Advertisement

American Journal of Cardiovascular Drugs

, Volume 9, Issue 3, pp 135–142 | Cite as

Management of Hypertension with the Fixed Combination of Perindopril and Amlodipine in Daily Clinical Practice

Results from the STRONG Prospective, Observational, Multicenter Study
  • Vinay K. Bahl
  • Uday M. Jadhav
  • Hemant P. Thacker
Original Research Article

Abstract

Background

Current clinical guidelines recognize that the use of more than one agent is necessary to achieve target BP in the majority of patients. The ASCOT-BPLA trial demonstrated that the free combination of amlodipine and perindopril effectively controlled BP and was better than a β-adrenoceptor antagonist (β-blocker)/diuretic combination in reducing total mortality and cardiovascular outcomes.

Objective

To evaluate the efficacy and tolerability of a fixed combination of perindopril and amlodipine in the clinical setting.

Study design

The STRONG (SafeTy & efficacy analysis of coveRsyl amlodipine in uncOntrolled and Newly diaGnosed hypertension) study was a prospective, observational, multicenter trial.

Setting

This was a naturalistic, real-world, clinic-based, outpatient study involving 336 general practitioners/ primary care physicians in 65 cities in India.

Patients

Adults aged 40–70 years with newly diagnosed/untreated stage 2 hypertension (BP ≥ 160/100 mmHg), hypertension uncontrolled with monotherapy (BP > 140/90 mmHg), or hypertension inadequately managed with another combination therapy.

Intervention

Fixed combination perindopril 4 mg/amlodipine 5 mg once daily for 60 days.

Main outcomes measure

The primary outcomes were the mean change in BP from baseline and the proportion of patients achieving adequate BP control (≤ 140/90 mmHg, or ≤ 130/80 mmHg in patients with diabetes mellitus) in the intent-to-treat (ITT) population. Secondary analyses included incidence of adverse events (ITT) and treatment adherence rate (completers).

Results

In total, 1250 patients comprised the ITT population: 32.6% with newly diagnosed hypertension; 40.5% with hypertension uncontrolled with monotherapy; and 26.9% with hypertension inadequately managed with another combination therapy. Mean SBP/DBP decreased significantly from baseline (167.4±15.2/101.4±9.1 mmHg) over 60 days (−41.9 ± 34.8/−23.2 ± 21.8 mmHg; p<0.0001). Target BP was achieved in 66.1% of patients in the total population, 68.3% of untreated patients, 68.4% of patients uncontrolled with monotherapy, and 59.9% of patients inadequately managed with combination therapy. In 161 patients with SBP >180 mmHg at baseline (newly diagnosed: n = 50; uncontrolled on monotherapy: n = 53; inadequately managed on combination therapy: n = 58), BP was reduced by 63.2 ± 32.5/29.0 ± 21.9 mmHg (p<0.0001) at day 60. The fixed combination was safe and well tolerated. All 1175 patients completing the 60-day study (94%) adhered to their treatment regimen.

Conclusion

Fixed combination perindopril/amlodipine was found to be an effective and well tolerated antihypertensive treatment, with an excellent rate of treatment adherence in the clinical setting. Fixed combination perindopril/amlodipine is expected to be useful in the management of hypertension in primary healthcare, with a positive impact on treatment adherence.

Keywords

Amlodipine Perindopril Calcium Channel Antagonist Fixed Combination Quinapril 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

This study was funded by an administrative grant from Serdia Pharmaceuticals (India) Pvt. Ltd. No other financial consideration was involved and the authors have no conflicts of interest that are directly relevant to the content of this manuscript. Medical writing assistance was provided by Mary Hines, Wolters Kluwer Health.

