The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-world Observational Study.

Objectives: The Indian Registry on Current Patient Profiles and Treatment Trends in Hypertension (Record) evaluated the current trends and outcomes related to hypertension (HTN) management at 3, 6, 12, and 24 months in India. This study highlights and evaluates the outcomes and trends noted at 24 months. Materials and methods: The detailed study methodology is provided in the earlier publication (interim analysis at 12 months). Aspects such as changes in the quality of life (QOL), percentage of patients reaching target blood pressure (BP), treatment pattern among patients with comorbid conditions, and difference in treatment patterns between public and private healthcare settings, at 24 months, were evaluated in the current study. Results: The study population included 2,000 patients (55.7% males) with a mean age of 54.45 years. Telmisartan (43.7%) and amlodipine + telmisartan (16.4%) were the most prescribed monotherapy and combination therapy among patients with newly diagnosed HTN. A significant decrease in both systolic BP (SBP) and diastolic BP (DBP) was noted in the overall patient population at 24 months (p < 0.001). The mean change in SBP and DBP was slightly higher at 24 months compared to 12 months. This was more evident among patients on combination therapy. A significant improvement in QOL was noted at 24 months. Conclusion: Treatment strategies in HTN management are changing and are associated with effective HTN control and improvements in QOL. However, there is a further need for improved awareness regarding the optimal usage of combination therapy for better management of uncontrolled HTN. How to cite this article: Rajadhyaksha GC, Reddy H, Singh AK, et al. The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-World Observational Study. J Assoc Physicians India 2023;71(11):43-49.

HEPATIC DYSFUNCTION IN MEDICAL INTENSIVE CAREUNIT PATIENTS PREDICTS POOR OUTCOME.

BACKGROUND: A large number of patients admitted to the medical intensive care unit (MICU) have abnormal liver function tests (LFT). This includes patients with critical illness with or without preexisting liver disease and patients with acute primary liver injury. There are very few studies which have investigated the spectrum of liver disease, clinical profile and outcome in patients admitted to the MICU. OBJECTIVE: To evaluate the occurrence, etiology, clinical profile, laboratory profile and outcome of hepatic dysfunction in patients admitted to the MICU. To evaluate the utility of model for end-stage liver disease (MELD) score on admission as a predictor of adverse short term outcome in patients with hepatic dysfunction admitted in MICU. METHODS: It was a prospective observational study, conducted from December 2017 to December 2018 in a tertiary care hospital. Two hundred and two patients admitted to the MICU with LFTs as per the inclusion criteria were analyzed and their short-term outcome at 7 days was studied in relation to various parameters. RESULTS: LFT abnormalities were present in 202/1126 (17.9%) of the patients admitted to MICU. Critical illness associated liver dysfunction was found in 172 (85.2%) patients, chronic liver disease in 11 (5.4%) patients and acute viral hepatitis in 19 (9.4%) patients. Most common symptom was fever (68.3%) followed by vomiting (48.0%). Among LFT abnormalities, elevated transaminases, raised international normalized ratio and high MELD score on admission correlated with poor short-term outcome. Requirement for inotropes and mechanical ventilation correlated with poor short-term outcome. Mortality did not differ significantly between patients with chronic liver disease, patients with acute viral hepatitis and patients with critical illness associated hepatic dysfunction. Hepatic dysfunction in MICU was associated with poor outcome and a high short-term mortality of 56.4% (114/202). CONCLUSION: Liver function abnormality is common in patients who are admitted to the MICU and its presence is an indicator of poor short-term outcome.

