Abnormal uterine bleeding (AUB) is an acute/chronic variation in the normal menstrual cycle that affects adolescents, women of reproductive age and perimenopausal women. AUB affects approximately 3-30% of reproductive-aged women worldwide, and reduces their quality of life and productivity whilst increasing the overall healthcare burden. Its management requires thorough medical evaluation and individualized treatment. Depending on the severity and cause of AUB, its treatment ranges from lifestyle modifications and hormonal therapies to more invasive procedures or surgery. Although hormonal therapy is the preferred first-line measure in AUB, the available pharmacological options have various adverse effects. There exists a need for safer and more efficient treatment regimens with high patient compliance to effectively treat AUB. Norethisterone, also known as norethindrone, is a widely used synthetic analogue of progestogen. Controlled release formulations of norethisterone/ norethisterone acetate help maintain constant drug levels in the blood and exert minimal side-effects; therefore, they are promising therapeutic agents for effective AUB management. The present review summarizes the epidemiology and diagnosis of AUB, with a focus on the safety, efficacy and tolerability of norethisterone/ norethisterone acetate in AUB management. We also report a case of AUB in a 40-year-old woman, who was treated with NETA tablets. The treatment resulted in favourable outcomes, and patient satisfaction.
{"title":"Effect of norethisterone dose and duration in the management of abnormal uterine bleeding: a narrative review and case report.","authors":"Arun Madhab Boruah, Dibyendu Banerjee, Farendra Bhardwaj, Subash Mallya, Rajat Singal, Sugandha Sharma, Ashutosh Gautam","doi":"10.7573/dic.2024-4-1","DOIUrl":"10.7573/dic.2024-4-1","url":null,"abstract":"<p><p>Abnormal uterine bleeding (AUB) is an acute/chronic variation in the normal menstrual cycle that affects adolescents, women of reproductive age and perimenopausal women. AUB affects approximately 3-30% of reproductive-aged women worldwide, and reduces their quality of life and productivity whilst increasing the overall healthcare burden. Its management requires thorough medical evaluation and individualized treatment. Depending on the severity and cause of AUB, its treatment ranges from lifestyle modifications and hormonal therapies to more invasive procedures or surgery. Although hormonal therapy is the preferred first-line measure in AUB, the available pharmacological options have various adverse effects. There exists a need for safer and more efficient treatment regimens with high patient compliance to effectively treat AUB. Norethisterone, also known as norethindrone, is a widely used synthetic analogue of progestogen. Controlled release formulations of norethisterone/ norethisterone acetate help maintain constant drug levels in the blood and exert minimal side-effects; therefore, they are promising therapeutic agents for effective AUB management. The present review summarizes the epidemiology and diagnosis of AUB, with a focus on the safety, efficacy and tolerability of norethisterone/ norethisterone acetate in AUB management. We also report a case of AUB in a 40-year-old woman, who was treated with NETA tablets. The treatment resulted in favourable outcomes, and patient satisfaction.</p>","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"13 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11235183/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141579237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01eCollection Date: 2024-01-01DOI: 10.7573/dic.2024-3-4
Francesco Serra, Riccardo Caccialanza, Paolo Pedrazzoli
Scientific research has often investigated the role of diet as a risk factor for cancer development. It is well known that cancer has a multifactorial origin in which several factors are involved: genetic predisposition, dietary factors, personal habits, and infectious and environmental factors. In this Commentary, the role of diet in cancer is discussed following the scientific evidence suggesting that excessive consumption of red meat and processed foods is correlated with a greater risk of contracting cancer. Nevertheless, public health strategies on nutrition in cancer prevention are struggling to take off. The decision to pursue a healthier diet, along with a healthier lifestyle, often comes when the cancer diagnosis is made and not before. On the other hand, scientific evidence demonstrates how nutritional support is increasingly important during oncological treatments. This paper highlights how far we are still from the global adoption of a healthy and sustainable food style from a health, economic, social and environmental perspective. Additionally, it highlights the ancient vision of the role of nutrition on cancer development in which diet is seen only as a possible risk factor, underestimating the protective role in terms of cancer prevention and the modulatory one once the oncological diagnosis has been made.
