Loss of Appetite in Adult Patients: Effectiveness and Safety of an Appetite Stimulating Medication in an Open-Label, Investigator-Initiated Study in India

Loss of appetite (LOA) may have a negative impact on a patient’s well-being owing to loss of nutrition and associated conditions. The current study assessed the effects of an appetite-stimulating medication containing multivitamins, lysine, and zinc in Indian patients with a history of LOA. Using an investigator-initiated, single-center, open-label, single-arm design, we evaluated the effectiveness and safety of the appetite-stimulating medication (15 mL) in 50 male or female patients (18–55 years old) attending the outpatient department, with a confirmed diagnosis of LOA after two weeks of therapy and assessed the change in Council on Nutrition Appetite Questionnaire (CNAQ) score and safety of the medication after two weeks of treatment. CNAQ scores were presented as mean (standard deviation (SD)). The mean age of patients was 42.1 years, with the majority (66%) being males. At weeks 1 and 2, a statistically significant improvement was observed in the mean CNAQ scores of 25.48 (5.10) and 25.48 (4.29), respectively, vs. baseline (22.08 (2.76); P ≤ 0.0001 both). Majority of the patients had CNAQ appetite scores of 17–28 at baseline (94%), week 1 (66%), and week 2 (78%) of treatment. For patients with acute and chronic illness, a statistically significant improvement was observed in the mean CNAQ score at week 1 (26.75 (3.69), P = 0.0256; 25.24 (5.33), P = 0.0004) and at week 2 (26.63 (3.46), P = 0.0027; 25.26 (4.43), P ≤ 0.0001) from baseline (21.88 (3.31) and 22.12 (2.69), respectively). No serious adverse events were reported during the study. The study findings suggest that appetite-stimulating medication containing multivitamins, lysine, and zinc could be a suitable treatment option for the management of LOA with no significant safety concerns.

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Subjective Well-Being in Non-Obese Individuals in View of Abdominal Fat Distribution and Muscle Mass Index: A General Population Study.

10.21203/rs.3.rs-482840/v1 ◽

2021 ◽

Author(s):

Małgorzata Chlabicz ◽

Marlena Paniczko ◽

Jacek Jamiołkowski ◽

Paweł Sowa ◽

Małgorzata Szpakowicz ◽

...

Keyword(s):

Body Composition ◽

General Population ◽

Muscle Mass ◽

Negative Impact ◽

Fat Distribution ◽

Well Being ◽

Abdominal Fat ◽

Satisfaction With Life Scale ◽

The Mean ◽

Eq Vas

Abstract Background While obesity has been correlated with welfare in the general population, there is not much data on the influence of body composition on welfare among the non-obese adult individuals. Methods A longitudinal, population-based study was conducted in 2017–2020. Body composition was assessed using Dual Energy X-ray Absorptiometry. Welfare was rated with Satisfaction with Life Scale (SWLS), Euro Quality of Life Visual Analogue Scale (EQ-VAS) and Beck Depression Inventory (BDI). Results A total of 726 non-obese individuals from general population were analyzed. The mean age was 46.8 ± 15.4 years and 42.1% of participants were male. The mean value for SWLS was 23.09 ± 5.43, for EQ-VAS was 78.0 ± 14.5, and for BDI was 6.7 ± 6.6. On SWLS the waist-hip ratio had a negative impact even after adjustment for age, gender and concomitant diseases. EQ-VAS was inversely associated with android fat distribution and directly associated with muscle mass. BDI value was inversely associated with lower muscle mass, especially of the lower limbs. The well-being of women was mainly associated with the distribution of adipose tissue and less with the distribution of muscle tissue - abdominal fat distribution has a particularly negative impact on well-being among women. In contrast, men's well-being depends more on muscle mass and to a lesser extent on the distribution of fat tissue - a positive significant effect has lean mass and a circumference of thigh below gluteal fold. Conclusions Body composition is significantly associated with welfare in non-obese population. Android type fat distribution may have a negative impact while muscle mass positive.

