Short-Term Mortality Associated With Hypertensive Emergencies: A Prospective Observational Cohort Study From South India.

Background and aims Hypertensive emergencies are caused by acutely occurring massive elevations in blood pressure with features suggestive of acute end-organ damage and are a common complication of hypertension. About 1-2% of all patients with hypertension develop this complication in their lifetime. This study was undertaken to assess short-term outcomes associated with hypertensive emergencies in a tertiary care center. Methods We conducted a prospective cohort study and recruited 66 consenting adults with a hypertensive emergency. Sociodemographic details, clinical characteristics, blood pressure readings at different intervals, in-hospital course, and diagnosis of end-organ damage were recorded. The in-hospital outcome was noted as dead or alive. After four weeks, patients were followed up through telephonic interviews and the patient's status was then reviewed and recorded. Multiple logistic regression determined the predictors of death. Data were analyzed in SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Results A total of 66 patients were enrolled, with a mean age of 54.57 (±38.18) years and a male predominance of 44 (66.35%) patients. The majority of patients were known hypertensives (n=55, 83.35%). Of the known hypertensives, 41 (74.54%) patients had discontinued their anti-hypertensive medications prior to admission. The median duration of hospitalization was 10 (7-14) days. The most common presenting complaints were dyspnea (n=35, 53.03%), pedal edema (n=29, 43.94%) and headache (n=25, 37.87%). Forty-one (62.12%) patients required ICU care, and 39 (59.09%) required ventilator support. The most common end-organ damage was acute-on-chronic kidney disease (n=21, 31.81%). The short-term mortality documented at the end of one month was 24 (36.36%). Of these, seven (10.6%) patients died in the hospital, and 17 (25.75) patients died within one month of getting discharged from the hospital. The factors that were associated with high mortality were newly-diagnosed hypertension and in-hospital hypotension. Conclusion We found high mortality associated with hypertensive emergencies. At one month follow-up, we found that more than one-third of the patients had died. Post-hospitalisation mortality was higher than in-hospital mortality. Most patients had discontinued their anti-hypertensive medication before admission. The most frequently encountered end-organ damage was acute-on-chronic kidney disease. The factors associated with high mortality were newly-diagnosed hypertension and in-hospital hypotension.

Timing of tofacitinib therapy is critical to improving outcomes in severe-critical COVID-19 infection: A retrospective study from a tertiary care hospital.

Describe the use of tofacitinib in severe and critical coronavirus disease-2019 (COVID-19), and explore the association of drug initiation time with survival. A retrospective study of inpatients with severe or critical COVID-19 at a tertiary care hospital, who were prescribed generic tofacitinib for at least 48 hours, was conducted. Baseline demographics, comorbidities, illness severity, treatment, adverse effects and outcomes were analyzed. Patients were grouped based on median duration of symptomatic illness prior to tofacitinib administration, as early or late initiation groups. Forty-one patients ([85.4% males], mean age 52.9 ±â€…12.5 years), were studied. 65.9% (n = 27) had severe COVID-19, while 34.1% (n = 14) were critically ill. Death occurred in 36.6% patients (n = 15). The median time to prescription of tofacitinib was 13 (9.50, 16.0) days of symptom onset. Tofacitinib was initiated early (8-13 days) in 56.1% of patients (n = 23), while the remaining received it beyond day 14 of symptom onset (late initiation group). Multivariate logistic regression adjusted for age, presence of diabetes mellitus and illness duration prior to hospitalization demonstrated higher odds of survival (adjusted odds ratio 19.3, 95% confidence interval 2.57, 145.2) in the early initiation group, compared to the late initiation group. Early initiation of tofacitinib in severe and critical COVID-19 has potential to improve survival odds.

Usability and feasibility assessment of a smartphone application (Suhriday) for heart failure self-care remote monitoring in an Indian tertiary health care setting: a pilot mixed-methods study.