{"title":"What are we doing concretely for the food prevention of cancer? Nutrition between scientific evidence and myopic policies.","authors":"Francesco Serra, Riccardo Caccialanza, Paolo Pedrazzoli","doi":"10.7573/dic.2024-3-4","DOIUrl":"10.7573/dic.2024-3-4","url":null,"abstract":"<p><p>Scientific research has often investigated the role of diet as a risk factor for cancer development. It is well known that cancer has a multifactorial origin in which several factors are involved: genetic predisposition, dietary factors, personal habits, and infectious and environmental factors. In this Commentary, the role of diet in cancer is discussed following the scientific evidence suggesting that excessive consumption of red meat and processed foods is correlated with a greater risk of contracting cancer. Nevertheless, public health strategies on nutrition in cancer prevention are struggling to take off. The decision to pursue a healthier diet, along with a healthier lifestyle, often comes when the cancer diagnosis is made and not before. On the other hand, scientific evidence demonstrates how nutritional support is increasingly important during oncological treatments. This paper highlights how far we are still from the global adoption of a healthy and sustainable food style from a health, economic, social and environmental perspective. Additionally, it highlights the ancient vision of the role of nutrition on cancer development in which diet is seen only as a possible risk factor, underestimating the protective role in terms of cancer prevention and the modulatory one once the oncological diagnosis has been made.</p>","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"13 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11235181/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141579238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-19eCollection Date: 2024-01-01DOI: 10.7573/dic.2024-2-2
Jesús Calleja-Escudero, Víctor Barrondo, Andrés Rodriguez-Alonso, Francisco Gómez-Veiga, Joan Bestard, Antonio Gómez-Caamaño, Anne-Sophie Grandoulier, Maria Pérez-Sampietro, Venancio Chantada-Abal, Raúl Poza de Celis
Introduction: Injectable extended-release formulations of luteinizing hormone-releasing hormone agonists (LHRHa) have simplified the treatment of prostate cancer with a satisfactory level of androgen castration. This study aims to determine the percentage of patients whose initial LHRHa prescription was renewed during follow-up, how many changed formulation and how their quality of life evolved.
Methods: This is an observational, prospective, multicentre study of men with prostate cancer who were to receive treatment with LHRHa (triptorelin every 3 or 6 months, leuprorelin every 3 or 6 months, or goserelin every 3 months) for 24 months. The treatment used was recorded and quality of life was assessed (QLQ-PR25 questionnaire) at four follow-up visits.
Results: A total of 497 men (median age 75 years) were evaluated. The median exposure to LHRHa was 24 months. The initial prescription was renewed in 95.7% at follow-up 1 and 75% at follow-up 4. The main reason for changing from a 6-month to a 3-month formulation was a preference for sequential treatment (according to the investigator) and to see the physician more frequently (according to the patient). The main reason for switching from the 3-month to 6-month formulation was simplification of treatment (according to the investigator) and for convenience (according to the patient). Findings in the QLQ-PR25 questionnaire revealed no changes in urinary or bowel symptoms, though an improvement in sexual activity was reported. Practically all investigators and patients were satisfied/very satisfied with the treatment.
Conclusion: Changes in formulation were scarce and generally justified by convenience factors or personal preferences. Patients maintained a good health status, with a high rate of retention of LHRHa treatment.
Clinical trial registration: Study number: A-ES-52014-224.A plain language summary is provided as supplementary material (available at: https://www.drugsincontext.com/wp-content/uploads/2024/05/dic.2024-2-2-Suppl.pdf).
