scholarly journals An Observational Study to Assess the Safety and Efficacy on Quality of Life and Patient Satisfaction With Raloxifene/Cholecalciferol Combination Therapy in Postmenopausal Women Requiring Prevention or Treatment for Osteoporosis

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A241-A242
Author(s):  
Yoon-Sok Chung ◽  
Dong-Yun Lee
Keyword(s):  
Quality Of Life ◽  
Patient Satisfaction ◽  
Bone Loss ◽  
Combination Therapy ◽  
Adverse Events ◽  
Observational Study ◽  
South Korea ◽  
Postmenopausal Women ◽  
Hot Flush

Abstract Background: Preventing bone loss is an important concern for women during post-menopausal period. Menopause significantly speeds bone loss and increases the risk for osteoporosis. The aim of this study was to investigate the effectiveness on quality of life (QOL), patient satisfaction in postmenopausal women receiving raloxifene/cholecalciferol combination therapy. In addition, we analyzed adverse events to assess the safety profile of this drug. Methods: This study is a multicenter, prospective, non-interventional observational study of women receiving raloxifene/cholecalciferol (raloxifene 60 mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) combination therapy to treat or prevent postmenopausal osteoporosis. Data have been collected from patients receiving routine clinical practice at 99 hospitals (local clinics and general hospitals) in South Korea. Patients were followed for more than 6 months to evaluate changes in, and QOL (EQ-5D-5L), patient satisfaction with efficacy and convenience (questionnaire), and safety. This study has been approved by Institutional Review Board and is in compliance with clinical research ethics regulations. Results: A total of 3,907 subjects with an average age of 67.68 ± 9.34 (Mean ± SD) were enrolled from November 2017 to July 2020. QOL was significantly improved from 0.77 ± 0.15 to 0.80 ± 0.12, 0.82 ± 0.11 (3 months, 6 months, respectively) after raloxifene/cholecalciferol therapy (p<0.001). Compared to prior drug regimens of all types (bisphosphonates, bisphosphonates with vitamin D, selective estrogen receptor modulators, etc.), QOL after raloxifene/cholecalciferol treatment was significantly improved (p<0.001). Patient satisfaction of efficacy was significantly increased from 37.25% to 67.70% over 6 months (p<0.0001), and patient satisfaction of convenience was significantly increased from 42.75% to 74.07% (p<0.0001). Serious adverse drug reaction (ADR) did not occur. Hot flush as ADR occurred in 12 subjects (0.30%), lower than Caucasian but similar with previous reports in Asians. Conclusion: In postmenopausal women, combination therapy with raloxifene/cholecalciferol significantly improved quality of life, and patient satisfaction with no serious adverse events. This drug regimen has been proven to be suitable therapy for postmenopausal women with osteoporosis in a real-world clinical setting. References: Kim et al., Expert Opin Drug Safety 2019; 18: 1001–8. Takeuchi et al., Menopause 2015; 22: 1134–7. Xu et al., Osteoporos Int 2011; 22: 559–65.

scholarly journals A New Curcuma Extract (Flexofytol®) in Osteoarthritis: Results from a Belgian Real-Life Experience

2014 ◽  
Vol 8 (1) ◽  
pp. 77-81 ◽  
Author(s):  
Thierry Appelboom ◽  
Nathalie Maes ◽  
Adelin Albert
Keyword(s):  
Quality Of Life ◽  
Patient Satisfaction ◽  
Observational Study ◽  
Life Experience ◽  
Real Life ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Patient Pain ◽  
Inflammatory Drugs

This retrospective observational study summarizes the experiences of 820 patients treated with a new Curcuma extract (Flexofytol®, 4-6 capsules per day), for more than 6 months for various forms of painful osteoarthritis. These experiences were reported by 110 Belgian general practitioners via a questionnaire that included quality-of-life parameters for assessing patient experience. Data were submitted to an independent statistician for analysis. Within the first 6 weeks, Flexofytol® improved patient pain, articular mobility, and quality of life. Excellent tolerance was reported, and more than half of these patients were able to discontinue analgaesic and anti-inflammatory drugs. Patient satisfaction was confirmed by their decision to maintain Flexofytol® therapy for more than 6 months. These data must be confirmed with randomized controlled studies. We currently conclude that Flexofytol® which is based on a new preparation of curcumin, is as a potential neutraceutical for the care of patients complaining of joint problems, with excellent tolerance and rapid benefits for articular mobility, pain, and quality of life.

