Safety, tolerability, and efficacy of a fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in daily practice

Peter Bramlage,1 Claudia Zemmrich,1 Reinhard Ketelhut,2 Wolf-Peter Wolf,3 Eva-Maria Fronk,4 Roland E Schmieder5 1Institut f&uuml;r Pharmakologie und Pr&auml;ventive Medizin, Mahlow, Germany; 2Institut f&uuml;r Sportmedizin, Universit&auml;tsklinikum Charit&eacute;, Humboldt Universit&auml;t zu Berlin, Berlin, Germany; 3Daiichi Sankyo Deutschland GmbH, Munich, Germany; 4Daiichi Sankyo Europe GmbH, Munich, Germany; 5Universit&auml;tsklinikum Erlangen, Klinik f&uuml;r Nephrologie und Hypertensiologie, Erlangen, Germany Background: The safety and efficacy of olmesartan 40 mg and hydrochlorothiazide (HCTZ) as a fixed-dose combination has been investigated in clinical trials leading to its approval. The aims of the present study were to confirm these data in an unselected patient population in daily practice and to determine the impact of physical activity on blood pressure control. Methods: In a multicenter, noninterventional study, 3,333 patients with either insufficient blood pressure control on olmesartan 40 mg alone or on a fixed/free combination of olmesartan 40 mg and HCTZ 12.5/25 mg were primarily assessed for safety and tolerability of the fixed-dose combination of olmesartan 40 mg and HCTZ 12.5/25 mg at 24 &plusmn; 2 weeks. Secondary objectives were blood pressure reduction, treatment compliance, and impact of physical activity as measured by the sum of weekly energy costs. Results: The mean patient age was 63.2 &plusmn; 11.46 years, mean baseline blood pressure was 159.6 &plusmn; 15.28/93.5 &plusmn; 9.52 mmHg, and 70.9% had at least one additional cardiovascular risk factor. Adverse drug reactions were rare (n = 19), and no serious adverse drug reactions occurred. Compliance with drug therapy was at least sufficient in more than 99% of patients at the end of the study. Blood pressure at the last available visit was reduced by 26.1 &plusmn; 15.5/13.0 &plusmn; 10.1 mmHg versus baseline (P < 0.0001), but had reduced effectiveness in patients &ge;75 years with diabetes or impaired renal function. In 69% of patients, blood pressure was normalized (<140/90 mmHg). No noteworthy differences in baseline characteristics or baseline blood pressure were found between patients with an activity level (sum of weekly energy costs) above or below the median of 9,460.6. A higher versus lower physical activity score had no impact on blood pressure reduction. Conclusion: Our data confirm randomized trial data concerning safe and efficient blood pressure reduction using a fixed-dose combination of olmesartan 40 mg and HCTZ 12.5/25 mg in a large, unselected patient population, independent of physical activity level. Keywords: blood pressure, antihypertensive agents, administration, dosage, physical activit

The impact of age on the benefits and risks of aliskiren treatment: analyses of the 3A registry

We aimed to analyze benefits and risks of aliskiren treatment in older adults (>=65 years) in clinical practice. Patients (n=14 986) were assigned to either aliskiren (ALIS), an angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker (ACEi/ARB), or an agent not blocking the renin-angiotensin system (non-RAS). Older adults (n=7396) had a longer history of hypertension (8.7 vs 4.7 years; P<0.0001), lower mean diastolic blood pressure (DBP; 87.7+/-11.0 vs 92.1+/-11.0 mm Hg) and more renal (12.0 vs 5.6%; P<0.0001) or cardiovascular disease (44.0 vs 18.9%; P<0.0001); 4548 received aliskiren (68.8%), 1215 ACEi/ARBs (18.4%) and 850 non-RAS treatments (12.9%). Office BP at 1 year was reduced by 18.4+/-21.5/7.2+/-12.0 mm Hg. BP reductions were greater (19.5+/-21.7/7.6+/-12.1 mm Hg) in the aliskiren group than in the ACEi/ARB (15.6+/-20.9/6.4+/-11.9) and non-RAS groups (16.1+/-20.7/6.5+/-11.7 mm Hg), respectively (P<0.0001 for systolic BP (SBP) and <0.01 for DBP). After multivariable adjustment, differences in SBP reductions were clinically irrelevant and no differences were noted for DBP. Adverse effects were higher in older adults with no differences between treatment groups. In conclusion, the present analysis of a large, unselected cohort of patients in clinical practice from the 3A study, offers real-life evidence of the effectiveness and safety of aliskiren for the treatment of hypertension in older adults

CMR first-pass perfusion for suspected inducible myocardial ischemia

Cardiovascular magnetic resonance (CMR) has evolved from a pioneering research tool to an established noninvasive imaging method for detecting inducible myocardial perfusion deficits. In this consensus document, experts of different imaging techniques summarize the existing body of evidence regarding CMR perfusion as a viable complement to other established noninvasive tools for the assessment of perfusion and discuss the advantages and pitfalls of the technique. A rapid, standardized CMR perfusion protocol is described, which is safe, clinically feasible, and cost-effective for centers with contemporary magnetic resonance equipment. CMR perfusion can be recommended as a routine diagnostic tool to identify inducible myocardial ischemia