Uncontrolled Patients Research Articles

Quality of life in elderly people with type 2 diabetes using EQ-5D-5L tool: a case control study

BackgroundAccording to the World Health Organization (WHO), quality of life is “an individual’s perception of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns. Researchers have conceptualized quality of life on many levels, and there are multiple views on how it should be defined and measured. Chronic diseases like diabetes mellitus are known to compromise the HRQoL. Type 2 diabetes mellitus (DM) is a chronic metabolic disease known to affect HRQoL adversely. Two types of tools have been developed to measure HRQoL. Generic tools are general purpose measures used to assess HRQoL of communities and also for comparison between populations. The EQ-5D-5L consists of two pages—the EQ-5D-5L descriptive system and the EQ visual analog scale (EQ VAS). The descriptive system comprises the five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).ObjectivesAssess of quality of life in elderly patients of type 2 diabetes mellitus as well as determine effects of factors related to diabetes and diabetic control on the quality of life of type 2 diabetes.Methods- Population of study and disease condition:◦ A total of 60 participants were enrolled in this study, and all of the participants were among the geriatric group of people (age ≥ 60 years old).◦ Thirty of them self-reported to have diabetes mellitus type 2, while the other 30 subjects were a control group (self-reported no to have diabetes mellitus).◦ All participants were subjected to careful history taking, full clinical examination, in addition to laboratory investigation in the form of HBA1C.◦ All participants had to fill in self-reported questionnaire which is used as a tool for the assessment of HRQOL named EQ-5D-5L (some patients were illiterate so the questionnaire was interviewed to them).◦ All participants underwent interview questionnaires of the following HRQOL scales: geriatrics depression scale, ADL (activities of daily living scale), and IADL (instrumental activities of daily living scale).ResultsEQ-5D-5L score is significantly higher in diabetic patients than non-diabetics (p value < 0.001).EQ VAS score is significantly lower in diabetic patients than non-diabetics (p value < 0.001).ADL (activities of daily living) functional assessment impairment is higher in diabetics than non-diabetics (p value < 0.001). IADL (independence in activities of daily living) functional assessment impairment is higher in diabetics than non-diabetics (p value < 0.001).Visual prop is impaired in diabetics more than non-diabetics (p value < 0.001).Pain severity is mainly affected in diabetics more than non-diabetics.ConclusionType 2 diabetes mellitus in elderly patients affects their health-related quality of life and their daily activities.In our study, the HRQOL of uncontrolled diabetic patients were more negatively affected than that of the controlled diabetic patients.Moreover, some of our diabetic patients were found to suffer from cognitive disorders (insomnia and depression) as a complication of diabetes.We also found that the EQ-5D-5L of diabetic patients with comorbidities was higher than those without comorbidities and EQ-VAS was lower in comorbid diabetic patients.

Characteristic alterations of gut microbiota in uncontrolled gout.

Microbiome research has been on the rise recently for a more in-depth understanding of gout. Meanwhile, there is a need to understand the gut microbiome related to uric acid-lowering drug resistance. In this study, 16S rRNA gene-based microbiota analysis was performed for a total of 65 stool samples from 17 healthy controls and 48 febuxostat-treated gout patients (including 28 controlled subjects with decreased uric acid levels and 20 uncontrolled subjects with non-reduced uric acid levels). Alpha diversity of bacterial community decreased in the healthy control, controlled, and uncontrolled groups. In the case of beta diversity, the bacterial community was significantly different among groups (healthy control, controlled, and uncontrolled groups). Taxonomic biomarker analysis revealed the increased population of g-Bifidobacterium in healthy controls and g-Prevotella in uncontrolled patients. PCR further confirmed this result at the species level. Additionally, functional metagenomics predictions led to the exploration of various functional biomarkers, including purine metabolism. The results of this study can serve as a basis for developing potential new strategies for diagnosing and treating gout from microbiome prospects.

Prevalence of surgical site infection among bile spillage and non-spillage patients undergoing laparoscopic cholecystectomy: A cross-sectional study