Disfunção hepática em pacientes de unidade de terapia intensiva médica prevê desfecho desfavorável / Hepatic dysfunction in medical intensive careunit patients predicts poor outcome

ABSTRACT Background: A large number of patients admitted to the medical intensive care unit (MICU) have abnormal liver function tests (LFT). This includes patients with critical illness with or without preexisting liver disease and patients with acute primary liver injury. There are very few studies which have investigated the spectrum of liver disease, clinical profile and outcome in patients admitted to the MICU. Objective To evaluate the occurrence, etiology, clinical profile, laboratory profile and outcome of hepatic dysfunction in patients admitted to the MICU. To evaluate the utility of model for end-stage liver disease (MELD) score on admission as a predictor of adverse short term outcome in patients with hepatic dysfunction admitted in MICU. Methods: It was a prospective observational study, conducted from December 2017 to December 2018 in a tertiary care hospital. Two hundred and two patients admitted to the MICU with LFTs as per the inclusion criteria were analyzed and their short-term outcome at 7 days was studied in relation to various parameters. Results: LFT abnormalities were present in 202/1126 (17.9%) of the patients admitted to MICU. Critical illness associated liver dysfunction was found in 172 (85.2%) patients, chronic liver disease in 11 (5.4%) patients and acute viral hepatitis in 19 (9.4%) patients. Most common symptom was fever (68.3%) followed by vomiting (48.0%). Among LFT abnormalities, elevated transaminases, raised international normalized ratio and high MELD score on admission correlated with poor short-term outcome. Requirement for inotropes and mechanical ventilation correlated with poor short-term outcome. Mortality did not differ significantly between patients with chronic liver disease, patients with acute viral hepatitis and patients with critical illness associated hepatic dysfunction. Hepatic dysfunction in MICU was associated with poor outcome and a high short-term mortality of 56.4% (114/202). Conclusion: Liver function abnormality is common in patients who are admitted to the MICU and its presence is an indicator of poor short-term outcome.

RESUMO Contexto: Um grande número de pacientes internados na unidade de terapia intensiva (UTI) tem testes de função hepática anormais (TFH). Isso inclui pacientes com doença crítica com ou sem doença hepática pré-existente e pacientes com lesão hepática primária aguda. Há poucos estudos que têm investigado o espectro da doença hepática, perfil clínico e desfecho em pacientes admitidos em UTI. Objetivo Avaliar a ocorrência, etiologia, perfil clínico, perfil laboratorial e desfecho de disfunção hepática em pacientes internados na UTI médica. Avaliar a utilidade do modelo para doença hepática em estágio terminal (MELD). Escore na admissão como preditor de desfecho adverso a curto prazo em pacientes com disfunção hepática admitida em UTI. Métodos: Foi realizado um estudo observacional prospectivo, de dezembro de 2017 a dezembro de 2018 em um hospital de atenção terciária. Foram analisados 202 pacientes internados na UTI com TFH conforme os critérios de inclusão e seu desfecho a curto prazo de 7 dias foi estudado em relação a diversos parâmetros. Resultados: Anormalidades dos testes estiveram presentes em 202/1126 (17,9%) dos pacientes internados na UTI. Doença crítica associada à disfunção hepática foi encontrada em 172 (85,2%) pacientes, doença hepática crônica em 11 (5,4%) pacientes e hepatite viral aguda em 19 (9,4%) pacientes. O sintoma mais comum foi a febre (68,3%), seguido de vômito (48,0%) casos. Entre as anormalidades do TFH, transaminases elevadas, INR e escore MELD elevados na admissão correlacionaram-se com desfecho ruim de curto prazo. Exigência de inotrópicos e ventilação mecânica correlacionaram-se com desfecho de curto prazo ruim. A mortalidade não diferiu significativamente entre pacientes com doença hepática crônica, pacientes com hepatite viral aguda e pacientes com doença crítica associada à disfunção hepática. A disfunção hepática em UTI esteve associada a um desfecho ruim e à uma alta mortalidade a curto prazo de 114/202 (56,4%). Conclusão: A anormalidade da função hepática é comum em pacientes que são admitidos nas unidades de tratamento intensivo e sua presença é um indicador de desfecho de curto prazo ruim.

Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting.

