Advances in Therapy

, Volume 25, Issue 5, pp 399–411 | Cite as

Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy

  • Johannes Brachmann
  • Anwar Ansari
  • Gerhard Mahla
  • Renate Handrock
  • Sven Klebs
Original Research



The addition of an angiotensin II receptor blocker to calcium channel blocker-based antihypertensive therapy may be associated with enhanced efficacy and reduced risk of adverse events.


This 8-week, open-label, single-arm trial evaluated the efficacy and tolerability of the combination of amlodipine and valsartan in patients not responding adequately to treatment with amlodipine or felodipine alone. Patients aged ≥18 years with moderate essential hypertension (defined as mean sitting systolic blood pressure [MSSBP] ≥160 and <180 mmHg) were treated for 4 weeks with once-daily amlodipine 5 mg or felodipine 5 mg. At week 4, patients not adequately responding were treated for an additional 4 weeks with once-daily amlodipine 5 mg plus valsartan 160 mg. Of 214 patients treated for 4 weeks with amlodipine 5 mg or felodipine 5 mg, 181 failed to achieve MSSBP <140 mmHg. These non-responders were treated for an additional 4 weeks with amlodipine 5 mg and valsartan 160 mg.


A clinically and statistically significant additional reduction in MSSBP of 13.1 mmHg (95% confidence interval [CI]: 11.4, 14.7; P<0.0001) and a mean sitting diastolic blood pressure of 5.3 mmHg (95% CI: 4.3, 6.3; P<0.0001) were observed. Of patients treated with amlodipine 5 mg and valsartan 160 mg, 51.1% achieved target blood pressure levels (<140/90 mmHg) after 4 weeks. Adverse event rates were low in both treatment phases, and most were mild or moderate in severity.


The combination of amlodipine/valsartan was effective and well tolerated.


amlodipine angiotensin II receptor blockers calcium channel blockers combination therapy felodipine hypertension valsartan 


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Copyright information

© Springer Healthcare Communications 2008

Authors and Affiliations

  • Johannes Brachmann
    • 1
  • Anwar Ansari
    • 2
  • Gerhard Mahla
    • 3
  • Renate Handrock
    • 4
  • Sven Klebs
    • 4
  1. 1.Department of CardiologyKlinikum Coburg, II. Medizinische KlinikCoburgGermany
  2. 2.Practice for Internal MedicineEinbeckGermany
  3. 3.Practice for General MedicineFeldafingGermany
  4. 4.Clinical & Regulatory AffairsNovartis Pharma GmbHNurembergGermany

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