导言:注射用促黄体生成素释放激素激动剂(LHRHa)缓释制剂简化了前列腺癌的治疗,并能达到令人满意的雄激素阉割水平。本研究旨在确定在随访过程中,最初使用促黄体生成素释放激素(LHRHa)的患者中重新获得处方的比例,有多少患者更换了制剂,以及他们的生活质量有何变化:这是一项观察性、前瞻性、多中心研究,研究对象为前列腺癌男性患者,他们将在 24 个月内接受 LHRHa(每 3 或 6 个月一次的曲普瑞林、每 3 或 6 个月一次的利普瑞林或每 3 个月一次的戈舍瑞林)治疗。记录所使用的治疗方法,并在四次随访中评估生活质量(QLQ-PR25问卷):共有 497 名男性(中位年龄为 75 岁)接受了评估。接受 LHRHa 治疗的时间中位数为 24 个月。在随访1和随访4时,分别有95.7%和75%的患者续用了最初的处方。 从6个月制剂改为3个月制剂的主要原因是更倾向于连续治疗(研究者认为)和更经常看医生(患者认为)。从 3 个月制剂改为 6 个月制剂的主要原因是简化治疗(研究人员认为)和方便(患者认为)。QLQ-PR25 问卷调查结果显示,泌尿系统或肠道症状没有变化,但性生活有所改善。几乎所有调查人员和患者都对治疗表示满意或非常满意:结论:配方的改变很少,一般都是出于方便因素或个人喜好。临床试验登记:研究编号A-ES-52014-224.A plain language summary is provided as supplementary material (available at: https://www.drugsincontext.com/wp-content/uploads/2024/05/dic.2024-2-2-Suppl.pdf).
{"title":"Evaluation of the criteria for renewal of LHRH agonists in patients with prostate cancer: results of the ANAREN Study.","authors":"Jesús Calleja-Escudero, Víctor Barrondo, Andrés Rodriguez-Alonso, Francisco Gómez-Veiga, Joan Bestard, Antonio Gómez-Caamaño, Anne-Sophie Grandoulier, Maria Pérez-Sampietro, Venancio Chantada-Abal, Raúl Poza de Celis","doi":"10.7573/dic.2024-2-2","DOIUrl":"10.7573/dic.2024-2-2","url":null,"abstract":"<p><strong>Introduction: </strong>Injectable extended-release formulations of luteinizing hormone-releasing hormone agonists (LHRHa) have simplified the treatment of prostate cancer with a satisfactory level of androgen castration. This study aims to determine the percentage of patients whose initial LHRHa prescription was renewed during follow-up, how many changed formulation and how their quality of life evolved.</p><p><strong>Methods: </strong>This is an observational, prospective, multicentre study of men with prostate cancer who were to receive treatment with LHRHa (triptorelin every 3 or 6 months, leuprorelin every 3 or 6 months, or goserelin every 3 months) for 24 months. The treatment used was recorded and quality of life was assessed (QLQ-PR25 questionnaire) at four follow-up visits.</p><p><strong>Results: </strong>A total of 497 men (median age 75 years) were evaluated. The median exposure to LHRHa was 24 months. The initial prescription was renewed in 95.7% at follow-up 1 and 75% at follow-up 4. The main reason for changing from a 6-month to a 3-month formulation was a preference for sequential treatment (according to the investigator) and to see the physician more frequently (according to the patient). The main reason for switching from the 3-month to 6-month formulation was simplification of treatment (according to the investigator) and for convenience (according to the patient). Findings in the QLQ-PR25 questionnaire revealed no changes in urinary or bowel symptoms, though an improvement in sexual activity was reported. Practically all investigators and patients were satisfied/very satisfied with the treatment.</p><p><strong>Conclusion: </strong>Changes in formulation were scarce and generally justified by convenience factors or personal preferences. Patients maintained a good health status, with a high rate of retention of LHRHa treatment.</p><p><strong>Clinical trial registration: </strong>Study number: A-ES-52014-224.A plain language summary is provided as supplementary material (available at: https://www.drugsincontext.com/wp-content/uploads/2024/05/dic.2024-2-2-Suppl.pdf).</p>","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"13 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11195525/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Chiloiro, Marialuisa Appetecchia, Antonio Bianchi, Denise Costa, Christine De Acetis, Patrizia Gargiulo, A. Giampietro, Andrea M Isidori, M. Jaffrain-Rea, Marina Passeri, Francesca Pigliaru, Maurizio Poggi, L. De Marinis
{"title":"Long-term pasireotide-LAR treatment in the personalized therapy of patients with complex acromegaly: a collection of clinical experiences","authors":"S. Chiloiro, Marialuisa Appetecchia, Antonio Bianchi, Denise Costa, Christine De Acetis, Patrizia Gargiulo, A. Giampietro, Andrea M Isidori, M. Jaffrain-Rea, Marina Passeri, Francesca Pigliaru, Maurizio Poggi, L. De Marinis","doi":"10.7573/dic.2024-1-2","DOIUrl":"https://doi.org/10.7573/dic.2024-1-2","url":null,"abstract":"","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"49 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140961537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Petra Staubach, Andreas Körber, Ralph M Trüeb, Caroline Mann, Ralph von Kiedrowski