Emerging concepts in combination chemotherapy for metastatic pancreatic cancer: A systematic review of randomized controlled trials.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 228-228
Author(s):  
Basile M. Njei ◽  
Ivo C. Ditah ◽  
Alexei Shimanovsky ◽  
Priscilla Owusu ◽  
John W Birk
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Overall Survival ◽  
Combination Therapy ◽  
Adverse Events ◽  
Combination Chemotherapy ◽  
Metastatic Pancreatic Cancer ◽  
Controlled Trials ◽  
Randomized Controlled

228 Background: Even though gemcitabine monotherapy is commonly used as first-line treatment for metastatic pancreatic cancer, many novel treatment approaches have focused on combination chemotherapy. FOLFIRINOX, a combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin, has recently been shown to improve survival compared to gemcitabine. However, it is unclear whether survival benefits are counterbalanced by a poor quality of life due to the adverse effects. The aim of this study was to review emerging strategies that enhance treatment of patients with metastatic pancreatic cancer. Methods: Two authors independently conducted a comprehensive search of the Cochrane library PUBMED, and published proceedings from major oncologic and gastrointestinal cancer meetings from January 1980 to July 2012. Only published randomized controlled trials were eligible for inclusion. Our primary outcome measures were: progression-free survival (PFS), overall survival (OS) and serious adverse events (grade 3 or 4). Results: Thirty-one studies involving 7,957 patients were included in the analysis. There was an overall statistically significant increase in OS (RR 1.10, 95% CI 1.03-1.30) and PFS (RR 1.27, 95% CI 1.14-1.46) for the gemcitabine-based combination therapy group versus the gemcitabine monotherapy group. Subgroup analysis showed that only patients with fluoropyrimidine and platinum containing regimens showed prolonged survival: RR 1.33, 95% CI 1.04-1.76 and RR 1.38, 95% CI 1.08-1.76, respectively. The most common severe adverse event (neutropenia) was found in 45% of patients treated with FOLFIRINOX. Conclusions: Overall, gemcitabine in combination with fluoropyrimidine or platinum containing regimens can improve overall survival in patients with metastatic pancreatic cancer compared to gemcitabine alone. Even though, FOLFIRINOX therapy is associated with better survival outcomes than gemcitabine, the prolonged survival comes at the cost of poorer quality of life due to a higher incidence of adverse events. More data is needed from studies involving novel combination therapy such as hedgehog pathway inhibitors and radio-immunotherapy.

scholarly journals Assessment of quality of life based on psychological, somatovegetative, and urogenital health problems among postmenopausal women in Urban Puducherry, South India: A cross-sectional observational study

2018 ◽  
Vol 9 (4) ◽  
pp. 173
Author(s):  
Venkatachalam Jayaseelan ◽  
Yuvaraj Krishnamoorthy ◽  
Gokul Sarveswaran ◽  
Manikandanesan Sakthivel ◽  
Yashodha Arivarasan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Observational Study ◽  
Postmenopausal Women ◽  
South India ◽  
Health Problems ◽  
Cross Sectional

Relative association of treatment-emergent adverse events with quality of life of patients with schizophrenia: post hoc analysis from a 3-year observational study

2010 ◽  
Vol 25 (6) ◽  
pp. 439-447 ◽  
Author(s):  
Cecilia Adrianzén ◽  
Cesar Arango-Dávila ◽  
Danilo Martínez Araujo ◽  
Ignacio Ruíz ◽  
Richard J. Walton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Observational Study ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Effectiveness and safety of the ACE inhibitor and diuretic combination in postmenopausal women with arterial hypertension

