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Clinical Adverse Events Profile during Combination Therapy with Amlodipine and Hydrochlorothiazide in Hypertensive Nigerians

Received: 6 December 2014     Accepted: 16 December 2014     Published: 19 December 2014
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Abstract

Background: Combination therapy with antihypertensive drugs from different classes has been recommended as an effective strategy to attain blood pressure (BP) goal. Although amlodipine (AML) and hydrochlorothiazide (HCZ) are frequently used as combination therapy in Nigeria, information regarding the adverse events associated with this regimen is scarce. Objective: To evaluate the clinical adverse events profile associated with a regimen of AML and HCZ therapy for 48 weeks (wks) in hypertensive Nigerians. Methods: Ninety male (M) and female (F) Nigerians aged 31-86 years with newly diagnosed uncomplicated essential hypertension (BP > 160/90 ≤ 180/120 mmHg), were enrolled. Patients, who were 30 each (15 Ms and 15 Fs) in AML, HCZ and AML-HCZ groups, were treated, respectively, with AML 5mg for 6 wks and the dose increased to 10mg till wk 12 (end of monotherapy) after which HCZ 25mg was added; HCZ 25mg till wk 6 (end of monotherapy) after which AML 5-10mg was added as needed; and AML 5-10mg + HCZ 25mg. Body mass index (BMI), BP and heart rate (HR) were assessed at baseline and at the end of wks 1, 3, 6, 12, 24, 36, and 48 during treatment. Adverse drug events were similarly monitored beginning from wk 1. Results: The three combination regimens comparably significantly reduced BP, though the effect in AML group was greater than the rest (P<0.05). Changes in BMI and HR were not statistically significant. Sixty one events of which polyuria, tachycardia and slight weight reduction were commonest as well as nausea and diaphoresis were recorded in AML group. Similarly, 91 events were observed in HCZ group, polyuria, tachycardia and weight loss being commonest plus impotence and visual disturbance. Although tachycardia and weight loss were more prominent among the 74 events in AML-HCZ group, polyuria was surprisingly uncommon. It is demonstrated that a regimen of AML to which HCZ is subsequently added provides superior tolerability and less bother to patients when compared with a regimen of HCZ to which AML is added as needed or with ab initio AML-HCZ combination therapy.

Published in American Journal of Clinical and Experimental Medicine (Volume 2, Issue 6)
DOI 10.11648/j.ajcem.20140206.19
Page(s) 165-170
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2014. Published by Science Publishing Group

Keywords

Adverse Drug Events, Antihypertensive Combination Therapy, Amlodipine, Hydrochlorothiazide, Nigerians

References
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[7] G.B.S. Iyalomhe, E.K.I. Omogbai, O.O.B. Iyalomhe. Long-term electrolyte effects during initiation of antihypertensive therapy with amlodipine or hydrochlorothiazide in diabetic Nigerians. American Journal of Medical Sciences and Medicine, 2013, 1(3), 1-7
[8] L. Ma, W. Wang, Y. Zhao, Y. Zhang, Q. Deng, M. Liu, H. Sun, J. Wang, L. Liu. Combination of amlodipine plus angiotensin receptor blocker or diuretics in high-risk hypertensive patients. American Journal of Cardiovascular Drugs, 2012, 12(2), 137-142
[9] G.B.S. Iyalomhe, E.K.I. Omogbai, A.O. Isah, O.O.B. Iyalomhe, F.L. Dada, S.I. Iyalomhe. Efficacy of initiating therapy with amlodipine and hydrochlorothiazide or their combination in hypertensive Nigerians. Clinical and Experimental Hypertension. Early online 1-8 2013, DOI: 10.3109/10641963.776570
[10] G.B.S. Iyalomhe, E.K.I. Omogbai, O.O.B. Iyalomhe, S.I. Iyalomhe. Serum and urine electrolyte profiles during amlodipine and hydrochlorothiazide combination therapy in Nigerian patients with essential hypertension. British Journal of Medicine and Medical Research, 2013, 3 (2), 428-441
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[16] G.B.S. Iyalomhe, E.K.I. Omogbai, R.I. Ozolua. Antihypertensive and biochemical effects of hydrochlorothiazide and furosemide in hypertensive Nigerians. Journal of Medical Sciences, Aug, 2007, 7(6), 977-983
[17] T.G. Pickering, J.E. Hall, L.J. Appel, B.E. Falkner, J. Graves, M.N Hill, D.W. Jones, T. Kurtz, S.G. Sheps, and E.J. Rocella, “Recommendations for blood pressure measurement in humans and experimental animals part1. Blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research”, Circulation, 2005, ΙΙΙ, 697-716
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    G. B. S. Iyalomhe, E. K. I. Omogbai, A. O. Isah, S. I. Iyalomhe. (2014). Clinical Adverse Events Profile during Combination Therapy with Amlodipine and Hydrochlorothiazide in Hypertensive Nigerians. American Journal of Clinical and Experimental Medicine, 2(6), 165-170. https://doi.org/10.11648/j.ajcem.20140206.19