Introduction: Laparoscopic cholecystectomy, a common procedure is not without complications, and bile spillage can cause surgical site infection (SSI). There is no local evidence in our hospital setting.&#x0D; Objective: The objective of this study was to find the prevalence of surgical site infection among bile spillage and non-spillage patients following laparoscopic cholecystectomy at BMCTH&#x0D; Methodology: A hospital-based cross-sectional study was conducted from 25 February 2021 to 25 August 2021 at the surgery department of BMCTH. We enrolled 120 patients through the total enumeration technique who underwent laparoscopic cholecystectomy. We enrolled all the eligible study participants who were more than 18 years excluding patients having age &gt;75 years, acute calculous cholecystitis, evidence of cholangitis and/or obstructive jaundice, previous biliary tract surgery, or previous Endoscopic retrograde cholangiopancreatography, evidence of uncontrolled diabetes mellitus and patients taking immunosuppressive drugs and immunosuppressed conditions like HIV/AIDS. The surgical site infection was assessed on the 7th postoperative day.&#x0D; Results: Among 120 patients undergoing laparoscopic cholecystectomy, the majority were female 92(76.7%) and 40-50 years age group 65(54.2%). Bile spillage was found in 27(22.5%) and non-spillage in 93(77.5%). The prevalence of surgical site infection (SSI) was found to be 7.5% which was more in the bile spillage group 25.9% than the non-spillage group 2.2%. The odds of having SSI among the spillage group was 15.9 times more than the non-spillage group and was statistically significant (p &lt;0.05). The pus culture of SSI found the predominant organism as Staphylococcus aureus 6(66.7%) followed by Escherichia coli 3(33.3%). The common indications of laparoscopic cholecystectomy were symptomatic cholelithiasis 95(79.1%) followed by chronic calculus cholecystitis 15(12.5%), gall bladder polyp 8(6.7%) and gall stone pancreatitis 2(1.7%).&#x0D; Conclusion: More than two and almost one out of ten had bile spillage and surgical site infection (SSI) respectively. A significantly higher number of SSI among the spillage group should be a concern of surgeons. We need to be extra careful with the spillage group for surgical site infection.

Insulin degludec/liraglutide versus its monotherapy on T2D patients: A lifetime cost-utility analysis in China.

Introduction: IDegLira (brand name Xultophy) is a novel fixed ratio combination of insulin degludec and liraglutide for type 2 diabetes (T2D) patients. This study aimed to investigate the lifetime cost-effective value of IDegLira compared with its single component (Degludec or Liraglutide) and to explore the suitable annual cost of IDegLira if necessary. Methods: UKPDS OM2 was applied to determine the long-term quality-adjusted life years (QALYs) and total costs. The efficacy data that were inputted into the model were synthesized from 6 randomized clinical trials (RCTs) that directly assessed the clinical benefit of IDegLira and its components in the treatment of uncontrolled T2D patients. The economic results were examined by one-way sensitivity analysis (OSA) and probabilistic sensitivity analysis (PSA). Further price reduction of IDegLira was investigated by binary search. Results: The IDegLira, IDeg, and Lira yielded 11.79 QALYs, 11.62 QALYs, and 11.73 QALYs and total cost of $20281.61, $3726.76, and $11941.26, respectively. The incremental cost-utility ratio (ICUR) of IDegLira versus IDeg was $99464.12/QALYs, and the ICUR of IDegLira versus Lira was $143348.26/QALYs, which indicated that IDegLira was not a cost-effective therapy for T2D patients compared with its components at the current price from a Chinese national healthcare system perspective. Base case results were robust to OSA and PSA. A further binary search showed that IDegLira appears to only be cost-effective if the annual cost of IDegLira is decreased by 58% when IDeg is considered as a reference, or by 30.57% when Lira is considered as a reference. Conclusion: In conclusion, IDegLira appears to not be cost-effective when compared with the current prices of IDeg or Lira for T2D patients in China. However, after the binary search, IDegLira appears to only be cost-effective if the annual cost of IDegLira is decreased 58% when IDeg is considered as a reference, or by 30.57% when Lira is considered as a reference.

Cardiovascular Risk Profile and Lipid Management in the Population-Based Cohort Study LATINO: 20 Years of Real-World Data.

The rising prevalence of cardiovascular (CV) risk factors in Portugal has translated into more than 35,000 annual deaths due to CV diseases. We performed a multicenter observational cohort study encompassing clinical activities performed between 2000 and 2019 to characterize the CV risk profile and LDL-C management of patients in every CV risk category using electronic health records of a regional population in Portugal. We analyzed data from 14 health centers and 1 central hospital in the north of Portugal of patients between 40 and 80 years that had at least 1 family medicine appointment at these institutions. Living patients were characterized on 31 December 2019. CV risk assessment was computed according to the 2019 ESC/EAS Guidelines. Lipid-lowering therapy (LLT) and achievement of LDL-C targets were assessed. In total, the analysis included 78,459 patients. Patient proportions were 33%, 29%, 22%, and 17% for low, intermediate, high, and very high CV risk, respectively. Moderate-intensity statins were the most frequently used medication across all CV risk categories. High-intensity statins were used in 5% and 10% of high and very high CV risk patients, respectively. Ezetimibe was used in 6% and 10% of high and very high CV risk patients, respectively. LDL-C targets were achieved in 44%, 27%, 7%, and 3% of low, intermediate, high, and very high CV risk patients, respectively. For uncontrolled patients in the high and very high CV risk categories, a median LDL-C reduction of 44% and 53%, respectively, would be required to meet LDL-C targets. There are clear opportunities to optimize LDL-C management in routine clinical practice. The prescription of LLT according to CV risk represents an important missed treatment opportunity.

Proposed Strategies to Improve Adult Asthma Management in Egypt: Expert Review and Recommendations.

