Data on prasugrel use in Japanese patients are limited to phase II/III clinical trials. This early postmarketing observational study evaluated the safety and efficacy of short-term prasugrel use in patients with acute coronary syndrome (ACS) in real-world clinical settings in Japan. From May 2014 to January 2015, we enrolled consecutive patients with ACS requiring percutaneous coronary intervention in each institution. Each patient started prasugrel treatment ≥1 month before the end of the study period. Safety outcomes included incidence rates of adverse drug reactions (ADRs) and bleeding adverse events (AEs). Efficacy outcomes were incidence rates of cardiovascular events (including major adverse cardiovascular events [MACE]). Case report forms were collected from 749 patients, 732 of whom were eligible for the safety and efficacy analysis sets. Approximately 95% of patients had a prasugrel loading/maintenance dose of 20 mg/3.75 mg/day. The incidences of ADRs and bleeding AEs were 8.6 and 6.4%, respectively. Twelve patients experienced major bleeding AEs; approximately 60% (seven patients) of which were gastrointestinal disorders. The incidence of bleeding AEs was significantly higher primarily in patients of female sex, aged ≥75 years, with low body weight (≤50 kg), severe cardiovascular disease, or severe renal impairment. The incidence of MACE was 1.9% during prasugrel treatment, and 3.1% at the end of the study period. This short-term study indicated that prasugrel treatment at loading/maintenance doses of 20 mg/3.75 mg/day was safe and effective in Japanese ACS patients in an acute setting.Clinical Trial Registration: This study is registered at http://www.umin.ac.jp/ctr/ under the identifier UMIN000014699.Electronic supplementary materialThe online version of this article (doi:10.1007/s12928-017-0459-8) contains supplementary material, which is available to authorized users.

The efficacy and safety of the angiotensin receptor blocker olmesartan medoxomil (OLM) H ypertension in the elderly is characterized by elevated systolic blood pressure (sBp) and normal diastolic blood pressure (DBp), a condition known as isolated systolic hypertension (isH). This phenomenon in elderly individuals is caused by the progressive increase in arterial stiffness accompanying advanced age, resulting in decreased elasticity of blood vessels and widened pulse pressure (pp), the difference between sBp and DBp. 1,2 isH is especially prevalent in individuals aged 75 years and older.Elevated sBp and pp are considered risk factors for cardiovascular diseases such as stroke, ischemic heart disease, and heart failure. [3][4][5][6][7] The systolic Hypertension in the Elderly program (sHEp) study 8 and systolic Hypertension in Europe (systEur) Trial 9 demonstrated that the risk of cardiovascular events is reduced by lowering sBp and pp with antihypertensive drugs, specifically a diureticbased regimen in the sHEp study and a calcium channel blocker (CCB)-based treatment program in the syst-Eur trial. Thus, management of hypertension in elderly patients with elevated sBp and pp is recommended. [10][11][12] in some elderly hypertensive patients with isH, there are concerns that pharmacologic antihypertensive therapy to reduce sBp might lower DBp excessively as an unwanted adverse drug reaction (aDr). findings from the sHEp study demonstrated a trend toward a slight increase in

Non-persistence rate (defined as not remaining on treatment) in patients taking a renin angiotensin system inhibitor plus calcium channel blocker was studied in three integrated 12-weeks surveys by matching separate drug combination therapy (CT) and fixed-dose combination (FDC). We also investigated medication adherence measured by proportion of days covered by using a claims database. The non-persistence rate was significantly lower in FDC than CT (p = 0.0074). In the database study, the medication adherence was higher in FDC than CT for 3, 6, and 12 months (all p < 0.001). In conclusion, use of single-tablet FDC antihypertensive therapy was associated with better medication-taking behavior.

The authors assessed the early antihypertensive efficacy of olmesartan medoxomil (OM) in a 12‐week prospective observational study. Of 2221 patients with untreated hypertension who received OM (mainly 10 or 20 mg), 331 patients whose blood pressure (BP) was measured at 1 week after initiation of treatment were defined as the ``early BP determination group,'' whereas the remaining 1890 patients were defined as the ``standard BP determination group.'' Baseline characteristics, doses of OM, concomitant drugs used, and BP during treatment did not differ between the 2 groups. The achievement rate of BP target (<140/90 mm Hg) was 28.4% at 1 week in the early BP determination group and 28.3% at 2 weeks in the standard BP determination group (P=NS). Rates of adverse drug reactions in the 2 groups were similar. The present study suggests that OM is safe and effective in reducing BP at an early time point of treatment.

Combination therapy with multiple anti-hypertensives is required to achieve target blood pressure (BP) control and is recommended as the first-line therapy in hypertension. Although angiotensin receptor blockers (ARBs) may be combined with other anti-hypertensives, it is unclear how the effects of ARBs are influenced by co-administered anti-hypertensives. We investigated the effect of olmesartan medoxomil (OLM) when it is given alone (monotherapy) or concomitantly with other anti-hypertensives in 6507 OLM-naive Japanese in "real world" clinical practice. After a 12-week treatment, BP was significantly reduced from baseline in both the monotherapy group and the combination therapy group (P < 0.0001). The BP-lowering efficacy after treatment and achievement rates of target BP were similar in both groups. In the combination therapy group, no significant difference of achieved BP level was detected between patients taking Calcium channel blockers and any other class of anti-hypertensive drugs. This study suggests that ARBs such as OLM-elicits BP-lowering efficacy as either a first- or second-line agent and its effects are minimally influenced by co-administered anti-hypertensives.