BACKGROUND/OBJECTIVES: Remote monitoring as a component of chronic heart failure (CHF) management programmes has demonstrated utility in reducing the risk of rehospitalisation and mortality. There is little evidence on mobile health app facilitated remote monitoring in India. We conducted a pilot usability and feasibility assessment of a smartphone-based application (Suhriday) to remotely monitor patients with CHF. METHODS: We used a mixed-methods design. Usability testing consisted of the think-aloud approach followed by semistructured in-depth interviews (SSIs) and a satisfaction questionnaire. Feasibility testing was done using acceptability and user satisfaction questionnaires in addition to SSIs. We trained five purposively sampled patients with CHF (based on health literacy and gender) and their caregivers (n=10) in self-care monitoring and app use. Usability was assessed using metrics such as task completion, time required for task completion and user satisfaction using Brooke's System Usability Scale (SUS). Content analysis of the transcripts with deductive coding was performed for both usability and feasibility interviews. The number and types of medical alerts transmitted through the app were captured and escalated to the treating team. RESULTS: Critical tasks involving (1) opening the app and identifying task list, (2) reporting blood pressure, weight, heart rate and fluid intake and (3) reporting symptoms were completed within 60 s by four patients. Median (IQR) SUS score was 85 (75-92.5) indicating high level of usability. There were 62 alerts from four patients over 4 weeks, with 36 (58.1%) excess fluid intake alerts and 16 (25.8%) blood pressure variations being the most frequent. One participant had challenges using the app and was monitored through active phone calls. CONCLUSION: Overall usability and satisfaction with Suhriday were good and we were able to remotely manage patients. However, patients with limited health literacy and those facing technological challenges required active structured telephone support.

Health-Related Quality of Life and Mortality in Heart Failure: The Global Congestive Heart Failure Study of 23 000 Patients From 40 Countries.

BACKGROUND: Poor health-related quality of life (HRQL) is common in heart failure (HF), but there are few data on HRQL in HF and the association between HRQL and mortality outside Western countries. METHODS: We used the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) to record HRQL in 23 291 patients with HF from 40 countries in 8 different world regions in the G-CHF study (Global Congestive Heart Failure). We compared standardized KCCQ-12 summary scores (adjusted for age, sex, and markers of HF severity) among regions (scores range from 0 to 100, with higher score indicating better HRQL). We used multivariable Cox regression with adjustment for 15 variables to assess the association between KCCQ-12 summary scores and the composite of all-cause death, HF hospitalization, and each component over a median follow-up of 1.6 years. RESULTS: The mean age of participants was 65 years; 61% were men; 40% had New York Heart Association class III or IV symptoms; and 46% had left ventricular ejection fraction ≥40%. Average HRQL differed between regions (lowest in Africa [mean± SE, 39.5±0.3], highest in Western Europe [62.5±0.4]). There were 4460 (19%) deaths, 3885 (17%) HF hospitalizations, and 6949 (30%) instances of either event. Lower KCCQ-12 summary score was associated with higher risk of all outcomes; the adjusted hazard ratio (HR) for each 10-unit KCCQ-12 summary score decrement was 1.18 (95% CI, 1.17-1.20) for death. Although this association was observed in all regions, it was less marked in South Asia, South America, and Africa (weakest association in South Asia: HR, 1.08 [95% CI, 1.03-1.14]; strongest association in Eastern Europe: HR, 1.31 [95% CI, 1.21-1.42]; interaction P<0.0001). Lower HRQL predicted death in patients with New York Heart Association class I or II and III or IV symptoms (HR, 1.17 [95% CI, 1.14-1.19] and HR, 1.14 [95% CI, 1.12-1.17]; interaction P=0.13) and was a stronger predictor for the composite outcome in New York Heart Association class I or II versus class III or IV (HR 1.15 [95% CI, 1.13-1.17] versus 1.09 [95% CI, [1.07-1.11]; interaction P<0.0001). HR for death was greater in ejection fraction ≥40 versus <40% (HR, 1.23 [95% CI, 1.20-1.26] and HR, 1.15 [95% CI, 1.13-1.17]; interaction P<0.0001). CONCLUSION: HRQL is a strong and independent predictor of all-cause death and HF hospitalization across all geographic regions, in mildly and severe symptomatic HF, and among patients with preserved and reduced ejection fraction. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03078166.

A qualitative, grounded theory exploration of the determinants of self-care behavior among Indian patients with a lived experience of chronic heart failure.

