7) 14 (5.3) 0.03 aExcluding transient
ischaemic attack bDefined as a documented Alpelisib nmr coronary atherosclerosis or stenosis cArrhythmia evidenced by an electrocardiogram dDefined as a serum concentration of at least 6.22 mmol/l total cholesterol, 4.14 mmol/l low-density lipoprotein cholesterol, or 2.26 mmol/l triglycerides, or 4EGI-1 cost as the use of statins eDefined as a fasting plasma glucose concentration from 7.1 to 11.0 mmol/l, or as the use of antidiabetic drugs or insulin fDefined as albuminuria or a serum creatinine concentration from 132.6 to 176.8 μmol/l in men and from 123.8 to 176.8 μmol/l in women gUse of drugs during the 2 weeks prior to the screening visit In the intention-to-treat analysis (n = 501), during the study treatment period, the dosage of the study medication remained at 150 mg/12.5 mg of irbesartan/hydrochlorothiazide per day in 313 patients (62.5 %) and increased to 300 mg/12.5 mg
and to 300 mg/25 mg of irbesartan/hydrochlorothiazide per day in 111 patients (22.2 %) and 77 patients (15.3 %), respectively. In the per-protocol analysis Selleck Tozasertib (n = 449), the corresponding numbers of patients were 272 (60.6 %), 105 (23.4 %), and 72 (16.0 %), respectively. 3.2 Antihypertensive Efficacy In the intention-to-treat analysis, the irbesartan/hydrochlorothiazide combination therapy reduced systolic/diastolic blood pressure from 162.5/97.9 mmHg at baseline to 138.7/86.4, 135.6/84.3, 134.2/83.9, and 134.7/84.4 mmHg at 2, 4, 8, and 12 weeks of follow-up, respectively (Fig. 1). The mean changes from baseline in systolic/diastolic blood pressure were −23.8/−11.6 mmHg, −26.8/−13.6 mmHg, −28.2/−14.0 mmHg, and −27.8/−13.5 mmHg at 2, 4, 8, and 12 weeks of follow-up, respectively (Fig. 2). Fig. 1 Systolic and diastolic blood pressure at baseline and during follow-up in the intention-to-treat analysis. The vertical lines denote the standard deviations of the mean systolic and diastolic blood pressure values Fig. 2 Mean changes from baseline in systolic and diastolic blood pressure in the intention-to-treat analysis At 12 weeks of follow-up, the
percentage of patients who attained the goal systolic/diastolic check blood pressure (<140/90 mmHg, or <130/80 mmHg in patients with diabetes mellitus) was 57.3 % (Table 2). The goal blood pressure-attaining rates in patients treated with irbesartan/hydrochlorothiazide 150 mg/12.5 mg per day (n = 313), 300 mg/12.5 mg per day (n = 111), and 300 mg/25 mg per day (n = 77) were 68.1, 53.2, and 19.5 %, respectively. If the goal systolic/diastolic blood pressure was defined as 140/90 mmHg in diabetic as well as nondiabetic patients, the goal blood pressure-attaining rates were 66.1 % in all subjects and 77.0, 62.2, and 27.3 % in patients treated with irbesartan/hydrochlorothiazide 150 mg/12.5 mg (n = 313), 300 mg/12.5 mg per day (n = 111), and 300 mg/25 mg per day (n = 77), respectively (Table 2; Fig. 3).