Several challenges face asthma management in Egypt, including the high percentage of uncontrolled patients, inadequate compliance, and overuse of short-acting beta-agonists (SABAs) leading to increased asthma-related morbidity and mortality. In this regard, the recent Global Initiative for Asthma (GINA) recommendations included inhaled corticosteroids containing therapy for mild asthma. Local healthcare systems and healthcare professionals (HCPs) often experience practical challenges when implementing global guidelines. The present expert review aims to outline the development of local guidelines and health policies that integrate global advances in asthma management while addressing unmet needs and challenges in Egypt. A steering committee of health policymakers and respiratory experts from the principal healthcare sectors in Egypt came together in March 2021 to develop a consent and national guideline for local asthma management, codifying the current challenges and the required elements for adequate control. The recommendations were either evidence-based or consensus-based from the clinical expertise and perspectives of the committee. The committee identified vital challenges facing all chronic airway diseases with initial focus on asthma management in Egypt in diagnosis, data collection, policymaking, patients' awareness, and physicians' attitudes. In general, the committee stated that globally adapted management protocols necessitate addressing from diverse perspectives through policymakers, HCPs, and patients. Accordingly, it is vital to provide relevant education for the patient and HCPs. The recommendations emphasize key elements concerning baseline assessment, diagnosis, treatment strategy with regular review of patient progress, and compliance toward the introduced reforms. Full integration of these recommendations into local practice allows physicians to sustain adequate management while reducing preventable exacerbations and unnecessary burdens. The proposed strategies outline efficient patient-centered management that approaches asthma as an inflammatory condition, encouraging health promotion and patients' compliance.

Eosinophil depletion with benralizumab is associated with attenuated mannitol airway hyperresponsiveness in severe uncontrolled eosinophilic asthma

Airway hyperresponsiveness (AHR) and eosinophilia are hallmarks of persistent asthma. We investigated whether eosinophil depletion with benralizumab might attenuate indirect mannitol AHR in severe uncontrolled asthma using a pragmatic open-label design. After a 4-week run-in period with provision of usual inhaled corticosteroids and/or long-acting β-agonist (baseline), adults with mannitol-responsive uncontrolled severe eosinophilic asthma received 3 doses of open-label benralizumab 30 mg every 4 weeks, followed by 16 weeks' washout after the last dose. The primary outcome was doubling difference (DD) in provocative dose of mannitol required to decrease FEV1 by 10% (PD10) at the end point after 12 weeks, powered at 90% with 18 patients required to detect 1 DD. Secondary outcomes included measures assessed by the asthma control questionnaire and mini-asthma quality of life questionnaire. Twenty-one patients completed 12 weeks' benralizumab therapy at the end point at week 12. Mean (SEM) age was 53 (4) years, and FEV1 80.2% (4.1%) inhaled corticosteroid dose was 1895 (59) μg, with 12 receiving long-acting muscarinic antagonist and 13 leukotriene receptor antagonists. Improvement in AHR was significant by 8 weeks, with a mean 2.1 DD (95% confidence interval 1.0, 3.3; P< .01) change in PD10 at week 12, while mean changes in asthma control questionnaire and mini-asthma quality of life questionnaire were significant by week 2 and sustained over 12 weeks, both exceeding the minimal important difference. Peripheral blood eosinophils were depleted by 2 weeks (439 to 6 cells/μL). No significant improvement occurred in lung function after 12 weeks. Domiciliary peak flow and symptoms also improved with benralizumab. Eosinophil depletion results in clinically meaningful attenuated AHR in severe uncontrolled asthma patients.

Temperature-controlled Laminar Airflow (TLA) in symptomatic severe asthma – a post hoc analysis of severe exacerbations, quality of life and health economics

PurposeUncontrolled severe asthma constitutes a major economic burden to society. Add-ons to standard inhaled treatments include inexpensive oral corticosteroids and expensive biologics. Nocturnal treatment with Temperature-controlled Laminar Airflow (TLA; Airsonett®) could be an effective, safe and cheaper alternative. The potential of TLA in reducing severe asthma exacerbations was addressed in a recent randomised placebo-controlled trial (RCT) in patients with severe asthma (Global Initiative for Asthma (GINA) step 4/5), but the results were inconclusive. We re-analysed the RCT with severe exacerbations stratified by the level of baseline asthma symptoms and Quality of Life.MethodsMore uncontrolled patients, defined by Asthma Control Questionnaire 7 (ACQ7) > 3, EuroQoL 5-Dimension Questionnaire Visual Analogue Scale (EQ5D-VAS) ≤ 65 and Asthma Quality of Life Questionnaire (AQLQ) ≤ 4 were selected for re-analysis. The rates of severe asthma exacerbations, changes in QoL and health-economics were analysed and compared between TLA and placebo.ResultsThe study population included 226 patients (113 TLA / 113 placebo.) The rates of severe asthma exacerbations were reduced by 33, 31 and 25% (p = 0.083, 0.073, 0.180) for TLA compared to placebo, dependent on selected control measures (ACQ7, EQ5D-VAS, AQLQ, respectively). For patients with less control defined by AQLQ≤4, the difference in mean AQLQ0-12M between TLA and placebo was 0.31, 0.33, 0.26 (p = 0.085, 0.034, 0.150), dependent on selected covariate (AQLQ, EQ5D-VAS, ACQ7, respectively). For patients with poor control defined by ACQ7 > 3, the difference in EQ5D-5 L utility scores between TLA and placebo was significant at 9 and 12 months with a cost-effective ICER. The results from the original study did not demonstrate these differences.ConclusionThis post hoc analysis demonstrated an effect of TLA over placebo on severe exacerbations, asthma control and health economics in a subgroup of patients with more symptomatic severe allergic asthma. The results are consistent with the present recommendations for TLA. However, these differences were not demonstrated in the full study. Several explanations for the different outcomes have been outlined, which should be addressed in future studies.FundingNIHR Health Technology Assessment Programme and Portsmouth Hospitals NHS Trust.

