Abstract 306: China Observational Study on Efficacy and Safety of Valsartan/Amlodipine Single-Pill Combination in Treating Patients with Blood Pressure Uncontrolled by Monotherapy (China STATUS II): Interim Analysis

Hypertension ◽  
2012 ◽  
Vol 60 (suppl_1) ◽  
Author(s):  
Dayi Hu ◽  
Lisheng Liu ◽  
Weimin Li
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Observational Study ◽  
Interim Analysis ◽  
Chinese Patients ◽  
Blood Pressure Goal ◽  
Efficacy And Safety ◽  
Hypertensive Patients ◽  
Single Pill ◽  
Trial Drug

BACKGROUND Single-pill combination (SPC) in hypertension treatment has been recommended in guidelines for its benefits on improving blood pressure (BP) control and reducing adverse events (AEs) by simplifying treatment. OBJECTIVE To evaluate efficacy and safety of valsartan/amlodipine SPC on BP control in Chinese hypertensive patients in a real-life practice setting. METHODS This is a multicenter, open-label, observational study in Chinese hypertensive patients. Adults (18 and older) who were not at BP goal (<140/90 mmHg for uncomplicated patients, and <130/80 mmHg for patients with diabetes and chronic kidney disease) on monotherapy were eligible to the study. Patients were treated with valsartan/amlodipine 80/5 mg SPC and were followed over 8 weeks with approximately monthly intervals between clinic visits. For patients not achieving BP goal at week 4, other antihypertensives might be added. RESULTS A total of 11,879 patients were recruited into the study. In this interim analysis (from October 12, 2010 to October 11, 2011), a total of 4,609 patients were included. Among them, 39 were excluded due to violation of inclusion criteria, 20 discontinued (9 due to AEs). In total, 4,562 were included in the analysis. Mean age was 57.6 years, 7.1% (324 of 4562) of patients aged ≥80. Overall, mean BP was reduced from 159.7/95.6 mmHg at baseline to 132.0/80.3 mmHg at week 8 (-27.7/-15.3 mmHg, P<0.0001). The magnitude of BP reduction increased by severity of baseline BP. Blood pressure goal was achieved in 67.4% (3076 of 4562) of patients. In patients aged 80 or over, 65.1% (211 of 324) achieved BP goal. Add-on antihypertensives were prescribed in 6.2% (283 of 4562) of patients with diuretics the most often used. Adverse events were reported in 2.2% (99 of 4604) of patients. Edema was reported in 12 patients (0.3%). Three patients experienced serious AEs, of which none were trial drug related. In patients aged ≥80, AEs were reported in 1.2% (4 of 327) of patients, with 2 trial drug related AEs (0.61%), 1 of hypotension and 1 of flush. CONCLUSION In this 1 st largest observational study in Chinese hypertensive patients, the interim analysis results showed that valsartan/amlodipine SPC was effective and safe on BP control in Chinese patients, as well as in patients aged 80 and over.

Bortezomib (Velcade ™) Observational Study in China: Efficacy and Safety of Bortezomib-Based Regimen in 395 Relapsed or Refractory Multiple Myeloma Patients

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5179-5179
Author(s):  
Zhi-Xiang Shen ◽  
Hua Yan ◽  
Linna Wang
Keyword(s):  
Multiple Myeloma ◽  
Adverse Events ◽  
Observational Study ◽  
Response Rate ◽  
Complete Response ◽  
Chinese Patients ◽  
Efficacy And Safety ◽  
Female Ratio ◽  
Bortezomib Treatment ◽  
Grade 3

