Blood Pressure Reduction In Patients Research Articles

Effects of Calcium Channel Blockers on Proteinuria in Patients With Diabetic Nephropathy

Diabetic nephropathy management should include the use of an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker with additional antihypertensive medications to reduce proteinuria and cardiovascular events. Some studies suggest that adding a nondihydropyridine rather than a dihydropyridine calcium channel blocker (CCB) may more effectively lower proteinuria. We hypothesized that a trandolapril/verapamil SR (T/V) fixed-dose combination (FDC) was superior to a benazepril/amlodipine (B/A) FDC for reducing albuminuria in 304 hypertensive diabetic nephropathy patients when treated for 36 weeks. No statistically significant differences were observed between groups in the primary end point; adjusted percentage change in urinary albumin/creatinine ratio (UACR), which increased (mean T/V, 29.29%; mean B/A, 8.49%; difference, 20.80%; P=.34); or in change in absolute UACR, which decreased (mean [g/g] T/V, -0.11; mean [g/g] B/A, -0.08; difference -0.03; P=.78). There were significant reductions in log UACR (mean change in T/V, -0.28; P<.01; mean change in B/A, -0.31; P<.001) and diastolic blood pressure in both groups and in systolic blood pressure in the B/A group. T/V was not superior to B/A for reducing UACR. Both ACEI/CCB FDCs may reduce albuminuria; in the case of T/V, this appears to be independent of systolic blood pressure reduction in patients who had previously been treated and had baseline blood pressure levels of 142/77 mm Hg.

Can Ischemic Stroke Be Caused by Acute Reduction of Blood Pressure in the Acute Phase of Cardiovascular Disease?

Acute-phase cardiovascular disease (CVD) frequently presents with markedly elevated blood pressure (BP) levels and often requires fairly rapid lowering of BP. On the other hand, aggressive lowering of systemic BP to the point that the cerebral BP decreases below a certain threshold may result in ischemic stroke. The authors retrospectively studied 192 consecutive patients with CVD who had markedly elevated BP and end-organ damage. Ischemic stroke was noted in 12 of these patients during BP-lowering therapy. The incidence of ischemic stroke did not differ significantly between a standard BP-lowering group, in which the target BP reduction was within the parameters of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines, and a rapid BP-lowering group, in which the target BP was below these guidelines (7.1% vs 2.6%, respectively; P=.27, not significant). In stepwise multiple regression analysis, diabetes mellitus (beta=0.203, P=.008) and acute pulmonary edema (beta=0.228, P=.003) remained significant factors associated with the incidence of stroke. Thus, acute pulmonary edema and diabetes were the most important factors related to ischemic stroke during BP reduction in patients with marked elevations of BP regardless of the rapidity of BP lowering.

Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial

This double-blind study compared long-term efficacy, safety and tolerability of the oral direct renin inhibitor aliskiren and the angiotensin-converting enzyme inhibitor ramipril alone and combined with hydrochlorothiazide in patients with hypertension. After a 2-4-week placebo run-in, 842 patients [mean sitting diastolic blood pressure (msDBP) 95-109 mmHg] were randomized to aliskiren 150 mg (n = 420) or ramipril 5 mg (n = 422). Dose titration (to aliskiren 300 mg/ramipril 10 mg) and subsequent hydrochlorothiazide addition (12.5 mg, titrated to 25 mg if required) were permitted at weeks 6, 12, 18 and 21 for inadequate blood pressure control. Patients completing the 26-week active-controlled treatment period were re-randomized to their existing regimen or placebo for a 4-week double-blind withdrawal phase. Six hundred and eighty-seven patients (81.6%) completed the active treatment period. At week 26, aliskiren-based therapy produced greater mean reductions in mean sitting systolic blood pressure (17.9 versus 15.2 mmHg, P = 0.0036) and msDBP (13.2 versus 12.0 mmHg, P = 0.025), and higher rates of systolic blood pressure control (< 140 mmHg; 72.5 versus 64.1%, P = 0.0075) compared with ramipril-based therapy. During withdrawal, blood pressure increased more rapidly after stopping ramipril than aliskiren-based therapy; median blood pressure reached 140/90 mmHg after 1 and 4 weeks, respectively. Blood pressure reductions were maintained with continued active treatment. Aliskiren therapy was well tolerated. Overall adverse event rates were similar with aliskiren (61.3%) and ramipril (60.4%); cough was more frequent with ramipril (9.5%) than aliskiren (4.1%). Aliskiren-based therapy was well tolerated and produced sustained blood pressure reductions in patients with hypertension over 6 months, greater than those with ramipril-based therapy.