The scalp is the most common site affected in patients with psoriasis with up to 80% of these patients having some degree of scalp involvement. In this narrative review, we evaluate available data on the use of an innovative aerosol foam formulation of calcipotriol plus betamethasone dipropionate (Cal/BD) to treat patients with psoriasis and scalp involvement. The full PubMed database was searched using the terms “cal-cipotriol”, “betamethasone dipropionate” and “aerosol foam”, and all articles relating to “psoriasis with scalp involvement” were retrieved and used in the preparation of this review. The evidence supporting the clinical effectiveness, tolerability and impact on health outcomes of Cal/BD aerosol foam in patients with scalp psoriasis was obtained from a phase II clinical trial and real-world evidence data from a non-interventional study as well as from two case series. The findings from these studies show that Cal/BD aerosol foam is rapidly effective, improves skin condition, alleviates symptoms such as itch, and has a positive impact on patient quality of life. These attributes address several unmet needs for patients with psoriasis with scalp involvement and have the potential to improve individual adherence to treatment
{"title":"A narrative review of fixed combination calcipotriol/betamethasone aerosol foam (Enstilar®) in the management of psoriasis with scalp involvement","authors":"Petra Staubach, Andreas Körber, Ralph M Trüeb, Caroline Mann, Ralph von Kiedrowski","doi":"10.7573/dic.2024-1-6","DOIUrl":"https://doi.org/10.7573/dic.2024-1-6","url":null,"abstract":"The scalp is the most common site affected in patients with psoriasis with up to 80% of these patients having some degree of scalp involvement. In this narrative review, we evaluate available data on the use of an innovative aerosol foam formulation of calcipotriol plus betamethasone dipropionate (Cal/BD) to treat patients with psoriasis and scalp involvement. The full PubMed database was searched using the terms “cal-cipotriol”, “betamethasone dipropionate” and “aerosol foam”, and all articles relating to “psoriasis with scalp involvement” were retrieved and used in the preparation of this review. The evidence supporting the clinical effectiveness, tolerability and impact on health outcomes of Cal/BD aerosol foam in patients with scalp psoriasis was obtained from a phase II clinical trial and real-world evidence data from a non-interventional study as well as from two case series. The findings from these studies show that Cal/BD aerosol foam is rapidly effective, improves skin condition, alleviates symptoms such as itch, and has a positive impact on patient quality of life. These attributes address several unmet needs for patients with psoriasis with scalp involvement and have the potential to improve individual adherence to treatment","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"72 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140973711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Antibiotics are drugs of natural or synthetic origin used to treat various infections. The practice of excessive and inappropriate antibiotics use is the main global cause of bacterial resistance, which is one of the most serious global public health threats. It is estimated that about 50% of global antibiotic prescriptions are inappropriate. This study assesses the prevalence and pattern of inappropriate prescriptions of antibiotics amongst ambulatory care visits in Ethiopia.
Methods: A facility-based, cross-sectional study with a quantitative approach was conducted amongst randomly selected prescriptions issued for outpatients from May to June 2022 at Debre Markos Specialized Comprehensive Hospital, Northwest Ethiopia. Descriptive statistics, such as frequencies and percentages, were computed. For group comparisons, χ2 and independent sample t-tests were computed. The statistical significance of the association was considered at p<0.05.
Results: A total of 2640 antibiotics were prescribed for patients in the outpatient setting with various bacterial infections via 911 prescriptions, of which 49.5% were non-compliant with the national treatment guideline. Guideline non-compliant prescriptions increased remarkably amongst patients in the outpatient setting diagnosed with community-acquired pneumonia (38.8% versus 30.1%; p=0.006) and peptic ulcer disease (14.9% versus 9%; p=0.006). Moreover, inappropriate prescription was significantly higher amongst patients taking amoxicillin/clavulanic acid (33.2% versus 48.2%; p<0.001) and cephalexin (17.8% versus 24.3%; p=0.016).
