ABSTRACT
AIM: to assess the effectiveness, safety and tolerability of amlodipine/valsartan (Aml/Val) single-pill combination (SPC) in hypertensive patients in a real-world setting. METHODS: the Indonesian subset of the EXCITE (clinical EXperience of amlodIpine and valsarTan in hypErtension) study, which was a multinational, prospective, observational, open study in hypertensive patients treated with Aml/Val SPC for 26 weeks. Aml/Val SPCs (5/80, 5/160, 10/160 mg) were administered as monotherapy or as add-on therapy to other antihypertensive medications in patients not controlled by prior monotherapy. The effectiveness outcomes were (1) mean decrease in sitting systolic blood pressure and diastolic blood pressure (msSBP and msDBP) from baseline to week 26; (2) proportion of patients achieving BP goal (<140/90 mmHg for nondiabetics, or <130/80 mmHg for diabetics); (3) proportion of patients who were responders (achieving BP goal or BP reduction of >20/10 mmHg). The safety variables were the incidence of AEs and SAEs, and the incidence of edema. RESULTS: a total of 500 patients from Indonesia received Aml/Val SPC, 487 patients were analyzed for efficacy (by LOCF), and 464 patients completed the study. At study end (week 26), the overall msSBP and msDBP(95% CI) reductions from baseline were -33.7 (-35.2, -32.1) mmHg and -14.8 (-15.7, -13.8) mmHg, respectively. Among the 487 patients, 52.4% achieved BP goal and 80.5% were responders (LOCF). Among 464 patients who completed the study, 53.7% achieved BP goal and 84.5% were responders. Aml/Val SPC was effective in decreasing BP in Indonesian patients. AEs, including SAEs, were reported in 11.4% patients, with SAEs in 1% of patients, and death in 0.8% of patients. SAEs and deaths were considered unrelated to the study drug. Edema was reported by 9.4% of patients at baseline, and in 3.7% patients at end of study. Effectiveness, tolerability and compliance were rated good and very good in 90.8%, 92.2%, and 89.2% of patients, respectively, according to the investigators. CONCLUSION: Aml/Val SPC was effective for BP reductions and well tolerated in hypertensive patients, not adequately controlled by monotherapy, in a daily clinical setting in Indonesia.
Subject(s)
Amlodipine/therapeutic use , Antihypertensive Agents/therapeutic use , Hypertension/drug therapy , Valsartan/therapeutic use , Adult , Aged , Amlodipine/adverse effects , Antihypertensive Agents/adverse effects , Blood Pressure/drug effects , Cough/chemically induced , Drug Combinations , Drug Substitution , Dyslipidemias/chemically induced , Edema/chemically induced , Female , Headache/chemically induced , Humans , Indonesia , Male , Medication Adherence , Middle Aged , Prospective Studies , Valsartan/adverse effectsABSTRACT
OBJECTIVES: The VOICE Asia study aimed to establish the mode of thromboprophylaxis in medical patients admitted to intensive care units (ICU), and to describe the epidemiology of patients at high-risk of venous thromboembolism (VTE) and of patients who were prescribed low molecular weight heparin (LMWH). METHODS: This multinational, observational, cross-sectional study recruited medical patients admitted to ICU in whom a decision to give VTE prophylaxis had been taken. The treating physicians decided patient management. We recorded demographics, VTE risk factors, VTE risk assessment, thromboprophylaxis, and compliance to the American College of Chest Physicians (ACCP) guidelines. RESULTS: The study enrolled 2969 patients from 113 centers in 5 Asian countries. The most common VTE risk factors were age > 60 years (57.1%), prolonged immobility (50.6%), respiratory diseases (41.3%), and acute infectious disease (36.2%). There was a wide gap between physicians' assessment of 'very high' risk for VTE (8.4%) and Caprini 'very high' risk stratification (54.9%). 2919 (98.3%) patients received prophylaxis (22.9%-only mechanical, 31.2%-only pharmacological, 44.2%-both, mechanical and pharmacological and 1.7%- no prophylaxis). Early mobilization (44.3%) and LMWH (66.2%, mean duration of prophylaxis-8.6 days) were the most common mechanical and pharmacological prophylaxis, respectively. 80.6% of patients were given thromboprophylaxis as per the ACCP guidelines (and 4.7% per Japanese guidelines). CONCLUSIONS: There is substantial underestimation of VTE risk and non-adherence to guidelines for thromboprophylaxis in medical ICU patients in participating Asian countries. This emphasizes the need for increasing awareness about optimum VTE risk assessment and improved implementation of appropriate thromboprophylaxis in at-risk medical ICU patients.
