Post-marketing study of clinical experience of atorvastatin 80 mg vs 40 mg in Indian patients with acute coronary syndrome- a randomized, multi-centre study (CURE-ACS).

OBJECTIVE: To generate comparative clinical data in Indian patients with acute coronary syndrome (ACS) in terms of safety and efficacy of atorvastatin 80 mg vis-à-vis atorvastatin 40 mg MATERIALS AND METHODS: A total of 236 patients with diagnosed ACS (with TIMI Risk score > or = 3) within preceding 10 days were randomized to receive either atorvastatin 80 mg or atorvastatin 40 mg once daily for 12 weeks. Out of 236 patients, data for 173 was analyzed who had both baseline and post-baseline lipid assessment. The primary end point of the trial was percentage change in LDL-C at the end of treatment from baseline. Other end points were change in high sensitivity C reactive protein, incidence of increase in liver enzymes > or = 3 times upper limit of normal and incidence of myotoxicity (with or without elevation of creatinine phosphokinase) at the end of treatment. RESULTS: A dose-dependent response was observed with greater reduction of LDL -C in atorvastatin 80 mg (27.5% vs 19.04%) than that of atorvastatin 40 mg group. Both the treatment groups had a significant reduction (p < 0.001) in LDL-C at the end of 6 and 12 weeks in comparison to baseline. hs-CRP was also significantly reduced (p < 0.001) in both the treatment groups i.e. atorvastatin 80 mg (76.15%) and atorvastatin 40 mg (84.4%) from baseline at the end of 12 weeks. Both doses of atorvastatin were well tolerated. No patient had elevation of (> or = 3 times of upper limit of normal) liver enzymes or creatinine phosphokinase. One patient on atorvastatin 80 mg complained of myalgia. There were no dose-related differences in incidence of adverse events between two treatment groups. CONCLUSION: The CURE-ACS trial indicated that atorvastatin 80 mg was more effective than atorvastatin 40 mg in terms of reduction in LDL cholesterol and was as safe and well tolerated as 40 mg dose in Indian patients with ACS.

Cardiac resynchronization therapy is associated with improvement in clinical outcomes in Indian heart failure patients: Results of a large, long-term observational study.

BACKGROUND: Heart failure (HF) is a common health problem in South Asia, and its incidence and prevalence are projected to rise. Cardiac resynchronization therapy (CRT) has been shown to improve mortality, reduce hospitalizations, and improve symptoms in selected patients with HF. The South Asian Systolic Heart Failure Registry (SASHFR) was designed to be a large and comprehensive registry of Indian HF patients with the purpose of enhancing the quality of care and clinical outcomes of HF patients by promoting the adoption of evidence-based, guideline-recommended therapies, in particular CRT. METHODS: Overall, 471 patients on optimized medical therapy and meeting CRT implantation guidelines were followed up in 12 Indian hospitals. During the 2-year follow-up period, clinical response in terms of clinical composite score, overall performance and changes in HF performance metrics, mortality and hospitalizations rates were evaluated. RESULTS: Of 471 patients, 116 (24.6%) accepted to be implanted with a CRT device, while 355 (75.4%) refused, financial constraints being the main reason for refusing a CRT device. The study met its primary outcome, as the number of patients associated with an improvement in clinical composite score at 24 months was significantly higher (69.1%) in the CRT group than in the no-CRT group (44.7%) [odds ratio = 2 (95% confidence interval 1.25-3.20), p = 0.004]. Also, changes in HF metrics, mortality and hospitalizations rates indicated a more favorable response among patients who underwent CRT. CONCLUSIONS: The results from the SASHFR registry show a clear superiority of CRT over optimal pharmacological therapy in terms of improvement in clinical conditions among HF patients. The low rate of CRT acceptance, in patients indicated to this therapy, highlights the need for new health-care policies to improve awareness about HF disease and its therapies and possibly to enhance financial coverage of indicated therapies.

Profiling cardiac arrhythmia and heart failure patients in India: The Pan-arrhythmia and Heart Failure Observational Study.