2011 ◽  
Vol 10 (3) ◽  
pp. 35-39
Author(s):  
G. G. Semenkova ◽  
E. E. Matvienko
Keyword(s):  
Quality Of Life ◽  
Blood Pressure ◽  
Combination Therapy ◽  
Arterial Hypertension ◽  
Postmenopausal Women ◽  
Ace Inhibitor ◽  
Comparison Group ◽  
Combined Therapy ◽  
Modified Release

Aim. To assess effectiveness, tolerability, and safety of combined antihypertensive therapy (AHT) with an ACE inhibitor (perindopril) and thiazide-like diuretic (indapamide) in postmenopausal women with arterial hypertension (AH). Material and methods. This open, one-centre study included 43 postmenopausal women with AH. For 3 months, the patients in the main group (MG; n=22) received indapamide MR (modified release) (1,5 mg/d) and perindopril. The comparison group (CG; n=21) was administered non-MR indapamide (2,5 mg/d) and perindopril. The dynamics of office blood pressure (BP) levels, 24-hour BP monitoring parameters, laboratory parameters, quality of life (QoL), as well as therapy safety and tolerability, was assessed. Results. In both groups, the treatment was clinically effective, safe, and QoL-improving. Target BP levels were achieved in the majority of the patients: 85,3 % and 72,4 % in the MG and CG, respectively. The combination therapy including indapamide MR provided greater improvement of circadian BP rhythm, larger reduction in both morning BP surge and increased BP variability, as well as target BP achievement in higher proportion of the patients. Conclusion. In postmenopausal women with AH, combined therapy with perindopril and indapamide MR provided more benefits, compared to the treatment with perindopril and non-MR indapamide.

scholarly journals Multiprofessional Medication Management (MuMM) Intervention Aiming at Enhancing the Tolerability of Cancer Chemotherapy: A Randomized Feasibility Trial

2020 ◽  
Author(s):  
André Wilmer ◽  
Corinna Vucur ◽  
Andrea Tasar ◽  
Katharina Klima ◽  
Katrin Fleckenstein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Care ◽  
Patient Satisfaction ◽  
Adverse Events ◽  
Medication Management ◽  
Symptom Burden ◽  
Feasibility Trial ◽  
Care Providers ◽  
Basic Care

Abstract Background: A newly developed multiprofessional medication management (MuMM) intervention in an oncologic outpatient care setting was evaluated for its feasibility to enhance the tolerability of cancer-directed therapy. The intervention consisted of a basic care module for medication review including drug-drug interaction checks, and four supplementary modules for the management of common adverse events, specifically nausea/vomiting, mucositis, fatigue, and pain.Methods: A single-centre, unblinded, randomized two-arm trial was conducted in the oncologic outpatient ward of a municipal hospital in Bonn, Germany, with an associated community pharmacy. Feasibility of the intervention was assessed by analyzing the application of supplementary modules and semi-structured interviews with the participating health care providers. Symptom burden was assessed as primary outcome by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Furthermore, health-related quality of life and patient satisfaction with received information were analyzed.Results: 51 patients were randomized either to a control group receiving standard care (25 patients) or the intervention group receiving MuMM (26 patients). The results indicate that the MuMM intervention delivered by physicians, pharmacists, and nurses is needed and feasible, but hampered by several barriers concerning cooperation and communication within the multiprofessional health care team. The intervention did not affect symptom burden, quality of life, and patient satisfaction.Conclusion: The degree of implementation of the MuMM intervention was apparently not high enough to show a preliminary efficacy signal. Nevertheless, our study provides a starting point and methodological framework for future trials aiming at enhancing the tolerability of cancer-directed therapy.TRIAL REGISTRATION NUMBERDRKS00010128 at the German Clinical Trials Register (DRKS) Date of registration: March 7th, 2016 (retrospectively registered)

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