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Effect of Patiromer in Hyperkalemic Patients Taking and Not Taking RAAS Inhibitors

Journal of Cardiovascular Pharmacology and Therapeutics ◽

10.1177/1074248418788334 ◽

2018 ◽

Vol 23 (6) ◽

pp. 524-531 ◽

Cited By ~ 5

Author(s):

Robert A. Kloner ◽

Coleman Gross ◽

Jinwei Yuan ◽

Ansgar Conrad ◽

Pablo E. Pergola

Keyword(s):

Adverse Events ◽

Serum Potassium ◽

Common Adverse Event ◽

Open Label ◽

Serious Adverse Events ◽

End Point ◽

The Mean ◽

Baseline Characteristics ◽

Raas Inhibitors ◽

Post Hoc

Introduction: Hyperkalemia (potassium >5.0 mEq/L) affects heart failure patients with renal disease regardless of the use of renin–angiotensin–aldosterone system inhibitors (RAASi). The open-label TOURMALINE study showed that patiromer, a sodium-free, nonabsorbed potassium binder, lowers serum potassium of hyperkalemic patients similarly when given with or without food; unlike prior studies, patients were not required to be taking RAASi. We conducted post hoc analyses to provide the first report of patiromer in patients not taking RAASi. Methods: Hyperkalemic patients received patiromer, 8.4 g/d to start, adjusted to achieve and maintain serum potassium of 3.8 to 5.0 mEq/L. If taking RAASi, stable doses were required. The primary end point was the proportion of patients with serum potassium 3.8 to 5.0 mEq/L at week 3 or 4. This analysis presents data by patients taking or not taking RAASi. Results: Demographics and baseline characteristics were similar in patients taking (n = 67) and not taking RAASi (n = 45). Baseline mean (SD) serum potassium was 5.37 (0.37) mEq/L and 5.42 (0.43) mEq/L in patients taking and not taking RAASi, respectively. Mean (SD) daily patiromer doses were similar (10.7 [3.2] and 11.5 [4.0] g, respectively). The primary end point was achieved in 85% (95% confidence interval [CI]: 74-93) of patients taking RAASi and in 84% (95% CI: 71-94) of patients not taking RAASi. From baseline to week 4, the mean (SE) change in serum potassium was −0.67 (0.08) mEq/L in patients taking RAASi and −0.56 (0.10) mEq/L in patients not taking RAASi (both P < .0001 vs baseline, P = nonsignificant between groups). Adverse events were reported in 26 (39%) patients taking RAASi and 25 (54%) not taking RAASi; the most common adverse event was diarrhea (2% and 11%, respectively; no cases were severe). Five patients (2 taking RAASi) reported 6 serious adverse events; none considered related to patiromer. Conclusions: Patiromer was effective and generally well-tolerated for hyperkalemia treatment, whether or not patients were taking RAAS inhibitors.

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NE-180, a Novel glycoPEGylated Erythropoietin Demonstrates Dose-Dependent Activity in a Phase 1 Single Dose, Dose Escalating Study in Normal Human Volunteers (NHV).

Blood ◽

10.1182/blood.v108.11.1149.1149 ◽

2006 ◽

Vol 108 (11) ◽

pp. 1149-1149

Author(s):

Bruce A. Wallin ◽

Denise Ramjit ◽

Michael Seiberling ◽

David Zopf

Keyword(s):

