Long-term effects with policosanol on lipid profile according to hypercholesterolemia severity in older patients

2021 ◽  
Vol 4 (1) ◽  
pp. 026-38
Author(s):  
Julio C. Fernández-Travieso ◽  
José Illnait-Ferrer ◽  
Sarahí Mendoza-Castaño ◽  
Lilia Fernández-Dorta ◽  
Rafael Gámez-Menéndez ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Lipid Profile ◽  
Total Cholesterol ◽  
Older Patients ◽  
Lower Amount ◽  
Coronary Risk Factors ◽  
Serious Adverse Events ◽  
Old Patients ◽  
Proportional Intensity

Background: End-point based studies have demonstrated a direct relationship between coronary disease and elevated serum levels of low density lipoprotein cholesterol (LDL-C) and total cholesterol, as well as the benefits of lowering LDL-C with statins on clinical end-points. Policosanol is a mixture of very long chain fatty alcohols purified from sugar cane wax, with dislipidemia controlling effects, proved in numerous clinical assays in which patients with different conditions were included. The efficacy and tolerability of policosanol in the elderly have been also investigated in several clinical trials, being effective, safe and well tolerated. Objectives: To investigate the effects of policosanol treatment during three years on lipid profile with a proportional intensity to the initial dislipidemia severity in older hypercholesterolemic patients. Methods: The present analysis was obtained from the data of all patients treated with policosanol included in a previous prevention study. One thousand, ford hundred seventy old patients of both sexes, between 60 to 85 years old, with type II hypercholesterolemia, and ³ 1 non-lipid coronary risk factors, were randomized in two groups and treated with policosanol or placebo, during three years. Significant changes on lipid profile with a proportional intensity to the initial dislipidemia severity were considered primary efficacy variables. The analysis was done by Intention-to-treat method. Results: An analysis of the response intensity show that after treatment, reductions of LDL-C, total cholesterol and triglycerides were greater, and according to the initial hypercholesterolemia severity, so that, patients with severe hypercholesterolemia showed the better responses, followed by moderate and mild hypercholesterolemia. An opposite pattern, however, was observed for HDL-C serum concentration. Triglycerides did not respond in the same way. The frequency of vascular serious adverse events was lower in the policosanol group (15 events) compared with those on placebo group (49 events). There were 109 patients who experienced serious adverse events: 83 (11.3 %) in placebo and 26 (3.5 %) in policosanol group (p<0.0001). Twenty-three deaths occurred up to study completion: 19 patients belonging to placebo group (2.6 %) and 4 to the policosanol group (0.5 %). Conclusions: The treatment with policosanol produce positive changes on serum lipid profile according to hypercholesterolemia severity and with a significant lower amount of vascular serious adverse events, mortality, and frequency of total adverse events in older patients.

Efficacy and Safety of PEGPH20 in Pancreatic Cancer: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 17 ◽  
Author(s):  
Vinod Solipuram ◽  
Harish Gopalakrishna ◽  
Gayatri Naira ◽  
Akhila Mohan
Keyword(s):  
Pancreatic Cancer ◽  
Placebo Group ◽  
Febrile Neutropenia ◽  
Adverse Events ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Cochrane Library ◽  
Thromboembolic Events ◽  
Serious Adverse Events ◽  
Significant Difference

Introduction: Pancreatic cancer is an aggressive tumor that had an estimated 57,600 new cases and 47,050 deaths in 2020 in the US alone. Recent studies have targeted tumor microenvironment (TME) for better delivery of systemic chemotherapy like PEGPH20, which degrades hyaluronic acid in the extracellular matrix (ECM). A meta-analysis of these Randomized controlled trials (RCTs) to test the efficacy of PEGPH20 was performed. Methods: A systematic search was performed using PubMed, Embase, and Cochrane library without language limitations from inception to July 30, 2020. A total of 59 articles was identified, and 3 RCTs were included in the final analysis. The primary outcome was progression-free survival (PFS), and secondary outcomes were overall survival (OS), deaths from adverse events, thromboembolic events, serious adverse events (SAE), and febrile neutropenia. Results: There was no statistically significant improvement in PFS (HR= 0.94; 95%CI (0.79, 1.11)) in the PEGPH20 group when compared to the standard treatment/placebo group. There was no significant difference among OS (HR= 0.99, 95%CI (0.83, 1.17), deaths from adverse events (RR=0.97; 95%CI (0.54, 1.73)), thromboembolic events (RR= 1.49; 95%CI (0.92, 2.44)), and febrile neutropenia (RR= 0.88; 95%CI (0.45, 1.72), however, there was statistically significant increase in SAE (RR = 1.59; 95%CI (1.01, 2.52) in the PEGPH20 group compared to the placebo group. Conclusion: This meta-analysis showed that PEGPH20 did not improve the PFS or OS. Moreover, there is an increased incidence of serious adverse events with the use of PEGPH20 compared to standard therapies.