Abstract Introduction: Multiple myeloma (MM) is a plasma-cell malignancy and overall survival for patients who have relapsed after initial therapy is approximately 2 years. Bortezomib (VELCADE TM) is a first-in-class proteasome inhibitor that has demonstrated significant anti-tumor activity in MM patients. Here we report the results of an observational study of the efficacy and safety of bortezomib-based regimens in Chinese relapsed/refractory MM patients. Methods: This was a multi-center, open-label, phase IV observational study designed to enroll 550 patients with relapsed or refractory MM. From Mar 2006 to May 2008, 500 patients with relapsed or refractory MM were enrolled from 43 medical centers in China and 395 of them were evaluated. Bortezomib (0.7 to 1.6 mg/m2 i.v.) was given on days 1, 4, 8, and 11 in in a 21-day cycle, up to a maximum of 8 cycles, combined with other agents, mainly with the addition of dexamethasone (60.1%). Major endpoint included response rate, safety and time to response. Responses of 62% patients were determined by European Group for Blood and Marrow Transplantation criteria (EBMT). Bortezomib withheld if patients developed neutropenia fever, grade 4 haematologic adverse events (AEs), or grade 3 non-haematologic AEs, and re-administered at 75% of the initial dosage after recovery. Results: In 395 evaluable cases, the median age was 59 years (range 35–82) and the male/female ratio was 1.5:1. 90% of patients were in late stage(stage II/III) and 50% of them were IgG subtype. Patients had received various prior therapies before bortezomib treatment, including VAD (31.3%), VBMCP (M2, 15.1%) and thalidomide-based regimens(14.9%), with best response rate of 10.4% complete response (CR) and 42.3% partial response (PR) from prior therapies. 311 (82%) cases of patients received 1.0–1.4mg/m2 bortezomib-based regimens treatment and 38.5% of them received at least 4 cycles of treatment. 364 patients were evaluable for response, the overall response rate was 287/364 (78.8%), 89 patients (24.5%) achieved a CR, 30(8.24%) had a nearly complete response (nCR), 168 (46.2%) had a PR, 39 (10.7%) had minimal response (MR), 24 (6.6%) had stable disease (SD), and the other 14 (3.9%) had progressive disease (PD). Median time to response was 1 cycle of treatment (range 1–6). Patients who received 4 or more cycles of bortezomib treatment achieved a higher response rate (CR+PR: 81.5%) compared to those who received fewer cycles (partly due to adverse events). And prognosis-related analysis showed that the dosage of bortezomib at 1.0 mg/m2 or more had a significant influence on the time to response and response rate, but no obvious effect on response duration, time to progress or the survival time. Drug related adverse events (AEs) were reported in 50.4% of patients during treatment, including hematologic AEs (mainly thrombocytopenia, 22.5%), gastrointestinal AEs (24.8%), and peripheral neuropathy (22.5%). The rates of grade 3–4 AEs of them were 46.1%, 11.2% and 15.7%, respectively. Serious AEs occurred in 33 (8.4%) cases and 23 (70%) patients recovered finally. Most AEs were predictable and manageable. Conclusion: Bortezomib-based regimen is effective treatment with higher response rate and is well tolerated in most Chinese patients with relapsed and refractory MM patients. Long-term follow-up is continuing.

scholarly journals An observational study to evaluate factors responsible and actions taken for hypertensive patients who are not at blood pressure goal: i-target Goal Study

2012 ◽  
Vol 35 (6) ◽  
pp. 624-632 ◽  
Author(s):  
Saide Aytekin ◽  
Sema Guneri ◽  
Nese Cam ◽  
Ali Aydinlar ◽  
Guliz Kozdag ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Observational Study ◽  
Blood Pressure Goal ◽  
Hypertensive Patients

Efficacy and Safety of Fixed-Dose Perindopril Arginine/Amlodipine in Hypertensive Patients Not Adequately Controlled with Amlodipine 5 mg or Perindopril tert-Butylamine 4 mg Monotherapy

Cardiology ◽  
2016 ◽  
Vol 134 (1) ◽  
pp. 1-10 ◽  
Author(s):  
Dayi Hu ◽  
Yihong Sun ◽  
Yuhua Liao ◽  
Jing Huang ◽  
Ruiping Zhao ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Additional Treatment ◽  
Chinese Patients ◽  
Fixed Dose ◽  
Double Blind ◽  
Hypertensive Patients ◽  
Pressure Lowering ◽  
Single Pill ◽  
Tert Butylamine ◽  
Dose Combination

Objectives: To assess the blood pressure-lowering efficacy and tolerability of perindopril/amlodipine fixed-dose combinations in Chinese patients with mild-to-moderate essential hypertension not adequately controlled with monotherapy alone. Methods: In 2 separate double-blind studies, patients received a 4-week run-in monotherapy of amlodipine 5 mg or perindopril 4 mg, respectively. Those whose blood pressure was uncontrolled were then randomized to receive the fixed-dose combination of perindopril 5 mg/amlodipine 5 mg (Per/Amlo group) or remain on the monotherapy for 8 weeks. Patients who were uncontrolled at the week 8 (W8) visit were up-titrated for the Per/Amlo combination, or received additional treatment if on monotherapy, for a further 4 weeks. The main efficacy assessment was at 8 weeks. Results: After 8 weeks, systolic blood pressure (SBP; primary criterion) was statistically significantly lower in the Per/Amlo group (vs. Amlo 5 mg, p = 0.0095; vs. Per 4 mg, p < 0.0001). Uncontrolled patients at W8 who received an up-titration of the Per/Amlo combination showed a further SBP reduction. These changes were mirrored by reassuring reductions in diastolic blood pressure. The fixed-dose combinations were well tolerated. Conclusions: Single-pill combinations of perindopril and amlodipine provide hypertensive patients with a convenient and effective method of reducing blood pressure.

scholarly journals Epidemiological Observational Study on the Assessment of the Comorbidity and the Efficacy of the Treatment of Hypertensive Patients with Single Pill Combination of Lysinopril, Amlodipine and Rosuvastatin "PHENOTYPE-AG"