Adverse Events ◽

Animal Studies ◽

Phase 1 ◽

Stopping Rules ◽

Open Label ◽

Serious Adverse Events ◽

Maximal Increase ◽

The Mean ◽

Dose Dependent

Abstract NE-180 is a glycoPEGylated recombinant human erythropoietin that binds to and activates the erythropoietin (EPO) receptor. It has demonstrated in vitro activities comparable to EPO and an extended serum half-life in animal studies. This may allow less frequent dosing in patients being treated with chronic anemia. METHODS: A single center, open-label study of NE-180, administered as single escalating doses given by the SC or IV route, was conducted to assess the safety, tolerability, PK and PD. Subjects (male or female NHV) were planned to be assigned to one of 4 dose groups, 10 subjects per dose with 5 SC and 5 IV subjects per group: 0.5, 1.5, 3, or 4.5 mg/kg. Each dose group was planned to be initiated in an ascending, sequential fashion unless or until stopping rules were met. RESULTS: 25 NHV (16 females) were enrolled in the first two dose cohorts and have completed 56 day follow-up. The 1.5 mg/kg IV cohort met the protocol-specified Hb rate of rise stopping rule (change in Hb greater than 1 g/dL during any 14 day period). Injections were generally well tolerated with no discontinuations for adverse events or serious adverse events. Reticulocyte increases were dose proportional. Average reticulocyte count at baseline was 1.0±0.3%. The maximal increase occurred at day 7. The mean change from baseline for the 0.5 and 1.5 mg/kg SC group was: 0.9±0.4% and 2.2±0.9%, respectively. The mean change from baseline for the 0.5 and 1.5 mg/kg IV group was: 1.7±0.8% and 2.3±0.8%, respectively. PK data will be presented. CONCLUSIONS: Single doses up to 1.5 mg/kg of NE-180 administered to NHV were generally well tolerated and demonstrated potent dose-dependent erythropoietic activity.

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Open-Label, Dose Escalation Study of the Safety and Pharmacokinetic Profile of Tefibazumab in Healthy Volunteers

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.49.3.959-962.2005 ◽

2005 ◽

Vol 49 (3) ◽

pp. 959-962 ◽

Cited By ~ 20

Author(s):

Sandra Reilley ◽

Eric Wenzel ◽

Laurie Reynolds ◽

Beth Bennett ◽

Joseph M. Patti ◽

...

Keyword(s):

Healthy Volunteers ◽

Dose Escalation ◽

Maximum Concentration ◽

Dose Range ◽

Plasma Concentrations ◽

Open Label ◽

Serious Adverse Events ◽

Dose Escalation Study ◽

Label Dose ◽

The Mean

ABSTRACT Tefibazumab (Aurexis) is a humanized monoclonal antibody being evaluated as adjunctive therapy for the treatment of Staphylococcus aureus infections. This open-label, dose escalation study evaluated the safety and pharmacokinetics of tefibazumab in 19 healthy volunteers aged 18 to 69 years. Each subject received a single administration of tefibazumab at a dose of 2, 5, 10, or 20 mg/kg of body weight infused over 15 min. Plasma samples for pharmacokinetic assessments were obtained before infusion as well as 1, 6, 12, and 24 h and 3, 4, 7, 21, 28, 42, and 56 days after dosing. Plasma concentrations of tefibazumab were detected 1 h after the end of the infusion, with a mean maximum concentration of drug in serum (C max) of 59, 127, 252, and 492 μg/ml following doses of 2, 5, 10, and 20 mg/kg, respectively. The median time to maximum concentration of drug in serum (T max) was 1.0 h for each dose. The mean elimination half-life (t 1/2) was approximately 22 days. The volume of distribution (V) was 4.7, 6.7, 7.2, and 7.2 liters after doses of 2, 5, 10, and 20 mg/kg, respectively. Clearance (CL) was 6.0, 9.2, 10.2, and 9.9 ml/hr, respectively. At the highest dose, plasma levels of tefibazumab were >100 μg/ml for 21 days. On day 56, the mean plasma concentrations were 6.3, 10.0, 16.4, and 30.5 μg/ml for the 2, 5, 10, and 20 mg/kg doses, respectively. Tefibazumab exhibited linear kinetics across doses of 5, 10, and 20 mg/kg. No anti-tefibazumab antibodies were detected after dosing in any subject. There were no serious adverse events, and tefibazumab was well tolerated over the entire dose range.

