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Efficacy of amlodipine/olmesartan ± hydrochlorothiazide in patients uncontrolled on prior calcium channel blocker or angiotensin II receptor blocker monotherapy.
Adv Ther. 2012 Jun; 29(6):508-23.AT

Abstract

INTRODUCTION

While monotherapy is often recommended as initial treatment, most patients require dose escalation and add-on agents to achieve their blood pressure (BP) goal. This secondary analysis evaluated the efficacy and safety of initiating patients on a regimen of fixed-dose amlodipine (AML)/olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) who were uncontrolled on prior monotherapy with a calcium channel blocker (CCB) or angiotensin II receptor blocker (ARB).

METHODS

Patients uncontrolled on prior monotherapy with CCB or ARB therapy were initiated on AML/OM 5/20 mg and up-titrated every 4 weeks to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 + HCTZ 12.5 mg, and AML/OM 10/40 + HCTZ 25 mg. Patients were up-titrated to a higher AML/OM dose if mean seated cuff BP (SeBP) was ≥120/70 mmHg, and up-titrated to any HCTZ dose if mean SeBP was ≥125/75 mmHg. The primary efficacy endpoint was the cumulative proportion of patients achieving a seated cuff systolic BP (SeSBP) goal of <140 mmHg (<130 mmHg for patients with diabetes) after 12 weeks. Secondary endpoints included mean change from baseline in SeBP and ambulatory BP, ambulatory BP target achievement, and safety.

RESULTS

For the prior CCB (n = 118; baseline SeBP: 153.4/91.5 mmHg) and ARB (n = 237; 154.6/92.6 mmHg) groups, SeSBP goal achievement after 12 weeks was 72.7% and 76.9%, respectively. Mean changes (± SE) from baseline in SeBP were dose proportional for prior CCB and ARB patients, ranging from -9.9 (± 1.25)/-5.8 (± 0.83) mmHg and -13.9 (± 0.79)/-7.6 (± 0.47) mmHg at the AML/OM 5/20 mg dose, respectively, to -21.8 (± 1.68)/-11.6 (±.12) mmHg and -26.2 (± 1.31)/-15.0 (± 0.86) mmHg at the AML/OM 10/40 mg + HCTZ 25 mg dose (P < 0.0001 for all).

CONCLUSION

An AML/OM-based titration regimen was efficacious in achieving BP goal in patients uncontrolled on prior monotherapy with a CCB or ARB.

Authors+Show Affiliations

Department of Clinical Pharmacology, Orange County Research Center, Tustin, CA 92780, USA. jmneutel@aol.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22773358

Citation

Neutel, Joel, et al. "Efficacy of Amlodipine/olmesartan ± Hydrochlorothiazide in Patients Uncontrolled On Prior Calcium Channel Blocker or Angiotensin II Receptor Blocker Monotherapy." Advances in Therapy, vol. 29, no. 6, 2012, pp. 508-23.
Neutel J, Shojaee A, Maa JF. Efficacy of amlodipine/olmesartan ± hydrochlorothiazide in patients uncontrolled on prior calcium channel blocker or angiotensin II receptor blocker monotherapy. Adv Ther. 2012;29(6):508-23.
Neutel, J., Shojaee, A., & Maa, J. F. (2012). Efficacy of amlodipine/olmesartan ± hydrochlorothiazide in patients uncontrolled on prior calcium channel blocker or angiotensin II receptor blocker monotherapy. Advances in Therapy, 29(6), 508-23. https://doi.org/10.1007/s12325-012-0030-z
Neutel J, Shojaee A, Maa JF. Efficacy of Amlodipine/olmesartan ± Hydrochlorothiazide in Patients Uncontrolled On Prior Calcium Channel Blocker or Angiotensin II Receptor Blocker Monotherapy. Adv Ther. 2012;29(6):508-23. PubMed PMID: 22773358.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of amlodipine/olmesartan ± hydrochlorothiazide in patients uncontrolled on prior calcium channel blocker or angiotensin II receptor blocker monotherapy. AU - Neutel,Joel, AU - Shojaee,Ali, AU - Maa,Jen-Fue, Y1 - 2012/07/04/ PY - 2012/05/07/received PY - 2012/7/10/entrez PY - 2012/7/10/pubmed PY - 2012/12/10/medline SP - 508 EP - 23 JF - Advances in therapy JO - Adv Ther VL - 29 IS - 6 N2 - INTRODUCTION: While monotherapy is often recommended as initial treatment, most patients require dose escalation and add-on agents to achieve their blood pressure (BP) goal. This secondary analysis evaluated the efficacy and safety of initiating patients on a regimen of fixed-dose amlodipine (AML)/olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) who were uncontrolled on prior monotherapy with a calcium channel blocker (CCB) or angiotensin II receptor blocker (ARB). METHODS: Patients uncontrolled on prior monotherapy with CCB or ARB therapy were initiated on AML/OM 5/20 mg and up-titrated every 4 weeks to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 + HCTZ 12.5 mg, and AML/OM 10/40 + HCTZ 25 mg. Patients were up-titrated to a higher AML/OM dose if mean seated cuff BP (SeBP) was ≥120/70 mmHg, and up-titrated to any HCTZ dose if mean SeBP was ≥125/75 mmHg. The primary efficacy endpoint was the cumulative proportion of patients achieving a seated cuff systolic BP (SeSBP) goal of <140 mmHg (<130 mmHg for patients with diabetes) after 12 weeks. Secondary endpoints included mean change from baseline in SeBP and ambulatory BP, ambulatory BP target achievement, and safety. RESULTS: For the prior CCB (n = 118; baseline SeBP: 153.4/91.5 mmHg) and ARB (n = 237; 154.6/92.6 mmHg) groups, SeSBP goal achievement after 12 weeks was 72.7% and 76.9%, respectively. Mean changes (± SE) from baseline in SeBP were dose proportional for prior CCB and ARB patients, ranging from -9.9 (± 1.25)/-5.8 (± 0.83) mmHg and -13.9 (± 0.79)/-7.6 (± 0.47) mmHg at the AML/OM 5/20 mg dose, respectively, to -21.8 (± 1.68)/-11.6 (±.12) mmHg and -26.2 (± 1.31)/-15.0 (± 0.86) mmHg at the AML/OM 10/40 mg + HCTZ 25 mg dose (P < 0.0001 for all). CONCLUSION: An AML/OM-based titration regimen was efficacious in achieving BP goal in patients uncontrolled on prior monotherapy with a CCB or ARB. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/22773358/Efficacy_of_amlodipine/olmesartan_±_hydrochlorothiazide_in_patients_uncontrolled_on_prior_calcium_channel_blocker_or_angiotensin_II_receptor_blocker_monotherapy_ L2 - https://dx.doi.org/10.1007/s12325-012-0030-z DB - PRIME DP - Unbound Medicine ER -