BACKGROUND: Prior reports have documented extremely poor adherence to evidence-based medications among South Asian patients with established chronic cardiovascular diseases. Treatment adherence is now considered a part of the 'self-care' process, the determinants of which have not been adequately explored or explained among South Asian patients with chronic heart failure (CHF). Our objective was to qualitatively ascertain the determinants of the self-care process among Indian patients with a lived experience of heart failure. METHODS: We conducted in-depth interviews (audio-recorded) among 22 purposively sampled patients living with chronic heart failure, diagnosed at least 4 weeks prior to the interview and 17 caregivers (n = 39) in a tertiary care teaching hospital in Southern India. We employed an inductive analytical approach using Charmaz's constructivist grounded theory. Initial line-by-line coding and categorization was followed by memo writing, reflexive analysis after interviewing and analyzing four, eight and twelve patients, and at each stage further theoretical sampling was carried out until we reached thematic saturation. We used NVivo ver. 12 to analyze and organize data. RESULTS: The mean age of our patients was 61 years and they represented 5 Indian states and spoke seven languages, distributed across socio-economic strata and literacy levels. We classified self-care determinants into 3 broad, simple categories and defined underlying themes namely, negative determinants (passivity, entrenched beliefs, negative affect, lack of knowledge, financial difficulties, and fatalism), intermediate factors (patient expectations, provider/hospital hopping) and facilitators or positive self-care determinants (intrinsic and extrinsic facilitators). Gender and the cultural background of patients' upbringing appear to shape these determinants, thereby affecting self-care decision making in chronic heart failure. CONCLUSION: We have empirically described a unique set of self-care determinants among Indian chronic heart failure patients, which in turn are shaped by economic and socio-cultural factors. Assessing for and addressing these determinants during clinical interactions through multi-factorial approaches may help improve self-care among Indian CHF patients, thus improving treatment adherence and clinical outcomes.

Impact of blood pressure lowering, cholesterol lowering and their combination in Asians and non-Asians in those without cardiovascular disease: an analysis of the HOPE 3 study.

BACKGROUND AND DESIGN: There are limited data on the effects of blood pressure and cholesterol lowering in Asians at intermediate risk and no cardiovascular disease. We report an analysis of the effects of blood pressure and cholesterol lowering in Asians enrolled in the Heart Outcomes Prevention Evaluation 3 (HOPE 3) trial. METHODS: We randomly assigned 6241 Asians and 6464 non-Asians at intermediate risk without cardiovascular disease to candesartan 16 mg/hydrochlorothiazide 12.5 mg or placebo and rosuvastatin 10 mg or placebo. The first co-primary outcome was a composite of cardiovascular disease death, myocardial infarction and stroke. The second co-primary outcome additionally included heart failure, cardiac arrest and revascularisation. Median follow-up was 5.6 years. RESULTS: Reduction in systolic blood pressure was less among Asians (4.3 vs. 7.7 mmHg for non-Asians, P < 0.0001) mainly due to a lesser effect in Chinese (2.1 mmHg) than in other Asians (7.3 mmHg), reduction in the latter being similar to non-Asians. The effect on the composite outcomes was similar, with no significant benefits from blood pressure lowering for either Asians (Chinese or non-Chinese) or non-Asians. Rosuvastatin reduced low-density lipoprotein cholesterol to a lesser degree in Asians (0.49 mmol/L (-19.1 mg/dL) compared with non-Asians 0.95 mmol/L (-36.7 mg/dL), Pinteraction < 0.0004). Yet both groups had similar reductions in the two co-primary outcomes. There was no increase in permanent medication discontinuation due to muscle-related symptoms in either group. There was an excess in new diabetes in non-Asians (4.70% rosuvastatin, 3.52% placebo, P = 0.025) but not in Asians (3.02% rosuvastatin, 4.04% placebo, P = 0.0342), Pinteraction = 0021. CONCLUSIONS: Candesartan/hydrochlorothiazide had fewer effects in reducing blood pressure in Chinese and rosuvastatin reduced low-density lipoprotein cholesterol to a lesser extent in Asians compared with non-Asians. There was no overall reduction in clinical events with lowering blood pressure in either Asians or non-Asians, whereas there were clear and consistent benefits with lipid lowering in both. Despite extensive analyses, we have no obvious explanation for the observed findings. Future studies need to include larger numbers of individuals from different regions of the world to ensure that the results of trials are applicable globally.