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    ACS Style

    G. B. S. Iyalomhe; E. K. I. Omogbai; A. O. Isah; S. I. Iyalomhe. Clinical Adverse Events Profile during Combination Therapy with Amlodipine and Hydrochlorothiazide in Hypertensive Nigerians. Am. J. Clin. Exp. Med. 2014, 2(6), 165-170. doi: 10.11648/j.ajcem.20140206.19

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    AMA Style

    G. B. S. Iyalomhe, E. K. I. Omogbai, A. O. Isah, S. I. Iyalomhe. Clinical Adverse Events Profile during Combination Therapy with Amlodipine and Hydrochlorothiazide in Hypertensive Nigerians. Am J Clin Exp Med. 2014;2(6):165-170. doi: 10.11648/j.ajcem.20140206.19

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  • @article{10.11648/j.ajcem.20140206.19,
      author = {G. B. S. Iyalomhe and E. K. I. Omogbai and A. O. Isah and S. I. Iyalomhe},
      title = {Clinical Adverse Events Profile during Combination Therapy with Amlodipine and Hydrochlorothiazide in Hypertensive Nigerians},
      journal = {American Journal of Clinical and Experimental Medicine},
      volume = {2},
      number = {6},
      pages = {165-170},
      doi = {10.11648/j.ajcem.20140206.19},
      url = {https://doi.org/10.11648/j.ajcem.20140206.19},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajcem.20140206.19},
      abstract = {Background: Combination therapy with antihypertensive drugs from different classes has been recommended as an effective strategy to attain blood pressure (BP) goal. Although amlodipine (AML) and hydrochlorothiazide (HCZ) are frequently used as combination therapy in Nigeria, information regarding the adverse events associated with this regimen is scarce. Objective: To evaluate the clinical adverse events profile associated with a regimen of AML and HCZ therapy for 48 weeks (wks) in hypertensive Nigerians. Methods: Ninety male (M) and female (F) Nigerians aged 31-86 years with newly diagnosed uncomplicated essential hypertension (BP > 160/90 ≤ 180/120 mmHg), were enrolled. Patients, who were 30 each (15 Ms and 15 Fs) in AML, HCZ and AML-HCZ groups, were treated, respectively, with AML 5mg for 6 wks and the dose increased to 10mg till wk 12 (end of monotherapy) after which HCZ 25mg was added; HCZ 25mg till wk 6 (end of monotherapy) after which AML 5-10mg was added as needed; and AML 5-10mg + HCZ 25mg. Body mass index (BMI), BP and heart rate (HR) were assessed at baseline and at the end of wks 1, 3, 6, 12, 24, 36, and 48 during treatment. Adverse drug events were similarly monitored beginning from wk 1. Results: The three combination regimens comparably significantly reduced BP, though the effect in AML group was greater than the rest (P<0.05). Changes in BMI and HR were not statistically significant. Sixty one events of which polyuria, tachycardia and slight weight reduction were commonest as well as nausea and diaphoresis were recorded in AML group. Similarly, 91 events were observed in HCZ group, polyuria, tachycardia and weight loss being commonest plus impotence and visual disturbance. Although tachycardia and weight loss were more prominent among the 74 events in AML-HCZ group, polyuria was surprisingly uncommon. It is demonstrated that a regimen of AML to which HCZ is subsequently added provides superior tolerability and less bother to patients when compared with a regimen of HCZ to which AML is added as needed or with ab initio AML-HCZ combination therapy.},
     year = {2014}
    }
    