scholarly journals Factors associated with mechanical and systemic adverse events after colonoscopy (France, 2010-2015)

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Laanani ◽  
A Weill ◽  
P O Blotière ◽  
J Pouchot ◽  
F Carbonnel ◽  
...  
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Older Patients ◽  
Public Hospitals ◽  
Serious Adverse Events ◽  
Logistic Regression Models ◽  
Factors Associated ◽  
Increased Risk ◽  
Experienced Endoscopists

Abstract Background More than one million colonoscopies are performed every year in France. They are associated with risks of mechanical and systemic serious adverse events (SAEs) which can be associated with patient, procedure, endoscopist, and facility characteristics. We tried to identify the factors associated with colonic perforation, gastrointestinal bleeding, splenic injury, shock, myocardial infarction, stroke, pulmonary embolism, acute renal failure, and urolithiasis after colonoscopy. Methods We analysed data from the French national claims databases (SNDS). A total of 4,088,799 patients, 30 years or older, undergoing a first screening or diagnostic colonoscopy between 2010 and 2015 were identified. SAE rates were estimated, and risk factors associated with SAEs were identified using multilevel logistic regression models, adjusted for patient, colonoscopy, endoscopist, and facility characteristics. Results Increasing age was associated with an increasing incidence of mechanical and systemic SAEs. Cancer and cardiovascular comorbidities were associated with mechanical SAEs, and a higher number of pre-existing conditions was associated with shock and acute renal failure. Polypectomy, especially of polyps larger than 1 cm, was associated with an increased risk of perforation (OR = 4.1; 95% CI, 3.4-5.0) and bleeding (OR = 13.3; 95% CI, 11.7-15.1). Mechanical SAEs were associated with the endoscopist’s experience, while systemic SAEs were more frequent in public hospitals than in private clinics. Conclusions SAEs related to colonoscopy were more frequent in older patients and in those with comorbidities. Mechanical SAEs were more frequent when colonoscopy was performed by less experienced endoscopists. Systemic SAEs were more frequent in public hospitals, reflecting patient selection processes. The risk of both mechanical and systemic SAEs should be taken into account when deciding to perform colonoscopy, particularly in older patients with multiple pre-existing conditions. Key messages Systemic SAEs are not uncommon after colonoscopy and, together with intestinal SAEs, should be considered when considering the need for colonoscopy. Patients at risk of SAEs should be identified and colonoscopy should be performed by experienced endoscopists in these patients. Less invasive alternatives should also be considered in these patients.

scholarly journals Saccharomyces boulardii to Prevent Antibiotic-Associated Diarrhea: A Randomized, Double-Masked, Placebo-Controlled Trial

2016 ◽  
Vol 3 (1) ◽  
Author(s):  
Stephan Ehrhardt ◽  
Nan Guo ◽  
Rebecca Hinz ◽  
Stefanie Schoppen ◽  
Jürgen May ◽  
...  
Keyword(s):  
Placebo Group ◽  
Clostridium Difficile ◽  
Adverse Events ◽  
Antibiotic Treatment ◽  
Controlled Trial ◽  
Saccharomyces Boulardii ◽  
Serious Adverse Events ◽  
Antibiotic Associated Diarrhea ◽  
Clostridium Difficile Associated Diarrhea ◽  
Systemic Antibiotic Treatment

Abstract Background.  Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Data on the efficacy of probiotics to prevent AAD and CDAD are unclear. We aimed to evaluate the efficacy of Saccharomyces boulardii to prevent AAD and CDAD in hospitalized adult patients. Methods.  We conducted a multicenter, phase III, double-masked, randomized, placebo-controlled trial in hospitalized patients who received systemic antibiotic treatment in 15 hospitals in Germany between July 2010 and October 2012. Participants received Perenterol forte 250 mg capsules or matching placebo twice per day within 24 hours of initiating antibiotic treatment, continued treatment for 7 days after antibiotic discontinuation, and were then observed for 6 weeks. Results.  Two thousand four hundred forty-four patients were screened. The trial was stopped early for futility after inclusion of 477 participants. Two hundred forty-six patients aged 60.1 ± 16.5 years and 231 patients aged 56.5 ± 17.8 were randomized to the S boulardii group and the placebo group, respectively, with 21 and 19 AADs in the respective groups (P = .87). The hazard ratio of AAD in the S boulardii group compared with the placebo group was 1.02 (95% confidence interval, .55–1.90; P = .94). Clostridium difficile-associated diarrhea occurred in 0.8% of participants (4 of 477). Nine serious adverse events were recorded in the S boulardii group, and 3 serious adverse events were recorded in the placebo group. None were related to study participation. Conclusions.  We found no evidence for an effect of S boulardii in preventing AAD or CDAD in a population of hospitalized patients without particular risk factors apart from systemic antibiotic treatment. ClinicalTrials.gov Identifier.  NCT01143272.

