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

Results from the STRONG Prospective, Observational, Multicenter Study

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American Journal of Cardiovascular Drugs Aims and scope Submit manuscript

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.

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Table I
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Table II

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Notes

  1. According to the protocol, patients should be switched from prior therapy, including β-blockers.

  2. According to the protocol, patients should be switched from prior therapy, including β-blockers.

  3. According to the protocol, patients should be switched from prior therapy, including β-blockers.

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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.

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Authors and Affiliations

  1. Department of Cardiology, Cardiothoracic Sciences Centre, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India

    Vinay K. Bahl

  2. Department of Noninvasive Cardiology, MGM, New Bombay Hospital, Mumbai, India

    Uday M. Jadhav

  3. Jaslok Hospital and Research Centre, Mumbai, India

    Hemant P. Thacker

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  1. Vinay K. Bahl
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Correspondence to Vinay K. Bahl.

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Bahl, V.K., Jadhav, U.M. & Thacker, H.P. Management of Hypertension with the Fixed Combination of Perindopril and Amlodipine in Daily Clinical Practice. Am J Cardiovasc Drugs 9, 135–142 (2009). https://doi.org/10.1007/BF03256570

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