Conclusion: Large proportions of antibiotic prescriptions for outpatients were non-compliant with the national treatment guideline, suggesting that prescribers need to give special attention to outpatients whilst ordering antibiotics such as amoxicillin/clavulanic acid and cephalexin. Antibiotic stewardship efforts to optimize outpatient antibiotic prescriptions and reduce the use of potentially inappropriate antibiotics are needed in Ethiopia.
{"title":"Antibiotic appropriateness at outpatient settings in Ethiopia: the need for an antibiotic stewardship programme.","authors":"Rahel Belete Abebe, Bezawit Mulat Ayal, Muluken Adela Alemu, Tirsit Ketsela Zeleke","doi":"10.7573/dic.2023-12-2","DOIUrl":"10.7573/dic.2023-12-2","url":null,"abstract":"<p><strong>Background: </strong>Antibiotics are drugs of natural or synthetic origin used to treat various infections. The practice of excessive and inappropriate antibiotics use is the main global cause of bacterial resistance, which is one of the most serious global public health threats. It is estimated that about 50% of global antibiotic prescriptions are inappropriate. This study assesses the prevalence and pattern of inappropriate prescriptions of antibiotics amongst ambulatory care visits in Ethiopia.</p><p><strong>Methods: </strong>A facility-based, cross-sectional study with a quantitative approach was conducted amongst randomly selected prescriptions issued for outpatients from May to June 2022 at Debre Markos Specialized Comprehensive Hospital, Northwest Ethiopia. Descriptive statistics, such as frequencies and percentages, were computed. For group comparisons, χ<sup>2</sup> and independent sample <i>t</i>-tests were computed. The statistical significance of the association was considered at <i>p</i><0.05.</p><p><strong>Results: </strong>A total of 2640 antibiotics were prescribed for patients in the outpatient setting with various bacterial infections via 911 prescriptions, of which 49.5% were non-compliant with the national treatment guideline. Guideline non-compliant prescriptions increased remarkably amongst patients in the outpatient setting diagnosed with community-acquired pneumonia (38.8% <i>versus</i> 30.1%; <i>p</i>=0.006) and peptic ulcer disease (14.9% <i>versus</i> 9%; <i>p</i>=0.006). Moreover, inappropriate prescription was significantly higher amongst patients taking amoxicillin/clavulanic acid (33.2% <i>versus</i> 48.2%; <i>p</i><0.001) and cephalexin (17.8% <i>versus</i> 24.3%; <i>p</i>=0.016).</p><p><strong>Conclusion: </strong>Large proportions of antibiotic prescriptions for outpatients were non-compliant with the national treatment guideline, suggesting that prescribers need to give special attention to outpatients whilst ordering antibiotics such as amoxicillin/clavulanic acid and cephalexin. Antibiotic stewardship efforts to optimize outpatient antibiotic prescriptions and reduce the use of potentially inappropriate antibiotics are needed in Ethiopia.</p>","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"13 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11090269/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140916231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-01eCollection Date: 2024-01-01DOI: 10.7573/dic.2024-2-3
Giorgio Walter Canonica, Piotr Kuna, Marcus Maurer, Ralph Mösges, Zoltan Novak, Nikolaus Papadopoulos, Pablo Rodriguez Del Rio
Background: Second-generation oral H1-antihistamines, including bilastine, represent the emerging treatments of allergic rhinitis (including rhinoconjunctivitis) and chronic urticaria in both adults and children. This study analyses available evidence supporting the use of bilastine amongst second-generation antihistamines for the symptomatic treatment of allergic rhinitis and urticaria in adults and children.
Methods: Consensus amongst experts from 17 countries on the ideal treatment of rhinitis and urticaria, and the specific role of bilastine was measured by means of a modified Delphi process. A total of 12 statements were voted on by the experts using a five-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = undecided; 4 = agree; 5 = strongly agree). The definition of consensus was set at a minimum of 80% concordance for 4+5 scores (agree or strongly agree).
Results: All proposed statements reached consensus, with a concordance of ≥98% for five statements and ≥96% for seven.
Conclusions: The wide consensus obtained for the proposed statements suggests a prominent role for bilastine in the management of allergic rhinitis and urticaria.
