Real World Evidence of Bempedoic Acid on Efficacy and Safety in Patients with Uncontrolled LDL-c and at High Risk of CVD

Background and Objective: Cardiovascular disease (CVD) is a significant cause of morbidity and mortality worldwide, with high-risk patients requiring effective management to reduce their risk of cardiovascular events. Bempedoic acid is a novel therapeutic agent recently approved as an add-on therapy to statins in patients with uncontrolled LDL-c. Bempedoic acid inhibits cholesterol synthesis in the liver, which ultimately reduces the risk of cardiovascular events. Therefore, the present study aims to assess the efficacy and safety of bempedoic acid in patients with uncontrolled LDL-c (Previously on moderate or high-intensity statins) with a high risk of CVD in real-world settings. Methods: This is a multicenter, retrospective, observational study on the data of high-risk-CVD patients collected from Bempedoic Acid on Efficacy and Safety in patients (BEST) Registry. The clinical data of 140 patients who were already on statin therapy and were receiving Bempedoic acid at a dose of 180 mg, along with measurements of the level of LDL-c, HbA1c, HDL, TG, TC, PPPG, FPG, AST, ALT, serum creatinine was taken into consideration. The primary outcome includes a change in LDL-c level, and secondary outcomes involve a change in the level of HbA1c, HDL, TG, TC, PPPG, FPG, AST, ALT, and serum creatinine at week 12 and 24. Adverse events were reported at both time points. Results: A total of 140 patients were included in the present study with a mean age of 51.8 ± 9.2 years and had primary confirmed diagnosis of dyslipidemia with uncontrolled LDL-c. The mean levels of LDL-c decreased from the mean baseline value of 142.67 ± 46.49 mg/dL, to 106.78 ±33.92 mg/d; a statistically significant reduction by 23.23% (p < 0.01) at week 12. Similarly, at week 24, the mean LDL-c value reduced to 90.39 ± 38.89 mg/dL. A 33.38 % decrease was observed (p < 0.01). Other parameters such as non-HDL, FPG, PPPG, AST and serum creatinine also showed statistically significant reduction at week 12 and week 24. Conclusion: The present study demonstrates that bempedoic acid is an effective add-on medication in lowering LDL-c levels in high-risk CVD patients with uncontrolled LDL-c.

Assessment of core capacities for antimicrobial stewardship practices in indian hospitals: Report from a multicentric initiative of global health security agenda

Introduction: Antimicrobial-resistant HAI (Healthcare associated infection) are a global challenge due to their impact on patient outcome. Implementation of antimicrobial stewardship programmes (AMSP) is needed at institutional and national levels. Assessment of core capacities for AMSP is an important starting point to initiate nationwide AMSP. We conducted an assessment of the core capacities for AMSP in a network of Indian hospitals, which are part of the Global Health Security Agenda-funded work on capacity building for AMR-HAIs. Subjects and Methods: The Centers for Disease Control and Prevention's core assessment checklist was modified as per inputs received from the Indian network. The assessment tool was filled by twenty hospitals as a self-administered questionnaire. The results were entered into a database. The cumulative score for each question was generated as average percentage. The scores generated by the database were then used for analysis. Results and Conclusion: The hospitals included a mix of public and private sector hospitals. The network average of positive responses for leadership support was 45%, for accountability; the score was 53% and for key support for AMSP, 58%. Policies to support optimal antibiotic use were present in 59% of respondents, policies for procurement were present in 79% and broad interventions to improve antibiotic use were scored as 33%. A score of 52% was generated for prescription-specific interventions to improve antibiotic use. Written policies for antibiotic use for hospitalised patients and outpatients were present on an average in 72% and 48% conditions, respectively. Presence of process measures and outcome measures was scored at 40% and 49%, respectively, and feedback and education got a score of 53% and 40%, respectively. Thus, Indian hospitals can start with low-hanging fruits such as developing prescription policies, restricting the usage of high antibiotics, enforcing education and ultimately providing the much-needed leadership support.