Home Blood Pressure Management Intervention in Low- to Middle-Income Countries: Protocol for a Mixed Methods Study.

BACKGROUND: Control of hypertension in low- and middle-income countries (LMICs) is poor, often less than 10%. A strong body of evidence demonstrates that home blood pressure management lowers blood pressure, and recent guidelines from the National Institute for Clinical Health and Excellence recommends home blood pressure monitoring. However, the preponderance of data on the benefits of home blood pressure management comes from studies in high-income countries. OBJECTIVE: The objective of the study is to examine whether an intervention of home blood pressure management is feasible in LMICs. Home blood pressure management is defined as self-monitoring of blood pressure and self-titration of antihypertensive medications. We will identify barriers and facilitators of home blood pressure management and explore unique contextual factors in LMICs that influence implementation of home blood pressure management. METHODS: Participants will be recruited from 6 sites from 2015 to 2018. Patients and health care workers will be included. We will use mixed methods including focus groups, interviews, and standardized checklists. When possible, we will adapt materials from prior successful studies so that they are culturally and contextually appropriate. RESULTS: This ongoing study is funded by the World Heart Federation. The information that is obtained will be used to develop a randomized clinical trial of home blood pressure management in LMICs. CONCLUSIONS: The data generated from this qualitative study will provide much needed information from patients and health care workers about barriers and facilitators of home blood pressure management and unique contextual factors that might influence implementation of home blood pressure management in LMICs.

Regional differences in presentation and antithrombotic treatment of patients with atrial fibrillation: Baseline characteristics from a clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with atrial fibrillation (IMPACT-AF).

Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. However, there are few contemporary comparative data on AF from middle-income countries. METHODS: Baseline characteristics of the IMPACT-AF trial were analyzed to assess regional differences in presentation and antithrombotic treatment of AF from 5 middle-income countries (Argentina, Brazil, China, India, and Romania) and factors associated with antithrombotic treatment prescription. RESULTS: IMPACT-AF enrolled 2281 patients (69 ± 11 years, 47% women) at 48 sites. Overall, 66% of patients were on anticoagulation at baseline, ranging from 38% in China to 91% in Brazil. The top 3 reasons for not prescribing an anticoagulant were patient preference/refusal (26%); concomitant antiplatelet therapy (15%); and risks outweighing the benefits, as assessed by the physician (13%). In a multivariable model, the most significant factors associated with prescription of oral anticoagulants were no prior major bleeding (odds ratio [OR] = 4.34; 95% CI = 2.22-8.33), no alcohol abuse (OR = 2.27; 95% CI = 1.12-4.55), and history of rheumatic valvular heart disease (OR = 2.10; 95% CI = 1.36-3.26), with a strong predictive accuracy (c statistic = 0.85), whereas the most significant factors associated with prescription of a combination of oral anticoagulants and antiplatelet drugs were prior coronary revascularization (OR = 5.10; 95% CI = 2.88-9.05), prior myocardial infarction (OR = 2.24; 95% CI = 1.38-3.63), and no alcohol abuse (OR = 2.22; 95% CI = 1.11-4.55), with a good predictive accuracy (c statistic = 0.76). CONCLUSIONS: IMPACT-AF provides contemporary data from 5 middle-income countries regarding antithrombotic treatment of AF. Lack of prior major bleeding and coronary revascularization were the most important factors associated with prescription of oral anticoagulants and their combination with antiplatelet drugs, respectively.

A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial.

