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Efficacy and Tolerability of Long-Acting Nifedipine GITS/OROS Monotherapy or Combination Therapy in Hypertensive Patients

Results of a 12-Week International, Prospective, Multicentre, Observational Study

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Abstract

Background: Achieving the maximum reduction in cardiovascular morbidity and mortality is the primary goal of blood pressure (BP) control. Current guidelines recommend several antihypertensive classes as first-line therapy for this purpose but the decision on which agent/s to use will likely be based upon the treating physician’s clinical experience. Observational studies provide a useful way of ascertaining the efficacy and tolerability of an anti-hypertensive in a real-life clinical setting.

Objective: The aim of this observational study was to determine the efficacy, tolerability and physician/patient satisfaction with long-acting nifedipine (gastrointestinal therapeutic system [GITS]/osmotic-controlled release oral delivery system [OROS]) in a large multinational cohort of hypertensive patients.

Methods: This observational study was conducted in adults (aged ≥18 years) with previously untreated or treated hypertension. The decision to prescribe nifedipine 30 or 60 mg once daily was made by the treating physician. Patients then attended up to three clinic visits any time over a 12-week period when medication could be up- or down-titrated or switched. The mean reduction in systolic BP (SBP)/diastolic BP (DBP) from first visit and whether target BP (<140/<90 mmHg or <130/<80 mmHg [for patients with diabetes mellitus]) had been achieved were recorded at the final visit and stratified according to hypertension grade and presence of cardiovascular risk factors. Subjective assessment of efficacy was reported by physicians and patients. All adverse events and their possible relationship to study drug were recorded. All assessments were performed on patients who received at least one dose of nifedipine GITS/OROS.

Results: A total of 14 344 patients received nifedipine GITS/OROS treatment (58.7% male; 77.7% non-diabetic; mean age 57.5 years); 14266 had at least one follow-up visit over a mean 10.2-week period, and 8000 patients had three visits over a mean 12-week period. Initially, 12 826 (89.4%) patients received nifedipine 30 mg, and 6912 patients (48.2%) overall received concomitant antihypertensive agents. The overall mean reduction in SBP/DBP was −27.7/−14.1 mmHg; BP reduction was linked to hypertension grade, age, the presence of five or more cardiovascular risk factors, and prior treatment. Target BP was achieved in 2485/7432 patients (33.4%) receiving nifedipine GITS/OROS monotherapy and in 1751/6912 (25.3%) receiving combination therapy (i.e. GITS/OROS plus any other antihypertensive agent). Non-diabetic patients with moderate (n = 3413) and high (n= 1138) risk reached their target BP goal in 62.5% and 54.2% of cases, respectively; the corresponding values in diabetic patients (moderate-added risk n = 8; high-added risk n=684) were 75.0% and 54.8%, respectively. A total of 229 patients (1.6%) reported experiencing 286 adverse events. Physician/patient satisfaction with treatment was high.

Conclusion: Long-acting nifedipine GITS/OROS, alone or in combination with other antihypertensive agents, provides effective and well tolerated treatment of hypertension in a broad spectrum of patients routinely seen in day-to-day clinical practice.

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Acknowledgements

This study and data analyses were funded by Bayer Schering Pharma, Leverkusen, Germany. The Bayer Global NIS department was responsible for global project management. The Contract Research Organisation (CRO) Institute Dr Schauerte, Oberhaching, Germany, was responsible for study logistics, data monitoring, data capture, data management of cases with adverse events or suspected adverse events, statistical analysis and reporting of study results. PAREXEL MMS provided writing assistance. The authors have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Department of Internal Medicine, Chung-Shan Medical University Hospital, School of Medicine, Institute of Medicine, Chung-Shan Medical University, 110, Section 1, Jian-Guo N. Road, Taichung City, 402, Taiwan

    Kwo-Chang Ueng

  2. Department of Cardiology, Peking University People’s Hospital, Beijing, China

    Sun Ningling

  3. Dr Erfan & Bagedo General Hospital, Jeddah, Saudi Arabia

    Abd El Maksod

  4. Clinical Department of Internal Medicine, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan

    Kuan-Yu Hung

  5. Second Affiliated Hospital of Chongqing Medical University, Chongqing, China

    Yin Yuehui

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  1. Kwo-Chang Ueng
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  2. Sun Ningling
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Correspondence to Kwo-Chang Ueng.

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Ueng, KC., Ningling, S., Maksod, A.E. et al. Efficacy and Tolerability of Long-Acting Nifedipine GITS/OROS Monotherapy or Combination Therapy in Hypertensive Patients. Clin. Drug Investig. 31, 631–642 (2011). https://doi.org/10.2165/11588970-000000000-00000

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