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Psychological and spiritual well-being aspects of the quality of life in colostomy patients

Vojnosanitetski pregled ◽

10.2298/vsp151118357r ◽

2018 ◽

Vol 75 (6) ◽

pp. 611-617

Author(s):

Gordana Repic ◽

Suncica Ivanovic ◽

Cedomirka Stanojevic ◽

Sanja Trgovcevic

Keyword(s):

Quality Of Life ◽

Negative Impact ◽

Age Groups ◽

Well Being ◽

Life Questionnaire ◽

Cross Sectional ◽

Psychological Well Being ◽

Spiritual Well Being ◽

The Mean

Background/Aim. Colorectal cancer and its treatment can have a negative impact on the quality of life which has become an important outcome measure for cancer patients. The aim of this work was assessment of psychological and spiritual dimension of the quality of life in colostomy patients, regarding the gender and age. Methods. This is a cross-sectional study conducted at the Abdominal Surgery Polyclinic in the Clinical Canter of Vojvodina among colostomy patients operated between January 2010 and June 2011. The instrument used in this study was Quality of Life Questionnaire for a Patient with an Ostomy (QOL-O). Results. Majority of respondents were male (M:F = 50.7% : 49.3%). The age ranged between 36?86 years. Respondents did not report difficulties in adjustment to stoma, but their great difficulty was to look at it and the sense of depression and anxiety. The care of stoma was worse perceived by younger respondents (p = 0.014). Respondents were mostly satisfied with their memorizing ability and having the sense of control. The lowest score was found in sensing satisfaction or enjoyment in life. The age had a significant impact on positive aspects of psychological well-being (p < 0.05). Higher scores were found among younger age groups. The mean score of spiritual well-being (6.47 ? 3.01) was lower than the mean score of psychological well-being (7.76 ? 2.35). There were no statistically significant differences regarding gender (t = -0.738, df = 65, p = 0.463) or age (F = 1.307, p = 0.280). Conclusion. Psychological and spiritual well-being in colostomy patients appeared to be at satisfactory level, but it is necessary to provide tailor made support in order to prevent and resolve negative responses to stoma.

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Randomized Cross-Over Study Comparing Two Infusion Sets for CSII in Daily Life

Journal of Diabetes Science and Technology ◽

10.1177/1932296816667510 ◽

2016 ◽

Vol 11 (2) ◽

pp. 253-259 ◽

Cited By ~ 5

Author(s):

Guido Freckmann ◽

Stephan Arndt ◽

Albrecht Fießelmann ◽

Gerhard Klausmann ◽

Kristina Pralle ◽

...

Keyword(s):

Adverse Events ◽

Insulin Infusion ◽

Insulin Pump ◽

Real Life ◽

Open Label ◽

Serious Adverse Events ◽

Life Conditions ◽

Essential Components ◽

The Mean

Background: Continuous subcutaneous insulin infusion (CSII) therapy is a valuable option especially for people with type 1 diabetes. Although insulin infusion sets (IIS) are essential components of most insulin pump systems, only few studies have been conducted on their performance and safety. In this study 2 IIS with soft cannulas were compared. Methods: In an open-label, randomized, crossover, multicenter 8-week study 80 type 1 diabetic subjects on CSII (20-74 years, mean 46.5 ± 12.9 years, 58.8% male) were enrolled to evaluate the use of 2 IIS. The Accu-Chek® FlexLink Plus (FL Plus) and the Accu-Chek® FlexLink infusion set (FL) were used 4 weeks each under real-life conditions at home. All patients had to record details about every IIS change in a diary. Insertion-related pain was assessed by means of a visual analogue scale (VAS). Results: The mean pain noted during insertion was similar for both IIS (VAS 6.1 ± 6.4 mm for the FL Plus and 5.8 ± 6.3 mm for the FL, P = .92). 20.0% of the 895 IIS changes with FL Plus and 16.0% of the 854 with FL were unplanned. During the 4243 patient days of the study, 13 patients had adverse events. Among these, 2 serious adverse events occurred. Both serious events and 1 nonserious adverse event were considered as related to the IIS. Of the patients, 18.7% had kinked cannulas. Most patients were satisfied with both IIS. Conclusion: Both IIS are safe and effective. The 2 IIS did not differ from each other with respect to pain observed during insertion.