BACKGROUND: Oral anticoagulation is underused in patients with atrial fibrillation. We assessed the impact of a multifaceted educational intervention, versus usual care, on oral anticoagulant use in patients with atrial fibrillation. METHODS: This study was a two-arm, prospective, international, cluster-randomised, controlled trial. Patients were included who had atrial fibrillation and an indication for oral anticoagulation. Clusters were randomised (1:1) to receive a quality improvement educational intervention (intervention group) or usual care (control group). Randomisation was carried out centrally, using the eClinicalOS electronic data capture system. The intervention involved education of providers and patients, with regular monitoring and feedback. The primary outcome was the change in the proportion of patients treated with oral anticoagulants from baseline assessment to evaluation at 1 year. The trial is registered at ClinicalTrials.gov, number NCT02082548. FINDINGS: 2281 patients from five countries (Argentina, n=343; Brazil, n=360; China, n=586; India, n=493; and Romania, n=499) were enrolled from 48 clusters between June 11, 2014, and Nov 13, 2016. Follow-up was at a median of 12·0 months (IQR 11·8-12·2). Oral anticoagulant use increased in the intervention group from 68% (804 of 1184 patients) at baseline to 80% (943 of 1184 patients) at 1 year (difference 12%), whereas in the control group it increased from 64% (703 of 1092 patients) at baseline to 67% (732 of 1092 patients) at 1 year (difference 3%). Absolute difference in the change between groups was 9·1% (95% CI 3·8-14·4); odds ratio of change in the use of oral anticoagulation between groups was 3·28 (95% CI 1·67-6·44; adjusted p value=0·0002). Kaplan-Meier estimates showed a reduction in the secondary outcome of stroke in the intervention versus control groups (HR 0·48, 95% CI 0·23-0·99; log-rank p value=0·0434). INTERPRETATION: A multifaceted and multilevel educational intervention, aimed to improve use of oral anticoagulation in patients with atrial fibrillation and at risk for stroke, resulted in a significant increase in the proportion of patients treated with oral anticoagulants. Such an intervention has the potential to improve stroke prevention around the world for patients with atrial fibrillation. FUNDING: Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer.

A clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AF): design and rationale.

Atrial fibrillation (AF) is common, increasing as the population ages, and a major cause of embolic stroke. While oral anticoagulation (OAC) is highly effective at preventing stroke in patients with AF, it continues to be underused in eligible patients worldwide. The objective of this prospective, cluster randomized controlled trial (IMPACT-AF; ClinicalTrials.gov #NCT02082548) is to determine whether a comprehensive customized intervention will increase the rate and persistence of use of OAC in patients with AF. IMPACT-AF will be conducted in approximately 50 centers in 5 low- to middle-income countries. Before randomization, sites within countries will be paired to match in size, practice type and baseline rate of OAC use. Site pairs will be randomized to intervention versus control. In total, 40 to 70 patients with AF and at least 2 CHA2DS2-VASc risk factors will be enrolled at each site using a consecutive enrollment strategy, with the goal of capturing actual practice patterns. We aim for patients with a new diagnosis of AF to comprise at least 30% of the study cohort. Assuming an average baseline OAC use of 60% and a post-intervention use of 70% with a post-control rate of 60%, there will be roughly 94-98% power with 25 clusters per group (intracluster correlation coefficient of 0.02). While this trial focuses on improving treatment use and reducing preventable strokes, we also aim to better understand the reasons for OAC underuse. This will improve the intervention with the goal of creating educational recommendations to improve care for patients with AF.

Training and Capacity Building in LMIC for Research in Heart and Lung Diseases: The NHLBI-UnitedHealth Global Health Centers of Excellence Program.

Stemming the tide of noncommunicable diseases (NCDs) worldwide requires a multipronged approach. Although much attention has been paid to disease control measures, there is relatively little consideration of the importance of training the next generation of health-related researchers to play their important role in this global epidemic. The lack of support for early stage investigators in low- and middle-income countries interested in the global NCD field has resulted in inadequate funding opportunities for research, insufficient training in advanced research methodology and data analysis, lack of mentorship in manuscript and grant writing, and meager institutional support for developing, submitting, and administering research applications and awards. To address this unmet need, The National Heart, Lung, and Blood Institute-UnitedHealth Collaborating Centers of Excellence initiative created a Training Subcommittee that coordinated and developed an intensive, mentored health-related research experience for a number of early stage investigators from the 11 Centers of Excellence around the world. We describe the challenges faced by early stage investigators in low- and middle-income countries, the organization and scope of the Training Subcommittee, training activities, early outcomes of the early stage investigators (foreign and domestic) and training materials that have been developed by this program that are available to the public. By investing in the careers of individuals in a supportive global NCD network, we demonstrate the impact that an investment in training individuals from low- and middle-income countries can have on the preferred future of or current efforts to combat NCDs.