Blood Pressure-Lowering Efficacy of Amiloride versus Enalapril as Add-On Drugs in Patients with Uncontrolled Blood Pressure Receiving Hydrochlorothiazide

A large proportion of patients with hypertension need a second drug to reach satisfactory control of blood pressure (BP), but there are few well-designed controlled trials comparing the efficacy of drugs added as a second option. In a double-blind randomized clinical trial, 82 patients with uncontrolled BP, receiving hydrochlorothiazide 25 mg daily, were selected to receive amiloride 2.5–5 mg/day (n = 39) or enalapril 10–20 mg/day (n = 43). Ambulatory blood pressure monitoring (ABPM) was done before and after 12-weeks of treatment. Office BP was measured in the 4th, 8th, and 12th weeks. The doses of amiloride and enalapril were doubled in the fourth week, and propranolol was added in the 8th week if office BP was above 140/90 mm Hg. There was a greater BP reduction in patients treated with enalapril. The ABPM δ values between the groups were 3.6 ± 2.2, 3.9 ± 2.2, and 1.1 ± 2.7 mmHg for 24-h, daily, and nightly systolic blood pressure, respectively, favoring enalapril. For diastolic blood pressure (DBP), the deltas were 1.7 ± 2.0, 3.2 ± 1.5, and 1.2 ± 1.9 mmHg, respectively (p = 0.039 for daily DBP). Office SBP decreased more and sooner in patients allocated to enalapril (p = 0.003). More patients taking amiloride required propranolol to control BP (p = 0.035). Potassium increased 0.3 mEq/L on the average in both groups. Cough, albeit predominantly mild, was reported more frequently by participants treated with enalapril. We conclude that enalapril is more effective than amiloride to lower BP of patients on hydrochlorothiazide with uncontrolled BP.Trial registration: ClinicalTrials.gov identifier: NCT00394394.

Resistant hypertension and aldosteronism

Resistant hypertension is defined as blood pressure that remains uncontrolled despite using at least three antihypertensive medications in effective doses, ideally including a diuretic. Stricter blood pressure goals, higher obesity rates, older age, and increased use of certain exogenous substances are related to an increasing prevalence of resistant hypertension. The evaluation of patients with resistant hypertension focuses on identifying contributing factors and secondary causes of hypertension including hyperaldosteronism, obstructive sleep apnea, renal artery stenosis, and pheochromocytoma. Hyperaldosteronism is now recognized as the most common secondary cause and all patients with resistant hypertension should be screened with a plasma aldosterone-renin ratio even if the serum potassium level is normal. Treatment includes reversal of contributing factors, appropriate treatment of secondary causes, and use of effective multidrug regimens. Recent studies indicate that the addition of spironolactone to standard treatment regimens induces significant blood pressure reduction in patients with resistant hypertension.

The effects of high‐dose amlodipine/benazepril combination therapies on blood pressure reduction in patients not adequately controlled with amlodipine monotherapy

Background. This study compared the efficacy and safety of amlodipine/benazepril (10/40 mg/day and 10/20 mg/day) with amlodipine 10 mg/day in patients whose blood pressure (BP) was not adequately controlled with amlodipine monotherapy. Methods. After a lead‐in period with amlodipine monotherapy, 812 non‐responder patients (mean sitting diastolic BP⩾95 mmHg) were randomized to one of three treatment groups. Ambulatory BP monitoring was conducted in 276 patients. Results. Treatment with amlodipine/benazepril 10/40 mg/day and 10/20 mg/day resulted in a decrease of mean sitting systolic and mean sitting diastolic BP by 13.3/12.7 mmHg and 12.1/11.6 mmHg, respectively, compared with monotherapy (6.6/8.5 mmHg) (p<0.0001). Both combinations resulted in more responders than monotherapy (74% and 65% vs. 54%; p<0.0001 and p<0.0085, respectively). Amlodipine/benazepril 10/40 mg/day and 10/20 mg/day decreased ambulatory systolic and diastolic BP by 9.9/6.7 mmHg and 7.4/5.2 mmHg compared with monotherapy (p<0.0001). The incidence of pedal edema was lower in the amlodipine/benazepril combinations compared with monotherapy (4.5%, 5.5% vs. 9.2%, respectively, p = NS). No significant metabolic side‐effects were noted among the combination groups. Conclusion. Amlodipine/benazepril combinations were well tolerated and resulted in significant BP reductions and better BP responder rates than amlodipine monotherapy.