STRONG investigators

Agartala A. Chakraborty, D. Chakraborty, J. Chakraborty, R. Debbarma, A. Mandal, S. Sarkar; Ahmedabad N. Suthar; Allahabad B.P. Agarwal, S. Ratna; Ambala A. Baveja, M. Singh; Amritsar S. Dixit, N.S. Sunil; Aurangabad M.B. Anandjiwala, J.S. Avad, S.V. Chandekar, R. Gujrathi, H.R. Tibrewala; Bangalore M.I. Ali, A.P. Bajaj, R. Keerthy, P. Kumar, M.R.K. Murthy, B.R. Prabhakar, V. Prasanna, M.B.S. Raman, B. Rao, C.S. Ravindra, H. Siddappa, B.M. Suraj, G. Suresh, N. Suryaprakash, K. Venkatesh; Bhopal A. Sharma; Bilaspur P. Verma; Calicut K. Bai, A. Krishnan; Chandigarh P. Changedia, A. Gupta; Chennai P.K. Gupta, A. Harish, P. Jaison, G.J. Kumar, R. Leo, N.V.R. Mohan, P. Mohan, A.K. Patwari, K. Premkumar, S. Ramanathan, J. Ramesh, M.M. Ravi, K.M. Shamsuddeen, S. Singhvi, J.S. Sundar, G. Thooyamani, G. Usha; Cochin G. Abraham, J.J. Kannampilly, A.S. Krishnan, P. Ramakrishnan; Coimbatore L.J. Chandra, K. Lakshminarayanan, V.U. Muruganandam, T. Saravanan, S. Sujithkumar; Dehradun A.K. Bhatt, S. Gaikwad, V. Gurung, R. Kumar, A. Rajput; Delhi S. Agarwal, P. Aneja, O.P. Chaddha, S. Dang, A. De, R. Dogra, A.S. Ghai, M.P. Girish, A. Gogna, A.V.S. Gupta, D. Gupta, R. Gupta, D.G. Jain, S.C. Juneja, A.K. Kaushik, R. Khandelwal, G.S. Kochar, H.V. Mahajan, C.M. Malhotra, V. Mehta, C.L. Mittal, S. Mohanty, A. Nigam, L. Patel, A. Rohatgi, H.S. Ruproi, D.P. Sarkar, B. Sharma, R.C. Sharma, C. Shekhar, T.P. Singh, B.K. Tripathi, J.P.S. Tulsi, R.N. Verma, S. Verma; Durgapur S.K. Roy, P. Sadani; Erode R. Gopinath, S.S. Kumar; Faridabad B.K. Prasad; Ghaziabad D.K. Jain; Guntur K. Chakravarty; Gurgaon S. Budhiraja, V.B. Gupta, P. Sahajpal, S.K. Sharma; Guwahati D. Agarwal, T.K. Bhuyan, A.S. Das; Hisar N.K. Khanna; Hyderabad A. Abbas, N. Athaullah, T.S. Babu, Y. Chandrashekhar, K.V.R. Kumar, G. Lakshmi, V.L. Ramachander, T. Ramu, A.V. Rao, K.S. Rao, L.V. Reddy, B.G. Sankar, M. Satyanarayana, M. Sudhir; Indore D. Balani, R. Bhatia, G. Taori; Jabalpur B.K. Behera, S.K. Mishra, N.S. Nim, A. Singh; Jaipur S. Gupta, S. Saxena; Jalgaon S. Patil; Jodhpur M. Balani, R. Chetiwal, S.K. Dadhich; Kalol P.K. Singhal; Kanpur V. Goel, A. Krishna; Kharagpur R. Mohan, S. Roy; Kolhapur J. Patil; Kolkata