Effectiveness and Safety of Aliskiren and Aliskiren Hydrochlorothiazide (HCT) in a Multiethnic, Real-World Setting

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• 作者：Srinivasa Rao Maddury (15)
  Abhay Pande (25)
  K. M. H. S. Sirajul Haque (35)
  Akram Echtay (45)
  Loewe Go (55)
  Tashbeeb Gulzar (65) (85)
  Mahomed Kadwa (75)
  Sashka Hristoskova (75)
  
• 关键词：Aliskiren ; Aliskiren HCT ; Asia ; Direct renin inhibitor ; Effectiveness ; Hypertension ; Middle East ; Observational ; Real ; world ; Tolerability
• 刊名：Advances in Therapy
• 出版年：2013
• 出版时间：February 2013
• 年：2013
• 卷：30
• 期：2
• 页码：176-189
• 全文大小：801KB
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• 作者单位：Srinivasa Rao Maddury (15)
  Abhay Pande (25)
  K. M. H. S. Sirajul Haque (35)
  Akram Echtay (45)
  Loewe Go (55)
  Tashbeeb Gulzar (65) (85)
  Mahomed Kadwa (75)
  Sashka Hristoskova (75)
  
  15. D.No.8-2-330/A/2, CARE Hospital, Banjara Hills, Road No. 5, Opposite Nokia Towers, Hyderabad, India
  25. Al Zahra Hospital, Sharjah, UAE
  35. Anwer Khan Modern Medical College, Dhanmondi, Dhaka, Bangladesh
  45. Hariri University Hospital, Beirut, Lebanon
  55. Saint Luke鈥檚 Medical Center, Quezon City, Philippines, USA
  65. Hameed Latif Hospital, Lahore, Pakistan
  85. the National Hospital Lahore, Lahore, Pakistan
  75. Novartis Pharma AG, Basel, Switzerland
  

文摘

Introduction Numerous randomized clinical trials have demonstrated the efficacy and tolerability of aliskiren and aliskiren hydrochlorothiazide (aliskiren HCT) single-pill combination therapy in patients with hypertension. The objective of the present study was to evaluate the effectiveness and safety of aliskiren-based therapy under daily life conditions in a multiethnic population. Methods This observational, multicenter, noninterventional study, conducted at 420 centers in Asia and the Middle East, included adult patients with hypertension who received treatment with aliskiren or aliskiren HCT as single or add-on therapy for a planned treatment period of at least 26 weeks. The main effectiveness assessments included the proportion of patients achieving therapeutic blood pressure (BP) goal (defined as systolic BP [SBP]/diastolic BP [DBP] <140/90 mmHg, or <130/80 mmHg in patients with diabetes) and BP response, and change in mean sitting BP from baseline to study end. Results Of 4,826 patients (mean age 51.4 years, 65.9% male, 64.5% Asian, 41.5% diabetic) included in the study, 3,473 received aliskiren and 1,353 received aliskiren HCT. Almost half the study population (48.1%) received aliskiren or aliskiren HCT as add-on therapy. The therapeutic BP goal was achieved in 49.5% of patients treated with aliskiren and 48.3% of patients receiving aliskiren HCT; attainment of BP goal increased to more than 70% when a classic BP target of <140/90 mmHg was applied for all patients. Reductions in mean sitting SBP/DBP were significantly lower versus baseline for both aliskiren (24.1/12.2 mmHg) and aliskiren HCT (27.6/14.1 mmHg) and BP response rates were consistently achieved in more than 80% of all patients during the study. Aliskiren treatment was well tolerated with only a small proportion of patients experiencing adverse events (AEs; 2.1%) and serious AEs (0.3%). Conclusion In this real-world, naturalistic setting, antihypertensive treatment with an aliskiren-based regimen was effective and well-tolerated in this multiethnic population with arterial hypertension.