Community health worker-based intervention for adherence to drugs and lifestyle change after acute coronary syndrome: a multicentre, open, randomised controlled trial.

BACKGROUND: Adherence to drugs and healthy lifestyles is low after acute coronary syndrome. We assessed whether trained community health workers could improve adherence to drugs, lifestyle changes, and clinical risk markers in patients with acute coronary syndrome in India. METHODS: In this study done at 14 hospitals in India we randomly assigned (1:1) patients with acute coronary syndrome 1 or 2 days before discharge from hospital to a community health worker-based intervention group or a standard care group. Patients were randomly assigned with a telephone randomisation service. In the intervention group, during four in-hospital and two home visits, community health workers used unstructured discussions, visual methods, and patient diaries to educate patients on healthy lifestyle and drugs, and measures to enhance adherence. The primary outcome was adherence to proven secondary prevention drugs (antiplatelet drugs, ß blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and statins) estimated using a Composite Medication Adherence Scale at 1 year. The secondary outcomes were difference in lifestyle factors (diet, exercise, and tobacco and alcohol use), and clinical risk markers (blood pressure, bodyweight, BMI, heart rate, and lipids). All analyses were by intention to treat. This trial is registered with the Clinical Trial Registry of India, number REF/2013/03/004737, and ClinicalTrials.gov, number NCT01207700. RESULTS: Between Aug 23, 2011, and June 25, 2012, 806 participants were randomly assigned (405 to a community health worker-based intervention group and 401 to a standard care group). At 1 year, 40 patients had died and 15 had discontinued or been lost to follow-up, so 750 (93%) were included in the analyses (375 in each group). Secondary prevention drugs prescribed at discharge were 98% (786/803) for any antiplatelet drug, 79% (638/803) for dual antiplatelet drugs, 69% (555/803) for ß blockers, 69% (552/803) for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, and 95% (762/803) for statins. At one year, overall adherence (≥80%) to prescribed evidence-based drugs was higher in the intervention group than in the control group (97% vs 92%, odds ratio [OR] 2·62, 95% CI 1·32-5·19; p=0·006). For individual drugs, we recorded significant differences for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers (97% [233/240] in the intervention group vs 93% [223/240] in the control group; p=0·036) and statins (97% [346/356] vs 93% [321/345]; p=0·011). The intervention group had significantly greater adherence to smoking cessation (85% [110/129] vs 52% [71/138], OR 5·46, 95% CI 3·03-9·86; p<0·0001), regular physical activity (89% [333/375] vs 60% [226/375], OR 5·23, 95% CI 3·57-7·66; p<0·0001), and healthy diet (score 5·0 vs 3·0, OR 2·47, 95% CI 1·88-3·25; p<0·0001). More patients in the intervention group had stopped alcohol use at 1 year (87% [64/74] vs 46% [46/67], OR 2·92, 95% CI 1·26-6·79; p =0·010). At 1 year, the mean systolic blood pressure (124·4 mm Hg [SD 13·5] vs 128·0 mm Hg [15·9]; p=0·002), weight (65·0 kg [11·0] vs 66·5 kg [11·5]; p<0·0001), cholesterol (157·0 [40·2] vs 166·9 [48·4]; p=0·184), LDL (81·0 [20·6] vs 87·3 [29·9]; p=0·191), HDL (42·0 [11·4] vs 38·2 [6·5]; p=0·042), and BMI (24·4 kg/m(2) [SD 3·7] vs 25·0 kg/m(2) [3·8]; p<0·0001) were lower in the intervention group than in the control group. However, we noted no significant difference in diastolic blood pressure and heart rate. INTERPRETATION: A community health worker-based personalised intervention strategy in patients with acute coronary syndrome improved adherence to evidence-based drugs and healthy lifestyles, and resulted in an improvement in clinical risk markers. Integration of trained community health workers can improve secondary prevention in coronary artery disease. FUNDING: US National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, and the UnitedHealth group, USA.