{"title":"Bilastine for the treatment of allergic rhinoconjunctivitis and urticaria: results from an international Delphi study.","authors":"Giorgio Walter Canonica, Piotr Kuna, Marcus Maurer, Ralph Mösges, Zoltan Novak, Nikolaus Papadopoulos, Pablo Rodriguez Del Rio","doi":"10.7573/dic.2024-2-3","DOIUrl":"10.7573/dic.2024-2-3","url":null,"abstract":"<p><strong>Background: </strong>Second-generation oral H<sub>1</sub>-antihistamines, including bilastine, represent the emerging treatments of allergic rhinitis (including rhinoconjunctivitis) and chronic urticaria in both adults and children. This study analyses available evidence supporting the use of bilastine amongst second-generation antihistamines for the symptomatic treatment of allergic rhinitis and urticaria in adults and children.</p><p><strong>Methods: </strong>Consensus amongst experts from 17 countries on the ideal treatment of rhinitis and urticaria, and the specific role of bilastine was measured by means of a modified Delphi process. A total of 12 statements were voted on by the experts using a five-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = undecided; 4 = agree; 5 = strongly agree). The definition of consensus was set at a minimum of 80% concordance for 4+5 scores (agree or strongly agree).</p><p><strong>Results: </strong>All proposed statements reached consensus, with a concordance of ≥98% for five statements and ≥96% for seven.</p><p><strong>Conclusions: </strong>The wide consensus obtained for the proposed statements suggests a prominent role for bilastine in the management of allergic rhinitis and urticaria.</p>","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"13 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11090268/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140916236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-29eCollection Date: 2024-01-01DOI: 10.7573/dic.2023-11-6
David Gómez-Ulloa, M Chris Runken, Wilton I Rodriguez, Basilio Hernández, Montserrat Chivite, E Anne Davis, Paul Nisbet
Background: As research continues towards improved treatments for Alzheimer disease (AD), there is growing interest in the views and needs from patients and caregivers on AD treatments.
Methods: In this study, we surveyed patients with AD and caregivers to determine the treatment goals that are most important to them. Patients with AD and caregivers were independently recruited in Europe and North America to complete a web-based survey. Eligible participants were ≥18 years old and diagnosed with mild cognitive impairment or mild-to-moderate AD (patient-reported group) or persons involved in the care of patients with AD (caregiver-reported group). A total of 322 patients and 614 caregivers completed the survey.
Results: The demographic characteristics of patients in the patient-reported and the caregiver-reported groups were similar. Disease severity of patients was greater in the caregiver-reported group compared with the patient-reported group (72.1% versus 46.9% moderate AD). The most important goal of AD treatment in both groups was maintenance of quality of life (QoL) (patient-reported group 31.1% and caregiver-reported group 38.8%; p=0.01). This was consistent across disease stages or symptom severity except for patients with mild cognitive impairment in the caregiver-reported group where slowing the progression of memory loss was the most important treatment goal.
Conclusions: Patient QoL was consistently the most relevant treatment goal for patients with AD and caregivers. In AD clinical trials, patient-relevant outcomes, for example, QoL, should be given high priority to reflect the needs and demands of patients with AD and their caregivers.A preliminary report of this work was presented at the 14th Clinical Trials on Alzheimer's Disease meeting (November 9-12, 2021).
