Efficacy and safety of valsartan in reducing blood pressure and albuminuria in Chinese patients with essential hypertension: a multicenter prospective open-label observational study

Abstract

Objective:

To evaluate the efficacy and safety of 80 or 160 mg/day valsartan in Chinese adult patients with essential hypertension and albuminuria.

Methods:

A multicenter prospective open-label observational study was conducted. Adult hypertensive patients with albuminuria were treated with 80 or 160 mg/day valsartan. Blood pressure (BP) was recorded at weeks 4, 8 and 12. Albuminuria was selectively measured at week 12.

Results:

The intent-to-treat (ITT) population included 1180 patients. Mean sitting systolic BP (MSSBP) and diastolic BP (MSDBP) at baseline was 153.5 [14.41] (mean [SD]) and 88.2 [11.99] (mean [SD]) mmHg. MSSBP and MSDBP at week 4 (mean [SD]: 139.1 [12.02] and 82.2 [8.54] mmHg), week 8 (mean [SD]: 135.3 [10.46] and 80.2 [7.55] mmHg) and week 12 (mean [SD]: 132.1 [9.80] and 78.1 [6.88] mmHg) were significantly lower than baseline (p < 0.001). The BP control rate of ITT patients at week 12 was 17.8%. Diabetic patients exhibited lower BP control rate than non-diabetic patients (14.0 vs. 22.4%, p < 0.001). A total of 904 patients had albuminuria assessed at week 12. UACR and UAER at week 12 were lower compared with baseline (p < 0.05). In all, 171 patients (18.9%) returned to normal albuminuria and albuminuria normalization percentage in diabetic patients exceeded that of non-diabetic patients (26.3 vs. 12.1%, p < 0.001). Albuminuria declined by more than 50% in 340 patients (37.6%) and more diabetic patients exhibited such decline in albuminuria than non-diabetic patients (41.7 vs. 33.8%, p < 0.05). No serious drug-related adverse effects (AEs) were observed.

Limitations:

Prior antihypertensive treatment before valsartan administration may interfere with the efficacy of subsequent treatment. The discrepancy between 80 and 160 mg may affect patient outcomes and occurrence of AEs.

Conclusions:

Valsartan can safely and effectively reduce BP and albuminuria in Chinese adult patients with essential hypertension and albuminuria. Valsartan has the more dramatic effect on albuminuria in diabetic patients than non-diabetic patients.

Keywords::

• Albuminuria
• Diabetes mellitus
• Hypertension
• Valsartan

Transparency

Declaration of funding

This study was supported by Beijing Novartis Pharma Co., Ltd. In compliance with the Uniform Requirements for Manuscripts, established by the International Committee of Medical Journal Editors, Novartis did not impose any impediment, directly or indirectly, on the publication of the study’s results. Medical writing assistance was provided by Medsci, funded by an unrestricted financial grant from Beijing Novartis Co., Ltd. Medsci’s services complied with international guidelines for Good Publication Practice (GPP2).

Declaration of financial/other relationships

There are no relationships to be declared for any of the authors.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors acknowledge the independent medical writing assistance provided by MedSci, funded from an unrestricted financial grant from Beijing Novartis Pharma Co., Ltd. MedSci’s services complied with international guidelines for Good Publication Practice (GPP2).

In addition to the authors, the following investigators participated in this study: Beijing Haidian Hospital, Wei Huang; Chongqing Medical University affiliated First Hospital, Huacong Deng; Tongji University affiliated Tongji Hospital, Jun Ma; Yunnan Provincial First People’s Hospital, Yuanming Xue; Liwan Hospital of Guangzhou Medical College, Hongbing Luo; Sichuan Provincial People’s Hospital, Lianqiu Li; Zhongshan Hospital of Dalian University, Bihu Gao; Ha’erbin Medical University affiliated First Hospital, Hongyu Kuang; Beijing Coal General Hospital, Hongmei Li; Huashan Hospital of Fudan University, Yong Gu; China Aerospace Center Hospital, Wei Li; Xi'an Central Hospital, Yu Hua; Beijing Friendship Hospital of Capital Medical University, Wenhu Liu; People's Liberation Army No. 455 Hospital, Jinyuan Zhang; Shanghai Yangpu District Central Hospital, Yun Zhang; Sun Yat-Sen University affiliated First Hospital, Yanbing Li; Second Hospital of Jilin University, Lining Miao; Union Hospital of Fujian Medical University, Libin Liu; Second Hospital of Yinzhou Ningbo, Beiyan Bao; Shanghai East Hospital, Haidong Yan; People's Liberation Army No. 85 Hospital, Huang Yang; Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, Liqun He; Fujian Provincial Hospital, Fuyuan Hong; Shanghai Putuo District Central Hospital, Wen Peng; Sun Yat-Sen University affiliated Second Hospital, Li Yan; People’s Liberation Army No. 263 Hospital, Changbao Han; Nanjing Medical University affiliated Second Hospital, Hang Miu; Peking University Third Hospital, Jie Niu; Guangzhou University of Chinese Medicine affiliated First Hospital, Wenjiu Cai; Xinhua Hospital of Shanghai Jiaotong University, Gengru Jiang; Shanxi Provincial People's Hospital, Tao Wen; and Beijing Military General Hospital, Yaping Wang.