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  • TY  - JOUR
    T1  - Clinical Adverse Events Profile during Combination Therapy with Amlodipine and Hydrochlorothiazide in Hypertensive Nigerians
    AU  - G. B. S. Iyalomhe
    AU  - E. K. I. Omogbai
    AU  - A. O. Isah
    AU  - S. I. Iyalomhe
    Y1  - 2014/12/19
    PY  - 2014
    N1  - https://doi.org/10.11648/j.ajcem.20140206.19
    DO  - 10.11648/j.ajcem.20140206.19
    T2  - American Journal of Clinical and Experimental Medicine
    JF  - American Journal of Clinical and Experimental Medicine
    JO  - American Journal of Clinical and Experimental Medicine
    SP  - 165
    EP  - 170
    PB  - Science Publishing Group
    SN  - 2330-8133
    UR  - https://doi.org/10.11648/j.ajcem.20140206.19
    AB  - Background: Combination therapy with antihypertensive drugs from different classes has been recommended as an effective strategy to attain blood pressure (BP) goal. Although amlodipine (AML) and hydrochlorothiazide (HCZ) are frequently used as combination therapy in Nigeria, information regarding the adverse events associated with this regimen is scarce. Objective: To evaluate the clinical adverse events profile associated with a regimen of AML and HCZ therapy for 48 weeks (wks) in hypertensive Nigerians. Methods: Ninety male (M) and female (F) Nigerians aged 31-86 years with newly diagnosed uncomplicated essential hypertension (BP > 160/90 ≤ 180/120 mmHg), were enrolled. Patients, who were 30 each (15 Ms and 15 Fs) in AML, HCZ and AML-HCZ groups, were treated, respectively, with AML 5mg for 6 wks and the dose increased to 10mg till wk 12 (end of monotherapy) after which HCZ 25mg was added; HCZ 25mg till wk 6 (end of monotherapy) after which AML 5-10mg was added as needed; and AML 5-10mg + HCZ 25mg. Body mass index (BMI), BP and heart rate (HR) were assessed at baseline and at the end of wks 1, 3, 6, 12, 24, 36, and 48 during treatment. Adverse drug events were similarly monitored beginning from wk 1. Results: The three combination regimens comparably significantly reduced BP, though the effect in AML group was greater than the rest (P<0.05). Changes in BMI and HR were not statistically significant. Sixty one events of which polyuria, tachycardia and slight weight reduction were commonest as well as nausea and diaphoresis were recorded in AML group. Similarly, 91 events were observed in HCZ group, polyuria, tachycardia and weight loss being commonest plus impotence and visual disturbance. Although tachycardia and weight loss were more prominent among the 74 events in AML-HCZ group, polyuria was surprisingly uncommon. It is demonstrated that a regimen of AML to which HCZ is subsequently added provides superior tolerability and less bother to patients when compared with a regimen of HCZ to which AML is added as needed or with ab initio AML-HCZ combination therapy.
    VL  - 2
    IS  - 6
    ER  - 

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Author Information
  • Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, Ekpoma, Nigeria

  • Department of Pharmacology and Toxicology, Faculty of Pharmacy, University of Benin, Benin City, Nigeria

  • Department of Internal Medicine, College of Medical Sciences, University of Benin, Benin City, Nigeria

  • Department of Public Health and Primary Health Care, Central Hospital, Auchi, Nigeria

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