Slovak trial on cardiovascular risk reduction following national guidelines with CaDUET® (the STRONG DUET study).

Abstract

INTRODUCTION:

The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe.

METHODS:

This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk.

RESULTS:

Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe.

CONCLUSION:

Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.

• Authors: Jan Fedacko, Daniel Pella, Peter Jarcuska, Frantisek Sabol, Jan Kmec, Tomas Lopuchovsky, Lucia Merkovska, Lucia Jedlickova, Martin Janicko, Matej Sajty
• Journal: Advances in therapy (Adv Ther) Vol. 30 Issue 1 Pg. 60-70 (Jan 2013) ISSN: 1865-8652 [Electronic] United States
• PMID: 23328937 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• Drug Combinations
• Heptanoic Acids
• Hypolipidemic Agents
• Pyrroles
• amlodipine, atorvastatin drug combination
• Amlodipine

Topics

• Aged
• Amlodipine (therapeutic use)
• Antihypertensive Agents (therapeutic use)
• Cardiovascular Diseases (prevention & control)
• Drug Combinations
• Female
• Heptanoic Acids (therapeutic use)
• Humans
• Hyperlipidemias (drug therapy)
• Hypertension (drug therapy)
• Hypolipidemic Agents (therapeutic use)
• Male
• Middle Aged
• Pyrroles (therapeutic use)
• Risk Factors
• Slovakia
• Treatment Outcome