Relationship between the Frequency of Blood Pressure Self-Measurement and Blood Pressure Reduction with Antihypertensive Therapy

This subanalysis of the OLMETEL (OLMEsartan TELemonitoring blood pressure) study in patients with essential hypertension assessed the relationship between the frequency of blood pressure self-measurement (BPSM) and the response to blood pressure (BP)-lowering therapy with olmesartan medoxomil, and the number of BP readings per week necessary to detect a mean systolic or diastolic BP reduction > or =5mm Hg. A total of 53 patients with essential hypertension received treatment with olmesartan medoxomil 10, 20 or 40 mg daily for 12 weeks. BPSM was performed for the first 9 weeks using a TensioPhone TP2 device. Patients were instructed to measure BP at least twice daily (morning and evening). After the first 9 weeks of the 12-week treatment period, the extent of BP reduction correlated with the number of BPSMs. Systolic/diastolic BP reductions in patients with a 100% adherence to at least two BP measurements daily were -16.6/-8.0mm Hg compared with -0.2/-3.3mm Hg in patients with only a 75% adherence to at least one BP measurement daily. Obtaining five home BP readings per week resulted in a sensitivity of 94.8% and a specificity of 90.0% to detect a BP reduction of > or =5mm Hg. Patients adhering to the instructions for BPSM (at least two measurements daily) had a better response to antihypertensive treatment with olmesartan medoxomil. Whether BPSM per se resulted in an improved adherence to therapy or whether the number of recordings was an indicator of already existing adherence remains to be determined. Obtaining at least five home BP readings per week was identified as the threshold for correctly predicting response to olmesartan medoxomil treatment.

Intravenous Nicardipine

Nicardipine is a water soluble calcium channel antagonist, with predominantly vasodilatory actions. Intravenous (IV) nicardipine (Cardene IV), which demonstrates a relatively rapid onset/offset of action, is used in situations requiring the rapid control of blood pressure (BP). IV nicardipine was as effective as IV nitroprusside in the short-term reduction of BP in patients with severe or postoperative hypertension. A potential role for IV nicardipine in the intraoperative acute control of BP in patients undergoing various surgical procedures (including cardiovascular, neurovascular and abdominal surgery), and in the deliberate induction of reduced BP in surgical procedures in which haemostasis may be difficult (e.g. surgery involving the hip or spine) was demonstrated in preliminary studies. Preliminary studies also indicated the ability of a bolus dose of IV nicardipine to attenuate the hypertensive response, but not the increase in tachycardia, after laryngoscopy and tracheal intubation in anaesthetised patients. In large, well designed studies, IV nicardipine prevented cerebral vasospasm in patients with recent aneurysmal subarachnoid haemorrhage; however, overall clinical outcomes at 3 months were similar to those in patients who received standard management. Small preliminary studies have investigated the use of IV nicardipine in a variety of other settings, including acute intracerebral haemorrhage, acute ischaemic stroke, pre-eclampsia, acute aortic dissection, premature labour and electroconvulsive therapy.In conclusion, the efficacy of IV nicardipine in the short-term treatment of hypertension in settings for which oral therapy is not feasible or not desirable is well established. The ability to titrate IV nicardipine to the tolerance levels of individual patients makes this agent an attractive option, especially in critically ill patients or those undergoing surgery. Potential exists for further investigation of the use of this agent in clinical settings where a vasodilatory agent with minimal inotropic effects is appropriate.

