 6-month continuation of duloxetine treatment (80 mg/d, 2.1%; 120 mg/d, 1.3%) was similar to placebo (1.6%). Following abrupt discontinuation after 8 months of treatment, nausea was reported by 1.6% of patients receiving duloxetine 120 mg/d compared with 0% for those receiving duloxetine 80 mg/d and 0% for placebo. CONCLUSIONS: Duloxetine induced mild to moderate nausea in a subset of patients with MDD during treatment initiation. Nausea resolved rapidly with continued treatment. The incidence of duloxetine-induced nausea resembled that produced by paroxetine and fluoxetine.

Adolescent↗
PubMed2006

Esomeprazole for the prevention of postoperative nausea and vomiting. A randomized, placebo-controlled trial.

BACKGROUND: Postoperative nausea and vomiting still represents a major problem after surgery. Although risk factors for postoperative nausea and vomiting and procedures to reduce postoperative nausea and vomiting have been described, the incidence of postoperative nausea and vomiting remains high. The aim of the present study was to investigate the potential role of the proton pump inhibitor esomeprazole to reduce postoperative nausea and vomiting after elective surgery. METHODS: In a randomized, double-blind trial, ASA I-III patients at high risk for postoperative nausea and vomiting received esomeprazole tablets 3 x 40 mg or matching placebo the evening before surgery, 2 h preoperatively and 24 h postoperatively. Total intravenous anaesthesia with propofol and remifentanil without nitrous oxide (FiO2 0.5) was used. Patients were interviewed using a standardized postoperative nausea and vomiting questionnaire at discharge from the post-anaesthesia care unit, 6 h and 24 h later. The severity of nausea was estimated on a 0-100 point numerical scale (0 = no nausea, 100 = maximum nausea). RESULTS: The incidence of vomiting was similar in the esomeprazole (n = 45) and the placebo (n = 48) groups (64.4% vs. 60.5%, P > 0.05). The average nausea score was 17.8 with esomeprazole and was 18.7 with placebo (P > 0.05). Only 24.7% of all patients (esomeprazole 24.4%, placebo 25.0%) did not experience any nausea or vomiting. CONCLUSION: There is no evidence that prophylactic esomeprazole reduces the incidence of postoperative nausea and vomiting or the degree of postoperative nausea.

Adult↗
PubMed2002

Olfactory modulation of nausea during early pregnancy?

OBJECTIVES: To investigate whether nausea and vomiting and olfactory sensitivity are correlated, we determined whether subjects with little or no nausea and vomiting are less sensitive to odours than subjects who indicate a high degree of nausea and vomiting, and whether subjects with relatively low olfactory sensitivity are less prone to nausea and vomiting than subjects with relatively higher olfactory sensitivity. DESIGN: Cross sectional study. SETTING: The Unit of Perinatal Physiology, Department of Obstetrics, University Hospital, Zurich, Switzerland. POPULATION: Fifty-three women in early pregnancy. METHODS: Following a detailed history related to olfaction and nausea and vomiting, subjects filled in a nausea profile which provided a 'general nausea score' comprised of the factors 'somatic distress', 'gastrointestinal distress', and 'emotional distress'. Olfactory function was assessed using pen-like odour dispensing devices ('sniffin' sticks'). Tests included n-butanol odour threshold, odour discrimination and odour identification. MAIN OUTCOME MEASURES: Olfactory function assessed by means of the sniffing sticks nausea profile. RESULTS: Correlational analyses between results of olfactory sensitivity and scores from the nausea questionnaire were not significant. Further, when subjects were divided into groups with relatively low or relatively high overall scores in the nausea profile, olfactory sensitivity did not differ between groups. Similarly, other analyses did not indicate a modulation of nausea and vomiting through olfactory sensitivity. CONCLUSIONS: These findings do not support the hypothesis that higher olfactory sensitivity relates to an increase of nausea. However, they do support the idea that olfactory-induced nausea is independent of subjectively perceived intensity. Olfactory-induced nausea appears to be due to the cognitive processing of olfactory information which, in early pregnancy, is reported to be altered in an unsystematic fashion.

Adolescent↗
PubMed2006

[Risk factors and frequency of postoperative nausea and vomiting in patients operated under general anesthesia].