First Massive Transfusion Protocol (MTP) Implementation Proposal in Egypt

Abstract Introduction/Objective Massive transfusion is often defined as transfusion of adults with 10 or more of packed red blood cells units in 24 hours period or transfusion of 4 or more units of packed red blood cells (PRBCs) in one hour when on-going need for more transfusion is foreseeable. Massive transfusion protocol in children is defined as transfusion of &amp;gt;40 mL/kg. Massive transfusion protocol (MTP) is a vital element of damage control resuscitation and provides a coordinated clinical response to hemorrhage in patients requiring massive blood transfusions after hospital admission. Hemorrhage is the most common cause of death within the first hour of arrival to the trauma center. Methods/Case Report This study aims to develop and establish the first massive protocol in Egypt to provide a consistent treatment for blood transfusion for trauma patients that will Reduce delay in ordering and administering blood products and Deliver a reasonable ratio of plasma to red blood cells. The protocol will be first implemented in a military hospital in Egypt. Developing the massive transfusion protocol will allow the practitioners to follow algorithm for rapid replacement of blood products using uncrossmatched packed red blood cells, Plasma, platelets and cryoprecipitate if necessary. Adopting the American Association of Blood Banks (AABB) and the American College of Surgeons (ACS) guidelines are the best practice around the world. The Protocol will be developed by multidisciplinary committee engagement, Blood bank, Diagnostic laboratory and Clinical care areas (OR, ER, ICU, OBS). Results (if a Case Study enter NA) The massive transfusion protocol ratio will be 3:2 (RBC: FFP) and one units of platelets for every 6 units of RBC. according to American College of Surgeons (ACS) guidelines the ratio should be 1:1 to 1:2 (RBC: FFP). The committee established defined criteria for MTP activation and termination. The delivery time of the blood products should be between 5-10 minutes. Administration of tranexamic acid to inhibit plasminogen activation and stabilize the clot. Conclusion The Developing and Implementing MTP in Egypt will provide reduction in mortality for trauma and uncontrolled hemorrhage patients. Once implemented, we will regularly evaluate the use and efficacy of the MTP to ensure positive patient outcomes., the MTP will be evaluated to ensure best practice.

Dupilumab Efficacy and Safety as an Add-On Therapy in Uncontrolled Asthma Patients: A Systematic Review

Asthma is a heterogeneous chronic inflammatory condition affecting the lung. Standard treatment, a high-dose inhaled corticosteroid (ICS) and long-acting bronchodilator (LABA), effectively manages asthma in most individuals. However, 5%-10% of individuals with asthma were ineffective with those treatments. Recent RCTs suggested that Dupilumab posed potential as an add-on therapy. This systematic review aims to support the efficacy (the annualized rate of severe asthma exacerbation and increase in FEV1) and the safety of Dupilumab as an add-on therapy in uncontrolled asthma patients. We used "(Asthma) AND (Dupilumab)" as keywords on PubMed and ScienceDirect. We included only RCT design studies comparing the efficacy and safety of Dupilumab with a placebo in uncontrolled asthma patients. The placebo was ICS and LABA or oral glucocorticoids. This paper included five RCTs with 3400 participants, and their quality was assessed using Critical Appraisal Tools Program (CASP) tools. We conducted a meta-analysis to calculate the pooled risk ratio (RR). In addition, we used Mantel-Haenszel with 95% confidence intervals for dichotomous data. Furthermore, we used a random-effects model to count for interstudy heterogeneity. Then, we processed data using Revman 5.4. Dupilumab as an add-on therapy significantly showed a consistent effect in lower the annualized rate of severe asthma exacerbation (RR= 0.46; 95% CI 0.36- 0.58; p=0.007) and increased FEV1 compared to placebo. In addition, the most common adverse effect of using Dupilumab were injection site reaction, upper respiratory tract infections, and eosinophilia. In conclusion, Dupilumab is safe and well-tolerated as moderate-to-severe uncontrolled asthma add-on therapy