Prevalence and determinants of nocturnal enuresis in school going children in Southern Maharashtra, India

Background: Nocturnal enuresis or bedwetting is a common health problem in children in the age group of 5 to 15 years. In India the prevalence of nocturnal enuresis ranges from approximately 7% to 12.6%. The prevalence from other parts of the world ranges from 6% to 42%. This study was planned to find the prevalence and determinants of nocturnal enuresis in school going children.Methods: This cross-sectional study was conducted in four primary and secondary schools in Solapur. A predefined questionnaire, prepared in English and translated to local languages, Marathi and Kannada, was handed over to all the children attending the selected schools. Children were asked to hand over the questionnaire to their parents and return with the filled questionnaire. The questionnaire was prepared to obtain the information related to the socio-demographic factors of the family and child, frequency of enuresis and information related the risk factors. Nocturnal enuresis was defined if the frequency of enuresis was more than twice per week.Results: The overall prevalence of nocturnal enuresis was 11.4 %. The maximum prevalence was found in the age group of 8 -9 years (22.96 %). The prevalence of nocturnal enuresis in boys (14.34 %) was significantly more than the prevalence in girls (8.31 %). The study showed that nocturnal enuresis was significantly associated with stress, poor school performance, sleep pattern (hard to awaken), family history, burning micturition etc. But it was not associated with maternal or paternal education, birth order, type of family.Conclusions: The prevalence of nocturnal enuresis is 11.40 % in school going children and it is associated with age, sex, stress, family history, burning micturition, hyperactive child, poor school performance, sleep pattern (hard to awake) avoidance of going to micturate before sleep etc.

Nutritional anaemia: clinical and haematological presentation in children

Background: There are three main causes of anemia, decreased production of RBCs, and excessive destruction of RBCs or Excessive blood loss. In India, the main reason of anaemia is the decreased production due to nutritional deficiency. The main nutrients required in the process of haemoglobin production are iron, folic acid and cyanocobalamine. The objective of the present study was to find the clinical presentations and hematological changes in children with nutritional anaemia.Methods: This Cross-sectional study was conducted from January 2018 to October 2018 in the department of Paediatrics of Ashwini Rural Medical College Hospital and Research Centre, Solapur. Children visiting the paediatric OPD due to any illness and having clinical suspicion of anemia were initially screened for inclusion in the study. Detailed laboratory investigation such as CBC, peripheral blood for Leishman's stain and reticulocyte count were performed. Serum Ferritin, vitamin B12, folic acid levels were also done to ascertain the cause of anemia. World Health Organization recommended criteria were used to diagnose and grade the anemia.Results: A total of 405 anemic children were included in the study. Out of that 213 were boys and 192 were girls. A total of 226 children presented with mild anemia. The most common clinical presentation was respiratory tract infection, found in 62.22 % of children followed by fever in 53.09 % of children. Maximum numbers of patients were suffering from iron deficiency anemia, followed by folic acid deficiency. Deficiency of both of these nutrients was also common. Vit B12 deficiency was found in only 5 children.Conclusions: The study concluded that iron deficiency anemia was the commonest nutritional anemia in children in the age group of 5 to 15 years. Second most common deficiency was of folic acid. Majority of the anemic patients presented with respiratory tract infection and fever.

Rare Patterns of Impacted Mandibular Teeth: A Case Series.

Tooth eruption is the axial movement of the tooth from its developmental position within the jaws to the functional position in the occlusion plane. Any interference in the complex sequential events or pathology of the surrounding bone may cause diffi culty in eruption. Th is may cause an ectopic eruption and aberrant eruption pattern. Th is process might be altered by genetic, molecular, cellular or tissue causes too. Impacted teeth may therefore, be non-functional, abnormal or pathological. Moreover, ectopic eruption of second molars is rarely seen and infrequent. Here we report a case series of ectopic eruption of permanent mandibular molars with some rarest presentation.

Fractured Genial Tubercles Displaced to Mid-Floor of Mouth: A Rare Case Report.

Fractured and displaced genial tubercles are a relatively rare happening in the field of oral and maxillofacial trauma. These tubercles are attached to the geniohyoid and genioglossus muscles, which are associated with lingual mobility and deglutition. Separation of these unilateral tubercles can lead to sublingual pain, dysphagia and difficulty in swallowing. Review of literature shows that only <15 cases of fractured genial tubercles have been reported in the English literature until now. Surgical interventions have been rarely reported in the literature as most of the cases have been managed conservatively. We report a case of fractured genial tubercle, following trauma, which was intervened surgically.

