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Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy is Safe and Effective in Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study

Abstract

Introduction

We investigate the safety and efficacy of telmisartan plus S-amlodipine single-pill combination in a real-world population.

Methods

A total of 44,715 patients who had hypertension and received a telmisartan/S-amlodipine single-pill combination at least once were included for safety and efficacy evaluation from 2852 primary to tertiary hospitals in Korea from August 2013 to December 2019. They were followed up for 3–6 months in terms of safety and efficacy of blood pressure (BP) lowering.

Results

A total of 44,715 patients were included for safety analysis and 41,579 for efficacy analysis. Mean duration of taking the drug was 175.86 ± 48.45 days. A total of 28,096 (62.8%) patients were on telmisartan 40 mg plus S-amlodipine 2.5 mg combination followed by 80/2.5 mg (8664, 19.4%) and 40/5 mg of the drug (7136, 16.0%). Adverse events, total adverse drug reactions, and serious adverse drug reactions were found in 808 patients (1.81%), 352 (0.79%), and 1 (0.002%), respectively. Dizziness and headache were most common (134 [0.30%] and 81 [0.18%]) among all adverse events. Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively. Systolic BP (SBP) and diastolic BP (DBP) was lowered from 143.1 ± 16.1/88.1 ± 11.8 mmHg to 129.6 ± 11.4/80.1 ± 9.0 mmHg (difference − 13.5/− 7.9 mmHg, P < 0.0001 for both). Target BP goal attainment rate defined as SBP < 140 mmHg and DBP < 90 mmHg was 74.6% (95% confidence interval [CI] 74.2–75.0) and BP response rate (defined as SBP < 140 mmHg or ≥ 20 mmHg reduction; DBP < 90 mmHg or ≥ 10 mmHg reduction) was 94.5% (95% CI 94.3–94.7).

Conclusion

Telmisartan plus S-amlodipine single-pill combination was safe and effective in patients with hypertension in a large real-world population.

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References

  1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018;71(19):e127–248.

    Article  Google Scholar 

  2. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39(33):3021–104.

    Article  Google Scholar 

  3. Kim SJ, Kwon OD, Cho B, Oh SW, Lee CM, Choi HC. Effects of combination drugs on antihypertensive medication adherence in a real-world setting: a Korean Nationwide Study. BMJ Open. 2019;9(6):e029862.

    Article  Google Scholar 

  4. Dahlöf B, Sever PS, Poulter NR, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet. 2005;366(9489):895–906.

    Article  Google Scholar 

  5. Yusuf S, Teo K, Anderson C, et al. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet. 2008;372(9644):1174–83.

    CAS  Article  Google Scholar 

  6. Yusuf S, Teo KK, Pogue J, et al. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Eng J Med. 2008;358(15):1547–59.

    CAS  Article  Google Scholar 

  7. Kim SH, Shin DW, Kim S, et al. Prescribing patterns of antihypertensives for treatment-naïve patients in South Korea: from Korean NHISS claim data. Inter J Hyperten. 2019;2019:4735876.

    Article  Google Scholar 

  8. Gupta A, Mackay J, Whitehouse A, et al. Long-term mortality after blood pressure-lowering and lipid-lowering treatment in patients with hypertension in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) Legacy study: 16-year follow-up results of a randomised factorial trial. Lancet. 2018;392(10153):1127–37.

    Article  Google Scholar 

  9. Dalal J, Mohan JC, Iyengar SS, et al. S-Amlodipine: an isomer with difference-time to shift from racemic amlodipine. Inter J Hyperten. 2018;2018:8681792.

    Article  Google Scholar 

  10. Ihm SH, Jeon HK, Cha TJ, et al. Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan (CKD-828) versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy: an 8-week, multicenter, randomized, double-blind, phase III clinical study. Drug Design Develop Ther. 2016;10:3817–26.

    CAS  Article  Google Scholar 

  11. Park CG, Ahn TH, Cho EJ, et al. Comparison of the efficacy and safety of fixed-dose S-amlodipine/telmisartan and telmisartan in hypertensive patients inadequately controlled with telmisartan: a randomized, double-blind, multicenter study. Clin Ther. 2016;38(10):2185–94.

    CAS  Article  Google Scholar 

  12. Galappatthy P, Waniganayake YC, Sabeer MI, Wijethunga TJ, Galappatthy GK, Ekanayaka RA. Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial. BMC Cardiovasc Disord. 2016;16(1):168.

    Article  Google Scholar 

  13. Liu F, Qiu M, Zhai SD. Tolerability and effectiveness of (S)-amlodipine compared with racemic amlodipine in hypertension: a systematic review and meta-analysis. Curr Thera Res Clin Exp. 2010;71(1):1–29.

    CAS  Article  Google Scholar 

  14. Oh GC, Lee HY, Kang HJ, Zo JH, Choi DJ, Oh BH. Quantification of pedal edema during treatment with S(-)-amlodipine nicotinate versus amlodipine besylate in female Korean patients with mild to moderate hypertension: a 12-week, multicenter, randomized, double-blind, active-controlled, phase IV clinical trial. Clin Ther. 2012;34(9):1940–7.

    CAS  Article  Google Scholar 

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Acknowledgements

Funding

This study was supported by Chong Kun Dang Pharmacy Corporation, Seoul, Korea. Sponsorship for this study and Rapid Service Fee were funded by Chong Kun Dang Pharmacy Corporation, Seoul, Korea. The funding source has no involvement in interpretation of data, in the writing of the report, and in the decision to submit the article for publication.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authorship Contributions

SHJ wrote, reviewed and revised the manuscript. CGP conceptualized, designed, performed the study and contributed to fund raising. SHJ contributed to the statistical analysis. SHJ, SJP, GRH, SWK, CGP contributed to recruiting patients and performing the study. SJP, GRH, SWK, CGP reviewed the draft. All authors have approved the submitted manuscript.

Disclosures

Sang-Ho Jo, Sung-Ji Park, Geu-Ru Hong, Sang Wook Kim and Chang-Gyu Park have nothing to disclose.

Compliance with Ethics Guidelines

This study was approved by the institutional review board from each hospital (Korean University Kuro Hospital IRB no: KUGH 16,023, 16,092). This study was performed in accordance with the Helsinki Declaration. We confirm that all subjects provided informed consent to participate in the study.

Data availability

All data generated or analyzed during this study are included in this published article/as supplementary information files.

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Corresponding author

Correspondence to Chang-Gyu Park.

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Jo, SH., Park, SJ., Hong, GR. et al. Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy is Safe and Effective in Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study. Adv Ther 38, 304–315 (2021). https://doi.org/10.1007/s12325-020-01533-5

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  • DOI: https://doi.org/10.1007/s12325-020-01533-5

Keywords

  • Cardiology
  • Efficacy
  • Safety
  • S-Amlodipine
  • Single pill
  • Telmisartan