Emergency Treatment of Submandibular Abscess Spreading to Buccal and Submental Spaces in Uncontrolled Diabetic Patients: A Case Study

Emergency Treatment of Submandibular Abscess Spreading to Buccal and Submental Spaces in Uncontrolled Diabetic Patients: A Case Study Cahyono Yudianto1*, Endang Sjamsudin2, Winarno Priyanto3, Agus Nurwiadh4, 1Resident of Oral and Maxillofacial Surgery, Faculty of Dentistry, Universitas Padjadjaran/ RSUP Dr. Hasan Sadikin, Bandung, Indonesia 2,3,4Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Universitas Padjadjaran/ RSUP Dr. Hasan Sadikin, Bandung, Indonesia *Email correspondence: cahyono19001@mail.unpad.ac.id ABSTRACT Introduction: Dental infections can extend to the maxillofacial space causing severe infections such as abscesses. Abscess in the maxillofacial space aggravated by the systemic disease of diabetes mellitus can delay healing and cause further complications. This case report discusses the emergency treatment of a submandibular abscess that extends to the buccal and submental spaces in a patient with diabetes mellitus. Case Report: A 41-year-old female patient came to the Emergency Department of Hasan Sadikin Hospital in Bandung, complaining of swelling on the right cheek. The swelling was felt for seven days which started in the right submandibular area and extended to the right cheek and submental area. The patient had a history of diabetes mellitus for eight years, and on arrival, his current blood sugar was 365 mg/dL. The patient was diagnosed with a submandibular abscess that extends to the right buccal and submental area with uncontrolled diabetes mellitus. Treatment includes a drainage incision, Penrose drain, extraction of the causative tooth, and administration of ceftriaxone, metronidazole, ketorolac, and omeprazole drugs. Conclusion: Submandibular abscess that extends to several maxillofacial spaces is an emergency condition that requires immediate management to prevent the spread of infection to other tissues, which can cause mortality. Keywords: Abscess, Submandible, Buccal, Submental, Diabetes Mellitus

ODP320 Immune Organs Enlarged in Acromegaly: Evaluation of Thymus Volume in Patients with Acromegaly

Abstract Objectives The thymus is an important immunological organ where T cell maturation takes place, especially in the early stages of life. Animal studies have shown that the structure and functions of the thymus are controlled by hormones. Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) stimulate both thymic epithelial cells and thymocytes. This causes an increase in the number of cells and the secretion of cytokines. These effects of GH and IGF-1 on the thymus have not yet been confirmed in humans. We have hypothesized that, acromegaly with chronic GH and IGF-1 elevation, may change the volume and the functions of the thymus. In this study, we have examined the thymus volume in patients with acromegaly. Materials and Methods In this single center study, 393 patients with acromegaly were retrospectively evaluated to identify patients who underwent chest CT for any reason before and/or after pituitary surgery. Since 64 patients in the acromegaly group had chest CT, we also selected 64 patients as an age- and sex-matched control group among trauma patients without any known disease who admitted to the emergency department. All chest CT images were reassessed by a radiologist to detect the thymus gland and calculate its volume (if visible) who was unaware of clinical data. The frequencies and volumes of visible thymus glands were compared between acromegaly and control groups. Results Mean (±SD) age was 49.9±13.8 years in acromegaly group and 51.7±14.1 years in control group(p= 0.32). Twenty-seven patients (42.2%) from each group were female. Median (IQR) GH levels were 10. 0 (21.1) ng/mL and mean±SD IGF-1 levels were 729.5±283.5 ng/mL. While 51 patients (79.7%) had a visible thymus gland at chest CT in acromegaly group, only 29 patients (45.3%) had a visible thymus gland in control group (p&amp;lt;0. 001). Median (IQR) values for the volumes of visible thymus glands in acromegaly and control groups were 13. 0 (9.4) cm 3 and 10.3 (7.6) cm 3, respectively (p=0. 014). There was no correlation between thymus gland volume and GH(r=-0. 02; p= 0.91) and IGF-1(r=0.11; p=0.49) levels. In acromegaly group, six patients had a visible thymus gland on both preoperative and postoperative chest CTs. After surgery, hormonal remission was achieved in four patients and thymus gland volume decreased in three of them (Patient 1: 15.26 to 17.23, Patient 2: 22.66 to 15.88, Patient 3: 19. 00 to 11.80 and Patient 4: 17.78 to 12. 07 cm 3). Volume increase was observed in two uncontrolled patients (Patients 5: 12.45 to 15.42, Patient 6: 6. 05 to 19.59 cm 3). Conclusion This study has firstly shown that, the thymus is enlarged in patients with acromegaly. Effective control of the disease reduces thymus volume. Further research is needed to elucidate this association and its putative clinical implications. Presentation: No date and time listed

OR27-4 Placebo-Controlled and Open-Label Extension Study of a Novel Hepatic-Targeted Antisense Cimdelirsen (IONIS-GHR-LRx) Under Investigation in Acromegaly Patients