SERIOUS ADVERSE EVENTS AMONG OLDER PATIENTS IN THE ALTTO TRIAL

2019 ◽  
Vol 10 (6) ◽  
pp. S14-S15 ◽  
Author(s):  
N. Pondé ◽  
D.Agbor Tarh ◽  
L. Korde ◽  
F. Hilbers ◽  
C. Jackisch ◽  
...  
Keyword(s):  
Adverse Events ◽  
Older Patients ◽  
Serious Adverse Events

scholarly journals Why deprescribing instead of not prescribing?

2020 ◽  
Vol 14 (4) ◽  
pp. 294-297
Author(s):  
Welma Wildes Amorim ◽  
Luiz Carlos Passos ◽  
Marcio Galvão Oliveira
Keyword(s):  
Adverse Events ◽  
Older People ◽  
Cognitive Processes ◽  
Older Patients ◽  
Potentially Inappropriate Medications ◽  
Patient Harm ◽  
Serious Adverse Events ◽  
Inappropriate Medications ◽  
Appropriate Prescription

Prescribing medications involves complex cognitive processes, and mistakes in prescription can cause serious adverse events. Deprescribing is one of the last opportunities to prevent patient harm from the use of drugs that should be avoided, especially among older patients. This viewpoint article aims to discuss the prescription process and some essential concepts, such as polypharmacy, prescription of potentially inappropriate medications, and, particularly, the relevance of deprescribing and its relationship with the appropriate prescription of medications in older people.

Safety of Recombinant Activated Coagulation Factor VII in Non-Hemophilia Patients.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3978-3978 ◽  
Author(s):  
Brett E. Skolnick ◽  
Lisa Payne Rojkjaer ◽  
Stephanie V. Seremetis
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Safety Data ◽  
Coagulation Factor ◽  
Factor Vii ◽  
Serious Adverse Events ◽  
Treatment Groups ◽  
Coagulation Factor Vii ◽  
Group Frequency ◽  
Wide Range

Abstract Background and Purpose: The safety of recombinant activated coagulation factor VII (rFVIIa) has been studied in a variety of clinical settings including von Willebrand disease, thrombocytopenia, trauma, liver surgery, and vitamin-K antagonist therapy, as well as upper gastrointestional and central nervous system bleeding. Although multiple interventions have been developed to treat bleeding through revised surgical management and blood product transfusions, current treatment often remains inadequate. Seventeen clinical trials have been conducted in the seven therapeutic areas described above to evaluate the efficacy and safety of rFVIIa for the reduction or elimination of excessive bleeding. The safety data are presented in this summary. Methods: A comprehensive review of rFVIIa safety data was performed, which included 1630 patients (rFVIIa: 1086; placebo: 544) from international studies in 7 therapeutic areas where patients received single or repeated doses ranging from 5–200 μg/kg, with a maximum of 8 doses. Results: Serious adverse events (SAEs) were evenly distributed among treatment groups: 350/1086 (32%) rFVIIa-treated patients experienced 491 SAEs, and 213/544 (39%) placebo-treated patients experienced 333 SAEs. Fifty-one thromboembolic SAEs occurred in 48 patients (4.4%) in the rFVIIa treatment group (frequency per patient: 5%), and 20 thromboembolic SAEs occurred in 20 patients (3.7%) in the placebo group (frequency: 4%). Of the 51 thromboembolic SAEs in the rFVIIa group, 28 were arterial (frequency: 2.6%) and 23 were venous (frequency: 2.1%). Of the 20 thromboembolic SAEs that occurred in the placebo group, 8 were arterial (frequency: 1.5%) and 12 were venous (frequency: 2.2%). Thromboembolic SAEs considered by the investigator to be related to treatment represented thirty-four thromboembolic SAEs in the rFVIIa group (frequency of events per patient: 3.1%) and 13 thromboembolic SAEs in the placebo group (frequency: 2.4%). A total of 231 deaths occurred among both treatment groups: 144 (13%) from the rFVIIa group (11 thromboembolic-related deaths), and 87 (16%) from the placebo group (3 thromboembolic-related deaths). Of the 11 (1%) thromboembolic deaths that occurred in the rFVIIa group, 6 were considered by the investigator to be possibly/probably related to treatment. Of the 3 (0.6%) thromboembolic deaths that occurred in the placebo group, 2 were considered by the investigator to be possibly/probably related to treatment. Conclusions: Recombinant FVIIa appears to be safely administered at total doses ranging from 5–1120 μg/kg for the treatment of a wide range of bleeding disorders. Continued safety and efficacy evaluations are underway to further elaborate on these observations. rFVIIa patients; n=1086 Placebo patients; n=544 Events Number of SAEs Frequency * Number of SAEs Frequency * * = number of SAEs/total patients x 100, TE = Thromboembolic, SAE = Serious Adverse Events TE SAEs 51 5% 20 4% Arterial TE SAEs 28 2.6% 8 1.5% Venous TE SAES 23 2.1% 12 2.2% TE SAEs related to treatment 34 3.1% 13 2.4% TE-related Deaths 11 (1%) - 3 (0.6%) -