BACKGROUND: The PANARrhythMia and Heart Failure Registry (PANARM HF) characterized demographic, clinical and interventional therapy indication profiles of cardiac arrhythmia (CA) and heart failure (HF) patients in India. METHODS: Consulting Physicians (CP) who medically manage CA and HF patients enrolled patients with one or more of the following: syncope, pre-syncope, dyspnea, palpitation, fatigue and LV dysfunction. The CPs were trained by interventional cardiologists (IC) to identify CA/HF patients indicated for implantable device/radiofrequency ablation (RFA). 59 CP's, 16 IC's & 2205 patients from 12 cities participated. Demographic, clinical, device/RFA indication and referral-consultation profiles were created. IC's provided device/RFA recommendations based on these profiles. RESULTS: The CA/HF distribution of patients was: HF - 58%, bradyarrhythmia - 15%, atrial fibrillation - 15%, other supraventricular tachyarrhythmia - 10% and ventricular tachycardia/fibrillation - 4.5%. 62% of the CA/HF population was male and 45% were below age 60. Coronary artery disease (52%), hypertension (44%), diabetes (30%) & myocardial infarction (20%) were prominent. 1011 (46%) of the CA/HF population were potential device/RFA candidates according to the IC's. However, only 700 (69%) of these patients were referred to the IC by the CP. Of referred patients, only 177 (25%) consulted the IC and were recommended therapy. Thus, 824 (83%) of patients indicated for interventional therapy were not advised therapy or did not opt for it. CONCLUSION: The India PANARM HF study provides new information and insights into the demographic, clinical, interventional therapy, referral and consultation pattern profiles of CA/HF patients in India.

Delayed embolization of Amplatzer septal occluder device: an unknown entity--a case report.

A case of delayed embolization of Amplatzer septal occluder, occurring at 2 weeks postimplantation in a 10-year-old girl with an oval-shaped secundum atrial septal defect is reported. The structurally intact device dislodged into the left atrium owing to reversal of transatrial pressure gradients and embolized to the left ventricular outflow tract from where it was retrieved surgically.

An endoscopic study of upper-GI mucosal changes in patients with congestive heart failure.

BACKGROUND: Congestive heart failure results in an increase in systemic venous pressure that is transmitted to the inferior vena cava and to the hepatic veins. This can cause GI vascular and mucosal congestion. The aim of this study was to define upper-GI mucosal changes in patients with congestive heart failure. METHODS: A total of 57 patients with congestive heart failure presenting with GI symptoms underwent upper endoscopy. Echocardiography was performed in all patients to determine the ejection fraction and the degree of tricuspid regurgitation. Transabdominal US was performed to measure the diameters of the hepatic veins, the inferior vena cava, and the portal vein. The presence and the severity of gastropathy and duodenopathy were compared with the parameters relating to severity of cardiac failure. RESULTS: Of the 57 patients studied, gastric mucosal changes were observed in 50 (88%), duodenal mucosal changes in 31 (54%), and esophageal mucosal changes in none. Gastric mucosal changes were the following: mosaic-like pattern (n = 50), punctate spots (n = 34), thickened folds (n = 5), watermelon stomach (n = 3), and telangiectasia (n = 10). Duodenal mucosal changes were the following: mosaic-like pattern (n = 29), thickened folds (n = 8), and telangiectasia (n = 2). Upper-GI symptoms were associated with gastropathy ( p = 0.027) and duodenopathy ( p = 0.003). The presence and the severity of duodenopathy showed a high degree of positive correlation with the presence and the severity of gastropathy (gamma value 0.690; p value <0.001). Patients with gastropathy and duodenopathy had higher mean inferior vena cava and hepatic vein diameters than those without gastropathy and duodenopathy. The severity of duodenopathy but not that of gastropathy was significantly associated with increasing severity of tricuspid regurgitation ( p = 0.001), larger portal vein diameter ( p = 0.02), and lower ejection fraction ( p = 0.008). CONCLUSIONS: Among patients with congestive cardiac failure with GI symptoms, changes of congestive gastropathy are evident in 88% and duodenopathy in 54%. The presence and the severity of duodenopathy was significantly associated with increasing severity of features of congestive heart failure.