The prognostic value of post-exercise blood pressure reduction in patients with hypertensive response during exercise stress test

Background Hypertensive response at peak-exercise and during the recovery phase of exercise stress test (ET) is associated with poor cardiovascular prognosis. We investigated whether decrease in blood pressure (BP) from peak to post-exercise would identify a subgroup at higher cardiovascular risk. Methods Eighty-six non-hypertensive patients (0–4 cardiovascular risk factors) with hypertensive reaction at peak-ET (systolic > 180 mm Hg and/or diastolic > 100 mm Hg) were divided based on BP 5 min after exercise termination into two groups: Normal response (NrmR) (< 160/90 mm Hg), Hypertensive response (HypR) (≥ 160/90 mm Hg). Five years later the prevalence of cardiovascular risk factors and cardiovascular morbidity and mortality was assessed for each group. Results Both groups had similar pre- and peak-exercise BP. However the HypR group had higher post-exercise BP (systolic: 163 ± 13 vs. 125 ± 14 mm Hg, respectively, p < 0.01, and diastolic: 74 ± 6 vs. 75 ± 4 mm Hg, respectively, p < 0.01), smaller decrease in BP after exercise (Δ systolic: 46.9 ± 3.1 vs. 73.9 ± 3.6 mm Hg, respectively, p < 0.01, Δ diastolic: 12.4 ± 1.5 vs. 26.5 ± 2.2 mm Hg, respectively, p < 0.01), and higher post- than pre-exercise BP (Δ systolic: 24.5 ± 3.5 vs. − 6 ± 4.1 mm Hg, respectively, p < 0.01, Ä diastolic: 19 ± 2.1 vs. − 13 ± 2.3 mm Hg, respectively, p < 0.01). Five years later, HypR group had higher prevalence of abnormal cholesterol serum level ( p < 0.01), hypertension ( p < 0.01) and combined ischemic heart disease and cerebrovascular disease (RR 1.32, 95% CI = 1.13–1.54, p < 0.01). Conclusion During ET evaluation, it is important to evaluate the BP at 5 min after exercise because reduced BP drop, at this routinely measured point, identifies a subgroup with higher cardiovascular risk.

Ramipril Reduces Large-Artery Stiffness in Peripheral Arterial Disease and Promotes Elastogenic Remodeling in Cell Culture

Ramipril improves cardiovascular outcome in patients with peripheral arterial disease; however, the precise mechanisms of benefit remain to be elucidated. The effect of ramipril on large-artery stiffness in patients with peripheral arterial disease was examined. In addition, we determined the effect of ramiprilat on extracellular matrix from human aortic smooth muscle cell culture. Forty patients with peripheral arterial disease were randomized to receive ramipril, 10 mg once daily or placebo for 24 weeks. Arterial stiffness was assessed globally via systemic arterial compliance and augmentation index (carotid tonometry and Doppler velocimetry), and regionally via carotid-femoral pulse wave velocity. Angiotensin-converting enzyme inhibition increased arterial compliance by 0.10+/-0.02 mL/mm Hg, (P<0.001, all probability values relative to placebo) and reduced pulse wave velocity by 1.7+/-0.2 m/s (P<0.001), augmentation index by 4.1+/-0.3% (P<0.001), and systolic blood pressure by 5+/-1 mm Hg (P<0.001). Ramipril did not reduce mean arterial pressure significantly compared with placebo (P=0.59). In cell culture, ramiprilat decreased collagen deposition by >50% and increased elastin and fibrillin-1 deposition by >3- and 4-fold respectively (histochemistry and immunohistochemistry). Fibrillin-1 gene expression was increased 5-fold (real-time reverse-transcriptase polymerase chain reaction). Ramiprilat also reduced gene and protein (Western) expression of both matrix metalloproteinase (MMP)-2 and MMP-3. In conclusion, ramipril promoted an elastogenic matrix profile that may contribute to the observed clinical reduction in large-artery stiffness and carotid pressure augmentation, which occurred independently of mean arterial blood pressure reduction in patients with peripheral arterial disease.