2021 ◽  
Vol 17 (4) ◽  
pp. 528-536
Author(s):  
M. P. Savenkov ◽  
S. N. Ivanov ◽  
M. V. Borschevskaya ◽  
I. N. Okuneva ◽  
S. V. Ivanova ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Side Effects ◽  
Observational Study ◽  
Low Frequency ◽  
Cerebrovascular Diseases ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Hypertensive Patients ◽  
Glucose Levels ◽  
Single Pill

Aim. To study the prevalence of comorbidity affecting the choice of antihypertensive treatment, as well as the efficacy and safety of the application of a single pill combination of lysinopril, amlodipine and rosuvastatin (SPC LAR) in hypertensive patients.Material and methods. Observational epidemiological study with the participation of 626 doctors and 13037 hypertensive patients with high cardiovascular risk and dyslipidemia treated with SPC LAR were held in 24 cities of Russia from November 2020 to March 2021. Prevalence and types of comorbidity, changes of blood pressure (BP), of total cholesterol (TC) and blood glucose levels and adverse events were studied during observation. Patients had 3 visits – initially, after 4 and 12 weeks. The obtained data was recorded by doctors through a web portal.Results. Concominant cardiovascular diseases found in all patients (in 38.7% of cases – from 2 to 5 diseases). The most commonly diseases were coronary artery disease (43.1%), metabolic syndrome (36.6%), diabetes (25.2%), chronic heart failure (24.9%), cerebrovascular diseases (12.3%) and chronic obstructive pulmonary disease (0.5%). SPC LAR with minimal doses of components (in 41.1% of patients) or with reinforced antihypertensive or hypocholesterolemic effects, based on the experience of treatment, the patient was prescribed as starting treatment with doctors. Reducing the level of systolic and diastolic BP, as well as the level Tc, respectively, by 20.9%, 16.9% and 29.7% found during the study. Target levels of systolic BP were achieved in 97.6% of patients, diastolic BP – in 99.6%, and target levels TC ≤5 mmol/l, ≤4 mmol/l and ≤3 mmol/l were achieved, respectively, in 94.5%, 68.6% and 23.5% patients. No significant dynamics of the level of glycemia were not found. The treatment was well tolerated by patients. Side effects found in 0.53% of patients (more often there was a dry cough, feet edema and headache). Commitment to treatment was 92.7%.Conclusion. The modern hypertension phenotype has cardiovascular atherosclerosis-associated diseases, which justifies the need to combine antihypertensive and hypolipidemic therapy. Triple SPC LAR, which effectively controlled the blood pressure and improved the violation of lipid metabolism was prescribed to patients in this observational study. The low frequency of side effects and good tolerance of treatment was accompanied by a high adherence of patients to treatment. 

scholarly journals Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO)

2021 ◽  
Vol 27 (1) ◽  
Author(s):  
Il Suk Sohn ◽  
Sang-Hyun Ihm ◽  
Gee Hee Kim ◽  
Sang Min Park ◽  
Bum-Kee Hong ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Observational Study ◽  
Rating Scale ◽  
Medication Possession Ratio ◽  
Hypertensive Patients ◽  
Multicenter Observational Study ◽  
Single Pill ◽  
The Mean ◽  
Observation Period

Abstract Background In this prospective, multicenter, non-comparative observational study, the effectiveness and safety of the triple single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OM/AML/HCTZ) were evaluated in a real clinical practice setting in Korean patients with essential hypertension. Methods A total of 3752 patients were enrolled and followed for 12 months after administration of OM/AML/HCTZ. Primary endpoint was change from baseline to month 6 in the mean systolic blood pressure (SBP). Secondary endpoints included changes from baseline in the mean SBP at month 3, 9, 12 and the mean diastolic blood pressure (DBP) at month 3, 6, 9, 12; changes in the mean SBP/DBP according to age and underlying risk factors; and blood pressure control rate (%) at different time points. Adherence to and satisfaction with OM/AML/HCTZ treatment among patients and physicians were assessed by medication possession ratio (MPR) and numeric rating scale, respectively, as exploratory endpoints. Safety was evaluated by the incidence and severity of adverse events (AEs) as well as the discontinuation rate due to AEs. Results OM/AML/HCTZ administration led to significant reductions in the mean SBP/DBP by 11.5/6.6, 12.3/7.0, 12.3/7.2, and 12.8/7.4 mmHg from baseline to month 3, 6, 9 and 12, respectively (P < 0.0001). The BP reductions were maintained throughout the 1-year observation period in all patients with different age groups and risk factors (diabetes mellitus, cardiovascular disease, and renal disease). The BP control rate (%) of < 140/90 mmHg was 65.9, 67.9, 68.9, and 70.6% at month 3, 6, 9, and 12, respectively. The mean MPR during the observation period was 0.96. The safety results were consistent with the previously reported safety profile of OM/AML/HCTZ. Conclusions Treatment with the triple SPC of OM/AML/HCTZ demonstrated significant effectiveness in reducing SBP/DBP and achieving target BP control with high adherence over the 1-year observation period in Korean hypertensive patients and was well-tolerated. Trial registration CRIS, KCT0002196, Registered 3 May 2016.

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