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Effect of fentanyl buccal tablet on pain-related anxiety: A 4-week open-label study among opioid-tolerant patients with chronic and breakthrough pain

Journal of Opioid Management ◽

10.5055/10.5055/jom.2011.0071 ◽

2018 ◽

Vol 7 (4) ◽

pp. 297-308

Author(s):

Lynn R. Webster, MD ◽

John Messina, PharmD ◽

Fang Xie, PhD ◽

Srinivas Nalamachu, MD

Keyword(s):

Breakthrough Pain ◽

Anxiety Symptoms ◽

Open Label ◽

Serious Adverse Events ◽

Fentanyl Buccal Tablet ◽

Buccal Tablet ◽

Titration Period ◽

History Of ◽

High Level ◽

The Impact

Objective: To evaluate the effect of fentanyl buccal tablet (FBT) on pain-related anxiety in opioid-tolerant patients with chronic pain and breakthrough pain (BTP).Design: This study consisted of a screening visit, open-label titration period, and 4-week open-label treatment period.Setting: Thirty-one US study centers.Patients: Opioid-tolerant adults with chronic, persistent pain experiencing 1-4 BTP episodes per day at baseline. Two hundred eighteen patients were enrolled in this study; 180 completed the titration period; and 169 completed the treatment period.Intervention: Patients were treated with FBT (100-800 g) for BTP episodes for 4 weeks while continuing their around-the-clock opioid regimens.Main outcome measures: Change from baseline in the Pain Anxiety Symptoms Scale (PASS) total score at the final visit.Results: Based on a mean baseline PASS total score of 82.6, study patients had a high level of anxiety; 92 patients (42 percent) had a history of anxiety disorders. The change from baseline in PASS total score was not statistically significant (mean change, −1.6; p = 0.322). Numerical improvements were reported in some secondary measures (eg, Beck Depression Inventory total score [mean change, −1.1; p = 0.038]) and categorical measures (eg, Pain Flare Treatment Satisfaction, Patient Assessment of Function, and Clinician Assessment of Patient Function ratings). FBT was generally well tolerated, with no serious adverse events related to study drug.Conclusions: Four weeks of treatment with FBT did not reduce anxiety to a clinically meaningful extent, although improvement was reported in several secondary measures of functioning. Further research is needed to assess the impact of treatment for BTP on anxiety symptoms in opioid-tolerant patients with BTP.

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Effect of Long Working Hours on Depression and Mental Well-Being among Employees in Shanghai: The Role of Having Leisure Hobbies

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16244980 ◽

2019 ◽

Vol 16 (24) ◽

pp. 4980

Author(s):

Zan Li ◽

Junming Dai ◽

Ning Wu ◽

Yingnan Jia ◽

Junling Gao ◽

...

Keyword(s):

Psychological Health ◽

Negative Impact ◽

Working Hours ◽

Well Being ◽

Working Time ◽

World Health ◽

Long Working Hours ◽

The Mean ◽

The Impact ◽

Mental Well Being

Our aim is to examine the associations between long working hours and depression and mental well-being among the working population in Shanghai, as well as to identify the impact of having hobbies on these relationships. A cross-sectional study was conducted in Shanghai, with depression assessed by the Patient Health Questionnaire-9 (PHQ-9) scale and mental well-being assessed by the World Health Organization five-item Well-Being Index (WHO-5) scale. The phenomenon of long working hours (69.3%) was quite common among employees in Shanghai, and the rate of working over 60 h was 19.3%. Those who worked over 60 h had the highest prevalence of poorer mental health compared with individuals working ≤40 h per week. After adjustment in the logistic regression model, those who reported weekly working time over 60 h were 1.40 (95%CI: 1.03–1.90) and 1.66 (95%CI: 1.26–2.18) times more likely to have depression and poor mental well-being (PMWB), respectively. Adjusted ORs for having hobbies were 0.78 (95%CI: 0.62–0.97) and 0.62 (95%CI: 0.51–0.75), respectively. Meanwhile, having hobbies could significantly lower the mean score on the PHQ-9 and elevate the mean score on the WHO-5 in each working time group, with no interaction effect. Long working hours could have a significantly negative impact on workers’ psychological health. Importantly, having hobbies in their daily lives might help to mitigate the adverse effects of long working hours on workers’ depression and mental well-being.

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Subjective Well-being in Non-obese Individuals Depends Strongly on Body Composition

10.21203/rs.3.rs-618350/v1 ◽

2021 ◽

Author(s):

Małgorzata Chlabicz ◽

Marlena Paniczko ◽

Jacek Jamiołkowski ◽

Paweł Sowa ◽

Magda Łapińska ◽

...