Purpose: To evaluate the safety and efficacy of favipiravir, which is prescribed for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) in India. Patients and Methods: This was a prospective, open-label, multicenter, single-arm postmarketing study conducted in India. Patients with mild-to-moderate COVID-19 received favipiravir (3600 mg [1800 mg orally twice daily] on the first day, followed by 800 mg orally twice daily, up to a maximum of 14 days) as a part of their treatment. The primary endpoints were to evaluate the safety of favipiravir by assessing the number of adverse events (AEs) and treatment-related AEs. The secondary endpoints were to evaluate the efficacy of favipiravir by assessing time to clinical cure, rate of clinical cure, time to pyrexia resolution, rate of oxygen requirement, and all-cause mortality. Results: A total of 1083 patients were enrolled in this study from December 2020 to June 2021. Adverse events were reported in 129 patients (11.9%), 116 (10.7%) of whom had mild AEs. Dose modification or withdrawal of favipiravir treatment was reported in four patients (0.37%). The median time to clinical cure and pyrexia resolution was 7 and 4 days, respectively. A total of 1036 patients (95.8%) exhibited clinical cure by day 14. Oxygen support was required by 15 patients (1.4%). One death was reported, which was unrelated to favipiravir. Conclusion: In the real-world setting, favipiravir was well-tolerated, and no new safety signals were detected.

Efficacy and Safety of a Phytopharmaceutical Drug Derived from Cocculus hirsutus in Adults with Moderate COVID-19: a Phase 2, Open-label, Multicenter, Randomized Controlled Trial.

INTRODUCTION: There is an urgent need for an effective, oral therapy for COVID-19. Purified aqueous extract of Cocculus hirsutus (AQCH) has shown robust antiviral activity in in vitro studies. We aimed to evaluate the efficacy and safety of AQCH plus standard of care in hospitalized patients with moderate COVID-19. METHODS: In an open-label, multicenter, randomized controlled trial conducted in India, eligible patients (aged 18-75 years) were randomized (1:1) to receive AQCH 400 mg orally three times a day plus standard of care (AQCH group) or standard of care alone (control group) for 10 days. Primary endpoint was the proportion of patients showing clinical improvement by day 14. Time to clinical improvement, time to viral clearance, and duration of hospitalization were secondary endpoints. RESULTS: A total of 210 patients were randomized. By day 14 most patients in both groups showed clinical improvement [difference - 0.01 (95% CI - 0.07 to 0.05); p = 1.0]. Median time to clinical improvement was 8 days (IQR 8-11) in the AQCH group versus 11 days (IQR 8-11) in the control group [HR 1.27 (95% CI 0.95-1.71); p = 0.032]. Time to viral clearance and duration of hospitalization were also significantly shorter in the AQCH group (p = 0.0002 and p = 0.016, respectively). AQCH was well tolerated, with no safety concerns identified. CONCLUSIONS: AQCH significantly reduced time to clinical improvement, time to viral clearance, and duration of hospitalization. In a pandemic, this has significant potential to decrease healthcare resource utilization and increase hospital bed availability. Further investigation of the therapeutic potential of AQCH in patients with COVID-19 is warranted. TRIAL REGISTRATION: Clinical Trials Registry - India (CTRI/2020/05/025397).

Beneficial effects of nandrolone decanoate in wasting associated with HIV.

Recent studies have demonstrated the role of nandrolone decanoate (ND) in reversal of wasting associated with HIV infection. However, such studies in Indian scenario are lacking. Hence, the present study was planned with an objective to assess the effect of ND in patients of HIV-associated wasting in Indian subjects. The study was a prospective, randomised, multicentric, open labelled and comparative one in male HIV-infected subjects, aged between 18 and 65 years with involuntary weight loss of 10% over 12 months or 7.5% over 6 months or 5% over 3 months. The subjects were on stable antiretroviral therapy including at least 2 agents with CD, count > or =50 cells/microl. In the treatment group, ND (150 mg) intramuscularly every 2 weeks for 12 weeks was administered according to randomisation. Fat-free mass (FFM), body weight, CD4 count, and patient perception of treatment were the main outcomes measures. Of the 73 enrolled subjects, 69 completed study duration of 12 weeks. Compared to baseline, ND treated group demonstrated significant increase in FFM (0.49 +/- 1.26 kg; p < 0.01) and body weight (1.31 +/- 1.87 kg; p < 0.01) and control group demonstrated significant increase in body weight (0.99 +/- 1.48 kg; p < 0.01) at the end of treatment period. Compared to control group, patient perception of benefit and subjective recovery of symptoms was significantly (p < .0001) greater in the ND group. None of the patients had any clinically significant deterioration of biochemical as well as laboratory safety parameters. Nandrolone was well tolerated with few reported adverse events of mild and non-serious in nature. Nandrolone improved patient perception of benefit and subjective recovery of symptoms in wasting associated HIV. Nandrolone therapy may prove to be effective and safe in reversing wasting associated with Indian HIV patients on antiretroviral therapy (ART) and nutritional replacement.