scholarly journals Comparative Toxicity and Effectiveness of Trastuzumab-Based Chemotherapy Regimens in Older Women With Early-Stage Breast Cancer

2017 ◽  
Vol 35 (29) ◽  
pp. 3298-3305 ◽  
Author(s):  
Katherine E. Reeder-Hayes ◽  
Anne Marie Meyer ◽  
Sharon Peacock Hinton ◽  
Ke Meng ◽  
Lisa A. Carey ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Propensity Score ◽  
Adverse Events ◽  
Older Patients ◽  
Early Stage ◽  
The United States ◽  
Health Care Use ◽  
Significant Shift ◽  
Serious Adverse Events ◽  
Adjuvant Trastuzumab

Purpose The combination of chemotherapy and trastuzumab is the standard of care for adjuvant treatment of human epidermal growth factor receptor 2–positive breast cancer. Two regimens have been widely adopted in the United States: doxorubicin, cyclophosphamide, paclitaxel, and trastuzumab (ACTH) and docetaxel, carboplatin, and trastuzumab (TCH). No head-to-head comparison of these regimens has been conducted in a clinical trial, and existing trial data have limited generalizability to older patients. Methods We used SEER-Medicare data from 2005 to 2013 to compare outcomes of ACTH versus TCH among patients age older than 65 years. Propensity score matching was used to balance cohort characteristics between treatment arms. Outcomes included toxicity-related hospitalization, survival, and trastuzumab completion. Data from 1,077 patients receiving ACTH or TCH were analyzed, and the propensity-matched subsample included 416 women. Results There was a significant shift toward TCH over time, with 88% of patients receiving ACTH in 2005 compared with 15% by 2011. Among propensity score–matched patients, we found no difference between regimens in health care use overall or for chemotherapy-related adverse events (ACTH, 34% v TCH, 36.5%; P = .46). Patients receiving TCH were significantly more likely to complete trastuzumab (89% v 77%; P = .001). There was no difference in 5-year breast cancer–specific survival (ACTH, 92% v TCH, 96%; hazard ratio, 2.08; 95% CI, 0.90 to 4.82) or overall survival. Conclusion Among a matched sample of older patients, ACTH compared with TCH was not associated with a higher rate of serious adverse events or hospitalizations, but it was associated with less completion of adjuvant trastuzumab. We did not detect a difference in 5-year survival outcomes for ACTH compared with TCH. In the context of limited evidence in older patients, selection between these two regimens on the basis of concerns about differential toxicity or efficacy may not be appropriate.

SAT0345 IS THERE A DIFFERENCE BETWEEN THE SEXES IN THE RATE OF PROGRESSION OF SYSTEMIC SCLEROSIS-ASSOCIATED ILD (SSC-ILD)? DATA FROM THE SENSCIS TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1118-1119
Author(s):  
E. Volkmann ◽  
S. Vettori ◽  
J. Varga ◽  
A. Herrick ◽  
M. Cutolo ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Trial Steering Committee ◽  
Annual Rate ◽  
P Value ◽  
Research Support ◽  
Serious Adverse Events ◽  
Female Patients ◽  
Males And Females ◽  
Rate Of Decline