High sensitivity C-reactive protein (hsCRP) & cardiovascular disease: An Indian perspective.

The role of low grade systemic inflammation as evidenced by elevated high sensitivity C-reactive protein (hsCRP) levels in the pathogenesis of atherosclerotic vascular disease has been intensely investigated through observational studies and clinical trials in the past two decades. On the basis of evidence that has accrued, hsCRP measurement has been integrated into the Reynolds risk scoring system to predict cardiovascular risk. The JUPITER trial proved the benefit of statins in cardiovascular risk reduction in patients with low grades of systemic inflammation and 'normal' cholesterol levels. However, substantial evidence has been generated from western studies. We, therefore, conducted a scoping review for studies done in India with a view to identify gaps in evidence and make further recommendations. Most Indian studies had small sample sizes and short term follow ups. There were no large population based prospective studies where patients were followed up for long periods of time for major cardiovascular end points. An analysis of the hsCRP level from the control arms of case-control studies derived a mean hsCRP value of 1.88 mg/l, which is higher than the western population where values < 1 mg/l are classified as low cardiovascular risk. Further large prospective cohort studies with longer term follow ups are essential before we can make further recommendations to integrate hsCRP into risk prediction models for cardiovascular disease prevention.

Rationale and design of a randomized controlled trial evaluating community health worker-based interventions for the secondary prevention of acute coronary syndromes in India (SPREAD).

BACKGROUND: There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease. There are no studies from low- to middle income countries (LMICs) evaluating trained community health worker (CHW)-based interventions for the secondary prevention of coronary heart disease. METHODS: We designed a hospital-based, open randomized trial of CHW-based interventions versus standard care. Patients after an acute coronary syndrome (ACS) were randomized to an intervention group (a CHW-based intervention package, comprising education tools to enhance self-care and adherence, and regular follow-up by the CHW) or to standard care for 12 months during which study outcomes were recorded. The CHWs were trained over a period of 6 months. The primary outcome measure was medication adherence. The secondary outcomes were differences in adherence to lifestyle modification, physiological parameters (blood pressure [BP], body weight, body mass index [BMI], heart rate, lipids), and major adverse cardiovascular events. RESULTS: We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities. The mean age was 56.4 (± 11.32) years, and 17.2% were females. A high prevalence of risk factors such as hypertension (43.4%), diabetes (31.9%), tobacco consumption (35.4%), and inadequate physical activity (70.5%) was documented. A little over half had ST-elevation myocardial infarction (53.7%), and 46.3% had non-ST-elevation myocardial infarction or unstable angina. CONCLUSION: The CHW interventions and training for SPREAD have been developed and adapted for local use. The results and experience of this study will be important to counter the burden of cardiovascular diseases in low- to middle income countries.

Age- and gender-related differences in drug utilisation and adverse drug reaction patterns among patients in a coronary care unit.

INTRODUCTION: This study aimed to examine age- and gender-related differences in the comorbidities, drug utilisation and adverse drug reaction (ADR) patterns of patients admitted to a coronary care unit (CCU). METHODS: The present study was a retrospective cohort study. Two trained physicians independently reviewed the case records of CCU patients over a period of one year (Jan-Dec 2008). The demographic, clinical, and drug prescription data of the patients were analysed according to age group (18-59 years vs ≥ 60 years) and gender. RESULTS: A total of 574 patients were admitted to the CCU during the study period. Of these 574 patients, 65.2% were male, and 48.4% were ≥ 60 years old. No significant gender-based differences were found for the prescription of cardiovascular and non-cardiovascular drugs, and ADR patterns (p > 0.05). Male patients aged ≥ 60 years were found to have a higher rate of polypharmacy than those aged 18-59 years (p = 0.001). The duration of hospital stay was longer in male than female patients (p = 0.008), and the duration of CCU stay was longer for male patients aged ≥ 60 years than males aged 18-59 years (p = 0.013). Compared to patients aged 18-59 years, a greater number of patients aged ≥ 60 years were prescribed cardiovascular (p = 0.006) and non-cardiovascular drugs (p = 0.015). Patients aged ≥ 60 years also had a higher rate of polypharmacy (p = 0.001) and ADRs (p = 0.013), and a longer duration of CCU stay (p = 0.013). Renal (p = 0.047) and cutaneous (p = 0.003) ADRs were found to be more common in patients aged ≥ 60 years. CONCLUSION: No major gender-related differences were observed in the prescription, drug utilisation and ADR patterns of our study cohort. Higher drug utilisation, ADR rates, and longer duration of CCU stay were noted in patients aged ≥ 60 years.