INTRODUCTION: Postoperative nausea and vomiting belong to fairly frequent postoperative complications, but they occupy a distant position on the list of complications, which most probably result from a general conviction that they do not pose a direct threat to patients. OBJECTIVE: The objective of this work is specification of factors facilitating occurrence of postoperative nausea and vomiting, and determination of frequency of their occurrence in patients operated under general anesthesia. MATERIAL AND METHODS: Questionnaire about the occurrence of postoperative nausea and vomiting (PONV), was carried out and included 253 adult sick persons (102 female and 151 male patients), in the age between 23-76 (average 42.3 +/- 6.1 years), who had undergone operative procedure in the field of abdominal and urology surgery, orthopedic, thyroid surgery and laryngological, ophthalmology and plastic surgery, under general anesthesia. The questionnaire form included preoperative characteristics of a patient (age, sex, smoking, motion sickness and migraine headaches in history, and PONV occurring earlier), type of operative procedure, used anesthetic agents, and analgesic agents applied in postoperative analgesia. The anesthesiologist administering anesthetic was not informed about the investigation carried out and did not receive any additional pieces of advice regarding the type of applied anesthetic agents or the method of conducting postoperative analgesia. Visual Analogue Scale (VAS) was used in the evaluation of nausea. Nausea and vomiting were assessed every two hours within the first postoperative 12 hours and every 4 hours for the next 24 hours. Nausea and vomiting were treated as two separate complications. RESULTS: Nausea itself occurred in 22.7% of patients; whereas vomiting in 13.2%. Both symptoms occurred in 14.2% of patients. Nausea occurred 4.1 +/- 0.8 hours after operation; whereas vomiting after 5.3 +/- 1.1 hours. Women suffered more often than men from (R = 0.678 p < 0.001). The same was registered for non-smokers (nausea: R = 0.623, vomiting: R = 0.437), and for the patients suffering from PONV earlier (R = 0.421 for nausea, and R=0.331 for vomiting). PONV also occurred more often in cases of obese patients (p < 0.002) and the patients anesthetized by younger anesthetists (p < 0.002). Clear relation between the frequency of postoperative nausea and vomiting occurrence and the type of operative procedure was also noticed. The relation appeared to be the strongest (R = 0.531; p < 0.001) in case of the sick who underwent abdominal and laryngological procedures (R= 0.421; p < 0.02), as well as ophthalmologic (R= 0.407; p < 0.02) procedures. However, the relation was the weakest in case of the sick who underwent orthopedic procedures (R =0.127; p < 0.02). The correlation between anesthesia induction agents and frequency of PONV was not observed. PONV was significantly more frequent in case of the sick receiving postoperative opioids than those who received nonsteroid anti-inflammatory drugs. CONCLUSIONS: (1) PONV is more frequent in women than in men. The same refers to non-smokers, suffering from migraine headaches, motion sickness, as well as obesity and suffering from PONV earlier. (2) The frequency of postoperative vomiting in the patients with nausea is higher by 65.2% than in the patients without nausea. (3) A clear relation between the frequency of postoperative nausea and vomiting occurrence and the type of operative procedure was noticed. It was the strongest in the sick who underwent orthopedic procedures. (4) The correlation between anesthesia induction agents and PONV was not observed.

Adult↗
PubMed2004

Patient expectation is a strong predictor of severe nausea after chemotherapy: a University of Rochester Community Clinical Oncology Program study of patients with breast carcinoma.

