Irbesartan in mild to moderate hypertensive patients a phase IV clinical trial

This study examines the efficacy of Irbesartan as a potent angiotensin receptor antagonist in achieving the recommended target SBP and DBP in diabetic [<130/80] and non-diabetic patients [<140/90], and the role of adding HCTZ in achieving control of BP in patients not responding adequately to Irbesartan mono-therapy. Moreover, the study emphasizes on the rate of BP control, and analyzes the rate of reduction in different treatment subgroups [Irbesartan 150 mg alone, Irbesartan 300 mg alone, and Irbesartan 300 mg plus HCTZ 12.5 mg]. The study also evaluates the safety profile in each treatment subgroup and the extent of its tolerability as compared to efficacy outcomes. Methods: This multicenter, prospective, open, non-randomized, non-comparative phase IV setting spanned a 3-months [12 weeks] treatment period for each patient, and was preceded by a 7 days prestudy screening period. 1630 subjects were actually enrolled. Each patient was assigned to 5 scheduled visits. The first 3 visits were for dose titration; one visit for follow up and dose maintenance, and a 5th visit for final assessment. The study was considered completed for a patient at the time he/she completed all scheduled study procedures [5 visits]. Patients started on Irbesartan 150 mg, taken orally, once daily with 24 hour interval for 3 weeks; if target BP is not achieved, patient was switched to Irbesartan 300 mg for further 3 weeks; and if target BP was still not achieved, patient was switched to Irbesartan 300 mg plus HCTZ 12.5 mg, for the rest of the study duration. The starting dose and the dose titration schedule were modified according to the Investigator's judgment and patients' BP response. . Results: By the end of the 3 month trial duration [week 12], 91.18% [1324 patients, n= 1452] of the overall ITT population who completed the study reached the target BP irrespective of their treatment subgroup with better BP control for non-diabetic patients, 96.04% [1116 patients, n= 1162] compared to 71.71% [208 patients, n= 290] for diabetics, p<0.001. The percentage of ITT population treated by Irbesartan 150 mg and reached the target blood pressure was 82.7% [81 patients, n= 98] for diabetic patients and 99.0% [500 patients, n=505] among non-diabetics patients, p<0.001. For patients failed to be controlled with Irbesartan 150 mg and treated with Irbesartan 300 mg, the percentage of those reaching the target BP among diabetics was 76.0% [76 patients, n=100] and 96.6% [314 patients, n=325] among non- diabetics, p<0.001. Proportion of enrolled patients reaching a blood pressure target were 55.4% [51 patients, n=92] among diabetics and 90.96% [302 patients, n=332] among non-diabetics for patients treated with Irbesartan 300 mg plus HCTZ 12.5 mg, p<0.001. Irbesartan showed a significant reduction in both mean systolic blood pressure [33.16 mmHg [21.11%], 33.09 mmHg [20.53%], and 29.63 mmg [18.09%] for any Irbesartan 150 mg, 300 mg, and 300 + HCTZ, respectively, p<0.001] and mean diastolic blood pressure [18.61 mmHg [18.98%], 18.42 mmHg [18.61%], and 16.07 mmHg [16.17%] for Irbesartan 150 mg., 300 mg, and 300 + HCTZ, respectively, p<0.001]. That was evident from the third week of treatment throughout the study period till week 12. The percentages of patients that reached the target blood pressure [controlled] were significantly higher in non-diabetics [99% [500], 96.6% [314], and 90.96% [302], for Irbesartan 150 mg, 300 mg, and 300 mg +HCTZ, respectively, p<0.001]compared to diabetics [82.7% [81], 76% [76], and 55.4% [51] for Irbesartan 150 mg, 300 mg, and 300 mg + HCTZ, respectively, p<0.001] for each of the Irbesartan strengths

Left ventricular haemodynamics after percutaneous transvenous mitral valvuloplasty

This study analyzed the immediate outcome of percutaneous balloon mitral valvuloplasty in patients with isolated mitral valve stenosis. Immediate results were analyzed in 20 patients. Mitral valve area after valvuloplasty was significantly increased, while mean transmitral pressure gradient, left atrial mean pressure, pulmonary artery systolic pressure and right atrial mean pressure decreased. LV end diastolic pressure increased, cardiac output in spite of decreased heart rate. EF increased, FS and diastolic filling time. Echocardiographic assessment 3 weeks later denoting persistent improvement in LV hemodynamics. So, Mitral valvuloplasty is a safe effective procedure to relieve the symptoms of mitral stenosis with improving LV hemodynamics

Percutaneous transluminal coronary angioplasty as assessted by stress echo VS stress thallium - 201 studies

This study was designed to assess the relationship between stress exercise echocardiography [echo] and 201-TI single photon emission computed tomography [SPECT] applied simultaneously in ten patients who were candidates for percutaneous transluminal coronary angioplasty [PTCA]. The study also aimed to assess the relation of the development of exercise induced wall motion abnormalities [echo], transient perfusion defects [SPECT] vs coronary artery disease [CAD] severity. The functional improvement after PTCA was compared. Before PTCA, there was 80% agreement between stress echo [new wall motion abnormalities] and SPECT [transient perfusion defects]. The results indicated that patients with critical CAD had a positive echo and SPECT. Four weeks after PTCA, an ischemic response at stress echo was found in 20% of the patients, while SPECT was positive in 40% of the cases. It was concluded that exercise echo and 201-TI SPECT are useful non-invasive tools for the functional assessment of patients before and after successful PTCA

Role of angiotensin II in pathogenesis of left ventricular hypertrophy [LVH] and microalbuminuria in essential hypertension

This study included 20 patients with essential hypertension and concomitant LVH, all were not receiving any medications before. They were assessed by M-mode echocardiography for assessment diagnosis of LV mass index. All patients were given 20 mg enalapril for 6 months and BP, LV mass index, microalbuminuria were assessed before and after treatment. There was significant drop of systolic and diastolic BP and regression of LV mass index with concomitant decrease in microalbuminuria. Systolic and diastolic BP were significantly correlated with LV mass index after treatment, while only diastolic BP was significantly correlated with microalbuminuria after treatment. These findings may point to role of angiotensin II in pathogenesis of LVH in essential hypertension

Coronary arteriograms and myocardial scintigrams for clinical and pathologic features of obstructive lesions in the predominant coronary circulation

The clinical features and the location and severity of obstructive coronary artery disease are contrasted in 8 patients with predominant left and 13 patients with predominant right coronary circulation, using exercise stress test and thallium perfusion scintigraphy. A significantly higher incidence of ventricular conduction and a greater incidence and severity of obstructive coronary artery disease, distinguishing the predominant left from the right coronary circulation. The results suggested an anatomic disadvantaged status for the predominant left coronary with the right predominant coronary circulation with respect to ventricular conduction defects and to coronary atherogenesis in mankind

Dysrhythmia in patients with mitral valve prolapse

The association of dysrhythmias with mitral valve prolapse in patients complaining of chest pain was investigated by graded treadmill exercise testing, and 24-hour Holter monitoring. 20 selected patients with a clinical diagnosis of mitral valve prolapse confirmed by echocardiography or angiography or both were studied. On Holter monitoring, 6 patients [30%] had potentially serious ventricular dysrhythmias, 5 of them had manifested ventricular dysrhythmias on treadmill testing. Neither st and ard ECG abnormalities nor clinical symptoms correlated with detected dysrhythmias. This study showed that potentially serious ventricular dysrhythmias are common in patients with mitral valve prolapse and that ambulatory ECG monitoring and treadmill exercise testing are useful for detecting dysrhythmias