A.H.S. Ahmed, A. Banerjee, A.K. Banerjee, P.K. Banerjee, C. Batabyal, S. Bhattacharya, P.C. Biswas, S.K. Biswas, S. Chatterjee, A.K. Chaudhuri, A. Das, B.K. Deria, R.K. Dutta, S. Ghosh, T. Ghosh, S. Guha, D. Konar, A. Malhotra, M. Mandal, S. Mandal, S.C. Mandal, B. Mitra, S.C. Mondal, R.D. Mukherjee, A. Pal, A. Parekh, A. Pramanik, A.K. Ray, D. Roy, D. Saha, T.K. Saha, B. Sarkar, M. Sarkar; Kota J.L. Jethwani; Latur S.R. Gatagat, S. Gandhi; Lucknow S. Gupta, S.C. Joshi, A. Kumar, A. Mehrotra, J.N. Mishra, S. Pandey, J. Prasad, H.K. Rastogi; Ludhiana Y. Arora, R. Sharma, R.K. Singla; Madurai C.R.M. Babu, M.K. Daniel, R. Govindarajan; Mangalore R. Bhat, U. Nayak, S.B. Rao, D. Venugopala; Meerut H.M. Rastogi; Mumbai R.K. Advani, S. Anand, R. Anjali, M. Beloskar, P. Bhatia, N. Chandra, V.V. Chandra, S. Doshi, P.S. Gangdev, S. Gautam, R.P. Jain, M. Jalgaonkar, P.S. Kadam, H.R. Kamat, R.M. Kewalramani, T. Koshy, S.H. Kothar, S.N. Mahale, M. Mavani, L. Momania, R.M. Mundada, H. Nanavati, A. Nanaware, S. Nayak, N.J. Padwal, B.M. Parekh, S. Pataria, D. Rajul, N. Redkar, S.K. Sabnis, S.B. Salagre, D. Shah, R.G. Shah, S.J. Shah, A.A. Sharma, R. Singh, R. Teckchandani, H. Thacker, A.Trailokya, S.M. Wani; Mysore P. Kavathe, M.G. Mahesh; Nagercoil J.J. Jerald, R. Mohanadhas, M.C. Nesamony; Nagpur A. Dharaskar, G. Heda; Nashik P.D. Supe; Panjim R. Bhatkurse, A.J. Borkar, T. Coutinho, A. Fernandes, D.L.S. Vas; Patna R.P. Chaudhary, S.N. Jha, R. Kumar, S.K. Pandey, A.K. Pratap, S.S. Shah, S. Singh, N. Sinha, V.K. Thakur; Puducherry K. Narayanan, R. Rajarathinam; Pune A.K. Bhattacharya, A. Bhondwe, S. Bulbule, C. Chivate, V.S. Dharmadhikari, A. Gupta, K. Kavediya, J.V. Mannikar, P.S. Mulay, P. Sengupta, M. Wayal; Raipur M.M. Agrawal, B.B. Solanki, R. Tiwari; Rajkot A.R. Hapani, P. Jethwani, B. Mori, P.P. Rajani, N. Vasavda; Salem K.S.A. Khaddar, P.C.T. Kiruba, V. Ram; Sangroli J.N. Mehta, D.K. Saraswat; Satna A.K. Jain, N. Sharma; Secundrabad A. Bajaj, P.A. Kumar, S.L. Paryani, P.D. Rao; Shimla D. Gupta; Thiruvananthapuram B. Krishnakumar, D.V. Kumar; S.K. Kumar, S.P. Sampath, N.S. Sibi; Trichy M. Prabhukumar, K.M.K. Raj, V. Ravindranath, K. Saravanan, G. Satishkumar, S. Velmurugan; Ujjain S. Khatod, V. Patidar, V. Porwal, S. Rajakumar; Vadodara M.L. Verma; Varanasi W.A. Ansari, K.N. Dwiwedi, M. Gupta, P. Jain, D. Kumar, K.P. Singh; Vijayawada U. Kumar, C.S. Rao, P.V. Satyanarayana, Y. Shivakumar.