BACKGROUND: Patients may use their past experiences with nausea, as well as information about the incidence of nausea from chemotherapy that other patients have experienced, to form a prediction, or response expectancy, of nausea from their own upcoming chemotherapy. Mounting evidence suggests that these expectancies relating to nausea are significant predictors, and, likely, contributing factors to the development of treatment-related nausea. METHODS: The patients in the current study were participants in the control arm of a multicenter clinical trial conducted between November 1999 and July 2001 by the University of Rochester Community Clinical Oncology Program. All patients in the current report were age >/= 18 years and were about to begin a first cancer treatment regimen containing doxorubicin. RESULTS: Expectancy of nausea assessed before patients received their first doxorubicin-based chemotherapy treatment was found to be a strong predictor of subsequent nausea and in fact was stronger than previously reported predictive factors, including age, nausea during pregnancy, and susceptibility to motion sickness. Women who believed it was "very likely" that they would have severe nausea from chemotherapy were five times more likely to experience severe nausea than fellow patients who thought its occurrence would be "very unlikely." CONCLUSIONS: Further studies confirming an expectancy of nausea as a risk factor are warranted as are studies examining the benefit to a patient's quality of life from modifying antiemetic treatment guidelines to take into account symptom expectancies. Finally, ethically acceptable interventions that are designed to reduce patients' nausea expectancies or increase their expectancies of nausea control should be developed and studied.

Adolescent↗
PubMed2006

Post hoc comparison of daily rates of nausea and vomiting with once- and twice-daily galantamine from a double-blind, placebo-controlled, parallel-group, 6-month study.

BACKGROUND: A once-daily extended-release galantamine(GAL-ER) formulation has been designed to improve tolerability compared with twice-daily immediate-release galantamine (GAL-IR). OBJECTIVE: The aim of this study was to conduct a post hoc analysis of the clinical presentation of nausea and vomiting with GAL-ER compared with GAL-IR in subjects with mild to moderate Alzheimer's disease (AD). METHODS: This is the report of a post hoc analysis of a large, randomized, double-blind, placebo-controlled, multicenter trial of GAL-ER with GAL-IR as the active control in subjects with mild to moderate AD. Galantamine dose was titrated every 4 weeks by increments of 8 mg/d to a daily dose of 16 or 24 mg, based on tolerability. Daily rates of nausea and vomiting were compared for the GAL-ER and GAL-IR groups. AUCs of the daily percentage of subjects reporting nausea/vomiting during dose titration were calculated. Antiemetic use for nausea/vomiting was compared between GAL-ER and GAL-IR groups. RESULTS: Demographic characteristics were similar between the GAL-ER, GAL-IR, and placebo groups. Nausea was reported by 16.9% (54/319) of GAL-ER, 13.8% (45/326) of GAL-IR, and 5.0% (16/320) of placebo patients; vomiting was reported for 6.6% (21/319) of GAL-ER, 8.6% (28/326) of GAL-IR, and 2.2% (7/320) of placebo patients. The mean (SD) daily rate of nausea in the total population was 3.1 (13.43%) in the GAL-ER group and 5.2% (22.07%) in the GAL-IR group (P = NS); the mean (SD) daily rate of vomiting for the total population was 0.6% (4.14%) in the GAL-ER group and 1.6% (14.50%) in the GAL-IR group (P = NS). The mean (SD) daily rate of nausea or vomiting in the total population was 1.2 (8.46) and 0.4 (5.44) in the placebo group, respectively. For subjects reporting nausea, the mean (SD, SE) percentage of days with nausea was lower with GAL-ER than with GAL-IR (18.4% [28.22%, 5.31%] vs 38.0% [48.23%, 6.04%]; P = 0.014). AUC of the daily percentage of subjects reporting nausea/vomiting during dose titration was significantly higher in the GAL-IR group compared with the placebo group (320.9 vs 102.9; P = 0.01); there was no statistical difference between the GAL-ER group and placebo (171.1 vs 102.9; P = NS). Antiemetic use by subjects reporting nausea or vomiting was significantly lower in the GAL-ER group than the GAL-IR group (33.3% vs 53.4%; P = 0.028). CONCLUSIONS: In these subjects with AD, the daily percentage of subjects reporting nausea and vomiting, and the percentage of days with vomiting among subjects reporting vomiting, did not significantly differ between the GAL-ER and GAL-IR groups. However, GAL-ER was associated with a significantly lower percentage of days with nausea than GAL-IR among subjects reporting nausea. AUC of the daily percentage of subjects with nausea or vomiting during dose titration did not differ significantly between the GAL-ER and placebo groups but was significantly higher in the GAL-IR group than placebo. Subjects with nausea or vomiting who received GAL-ER reported significantly less antiemetic use than those treated with GAL-IR. These results suggest the need for additional studies to explore the potential differences in the tolerability of these formulations.

Aged↗