Abstract Cimdelirsen (IONIS-GHR-LRx; ISIS 766720) is a novel, ligand-conjugated, hepatic-targeted investigative antisense molecule designed to reduce growth hormone receptor (GHr) synthesis, thereby inhibiting deleterious effects of growth hormone (GH) hypersecretion and reducing circulating insulin-like growth factor-1 (IGF-1) levels in acromegaly patients. Methods Cimdelirsen was evaluated in a 4-month double-blind, placebo-controlled phase 2 study (DBL) in uncontrolled acromegaly patients (IGF-1&amp;gt;1.3-&amp;lt;5xULN) treated with stable long-acting somatostatin receptor ligand (SRL) injections (NCT03548415). Due to COVID-19 pandemic, the study closed early resulting in smaller cohorts than planned. While no longer powered to assess Day 141 primary endpoint (PE), the study permitted placebo-controlled evaluation of safety and efficacy. The final analysis included 41 patients in the cimdelirsen low dose (60 and 80 mg; n=22), high dose (120 and 160 mg; n=7) or placebo (n=12) cohorts. 39 of these patients subsequently entered an open label extension (OLE) safety study where all patients were treated with cimdelirsen and at the time of interim analysis, 23 patients were treated for ≥ 1 year (NCT03967249).Patient reported outcomes were assessed using the validated ACROQoL and an acromegaly symptoms questionnaire. Results Cimdelirsen treatment resulted in a significant, dose dependent reduction in GH-binding protein (GHBP), a biomarker of hepatic GHR reduction: -2% placebo, -43% low dose, -64% high dose; p&amp;lt;0.001. Importantly, GHBP reductions were not associated with fasting GH increases. The GH mean change from baseline to PE was 1 ng/mL placebo, 0 ng/mL low dose and 1 ng/mL high dose (p&amp;gt;0.5). GHBP reductions without GH increases were maintained for up to 1 year of treatment in all patients.Integrated AUC for IGF-1 calculated after GHBP had reached near-maximal reductions (Day 57 to PE) demonstrated dose-dependent reductions that were significant at the high dose (+692%*day placebo, -460 low dose, and -1378 high dose; p=0.21 and 0.05 for the low dose and high dose groups, respectively). A greater reduction in IGF-1 AUC was observed in patients who had higher IGF-1 levels at baseline.Patients with higher IGF-1 levels showed significant improvements in ACROQoL at the PE; all patients demonstrated improvements after 1 year. Importantly, high-dose cimdelirsen improved sweating and headaches at PE.In both studies, there were no drug-related SAEs. The most frequently reported TEAE were UTI (16.1%) and COVID-19 (12.8%) in DBL and OLE, respectively. No safety signals were observed including no ALT elevation &amp;gt;3×ULN and no thrombocytopenia (&amp;lt;100 10^3/uL). Glycemic control remained stable and showed no worsening of HbA1c. Conclusion Once monthly SC cimdelirsen injections demonstrated long-term safety, were well-tolerated, and resulted in significant reductions in GHBP and IGF-1 AUC without increased GH levels. Cimdelirsen also improved PRO, collectively supporting further development of this novel, liver-directed potential therapy for uncontrolled acromegaly. Presentation: Tuesday, June 14, 2022 10:30 a.m. - 10:45 a.m.

Does Short Term Atorvastatin Treatment Improve Symptomatic Control in Patients with Mild to Moderate &amp; Uncontrolled Asthma?

Introduction: Asthma is a chronic disease characterized by recurrent episodes of breathlessness and wheezing. Keeping in view the problems in asthma control and side effects of available medication, there is a need for alternative treatments with better efficacies and fewer side effects. Atorvastatin is a statin that blocks HMG CoA reductase enzyme found in the liver, inhibiting the synthesis of cholesterol. Blockade of this pathway also inhibits production of GTPases which are involved in airway inflammation, airway remodeling and contraction of smooth muscles of the bronchi. Aims &amp; Objectives: To evaluate the symptomatic control in mild to moderate and uncontrolled asthma patients using standard treatment versus its combination with atorvastatin. Place and duration of study: This study was conducted in Pulmonology Department of Lahore General Hospital; Lahore over a 4-week duration from October 2018 till February 2019. Material &amp; Methods: Patients of mild to moderate and uncontrolled asthma were enrolled in this study based on inclusion and exclusion criteria. Patients were divided into two groups by lottery method, Group 1 and Group 2, with 34 patients in each group. Group 1 was continued with standard therapy of asthma and the Group 2 was administered atorvastatin 40 mg, once daily in addition to standard therapy for 4 weeks. The control of asthma before and after treatment was assessed based on Global Initiative for asthma (GINA) guideline questionnaire score. SPSS (Statistical Package for Social Sciences) version 22 was used for analysis of data. P-Value &lt; 0.05 was taken as significant. Results: Nonsignificant results were obtained when comparison between the groups was made based on GINA guidelines questionnaire score by Mann Whitney Utest Conclusion: It was concluded that atorvastatin has no role in symptomatic control in patients of mild to moderate and uncontrolled asthma.