References

  1. 1.
    Turnbull F. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials. Lancet 2003 Nov 8; 362 (9395): 1527–35.PubMedCrossRefGoogle Scholar
  2. 2.
    Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003 Dec; 42 (6): 1206–52.PubMedCrossRefGoogle Scholar
  3. 3.
    Mancia G, De Backer G, Dominiczak A, et al. 2007 Guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2007 Jun; 25 (6): 1105–87.PubMedCrossRefGoogle Scholar
  4. 4.
    Dahlof 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 Sep 10–16; 366 (9489): 895–906.PubMedCrossRefGoogle Scholar
  5. 5.
    Julius S, Cohn JN, Neutel J, et al. Antihypertensive utility of perindopril in a large, general practice-based clinical trial. J Clin Hypertens (Greenwich) 2004 Jan; 6 (1): 10–7.CrossRefGoogle Scholar
  6. 6.
    Opie LH, Schall R. Old antihypertensives and new diabetes. J Hypertens 2004 Aug; 22 (8): 1453–8.PubMedCrossRefGoogle Scholar
  7. 7.
    Weir MR. Calcium channel blockers: their pharmacologic and therapeutic role in hypertension. Am J Cardiovasc Drugs 2007; 7 Suppl. 1: 5–15.PubMedCrossRefGoogle Scholar
  8. 8.
    National Institute for Health and Clinical Excellence (NICE), British Hypertension Society (BHS). Hypertension: management of hypertension in adults in primary care. 2006 Jun 28 [online]. Available from URL: http://www.nice.org.uk/nicemedia/pdf/CG034NICEguideline.pdf [Accessed 2008 Jan 28].
  9. 9.
    Poulter NR, Chang CL, Dahlof B, et al. Evaluating the efficacy of the stepped-care anti-hypertensive strategies used in the Anglo-Scandinavian Cardiac Outcomes Trial BP Lowering Arm (ASCOT) [abstract no. OS11/1]. J Hypertens 2008; 26 Suppl. 1: S10.Google Scholar
  10. 10.
    Bertrand M, Sever P. Synergistic effect of perindopril and calcium channel blockers in prevention of cardiac events and death in coronary artery disease patients: analysis from the EUROPA study [abstract no. 3267]. Congress of the European Society of Cardiology (ESC); 2008 Aug 30; Munich.Google Scholar
  11. 11.
    Fox KM. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet 2003 Sep 6; 362 (9386): 782–8.PubMedCrossRefGoogle Scholar
  12. 12.
    Fogari R, Malamani G, Zoppi A, et al. Effect on the development of ankle edema of adding delapril to manidipine in patients with mild to moderate essential hypertension: a three-way crossover study. Clin Ther 2007 Mar; 29 (3): 413–8.PubMedCrossRefGoogle Scholar
  13. 13.
    Fogari R, Malamani GD, Zoppi A, et al. Effect of benazepril addition to amlodipine on ankle oedema and subcutaneous tissue pressure in hypertensive patients. J Hum Hypertens 2003 Mar; 17 (3): 207–12.PubMedCrossRefGoogle Scholar
  14. 14.
    Hair PI, Scott LJ, Perry CM. Fixed-dose combination lercanidipine/enalapril. Drugs 2007; 67 (1): 95–106.PubMedCrossRefGoogle Scholar
  15. 15.
    Miranda RD, Mion Jr D, Rocha JC, et al. An 18-week, prospective, randomized, double-blind, multicenter study of amlodipine/ramipril combination versus amlodipine monotherapy in the treatment of hypertension: the assessment of combination therapy of amlodipine/ramipril (ATAR) study. Clin Ther 2008 Sep; 30 (9): 1618–28.PubMedCrossRefGoogle Scholar
  16. 16.
    Jadhav UM, Bandukwalla SS. Quinapril in systemic hypertension (QUALISH) study [abstract no. P-103]. J Clin Hypertens (Greenwich) 2006; 8 Suppl. A (5): 50.Google Scholar
  17. 17.
    Dicpinigaitis PV. Angiotensin-converting enzyme inhibitor-induced cough: ACCP evidence-based clinical practice guidelines. Chest 2006 Jan; 129 (1 Suppl.): 169S–173S.PubMedCrossRefGoogle Scholar
  18. 18.
    Fogari R, Zoppi A, Mugellini A, et al. Effects of amlodipine, nifedipine GITS, and indomethacin on angiotensin-converting enzyme inhibitor-induced cough: a randomized, placebo controlled, double-masked, crossover study. Curr Ther Res 1999; 60 (3): 121–8.CrossRefGoogle Scholar
  19. 19.
    Sharma A, Bagchi A, Kinagi SB, et al. Results of a comparative, phase III, 12-week, multicenter, prospective, randomized, double-blind assessment of the efficacy and tolerability of a fixed-dose combination of telmisartan and amlodipine versus amlodipine monotherapy in Indian adults with stage II hypertension. Clin Ther 2007 Dec; 29 (12): 2667–76.PubMedCrossRefGoogle Scholar
  20. 20.
    Zannad F, Bernaud CM, Fay R. Double-blind, randomized, multicentre comparison of the effects of amlodipine and perindopril on 24 h therapeutic coverage and beyond in patients with mild to moderate hypertension. General Physicians Investigators’ Group. J Hypertens 1999 Jan; 17 (1): 137–46.PubMedCrossRefGoogle Scholar
  21. 21.
    Bangalore S, Kamalakkannan G, Parkar S, et al. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med 2007 Aug; 120 (8): 713–9.PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2009

Authors and Affiliations

  • Vinay K. Bahl
    • 1
  • Uday M. Jadhav
    • 2
  • Hemant P. Thacker
    • 3
  1. 1.Department of Cardiology, Cardiothoracic Sciences CentreAll India Institute of Medical SciencesAnsari NagarIndia
  2. 2.Department of Noninvasive Cardiology, MGMNew Bombay HospitalMumbaiIndia
  3. 3.Jaslok Hospital and Research CentreMumbaiIndia

Personalised recommendations