Evaluation of the efficacy, safety and tolerability of miglitol in adult Indian patients with uncomplicated type 2 diabetes mellitus.

Postprandial hyperglycaemia and spikes have deleterious effects on Insulin secretion and sensitivity. The present study was undertaken to evaluate the efficacy, safety and tolerability of miglitol 50 mg three times daily for 12 weeks in 129 patients with type 2 diabetes mellitus, inadequately managed with diet and exercise therapy alone for 3 months after obtaining their written informed consent. The primary efficacy variables were per cent change from baseline at week 12 in fasting and postprandial plasma glucose concentrations and glycosylated haemoglobin (HbA(1C)) levels. After treatment at the end of 12 weeks mean reduction in fasting plasma glucose levels was 35.7% and 44.33% in postprandial plasma glucose levels while the mean HbA(1C) was significantly reduced by 0.88% (p<0.05). Total cholesterol, HDL, LDL and TC/HDL ratio did not showed any significant change but a non-significant reduction in triglyceride levels was observed in some patients. The mean body mass index was reduced non-significantly by 8% from baseline values. A total 19.5% patients treated with miglitol reported adverse events like flatulence, abdominal pain, nausea/vomiting, diarrhoea and dyspepsia. Only one patient reported hypoglycaemia. The results of the present study indicate that miglitol reduces fasting and postprandial plasma glucose levels, Improving glycaemic control, which is reflected in a reduced HbA(1C) level in patients with type 2 diabetes mellitus. It could be a useful first-line therapy in patients with type 2 diabetes mellitus inadequately controlled by diet alone and as adjuvant therapy in patients who are inadequately controlled with diet and sulfonylureas.

Assessment of efficacy, safety and tolerability of fixed dose combination of telmisartan 40mg and hydrochlorothiazide 12.5mg in adult Indian patients with mild to moderate hypertension.

The objective of the study was to assess the efficacy, safety and tolerability of a fixed dose combination of telmisartan 40 mg and hydrochlorothiazide 12.5 mg in adult Indian patients with mild to moderate hypertension. A prospective, multicentric, open-label, non-comparative, phase IV study was conducted. A total of 353 patients of either sex, between 18- 65 years of age with supine blood pressure (BP) levels of systolic BP (SBP) of 140-200 mmHg and diastolic BP (DBP) of 95-114 mmHg were included. After a placebo run-in period of 2 weeks, each patient received a fixed dose combination of telmisartan/hydrochlorothiazide (40mg/12.5mg) once daily, for 8 weeks. Supine BP was assessed at the end of every 2 weeks. Tolerability and safety were assessed by physical examination, laboratory parameters and evaluation of adverse events. A total of 339 patients completed the study with 14 drop-out cases because of loss to follow-up. There was a significant fall (p<0.05) in both the SBP and DBP starting from the second week as compared to the baseline. Mean SBP had a significant reduction of 23.55 mmHg (15.0%) and 27.79 mmHg (18%) at the end of 6th and 8th week respectively, compared to baseline values. Mean DBP had also had a significant reduction of 12.51 mmHg (12.6%) and 15.17 mmHg (15.3%) at the end of 6th and 8th week respectively, compared to baseline values. This combination was well tolerated with only 3.9% of the total cases reporting mild adverse events like fatigue, dizziness, nausea, diarrhoea etc. The laboratory values were within normal limits. Fixed dose combination of telmisartan/hydrochlorothiazide (40 mg/12.5 mg) once daily has a significant therapeutic effect and a good tolerability profile in adult Indian patients with mild to moderate hypertension.