Keyword(s):

Body Composition ◽

General Population ◽

Muscle Mass ◽

Negative Impact ◽

Fat Distribution ◽

Well Being ◽

Lower Limbs ◽

Satisfaction With Life Scale ◽

The Mean ◽

Eq Vas

Abstract While obesity has been correlated with welfare in the general population, there is not much data on the influence of body composition on welfare among the non-obese adult individuals. A total of 726 non-obese individuals from general population were analyzed. The mean age was 46.8±15.4 years and 42.1% of participants were male. The mean value for Satisfaction with Life Scale (SWLS) was 23.09±5.43, for Euro Quality of Life Visual Analogue Scale (EQ-VAS) was 78.0±14.5, and for Beck Depression Inventory (BDI) was 6.7±6.6. On SWLS the waist-hip ratio had a negative impact even after adjustment for age, gender and concomitant diseases. EQ-VAS was inversely associated with android fat distribution and directly associated with muscle mass. BDI value was inversely associated with lower muscle mass, especially of the lower limbs. The well-being of women was mainly associated with the distribution of adipose tissue and less with the distribution of muscle tissue - abdominal fat distribution has a particularly negative impact on well-being among women. In contrast, men's well-being depends more on muscle mass and to a lesser extent on the distribution of fat tissue - a positive significant effect has lean mass and a circumference of thigh below gluteal fold.

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Burnout and Sense of Coherence in Dentistry Students of Karachi

Journal of The Pakistan Dental Association ◽

10.25301/jpda.303.170 ◽

2021 ◽

Vol 30 (03) ◽

pp. 170-177

Author(s):

Fasiha Moin Kazi ◽

◽

Shoaib Ahmed ◽

Shama Asghar

Keyword(s):

At Risk ◽

Sense Of Coherence ◽

Medical Condition ◽

Well Being ◽

Relationship Status ◽

Chronic Medical Condition ◽

P Value ◽

Psychiatric Condition ◽

History Of ◽

The Mean

OBJECTIVE: This study aimed to assess burnout and sense of coherence levels in dentistry students of Karachi. METHODOLOGY: A cross-sectional study involving 361 students from four renowned dental colleges in Karachi was carried out. The students were distributed a questionnaire derived from the Mayo Clinic Well-being Index (WBI) and a modified 13-item Antonovsky's Sense of Coherence Scale (SOC scale). They were stratified on the basis of gender, age, professional year, institution, relationship status, history of chronic medical condition and history of chronic psychiatric condition. Scores for the WBI and SOC scale were calculated. For the WBI, a score of >4 was a sign that an individual was at risk of developing burnout or other severe outcomes. A high or low total score on the SOC scale demonstrated whether the individual was able to cope with his environment or not. MS Excel and SPSS version 23 were used for data compilation and statistical analysis. Descriptive statistics were calculated. Chi-square test of independence was applied to gauge any association between the strata and outcome variables. After determination of statistical difference, Mann Whitney-U Test and Kruskal Wallis Test were applied to compare the means where a significant association was found. A p-value of 0.05 or less was considered significant. RESULTS: The mean WBI score was found to be 4.07. Around 64% respondents were at-risk of burnout (score > 4). A greater percentage of females was at risk (66%) as compared to males (50%). Third professional students were found to be the most affected (77% with WBI score > 4 and 9% in the low coherence category). The mean SOC score was found to be 36.39 (moderate levels of coherence). Overall, around 4-9% of each professional year students exhibited a low sense of coherence. Age, relationship status, institution and a history of chronic medical and/or psychiatric condition were not found to have a significant association with the outcome variables (p>0.05). CONCLUSION: A significant number of dentistry students are at risk of burn-out and suffer from a low sense of coherence. The risk factors need to be evaluated and solutions need to be found to create a healthy and conducive environment for the growth and learning of the students. More research needs to be focused on gathering data related to the well-being of dentistry students. KEYWORDS: Burnout, sense of coherence, well-being index, dentistry.

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