Salt reduction in a population for the prevention of hypertension

Hypertension is one of the major risk factors for cardiovascular disease, the prevention of which is acknowledged to be critically important. Human beings are the only animal species which consume large quantities of salt, and their consumption has increased with the advancement of civilization. Many observational and interventional epidemiologic studies have demonstrated that a high intake of salt results in elevation of blood pressure, and that a salt-reduced diet induces blood pressure reduction in patients with hypertension as well as in individuals with normal blood pressure. Reduced salt intake, blood pressure reduction, and a remarkable decrease in mortality due to stroke in Japan are important examples of this effect. A decrease in the mean blood pressure in an entire population can contribute significantly to decreased incidence of cardiovascular diseases. A population-based strategy for preventing hypertension, including a salt-reduced diet, is therefore desirable. Proposed measures include public health education by the mass media, reduced salt content in processed foods, salt reduction in foods served by schools or organizations and at restaurants, and labeling of salt content. Further studies are needed of population-wide salt reduction methods, and the effectiveness of such methods.

Examining therapeutic goals: population versus individual-based approaches

In the individual patient, the goal of antihypertensive treatment is to lower the blood pressure (BP) to a level that minimizes the patient's risk of cardiovascular complications. However, most of our knowledge regarding what this level of BP should be is derived from population studies and large clinical trials. Population studies have shown that elevated BP is associated with an increased risk of morbidity and mortality from coronary heart disease, stroke, heart failure, and renal failure. Cardiovascular risk begins to increase when BP exceeds 115/75 mm Hg and doubles with each increment of 20 mm Hg in systolic BP and 10 mm Hg in diastolic BP. The clinical benefit of BP reduction in patients with hypertension is well established. Thus, patients with less severe elevations in BP (high–normal) are at increased risk. Patients with diabetes or proteinuria benefit from even more aggressive reductions in BP. Despite the well-established benefits of BP reduction, hypertension is still not well treated, underscoring the need for more aggressive detection and better management. Although data from large clinical trials have provided valuable information to help guide treatment, application of clinical trial results to individual patients is limited by the heterogeneity of patient populations with respect to patient risk, comorbidities, and differences in genetic and environmental background. Ultimately, the treatment decisions should be tailored to each patient, integrating as much information as possible concerning the patient's history, risk, pathophysiology, and lifestyle.

Treatment of hypertensive patients with coexisting coronary arterial disease

Despite clear guidelines and an array of available antihypertensive medications, patients with hypertension and coronary artery disease are often inadequately treated. New data from HOPE, LIFE, and ALLHAT underscores the importance of blood pressure reduction for patients with coronary artery disease. Despite our improved understanding of the mechanism by which the various classes of antihypertensive medications achieve their effect, it remains the case that blood pressure reduction remains more important than the medication used to achieve the reduction. For most patients with coronary artery disease, combination therapy will be required to achieve a target blood pressure of less than 140/80. When tolerated, this therapy should include a beta-blocker and ACE inhibitor, both of which are of prognostic benefit for patients with coronary artery disease. There are also attractions in choosing calcium antagonists because of their efficacy in controlling anginal symptoms (Dihydropyridine calcium channel blockers if already on a beta-blocking agent and rate-limiting calcium channel blockers if beta blockers are contraindicated). Thiazide diuretics have proven themselves effective again in the ALLHAT study and are likely to be an integral part of treatment for the great majority of patients with coronary artery disease.

Treatment of hypertensive patients with coexisting coronary arterial disease.

Despite clear guidelines and an array of available antihypertensive medications, patients with hypertension and coronary artery disease are often inadequately treated. New data from HOPE, LIFE, and ALLHAT underscores the importance of blood pressure reduction for patients with coronary artery disease. Despite our improved understanding of the mechanism by which the various classes of antihypertensive medications achieve their effect, it remains the case that blood pressure reduction remains more important than the medication used to achieve the reduction. For most patients with coronary artery disease, combination therapy will be required to achieve a target blood pressure of less than 140/80. When tolerated, this therapy should include a beta-blocker and ACE inhibitor, both of which are of prognostic benefit for patients with coronary artery disease. There are also attractions in choosing calcium antagonists because of their efficacy in controlling anginal symptoms (Dihydropyridine calcium channel blockers if already on a beta-blocking agent and rate-limiting calcium channel blockers if beta blockers are contraindicated). Thiazide diuretics have proven themselves effective again in the ALLHAT study and are likely to be an integral part of treatment for the great majority of patients with coronary artery disease.

