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

Cardiovascular diseases among Egyptian patients with rheumatoid arthritis and its relation to traditional risk factors

Rheumatoid arthritis [RA] is associated with increased mortality which is due to accelerated coronary artery and cerebrovascular atherosclerosis and researchers have not been able to clearly identify specific aspects of RA or its treatment that might higher the risk for cardiovascular [CV] disease. Prevalence of CV events in patients with rheumatoid arthritis. Effects of rheumatoid arthritis as a risk factor in developing CV diseases as well as influence of early and proper treatment on such risk. Association between RA as a risk factor and other traditional risk factors on CV diseases. 300 patients with RA and 150 controls matched with age and sex were subjected to full clinical assessment, laboratory investigations especially for rheumatoid factor [RF], erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], electrocardiography [ECG], conventional radiographs of both hands and feet to detect joint erosions and Doppler echocardiography. 13.5% of patients with RA has CV events, 7% for myocardial infarction and 2% for stroke. RA-related risk factors [extra articular disease, joints erosions and presence of RF were associated with CV events, the use of disease modifying antirheumatic drugs [DMARDs] were associated with lower risk for CV events. Our study confirm the role of traditional risk factors and their interplay with RA-retated risk factors in development of CV events. It also supports the beneficial effects of some DMARDs in lowering such risks

Subclinical atherosclerosis in patients with early rheumatoid arthritis

Rheumatoid arthritis [RA] patients have increased mortality and morbidity as a result of cardiovascular [CV] and cerebrovascular diseases. Surprisingly the extent of atherosclerosis [AS] in RA is not known, nor have standard CVD risk factors have been fully evaluated. Study of these changes in early RA and early diagnosis of AS in this population might trigger more aggressive prophylaxis. To demonstrate subclinical atherosclerosis in early RA and possible underlying mechanism. 60 patients with early RA and 40 controls matched for age, sex and traditional risk factors for AS were selected. All patients and controls were subjected to a complete history and full clinical examination, laboratory assessment and carotid ultrasonography. Patients with early RA had average greater cIMT than controls and an increased prevalence of atherosclerotic plaques. Positive association between cIMT and age, joint count, disease activity score [DAS], smoking, serum cholesterol and c-reactive protein [CRP] were observed. Age and CRP were independently associated with atherosclerosis. Patients with early RA developed accelerated atherosclerosis compared with controls. Age and CRP are strong predictors for occurrence of CV disease before onset of symptoms

value of cardiac troponin I as a predictor of cardiac events after percutaneous coronary intervention

Elevation of cardiac troponin I [cTnI] is not uncommon after coronary interventions. Many studies tried to find factors responsible for this elevation and its prognosis on short and long term follow up. Whether or not elevation of cardiac troponin post coronary interventions is responsible for early in hospital and late adverse outcome is still under debate. To identify different predictors of cardiac troponin I elevation after coronary interventions, and to assess the relation between cardiac troponin I elevation post coronary interventions and [early and late] adverse clinical outcome. The study included 50 consecutive patients who underwent coronary angioplasty with stenting in the Cardiac Catheterization Laboratory at Benha University Hospital during the period from December 2004 to December 2005. Full medical history and clinical data were obtained from the patients with special emphasis on the major documented risk factors for coronary artery disease [CAD] [age, sex, obesity, smoking, diabetes mellitus, hypertension, hypercholesterolemia, positive family history of CAD], and history of previous myocardial infarction [MI] or anginal attack. Twelve-lead standard surface electrocardiogram [ECG] was done routinely before and after intervention, echocardiography was also done to determine the global left ventricular systolic function, and coronary angiography was done for all patients and angiographic analysis was performed. Stenosis was considered when there was > 75% reduction in luminal diameter at coronary angiography. Quantitative measurements of the target lesion was performed before intervention by measurement of the lesion length, minimal luminal diameter and reference diameter. Percutaneous Coronary Intervention [PCI] was done and stenting for all patients . The procedure was considered successful when the residual stenosis in the dilated segment was less than 20%. Troponin I and CK-MB were measured 2 hours before the procedure and 8 and 24 hours after the procedure by immuno-inhibition based on the change in troponin I and CK-MB level. The patients were divided into 2 groups: Group I: No elevation of cTnI [0.4ng/l] and, Group II: cTnI [>0.4 ng/l], which was subdivided into Group IIA: with elevated cTnI + CK-MB > 25 IU/L, and Group IIB: with elevated cTnI + CK-MB 25 IU/L. New ST depression and T wave abnormalities post procedural were predictive of post procedural elevation of cardiac troponin I after PCI [p < 0.05]. Parameters of quantitative angiographic analysis of the lesions including preprocedural minimal luminal diameter [p < 0.01], diameter stenosis [p < 0.01] and post procedural minimal luminal diameter [p<0.01] and diameter stenosis [p < 0.05] were strongly associated with post procedural cardiac troponin I elevation. Shorter stent length was also associated with cardiac troponin I elevation post cath. [p < 0.01]. Positive predictive value of cardiac troponin I post procedural for early complications was 23.1% and negative predictive value was l00%. Concordant cardiac troponin I and CK-MB elevation post procedural were strong predictors for early in hospital complications [p<0.01]. Positive predictive value for concordant cTnI and CK-MB elevation for early complications was 60% and negative predictive value was 100%. No association was found between cardiac troponin 1 elevation post cath or concordant elevation of cardiac troponin I and CK-MB elevation with late adverse clinical outcome

