Fondaparinux in Acute Coronary Syndromes.

Anticoagulant therapy is a major component in the management of acute coronary syndromes (ACS). Anticoagulant-associated adverse events like heparin-induced thrombocytopenia, bleeding complications and need of close monitoring of anticoagulation led to focus on developing agents causing anticoagulation without affecting primary haemostasis. Fondaparinux, a new-age synthetic anticoagulant, acts by inhibiting factor Xa. It is simple to administer and has low inter and intra-subject variability. Moreover, there is no risk of significant drug interactions and no need for monitoring the platelet count. Efficacy of fondaparinux has been studied in various disorders including prevention of venous thromboembolism in major orthopaedic surgery, abdominal surgery and acutely ill medical patients, treatment of venous thromboembolism, non-ST-elevation acute coronary syndromes and ST-elevation acute myocardial infarction. This article covers the review of fondaparinux and its practical advantages mainly in the management of ACS including non-ST-elevation acute coronary syndromes and ST-elevation acute myocardial infarction.

WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: results of an open label, non-comparative, multi-centric, post marketing observational study.

BACKGROUND: Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. OBJECTIVE: To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. MATERIAL AND METHODS: An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded. RESULTS: A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. CONCLUSION: Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension.

Pharmacologic reperfusion therapy with indigenous tenecteplase in 15,222 patients with ST elevation myocardial infarction - the Indian Registry.

OBJECTIVE: To study the efficacy and safety of single intravenous bolus administration of indigenously developed tenecteplase (TNK-tPA) in the management of patients with ST-elevation myocardial infarction (STEMI) in clinical practice. METHODS: Observational, prescription-event monitoring study. RESULTS: Data of 15,222 patients who had STEMI and received weight adjusted TNK injection was analyzed. Overall 95.43% patients had clinically successful thrombolysis (CST). In the different subgroups, hypertensives, diabetics, smokers and hyperlipidemic patients had CST rates comparable to the general patient data. CST rates were significantly lower in the elderly patients (>70 years; 92.11%; p < 0.0001), in patients with history of Ischemic Heart Disease (IHD, 93.86%; p = 0.0004) and in patients receiving delayed treatment (>6 h after onset of chest pain; 85.38%; p < 0.0001). CST was significantly higher in patients who received an early thrombolysis (<3 h after onset of chest pain; 96.54%; p = 0.006). Overall mortality was 1.69%, while it was significantly higher in the elderly (4.42%), patients with history of IHD (2.67%), females (2.93%) and in those who received delayed treatment (4.98%). The overall incidences of intracranial hemorrhage (ICH), bleeding excluding ICH, stroke and ventricular tachyarrhythmia were 0.39%, 2.01%, 0.16% and 2.35% respectively. Age >70 years, diabetes, hyperlipidemia and history of IHD were associated with a higher incidence of heart failure, myocardial re-infarction or ventricular tachyarrhythmias. However, incidence of ICH and bleeding other than ICH was comparable amongst all patient subgroups. CONCLUSION: This study confirms the safety and efficacy of indigenous tenecteplase in Indian patients with STEMI, including high risk subgroups. It also highlights the fact that delayed treatment denotes denial of benefits of pharmacologic reperfusion therapy.

Efficacy & safety of tenecteplase in 6000 patients with ST-elevation myocardial infarction from the Elaxim Indian Registry.

OBJECTIVE: To study the efficacy and safety of single intravenous bolus administration of indigenously developed tenecteplase in the management of patients presenting with ST-elevation myocardial infarction in clinical practice. METHODS: Post-licensure, observational, prescription-event monitoring study. RESULTS: Data of 6000 patients who had ST-elevation myocardial infarction and received weight-adjusted tenecteplase injection was analyzed. Overall 90.93% patients had clinically successful thrombolysis, with highest success rate (93.2%) in patients treated within 3 hours. Overall mortality was 3.23%. The elderly (< or = 65 yrs; 24.58%) and diabetics (38.2%) had clinically successful thrombolysis of 87.73% and 90.49% respectively. Female patients (16.38%) had success rates comparable to males but with higher (6.41%) mortality. The overall incidences of intracranial hemorrhage (ICH), severe bleeding, stroke and ventricular tachyarrhythmia were 0.62%, 3.18%, 0.12% and 3.07% respectively and were not significantly different in females, diabetics and elderly patients. Delay in treatment beyond 6 hours was associated with increased incidence of heart failure, ventricular tachyarrhythmia and mortality. CONCLUSION: This study confirms the efficacy and safety of indigenous tenecteplase in the management of patients with ST-elevation myocardial infarction.

Efficacy and safety of tenecteplase in ST elevation myocardial infarction patients from the Elaxim Indian Registry.

OBJECTIVE: to study the efficacy and safety of indigenously developed tenecteplase injection in the management of Indian STEMI patients in clinical practice. METHODS: post-licensure, observational, prescription event monitoring study. RESULTS: 2100 patients received weight-adjusted tenecteplase injection. More than 90% patients received aspirin, clopidogrel, and enoxaparin/heparin. Clinically successful thrombolysis was reported in 86.71%, in-hospital mortality was 3.48%. The adverse events recorded were comparable with previously published data. Any bleeding (excluding intra-cranial hemorrhage) was seen in 4.62% patients which was reported in 0.90% patients of which 47.34% patients had also received GpIIb/IIIa inhibitors. CONCLUSION: This study confirms the efficacy and safety of indigenous tenecteplase in Indian STEMI patients.

Prognostic significance of predischarge 2D-echocardiography after first transmural myocardial infarction.

Predischarge two dimensional echocardiography (2D Echo) was performed in 45 survivors of first transmural myocardial infarction to assess its value in predicting major cardiac complications (MCC) during convalescence. Wall motion score was derived for each patient by analysing endocardial motion in 11 left ventricular segments. In 18 months follow up 11 of 14 patients (78%) who had major cardiac complications had wall motion score of at least 5. Wall motion score of less than 5 was present in 29 of the 31 (94%) of patients in asymptomatic group. Non-invasively obtained wall motion score helps in risk stratification of survivors of AMI. Wall motion score at predischarge 2D Echo or more identifies high risk cases from a relatively asymptomatic group (Killip Class I & II).