Hypertension and Diabetes: the Scope of the Problem

Cardiovascular and renal diseases in diabetes stem from an accelerated form of atherosclerosis in both small and large blood vessels. Diabetic nephropathy is a clinical hallmark of microangiopathy and often leads to end-stage renal failure. Significantly, microalbuminuria is an independent predictor of cardiovascular morbidity and mortality in both the diabetic and non-diabetic population. In diabetic patients, it is also strongly associated with proliferative retinopathy, neuropathy and hypertension. Effective blood pressure reduction in patients with type 2 diabetes and diabetic nephropathy is known to reduce albuminuria, delay the progression of diabetic nephropathy, postpone renal failure and improve survival. These benefits have been demonstrated with a variety of blood pressure-lowering agents, including beta-blockers, calcium channel blockers, diuretics and angiotensin-converting enzyme (ACE) inhibitors. Less is known about the renal effects of the newest class of antihypertensive agents, the angiotensin II receptor antagonists (AIIRAs). Irbesartan is an AIIRA that provides antihypertensive efficacy comparable to ACE inhibitors but with superior tolerability. The PRogram for Irbesartan Mortality and morbidity Evaluations (PRIME) is an important morbidity and mortality program encompassing the Irbesartan Diabetic Nephropathy Trial (IDNT) and the IRbesartan MicroAlbuminuria type 2 diabetes mellitus in hypertensive patients (IRMA II) study. PRIME is evaluating the effects of irbesartan in preventing diabetic nephropathy and end-stage renal failure and in reducing cardiovascular events in high-risk hypertensive patients with type 2 diabetes. The trials were completed at the end of 2000.

Opera: design and rationale for a novel placebo control trial testing the benefits of blood pressure reduction in patients with stage I isolated systolic hypertension

Opera: design and rationale for a novel placebo control trial testing the benefits of blood pressure reduction in patients with stage I isolated systolic hypertension

Hypertension and stroke--rationale behind the ACCESS trial. Acute Candesartan Cilexetil Evaluation in Stroke Survivors.

Antihypertensive treatment achieves its greatest benefit in the primary prevention of stroke. Primary prevention studies show 38% fewer strokes when systolic/diastolic values are reduced by 10-12/5-6 mmHg. Secondary stroke prevention has been less investigated, but restrokes seems to be reduced with antihypertensive treatment. Secondary prevention achieves 25-30% less strokes, if diastolic BP can be reduced by 3-4 mmHg. Today's guidelines for antihypertensive therapy in acute ischemic stroke suggest reducing BP values over 220 mmHg systolic (AHA) or 200/110 (German Hypertension Society). No data are available about antihypertensive treatment in acute stroke patients. No intervention trials have so far evaluated an immediate BP reduction on the clinical outcome of the patients neurological status (morbidity) or mortality rates in the acute stroke situation. However, some studies show an increase in mortality after a quick and rapid BP reduction in a short time interval. The ACCESS study was designed to evaluate the possible benefits of a careful and moderate, but immediate blood pressure reduction in patients with an acute stroke compared to a restrictive antihypertensive therapy. Candesartan cilexetil was selected as the antihypertensive drug for its slow onset of action and moderate BP reduction, as well as its very good tolerability. Experimental studies point at possible advantages in acute stroke. The study was designed as a prospective, randomized, double-blind, placebo-controlled, multicenter trial (500 patients). Inclusion criteria were an acute ischemic stroke with a motor paresis and severe hypertension. Primary endpoints were the patients morbidity (functional status measured with Rankin and Barthel index, degree of motor deficity by NIH scale) and mortality rates after three months. First results are presented.

TAMSULOSIN TREATMENT OF 19,365 PATIENTS WITH LOWER URINARY TRACT SYMPTOMS: DOES CO-MORBIDITY ALTER TOLERABILITY?