role of heart rate variability in the diagnosis of rheumatic fever in children

Rheumatic fever is a characteristic constellation of multisystem disease, which occurs after a lag period following pharyngeal infection with group A streptococci Heart Rate Variability [HRV] is defined as the amount of heart rate fluctuations around the mean heart rate. HRV can be used as a mirror of the cardio-respiratory control system and represents one of the most promising and easy markers of sympathetic and parasympathetic function of the autonomic nervous system. Determining HRV changes in children with rheumatic fever, as well as using HRV as a diagnostic marker of rheumatic heart disease. This cross-sectional case-control study included 50 children suffering from rheumatic fever [25 males and 25 females], their ages ranged between 5-12 years with a mean of 8.52 +/- 3.45 year and their mean weight was 27.28 +/- 8.07 Kg. Forty healthy children [20 males and 20 females] of the same age and with a mean weight 25.35 +/- 6.22 Kg were studied as a control group. All cases were subjected to thorough clinical examination, laboratory investigations [erythrocyte sedimentation rate, anti-streptolysin O titer, C reactive protein, X-ray chest and heart, electrocardiographic recording, echocardiographic assessment, and HRV measurement. All indicators of HRV showed a highly statistical significant impairment in cases with rheumatic heart disease compared to controls [P<0.01], and showed a statistical significant decrease in patients with rheumatic carditis with or without heart failure in comparison to controls [P<0.05]. Also, the results of this study showed that patients with rheumatic carditis with or without heart failure had significant increase in average rate and significant decrease in P-R interval in comparison to controls [P <0.05]. Cases urith rheumatic arthritis showed insigniftant decrease in HRV indices [P>0.05]. HRV indices are impaired in patients with rheumatic heart disease and more significantly impaired in patients with rheumatic carditis with or without heart failure, suggesting alteration of autonomic activity in the form of decreased parasympathetic tone on the heart. Therefore, HRV could be used as a diagnostic marker of carditis in cases with rheumatic heart disease .HRV indices are impaired in cases with rheumatic heart disease in spite of taking antifailure drugs that increase HRV, so HRV will be more impaired without treatment with these drugs

Endothelial dysfunction assessmentas a predictor of coronary arterydisease in egyptian patients

Background : Endothelial dysfunction appears to be a generalizedprocess that is not necessarily confined to vessels with overt atheroscle-rotic alterations. This assumption is strengthened by the finding of a cor-relation between coronary and peripheral endothelial dysfunction

Objective:To assess if flow-mediated vasodilation [FMD%] of the bra-chial artery, could be used as a diagnostic screening test in patients withcoronary artery disease.Patients: Three groups of patients will be included in the study:Group A:Twenty patients had no chest pain, normal ECG and neg-ative stress ECG.Group B: Twenty patients had chest pain, normal ECG, negativestress ECG and normal coronary angiogram.Group C:Twenty patients had documented coronary artery dis-ease [CAD] by coronary angiogram

Methods:Complete history taking and through clinical examination,laboratory investigation, ECG, stress ECG, coronary angiogram and B-mode ultrasound images of the brachial artery

