Evaluation of the Efficacy and Safety of Azilsartan in Adult Patients with Essential Hypertension: A Randomized, Phase-III Clinical Study in India.

BACKGROUND: Globally, women and men over the age of 25 years suffer from hypertension, the need for new treatment strategies to treat hypertension is due to the multi-faceted nature of the disease. Lack of optimal blood pressure control can lead to multiple complications. Therefore, this phase 3 study was conducted to assess the efficacy, safety and tolerability of potential product azilsartan hydrochloride for reduction in blood pressure in Indian patients with essential hypertension. METHODS: This was a prospective, multicentre, randomized, comparative, parallel study of 303 participants over six weeks of treatment period with either azilsartan 40 mg or azilsartan 80 mg or telmisartan 40 mg in adult patients with essential hypertension. The primary endpoint was the change in mean trough sitting clinic systolic blood pressure (scSBP) from baseline to week 6. The secondary endpoints were the change in mean trough sitting clinic diastolic blood pressure (scDBP) from baseline and change in the 24-hour mean ambulatory systolic blood pressure (SBP)and diastolic blood pressure (DBP) from baseline. RESULTS: The change in mean trough scSBP from baseline to week 6 was -27.2 ± 9.99, -28.2 ± 10.06 and -26.7 ± 9.72 (Per Patient (PP) Population) and -27.2 ± 9.93, -28.3 ± 10.01 and -26.7 ± 9.67 (Intent to Treat (ITT) Population) in the azilsartan 40mg, 80mg and telmisartan 40mg groups respectively. The lower limit of 95% CI of difference in change in mean systolic blood pressure was -2.35(Azilsartan 40mg) and 1.32 (Azilsartan 80mg) is less than the non-inferiority margin (i.e. 2.67). The change in mean trough scDBP from baseline to week 6 was -13.1 ± 8.46, -12.9 ± 7.20, and -13.0 ± 7.96 (PP) and -13.1 ± 8.42, -12.9 ± 7.16 and -13.0 ± 7.92 (ITT) in Azilsartna 40 mg, Azilsartan 80 mg and Telmisartan 40 mg respectively. The reduction in trough scDBP in Azilsartan 40 mg (p=0.9461: PP; p=0.9330: ITT) and Azilsartan 80 mg (p=0.9090: PP; p=0.9158: ITT) was not statistically significant compared to Telmisartan 40 mg. The difference in fall in the trough scSBP, scDBP and ambulatory SBP and DBP was similar between the groups from baseline to week 6 (P >0.05). Headache and dizziness were the most frequent treatmentrelated treatment-emergent adverse events. CONCLUSION: Azilsartan is an effective blood pressure lowering drug and well tolerated and was non- inferior to telmisartan in its safety and efficacy.

Ultrathin, biodegradable polymer-coated everolimus-eluting stents for patients undergoing percutaneous coronary intervention: Final three-year results of the PERFORM-EVER registry.

The registry reports 3-year safety and clinical performance of the ultrathin strut (60 µm) biodegradable polymer-coated Tetrilimus, an everolimus-eluting stent (EES) (Sahajanand Medical Technologies Limited, India), in 'real-world' patients with coronary artery disease. A total of 815 Tetrilimus EES were implanted in 735 lesions in 594 patients. At 3-year follow-up, primary endpoint (target lesion failure, TLF) was reported in 8.6 % patients, including 2.6 % cardiac deaths, 3.5 % myocardial infarction and 2.6 % target lesion revascularization. At three-year, no cases of definite stent thrombosis were reported. The final three-year results of PERFORM-EVER registry endorse the continuous safety and effectiveness Tetrilimus EES.

Salvageability of kidney in Grade IV renal trauma by minimally invasive treatment methods.

CONTEXT: Renal trauma is increasingly being managed conservatively. Grade I-III injuries are managed conservatively whereas Grade V injuries may end in surgery. Managing Grade IV renal trauma is individualized and managed accordingly. AIMS: To evaluate retrospectively all Grade IV renal injuries managed in our institute over five years and to review the available literature. SETTINGS AND DESIGN: Reviewing the records of patients who sustained renal trauma and study all Grade IV renal injuries. MATERIALS AND METHODS: We retrospectively analyzed all Grade IV renal injuries (16) managed at our institute between July 2008-August 2013. All patients were treated conservatively initially by hemodynamic stabilization, strict bed rest, if required endoscopic procedures. These patients were followed up with CECT. STATISTICAL ANALYSIS: Descriptive statistics was performed using Microsoft excel spreadsheet 2007. Continuous data were described as mean and range. Categorical data was described as percentages. RESULTS: Sixteen patients with Grade IV renal injury were included in the study. All patients had gross hematuria and 15 had urinary extravasation. D-J Stenting was done in 7 patients; perinephric tube drainage with D-J stentingwas done in 2 patients. One required selective upper pole arterial embolisation. Nephrectomy was not required in any of the patients. In the follow-up period, no patient had delayed complications. CONCLUSIONS: Successful conservative management of Grade IV renal trauma requires constant monitoring both clinically and radiologically, and if properly managed, kidneys can be salvaged in all stable patients as reinforced by our study.

Off-pump coronary artery bypass in congenital absence of pericardium.

Off-pump coronary artery bypass involves precise manipulations for proper positioning the heart without causing hemodynamic compromise. Pericardial stay sutures exerting appropriate traction play an important role in off-pump surgery. We report a rare case in which a congenital pericardial defect was discovered after sternotomy in a patient undergoing off-pump coronary artery bypass.