Patterns and determinants of cardiovascular drug utilization in coronary care unit patients of a tertiary care hospital.

BACKGROUND: A wide variation exists in the patterns of pharmacotherapy among patients admitted with cardiovascular diseases. Very few studies have evaluated the potential determinants of drug utilization. Our objective was to evaluate the clinical characteristics and patterns of cardiovascular drug utilization among patients in coronary care unit (CCU) and assess the determinants of cardiovascular drug use among patients with coronary artery disease (CAD). METHODS: In this retrospective cohort study, the medical records of CCU patients were reviewed independently by two trained physicians over one year. Patients were analyzed as two groups - those with CAD and without CAD. Multivariate logistic regression was done to identify the determinants of cardiovascular drug utilization in the CAD group. RESULTS: Of 574 patients, 65% were males, 57% were <60 years. The five commonly prescribed drug classes were platelet inhibitors (88.7%), statins (76.3%), ACE-inhibitors/Angiotensin receptor blockers (72%), beta-blockers (58%) and heparin (57%). Poly-pharmacy (>5 drugs) was noticed in 71% of patients. A majority of patients had diagnosis of CAD (72.6%). CAD patients received significantly higher median number of drugs and had longer duration of CCU stay (p < 0.0001). Renal dysfunction for ACE-inhibitors [0.18 (0.09-0.36)], ST-elevation myocardial infarction for calcium channel blockers [0.29 (0.09-0.93)] and brady-arrhythmias for beta-blockers [0.3 (0.2-0.7)] were identified as determinants of decreased drug use in CAD group. CONCLUSION: Predominance of male gender, age <60 and poly-pharmacy was observed in CCU. Antithrombotics, statins, ACE-inhibitors/Angiotensin receptor blockers and beta-blockers were the most frequently prescribed drugs. Clinical co-morbidities (renal dysfunction, arrhythmias) decreased the utilization of ACE-inhibitors, beta-blockers among CAD patients.

Patterns, predictors and preventability of adverse drug reactions in the coronary care unit of a tertiary care hospital.

AIM: To determine the frequency of occurrence, risk factors, clinical spectrum and drugs associated with adverse drug reactions (ADRs) occurring in the coronary care unit (CCU) of a tertiary care hospital. METHODS: This was a retrospective cohort study based on evaluation of the medical records of consecutive patients admitted to the CCU between January 2008 and December 2008. Each prescription was monitored for ADRs, and each ADR was assessed for causality, severity, predictability and preventability by two physicians using relevant scales. The chi-square test and independent t test were used to compare the ADR and non-ADR groups. Multiple binary logistic regression was used to identify risk factors for developing ADRs in the CCU. RESULTS: Of 595 patients, 152 (25.5%) developed ADRs, of which 45% were potentially preventable. Severe ADRs constituted 28.6% of the total ADRs. Patients who developed an ADR had a longer duration of stay in the hospital (2.8 extra days) (p < 0.05). Hypokalemia/hyperkalemia (22%), bleeding (11%) and cardiac arrhythmias (11%) were the commonest ADRs. The highest rates of ADRs were seen with streptokinase (59.4%). The predictors for developing an ADR in the CCU included renal dysfunction [odds ratio (OR) 1.66, 95% confidence interval (CI) 1.007-2.72], arrhythmias (OR 1.74, 95% CI 1.052-2.87) and polypharmacy with more than ten drugs (OR 11.3, 95% CI 1.45-87.44). CONCLUSION: A high frequency of ADR occurrence was identified, with many of the ADRs being potentially preventable. Patients with renal dysfunction or cardiac arrhythmias and those receiving polypharmacy were at an increased risk for developing an ADR in the CCU.