Astımlı Hastalarda D Vitamini Düzeyinin Astım Kontrolü Üzerine Etkisi

The aim of this study is to evaluate the effects of serum vitamin D level on asthma control and pulmonary functions in asthmatic patients. 35 healthy controls and 60 asthma patients were included. Demographic characteristics, ACT and PFT were recorded and laboratory tests were measured. 53 asthmatic patients and 32 controls with decreased vitamin D levels were referred to the Endocrinology Department for vitamin D replacement therapy. In asthmatic patients, ACT and PFT were repeated at third month of therapy. In terms of age, sex, sociodemographic characteristics, smoking status, daily sun exposure, calcium-containing diet, and menopausal status, there was no significant difference between asthmatics and controls, and laboratory test findings were similar. Vitamin D levels were low in about 90%. While 71,7% of asthmatic patients were uncontrolled at initial admission, the rate of uncontrolled patients decreased to 13,2% after the post-replacement evaluation. There was a significant increase of ACT with vitamin D replacement. There was also significant increase in FVC, FEV1 and FEV1/FVC after replacement therapy. The mean BMI were high in both groups (≥30 kg/m²). The mean ACT score was lower in obese asthmatics than in non-obese patients, but the difference was not significant. Presence of controlled or uncontrolled disease was similar between the obese and non-obese. According to our findings, vitamin D replacement therapy has a positive effect on asthma control and pulmonary function.

Status of home blood pressure monitoring and influencing factors of regular home blood pressure monitoring among elderly uncontrolled hypertensive patients in Central and Western China

Objective: To describe the prevalence of home blood pressure monitoring and analyze the factors influencing regular blood pressure monitoring among elderly uncontrolled hypertensive patients in Central and Western China. Methods: It was a cross-sectional study, which enrolled hypertensive patients aged over 60 years with office blood pressure ≥140/90 mmHg (1 mmHg=0.133 kPa) from September 2019 to July 2020 in 72 hospitals in Central and Western China. Patients completed the electronic questionnaires, and were divided into regular and irregular home blood pressure monitoring groups. The proportion of patients using different types of sphygmomanometers and the percentage of patients with regular home blood pressure monitoring (at least weekly) were explored. The generalized linear mixed model was used to define the influencing factors of regular home blood pressure monitoring. Results: A total of 3 857 patients were included in this study. Age was 67(64,71) years old and there were 2 163 males (56.1%). Overall, sphygmomanometer was available at home for 3 044(78.9%) patients, 2 168(56.2%) patients conducted regular home blood pressure monitoring. Among the patients with a sphygmomanometer at home, 2 370(77.9%) of the sphygmomanometers were upper arm electronic device. Older age, higher income, longer history of hypertension, multiple antihypertensive medications and awareness of diagnostic criteria of hypertension and hypertension complications were associated with a higher prevalence of regular home blood pressure monitoring (all P<0.05). Conclusions: Among the elderly hypertensive patients with uncontrolled blood pressure in Central and Western China, there is a relatively high prevalence of home sphygmomanometer ownership and regular monitoring. Age, family income, history of hypertension, number of antihypertensive drugs and knowledge of hypertension are the influencing factors of regular home blood pressure monitoring in this population.

Cost-effectiveness of benralizumab versus mepolizumab and dupilumab in patients with severe uncontrolled eosinophilic asthma in Spain

Objective To assess the cost-effectiveness of benralizumab (benra) vs. mepolizumab (mepo) and dupilumab (dupi) for the treatment of patients with severe uncontrolled asthma from the Spanish Health System perspective. Methods Exacerbations avoided, quality-adjusted life years (QALYs) gained and costs in a 5-year period were estimated with a Markov model for a cohort of 1,000 patients in which, based on published evidence, 31% of the patients received biologics + oral corticosteroids (OCS) and 69% received only biologics. Efficacy data (exacerbation reduction and OCS elimination) were derived from a matching-adjusted indirect comparison. Published EQ-5D utilities per health state (biologic alone, biologic + OCS, standard of care + OCS, exacerbations, and post-exacerbations) were used for QALY estimation. Utility decrements associated with exacerbation management [-0.1 (OCS or emergency visits), −0.2 (hospitalization)] derived from the literature were applied. Costs (€, 2022) included drug acquisition (ex-factory price), administration and disease management. An expert panel (2 pneumologists and 1 pharmacist) validated all inputs. Results Benra was more effective (52.21 QALYs) than mepo (51.39 QALYs) and dupi (51.30 QALYs). Benra avoided more exacerbations (2.87 exacerbations) compared to mepo (4.70 exacerbations) and dupi (5.11 exacerbations) for the 5-year horizon. Total costs/patient were €56,093.77 (benra), €59,280.45 (mepo) and €62,991.76 (dupi), resulting in benra dominating (more QALYs with lower costs) vs. mepo and dupi. Conclusions Benralizumab can be considered as a dominant treatment alternative vs. other biologic drugs for the treatment of uncontrolled severe eosinophilic asthma patients in Spain.