Results:There was no statistically significant difference between thethree groups regarding age, sex, hypertension, hypercholesterolemia,presence of diabetes mellitus smoking and family history of CAD[P>0.05]. In comparing group A with group B, there was no statisticallysignificant difference between the two groups regarding flow mediateddilatation [FMD%, NTG mediated dilatation % and ratio of FMD to NTGmediated dilatation [P>0.05], but there was a highly statistically significant difference between group A and group C regarding FMD% and FMD:NTG ratio [P<0.01] and statistically significant difference between thetwo-groups regarding NTG% [P<0.05]. In comparing group B and C, therewas statistically significant difference between the two groups regardingFMD%, NTG% and FMD to NTG% ratio [P<0.05]. The sensitivity, specificityand positive predictive value of FMD% <4.5% in relation to coronary angiogram for detection of CAD was [75%, 80% and 88%] respectively. Re-garding the effect of risk factors on FMD%, FMD% was significantly de-creased in smokers, diabetic and hypertensive [P<0.05]. Also it wasdecreased in hypercholesterolemic [P<0.01]. However it was decreased inobese and those with positive family history but the difference was notstatistically significant [P>0.05]

Conclusion: The determination of endothelial dysfunction expressedby FMD% was found to be a sensitive and specific screening test to pre-dict the presence of CAD. Because this is non invasive, non-radioactiveand cost-effective approach, it warrant further evaluation to determine itis value in daily clinical practice as an additional screening test in diag-nosis of CAD

Predictive value of c-reactive protein for coronary in stent restenosis

C-Reactive protein [CRP] should be measured in all patients undergoing coronary angioplasty for prognostic stratification. Preprocedural levels are of proved efficacy. CRP levels can be used as a guide to therapy in PCI. The aim of this study is to evaluate the predictive value of CRP plasma leve1 for coronary instent restenosis [ISR]. This study included 60 patients who underwent successful coronary stenting. All patients included in. this study were subjected to the following. Full history taking, thorough clinical examination, risk factors evaluation, 12 leads surface ECG, plain chest x-ray echocardiography, coronary angiography and laboratory investigations [Blood sugar level lipid profile and CRP] with follow up period for six month. Patients were classified into two groups according to ISR. Group [I] with ISR included 22 patients [43.1%] and 22 lesions treated with 25 stents [45%]. Group [II] without ISR included 29 patients [59.9%] with 29 lesions treated with 30 stents [55%]. At follow up, focal ISR [<10 mm] was detected in 5 patients [22.7%]. diffuse [>10 mm] in 7 patients [31.8%], proliferative ISR in 5 patients t22. 7%] and total occlusion in 5 patients [22.7%]. In restenotic group [I] 8 patients [36.4%] were asymptomatic, two p [9.1%] had unstable angina and 12 patients [54.5%] had stable angina. In the non restenotic group [II] 22 patients [75.9%] were asymptomatic four patients [138%] had unstable angina and three patients [102%] had stable angina. Clinical, lesional and procedural variables are not associated with in creased risk of ISR. The only variable for exclusion of ISR was a normal level of CRE in plasma [72 hours after coronary stenting]. Its specificity was [100%]

Prevalence of carotid atherosclerosis in patients with coronary artery disease

Many studies have identified the relationship between carotid atherosclerosis and coronary artery diseases. The rationale for testing carotid artery stenosis in patients with coronary artery disease, have several benefits for early detection of asymtomatic carotid stenosis. The aim of this study is to evaluate the prevalence of carotid artery patients with coronary artery disease. The study included 102 patients proved to be ischemic heart disease angiography, underwent carotid duplex. These patients classified into two groups according to carotid duplex result, group A [negative duplex] and group B [positive carotid duplex]. All patients were subjected to the following:-Full history taking, thorough clinical examination, laboratory investi-gation, 12 leads surface ECG, echocardiography, coronary angiography and carotid duplex. Age was significantly higher in group B than in group A. No statistically significant difference between both groups as regard EF% and history of myocardial infarction. There was close association between carotid atherosclerosis and multivessel coronary artery disease. Carotid atherosclerosis and degree of stenosis in. left carotid artery was significantly higher than in right one. From this study we concluded that there was a close relationship between coronary and carotid atherosclerosis both sharing more or Less, the same risk factors [smoking, diabetes mellitus, hypertension, hyperlipidemia and left ventricular hypertrophy], the degree of carotid atherosclerosis can be used as non invasive procedure for assessment of patients prepared for coronary angiogram