Purpose We compare the tolerability and blood pressure effects of 0.4 mg. tamsulosin once daily in patients with lower urinary symptoms suggestive of benign prostatic obstruction with or without concomitant disease and/or antihypertensive medication. Materials and Methods Data from 2 open label, observational studies (study 1, 9,507 patients treated for 4 weeks and study 2, 9,858 patients treated for 12 weeks) were analyzed for global tolerability and effects on blood pressure stratifying for co-morbidity (none, diabetes, hypertension, other cardiovascular disease) and co-medication (diuretics, beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors). Results Overall 90 and 95% of patients in studies 1 and 2, respectively, reported good or very good tolerability. While global tolerability was slightly reduced in patients with concomitant disease or some forms of medication (p <0.05), it was rated as good or very good by more than 90 and 95% of patients even in those groups. In control patients, that is those with neither co-morbidity nor co-medication, the tamsulosin induced blood pressure reductions were similar to those previously reported for placebo treatment but were statistically significant (p <0.05). Mean additional blood pressure reductions in patients with concomitant disease or medication were not more than 2 mm. Hg. Conclusions Tamsulosin is well tolerated and has marginal effects on blood pressure in the majority of patients. It largely maintains its good global tolerability and minimal blood pressure effects in patients with cardiovascular co-morbidity or diabetes, or those on co-medication with antihypertensive agents.

Tamsulosin treatment of 19,365 patients with lower urinary tract symptoms: does co-morbidity alter tolerability?

We compare the tolerability and blood pressure effects of 0.4 mg. tamsulosin once daily in patients with lower urinary symptoms suggestive of benign prostatic obstruction with or without concomitant disease and/or antihypertensive medication. Data from 2 open label, observational studies (study 1, 9,507 patients treated for 4 weeks and study 2, 9,858 patients treated for 12 weeks) were analyzed for global tolerability and effects on blood pressure stratifying for co-morbidity (none, diabetes, hypertension, other cardiovascular disease) and co-medication (diuretics, beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors). Overall 90 and 95% of patients in studies 1 and 2, respectively, reported good or very good tolerability. While global tolerability was slightly reduced in patients with concomitant disease or some forms of medication (p < 0.05), it was rated as good or very good by more than 90 and 95% of patients even in those groups. In control patients, that is those with neither co-morbidity nor co-medication, the tamsulosin induced blood pressure reductions were similar to those previously reported for placebo treatment but were statistically significant (p < 0.05). Mean additional blood pressure reductions in patients with concomitant disease or medication were not more than 2 mm. Hg. Tamsulosin is well tolerated and has marginal effects on blood pressure in the majority of patients. It largely maintains its good global tolerability and minimal blood pressure effects in patients with cardiovascular co-morbidity or diabetes, or those on co-medication with antihypertensive agents.

Tamsulosin: Real Life Clinical Experience in 19,365 Patients

Objective: To compare the efficacy, global tolerability and blood pressure effects of tamsulosin (0.4 mg once daily) in subgroups of patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO). Methods: Data from two open-label, observational studies (Study I: 9,507 patients treated for 4 weeks, Study II: 9,858 patients treated for 12 weeks) were analyzed to compare efficacy, global tolerability and effects on blood pressure in subgroups of patients. Results: The efficacy of tamsulosin was largely unaffected by age or previous phytotherapy; in patients with severe symptoms, the efficacy was at least as large as in those with mild or moderate symptoms. More than 90% of patients reported a good or very good tolerability; in a multivariate analysis, this was slightly reduced in patients with concomitant disease but not affected by antihypertensive co-medication or baseline blood pressure. In patients without co-morbidity or co-medication, the tamsulosin-induced blood pressure reductions were similar to those previously reported for placebo treatment; mean additional blood pressure reductions in patients with concomitant disease or medication was not more than 2 mm Hg. Patients who had previously been treated with β-sitosterol, other plant extracts or finasteride reported tamsulosin to be more effective than their previous treatment. Patients who had previously received β-sitosterol or other plant extracts rated the global tolerability of tamsulosin to be similar to that of their previous treatment, while those who had previously received finasteride or other α₁-adrenoceptor antagonists rated the global tolerability of tamsulosin to be significantly better than that of their previous treatment. Conclusions: We conclude that tamsulosin is efficacious in all types of patients with LUTS suggestive of BPO. It is globally well tolerated and has marginal effects on blood pressure, including the vast majority of patients with cardiovascular comorbidity, diabetes or on antihypertensive comedication.