Evaluation of ketoconazole as a treatment for Cushing's disease in a retrospective cohort.

ObjectiveThe first-line treatment for Cushing’s disease is transsphenoidal surgery, after which the rates of remission are 60 to 80%, with long-term recurrence of 20 to 30%, even in those with real initial remission. Drug therapies are indicated for patients without initial remission or with surgical contraindications or recurrence, and ketoconazole is one of the main available therapies. The objective of this study was to evaluate the safety profile of and the treatment response to ketoconazole in Cushing’s disease patients followed up at the endocrinology outpatient clinic of a Brazilian university hospital.Patients and methodsThis was a retrospective cohort of Cushing’s disease patients with active hypercortisolism who used ketoconazole at any stage of follow-up. Patients who were followed up for less than 7 days, who did not adhere to treatment, or who were lost to follow-up were excluded.ResultsOf the 172 Cushing’s disease patients who were followed up between 2004 and 2020, 38 received ketoconazole. However, complete data was only available for 33 of these patients. Of these, 26 (78%) underwent transsphenoidal surgery prior to using ketoconazole, five of whom (15%) had also undergone radiotherapy; seven used ketoconazole as a primary treatment. Ketoconazole use ranged from 14 days to 14.5 years. A total of 22 patients had a complete response (66%), three patients had a partial response (9%), and eight patients had no response to treatment (24%), including those who underwent radiotherapy while using ketoconazole. Patients whose hypercortisolism was controlled or partially controlled with ketoconazole had lower baseline 24-h urinary free cortisol levels than the uncontrolled group [times above the upper limit of normal: 0.62 (SD, 0.41) vs. 5.3 (SD, 8.21); p < 0.005, respectively] in addition to more frequent previous transsphenoidal surgery (p < 0.04). The prevalence of uncontrolled patients remained stable over time (approximately 30%) despite ketoconazole dose adjustments or association with other drugs, which had no significant effect. One patient received adjuvant cabergoline from the beginning of the follow-up, and it was prescribed to nine others due to clinical non-response to ketoconazole alone. Ten patients (30%) reported mild adverse effects, such as nausea, vomiting, dizziness, and loss of appetite. Only four patients had serious adverse effects that warranted discontinuation. There were 20 confirmed episodes of hypokalemia among 10/33 patients (30%).ConclusionKetoconazole effectively controlled hypercortisolism in 66% of Cushing’s disease patients, being a relatively safe drug for those without remission after transsphenoidal surgery or whose symptoms must be controlled until a new definitive therapy is carried out. Hypokalemia is a frequent metabolic effect not yet described in other series, which should be monitored during treatment.

КЛИНИЧЕСКИЕ ИСХОДЫ COVID-19 СРЕДИ ЛИЦ, ЖИВУЩИХ С ВИРУСОМ ИММУНОДЕФИЦИТА ЧЕЛОВЕКА

Abstract. Introduction. Since the early 1980s, the world has experienced an epidemic of human immunodeficiency virus infection. After that, in 2019 healthcare system faced a pandemic of infection caused by the emergence of a new coronavirus SARS-CoV-2, which caused high morbidity and mortality worldwide. Data on the incidence, course, and outcomes of COVID-19 in people living with human immunodeficiency virus are limited. Aim. The aim of the study is to examine data from publications on clinical outcomes of COVID-19 in people living with human immunodeficiency virus. Material and methods. A thorough literature search was carried out using the MEDLINE, Embase, Scopus databases, 21 sources were selected and analyzed. Results and discussion. Publication data do not indicate that people living with human immunodeficiency virus are more susceptible to COVID-19 than the general population. As in the general population, older age and the presence of comorbidities worsen the prognosis in patients with human immunodeficiency virus and COVID-19. A number of authors note higher mortality rates from COVID-19 infection in HIV-infected patients of African and Asian descent. Well-controlled human immunodeficiency virus infection does not change the clinical presentation or worsen the clinical outcome of hospitalization for COVID-19 infection in HIV-infected patients. Patients with human immunodeficiency virus in the advanced stages of the disease may show less severe symptoms of COVID-19 infection due to a reduction in the severity of immune responses. Conclusion. Clinical outcomes of COVID-19 in patients with and without human immunodeficiency virus coinfection are comparable. The high-risk group for COVID-19 includes human immunodeficiency virus patients with pre-existing comorbidities and individuals in older age groups. Controlled human immunodeficiency virus patients with an undetectable viral load have a better prognosis than uncontrolled patients.

A RARE CAUSE OF COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA IN A PATIENT WITH POORLY CONTROLLED DIABETES

A RARE CAUSE OF COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA IN A PATIENT WITH POORLY CONTROLLED DIABETES