Study of treatment outcomes in tuberculosis patients on DOTS therapy at five centres in Goa.

Background: The objective was to study the treatment outcomes in tuberculosis patients on DOTS therapy in five centres in Goa in terms of cure rates, treatment completion rates, unfavourable outcomes and factors responsible for unfavorable outcomes. Methods: Study setting: It was a facility based study at five DOTS centres from the Panaji Tuberculosis Unit (TU). Study design: prospective follow up design was used for the study. Study subjects: All patients registered at the selected five DOTS centres for DOTS therapy under RNTCP in the period from 1st April 2011 to 31st December 2011 were selected as study subjects and followed prospectively for a period of nine months till 30th September 2012. Study instruments: data was collected from patients by personal interview and a pretested structured questionnaire. Data was also obtained from patient treatment cards and by interviewing the DOTS provider. Statistical analysis: Data was analysed using SPSS software. The statistical tests used were frequencies, descriptive, Chi square test, odds ratio and logistic regression analysis. Results: Overall 42.9% of the patients were declared cured, 42.3% had treatment completed as the outcome, 4.9% were defaulters, 2.7% patients died, 1.6% were classified as treatment failure, 2.2% were transferred out and 0.5% of the patients were shifted to Non-DOTS treatment regimen while in 2.7% of the patients treatment outcome was not available. Presence of diabetes mellitus, hypertension and alcohol use were found to be significantly associated with unfavourable outcomes in Tuberculosis patients on DOTS. Conclusions: Patients with alcohol addiction and concomitant hypertension were found to have higher levels of un-favourable outcomes; therefore such patients require continuous monitoring and support to ensure treatment success.

Detection of Mycobacterium tuberculosis directly from sputum specimens & phenotypic drug resistance pattern of M. tuberculosis isolates from suspected tuberculosis patients in Chennai.

Background & objectives: mRNA is more rapidly destroyed in cells than rRNA or genomic DNA, an assay targeting bacterial mRNA would provide a better guide to mycobacterial viability than amplification tests directed at DNA or rRNA targets. This study was carried out to standardize reverse transcriptase PCR (RT-PCR) targeting 85B gene for the rapid detection of viable Mycobacterium tuberculosis from sputum specimens of suspected TB patients at Chennai, South India and to detect MDR-TB circulating in this population. Methods: Sputum samples from clinically suspected tuberculosis patients (n=301) and 78 controls were included in the study. The sputum samples were collected in sterile diethyl pyrocarbonate (DEPC) treated containers and transported in ice to the laboratory within 2 h to prevent degradation of RNA. RT-PCR targeting 85B gene, mycobacterial culture and phenotypic drug susceptibility testing for the first line drugs streptomycin (S), isoniazid (H), rifampicin (R), ethambutol (E) and pyrazinamide (Z) were performed by BACTEC microMGIT culture system for all the sputum specimens. Results: All the 78 controls were negative for culture and RT-PCR. Among the 301 sputum specimens from patients, 231 (76.8%) were RT-PCR positive and 70 (23.2%) were negative. There were 166 M. tuberculosis isolates, of which 11 (2.9%) were MDR-TB, 33 (8.7%) were polyresistant, 31 (8.2%) were monoresistant and 91 (30.2%) were sensitive to all five first line anti-tuberculous drugs by phenotypic drug susceptibility testing. Monoresistance was higher with Z [20 (20.8%)], followed by S [6 (3%)]. Interpretation & conclusions: RT-PCR targeting 85B gene of M. tuberculosis was a specific, rapid, reliable technique to detect the M. tuberculosis directly from sputum specimens. Our results showed that 2.9 per cent of M. tuberculosis isolates in the study population of Chennai were MDR.

Non-parasitic hepatic cysts causing obstructive jaundice: two cases.

Non-parasitic hepatic cysts rarely cause jaundice. We report two patients with such lesions treated by percutaneous drainage.