{"title":"Understanding treatment goals and their application in clinical trial design for patients with Alzheimer disease and caregivers.","authors":"David Gómez-Ulloa, M Chris Runken, Wilton I Rodriguez, Basilio Hernández, Montserrat Chivite, E Anne Davis, Paul Nisbet","doi":"10.7573/dic.2023-11-6","DOIUrl":"https://doi.org/10.7573/dic.2023-11-6","url":null,"abstract":"<p><strong>Background: </strong>As research continues towards improved treatments for Alzheimer disease (AD), there is growing interest in the views and needs from patients and caregivers on AD treatments.</p><p><strong>Methods: </strong>In this study, we surveyed patients with AD and caregivers to determine the treatment goals that are most important to them. Patients with AD and caregivers were independently recruited in Europe and North America to complete a web-based survey. Eligible participants were ≥18 years old and diagnosed with mild cognitive impairment or mild-to-moderate AD (patient-reported group) or persons involved in the care of patients with AD (caregiver-reported group). A total of 322 patients and 614 caregivers completed the survey.</p><p><strong>Results: </strong>The demographic characteristics of patients in the patient-reported and the caregiver-reported groups were similar. Disease severity of patients was greater in the caregiver-reported group compared with the patient-reported group (72.1% <i>versus</i> 46.9% moderate AD). The most important goal of AD treatment in both groups was maintenance of quality of life (QoL) (patient-reported group 31.1% and caregiver-reported group 38.8%; <i>p</i>=0.01). This was consistent across disease stages or symptom severity except for patients with mild cognitive impairment in the caregiver-reported group where slowing the progression of memory loss was the most important treatment goal.</p><p><strong>Conclusions: </strong>Patient QoL was consistently the most relevant treatment goal for patients with AD and caregivers. In AD clinical trials, patient-relevant outcomes, for example, QoL, should be given high priority to reflect the needs and demands of patients with AD and their caregivers.A preliminary report of this work was presented at the 14th Clinical Trials on Alzheimer's Disease meeting (November 9-12, 2021).</p>","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"13 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11065135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140853984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Fixed-dose combinations (FDCs) were brought into the market with the intent of providing benefits primarily to patients and physicians. Nevertheless, despite their multiple advantages, they have their own set of drawbacks, especially regarding irrational FDCs. If physicians continue to prescribe them, prohibiting their sale would become all the more challenging. This cross-sectional survey study was planned to comprehend the level of knowledge, attitude and practice of physicians regarding such FDCs at a tertiary care teaching institute of western Uttar Pradesh, India.
Methodology: A pre-validated questionnaire was communicated electronically to all the attending physicians. For data analysis, descriptive statistics were applied and a χ2 test was performed for inter-group comparison.
Results: Amongst the 108 respondents, participation was almost comparable from both medical and surgical branches, with most participants being junior residents (58%). Even with sound knowledge of FDCs, only 46.30% of them were aware of banned FDCs. Similarly, only 6.48% could correctly identify the disadvantages associated with the use of FDCs, and 33.18% could correctly recognize irrational FDCs. This finding was consistently reflected in their attitude and practice and only 15.74% of respondents cross-referenced FDCs with the available literature. Furthermore, despite 88.89% of respondents checking for rationality of FDCs before prescribing them, a compendium of irrational FDCs is routinely prescribed.
Conclusion: To amend these shortcomings in prescribing of irrational FDCs, some recommendations are proposed by the authors herein.
{"title":"Assessment of knowledge, attitude and practice of fixed-dose combinations amongst attending physicians and residents: a cross-sectional evaluation.","authors":"Dhyuti Gupta, Prithpal Singh Matreja, Shilpa Patrick, Meenu Thomas, Pooja Agarwal, Preeti Singh","doi":"10.7573/dic.2024-2-1","DOIUrl":"https://doi.org/10.7573/dic.2024-2-1","url":null,"abstract":"<p><strong>Background: </strong>Fixed-dose combinations (FDCs) were brought into the market with the intent of providing benefits primarily to patients and physicians. Nevertheless, despite their multiple advantages, they have their own set of drawbacks, especially regarding irrational FDCs. If physicians continue to prescribe them, prohibiting their sale would become all the more challenging. This cross-sectional survey study was planned to comprehend the level of knowledge, attitude and practice of physicians regarding such FDCs at a tertiary care teaching institute of western Uttar Pradesh, India.</p><p><strong>Methodology: </strong>A pre-validated questionnaire was communicated electronically to all the attending physicians. For data analysis, descriptive statistics were applied and a χ<sup>2</sup> test was performed for inter-group comparison.</p><p><strong>Results: </strong>Amongst the 108 respondents, participation was almost comparable from both medical and surgical branches, with most participants being junior residents (58%). Even with sound knowledge of FDCs, only 46.30% of them were aware of banned FDCs. Similarly, only 6.48% could correctly identify the disadvantages associated with the use of FDCs, and 33.18% could correctly recognize irrational FDCs. This finding was consistently reflected in their attitude and practice and only 15.74% of respondents cross-referenced FDCs with the available literature. Furthermore, despite 88.89% of respondents checking for rationality of FDCs before prescribing them, a compendium of irrational FDCs is routinely prescribed.</p><p><strong>Conclusion: </strong>To amend these shortcomings in prescribing of irrational FDCs, some recommendations are proposed by the authors herein.</p>","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"13 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11065134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140860340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}