Relationship between microalbuminuria and subclinical cardiac structural changes in isolated systolic hypertension in elderly patients

Isolated systolic hypertension is common in elderly people and accounts for more than 50% of all cases with hypertension above the age of 65 years. Microalbuminuria represents an early marker of cardiac structural damage

The aim of this work: is to study the relationship between micro albuminuria and subclinical cardiac structural changes [septal wall thickness [SWT], left ventricular mass [LVM] and left ventricular mass index [LVMI]] in isolated systolic hypertension in elderly patients

Result: showed significant positive correlation between microalbuminuria and cardiac structural changes [LVMI - P = 0.001, SWT - P = 0.002 and LVM - P = 0.00011]. There was a significant positive correlation between the duration of hypertension and microalbuminuria, LVM [P=0.02] and LVH [P=0.001]. Also, there was a significant positive correlation between age of patients and LVM [P = 0.01] and LVH [P = 0.01]

Conclusion: taken together this study showed that microalbuminuria represents an early marker of crdiac structural changes in isolated systolic hypertension in elderly patients. It is considered one of the new associated risk factors of hypertension. Cardiovascular prognosis depends not only on the blood pressure level but also on hte presence of target organ damage. So we recommend early detection of microalbuminuria in every hypertensive patient as it is an early sign of endothelial dysfunction and damaged blood vessels

Diagnostic, prognostic and predictive value of posterior chest leads in acute inferior myocardial infarction

The aim of this work was to study the diagnostic, prognostic and predictive value of posterior chest leads [PCL] V7- V9 in patients with acute inferior myocardial infarction [AIMI] and its correlation coronary angiography. 30 patients with AIMI were included in this study they were into 2 groups: group A, 11 patients with AIMI and ST-segment elevation [STE] in PCL group B, 19 patients with AIMI without STE in PCL. Routine laboratory investigation, creatine phosphokinse [CPK], 15 leads ECG, echocardiographic examination and coronary angiongraphy. The prevalence of STE in PCL in-patients with AIMI was 36.7% [group A], were older, more hyperlipidemic, had higher incidence of R/S>1 in V1-V2, more STD in V1-V3, taller upright T wave, higher CPK level, lower EF, higher incidence of MR and more complication [heart failure, MR, arrhythmia and postinfarction angina] than group B [P <0.05] they had more wall motion abnormalities [WMA] mainly posterolateral and inferolateral [P<0.01]. Left circumflex coronary artery was the infarct related artery in virtually all patients in group A while right coronary artery was in 89.5% of patients in group B there was a higher incidence of multivessel disease proximal and diffuse lesions in group A the sensitivity and specificity of STE in PCL, R/S >1 in V1-V2 and STD in V1-V3 in relation to PWMA in diagnosis of posterior myocardial infarction was 100%, 82.6%, 71.4%, 100%. 100% and 78.3% respectively. We recommend routine recording of leads V7 to V9 in all patients with an AIMI and suggest that STE identifies a group of big infarction who at higher risk

Incidence and predictors of immediate elastic recoil after percutaneous translumenal coronary angioplasty

To assess the incidence and magnitude of elastic recoil that occurs immediately after coronary angioplasty and to detect the clinical and angiographic predictors of this process. Forty ischaemic heart patients who were scheduled for PTCA: with clinical diagnosis of stable angina, unstable angina or prior myocardial infarction [MI Their ages ranged 31-76 years; with mean age 49.47 +/- 11.89 years. Thirty-six [90%]were males and four [10%]were female Qualitative and Quantitative coronary angiographic evaluation before, during, and immediately after PTCA were done for all patients included in this study to detect the occurrence of elastic recoil, its magnitude, and its predictors. All patients showed different degrees of elastic recoil; with an average of 0.56 +/- 0.43 mm. Elastic recoil was responsible for a mean cumulative loss of 18.48 +/- 14.19% of the theoretically achievable gain immediately after balloon deflation. The following factors were found to have a positive correlation with the increased incidence and degree of recoil: bal loon over sizing, lesion calcification, and eccentricity of lesion. However, elastic recoil was not influenced by age, sex, coronary risk factors or the patient's clinical diagnosis [stable angina, unstable angina or old MI]. Elastic recoil was extremely common and caused loss of nearly 20% of the potential gain obtained during maximal balloon inflation. The present study identified the predictors of this unwanted event: the use of an oversized balloon for dilatation, lesion calcification and lesion eccentricity