Background:Previous studies suggested that male sex may be associated with a greater rate of decline in FVC in patients with SSc-ILD. In the SENSCIS trial, nintedanib reduced the rate of FVC decline over 52 weeks vs placebo.Objectives:Analyse the rate of decline in FVC and the efficacy and safety of nintedanib in the SENSCIS trial in subgroups by sex.Methods:Patients with SSc-ILD with first non-Raynaud symptom <7 years before screening and ≥10% fibrosis of the lungs on HRCT were randomised to nintedanib or placebo. We analysed the rate of decline in FVC (mL/year) and adverse events over 52 weeks in male and female patients.Results:Of 576 patients, 433 (75.2%) were female. Compared with males, the female subgroup included a smaller proportion of White patients (64.7% vs 74.8%), a smaller proportion on mycophenolate at baseline (46.9% vs 53.1%), a greater proportion of ATA positive patients (63.3% vs 53.1%), and had a lower mean weight at baseline (66.6 vs 79.1 kg). FVC % predicted (72.8% vs 71.7%) and mRSS (11.2 vs 10.8) were similar in females and males. The adjusted annual rate of decline in FVC in the placebo group was numerically greater in male than female patients (-126.8 [SE 29.0] vs -82.0 [16.2] mL/year). The estimated effect of nintedanib vs placebo on reducing the rate of decline in FVC was numerically more pronounced in males than females (difference: 58.6 [95% CI -18.0, 135.1] vs 34.6 [-9.3, 78.4] mL/year), but the interaction p-value did not indicate heterogeneity in the treatment effect between subgroups (p=0.59). Among nintedanib-treated patients, diarrhoea was reported in similar proportions of females and males (74.7% vs 79.1%); nausea, vomiting and liver test abnormalities were reported in greater proportions of females vs males (35.3% vs 19.4%, 28.1% vs 13.4%, and 15.4% vs 9.0%), while serious adverse events were more frequent in males (32.8% vs 21.3%). In the nintedanib and placebo groups, respectively, adverse events leading to treatment discontinuation were reported in 16.7% and 8.5% of females and 13.4% and 9.2% of males.Conclusion:In the SENSCIS trial in patients with SSc-ILD, the annual rate of decline in FVC in the placebo group was numerically greater in male than female patients. The rate of FVC decline was lower with nintedanib than placebo both in males and females. The safety profile of nintedanib was similar between males and females.Disclosure of Interests:Elizabeth Volkmann Grant/research support from: Forbius, Corbus Pharmaceuticals, Consultant of: Boehringer Ingelheim, Forbius, Speakers bureau: Boehringer Ingelheim, Serena Vettori Consultant of: Boehringer Ingelheim, John Varga Grant/research support from: John Varga is awaiting grants from Boehringer Ingelheim and has received grants from Bristol-Myers Squibb, Pfizer, Takeda, and TeneoBio, Consultant of: John Varga has acted as a consultant for Boehringer Ingelheim, Bristol-Myers Squibb, Emerald Health, and TeneoBio, Ariane Herrick: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Ana Cordeiro Consultant of: Ana Cordeiro has acted as a consultant for Roche, Speakers bureau: Ana Cordeiro has received speaker fees from Boehringer Ingelheim, Lilly, and Vitoria, Valderilio F Azevedo Grant/research support from: Abbvie, Janssen, Bristol-Myers Squibb, Boehringer-Ingelheim, Lilly and Novartis, Consultant of: Lilly, Novartis, Janssen, Boehringer-Ingelheim, Amgen, Pfizer and Abbvie, Speakers bureau: Sandoz, Celltrion, Lilly, Novartis, Janssen, Boehringer-Ingelheim, Amgen, Pfizer and Abbvie, Sindhu Johnson Grant/research support from: Boehringer Ingelheim, Corbus Pharmaceuticals, GlaxoSmithKline, Roche, Merck, Bayer, Consultant of: Boehringer Ingelheim, Ikaria, Christian Stock Employee of: Employee of Boehringer Ingelheim, Martina Gahlemann Employee of: Employee of Boehringer Ingelheim, Lizette Moros Employee of: Lizette Moros is an employee of Boehringer Ingelheim, Margarida Alves Employee of: Employee of Boehringer Ingelheim, Maureen Mayes Grant/research support from: Maureen Mayes has received grants from Boehringer Ingelheim, Corbus, CSL Behring, Eicos, and Galapagos, Consultant of: Maureen Mayes has acted as a consultant for Boehringer Ingelheim, Eicos, and Galapagos. She was a member of the SENSCIS trial Steering Committee (Boehringer Ingelheim)

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