EFFICACY OF FIX DOSE COMBINATION (ATORVASTATIN AND AMLODIPINE) IN TREATMENT OF UNCONTROLLED HYPERTENSION AND DYSLIPIDEMIA

Authors

  • Saira Bashir
  • Misbah Ul Islam Khan Sherwani
  • Iffat Shabbir
  • Asia Batool

Abstract

Background: The fixed-dose combination containing the antihypertensive agent amlodipine and thestatin, atorvastatin, is the first combination of its kind designed to treat two risk factors forcardiovascular disease (CVD), i.e., hypertension and dyslipidemia. In this study, blood pressure andlipid lowering effects of combination of amlodipine and atorvastatin were evaluated in uncontrolledhypertensive patients. Methods: Thirty patients both male and female in the age group 35–60 yearsattending the Hypertensive Clinic of PMRC FJMC suffering from uncontrolled hypertension wereselected. Baseline blood pressure was checked after half hour rest in sitting and standing position usingmercury sphygmomanometer. Blood sample was collected from all patients after overnight fasting forassessment of serum cholesterol, triglycerides, LDL and HDL cholesterol levels. They were prescribedwith fixed dose combination of 5 mg amlodipine and 10 mg atorvastatin. Patients were followed fortheir blood pressure measurement after every 4 weeks up to 12 weeks. At the end of 12 weeks theirfasting blood sample was taken again for determination of serum cholesterol, triglyceride, LDL andHDL cholesterol levels. Results: Systolic blood pressure after 4, 8 and 12 weeks was significantlylower at all intervals from baseline. When systolic blood pressure after 8 and 12 weeks was comparedwith 4 weeks, the effect was again significant (p=0.024, p=0.002 respectively).There was no significantreduction seen in 8 versus 12 weeks (p=0.493). Diastolic blood pressure at 4, 8 and 12 weeks wassignificantly lower from baseline. Diastolic blood pressure after 4 and 8 weeks when compared with 8and 12 weeks was not significantly low (p=0.99 and 0.91 respectively). Lipid profile of the patients wassignificantly reduced from baseline after twelve weeks of fixed dose combination of treatment(p<0.000). Conclusion: Combination therapy proved to be effective in controlling hypertension anddyslipidemia than single pill. It also improved patient’s compliance. It is suggested that polypill shouldbe prescribed instead of multiple drugs.Keywords: combination therapy, atorvastatin, amlodipine, uncontrolled hypertension, dyslipidemia

References

Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, et

al. Heart disease and stroke statistics —2008 update: a report from

the American Heart Association Statistics Committee and Stroke

Statistics Subcommittee. Circulation 2008;117(4):e25–e146.

Volpe M, Alderman MH, Furberg CD, Jackson R, Kostis JB,

Laragh JH, et al. Beyond hypertension toward guidelines for

cardiovascular risk reduction Am J Hypertens 2004;17(11 Pt-

:1068–74.

National Center for Health Statistics Report. Feb 24, 2008.

Accessed on Jan 10, 2009. Available from: http://www.cdc.gov/

nchs

Iqbal SP, Dodani S, Qureshi R. Risk factors and behaviors for

coronary artery disease (CAD) among ambulatory Pakistanis. J

Pak Med Assoc 2004;54:261–6.

Heart Protection Study Collaborative Group. MRC/BHF Heart

Protection Study of cholesterol lowering with simvastatin in

,536 high-risk individuals: a randomised placebo-controlled

trial. Lancet 2002;360(9326):7–22.

Sever PS, Dahlof B, Poulter NR, Wedel H, Beevers G, Caulfield

M, et al. Prevention of coronary and stroke events with

atorvastatin in hypertensive patients who have average or lowerthan-average cholesterol concentrations, in the AngloScandinavian Cardiac Outcomes Trial–Lipid Lowering Arm

(ASCOT-LLA): a multicentre randomised controlled trial. Lancet

;361(9364):1149–58.

Turnbull F. Effects of different blood-pressure-lowering

regimens on major cardiovascular events: results of

prospectively-designed overviews of randomised trials. Lancet

;362(9395):1527–35.

Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil

HA, Livingstone SJ, et al. Primary prevention of cardiovascular

disease with atorvastatin in type 2 diabetes in the Collaborative

Atorvastatin Diabetes Study (CARDS): multicentre randomised

placebo-controlled trial. Lancet 2004;364(9435):685–96.

Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S,

Hansson L et al. Outcomes in hypertensive patients at high

cardiovascular risk treated with regimens based on valsartan or

amlodipine: the VALUE randomised trial. Lancet

;363(9426):2022–31.

Blank R, LaSalle J, Reeves R, Maroni J, Tarasenko L, Sun F.

Single-pill therapy in the treatment of concomitant hypertension

and dyslipidemia (the amlodipine/atorvastatin gemini study). J

Clin Hypertens (Greenwich) 2005;7(5):264–73.

Chung M, Calcagni A, Glue P, Bramson C. Effect of food on the

bioavailability of amlodipine besylate/atorvastatin calcium

combination tablet. J Clin Pharmacol 2006;46(10):1212–6.

Preston RA, Harvey P, Herfert O, Dykstra G, Sun F, Maroni J, et

al. Reduction in Framingham cardiovascular risk with

concomitant treatment of hypertension/dyslipidemia with

amlodipine/atorvastatin. Am J Hypertens 2005;18:A226.

Messerli FH, Bakris GL, Ferrera D, Houston MC, Petrella RJ,

Flack JM, et al. Efficacy and safety of co-administered

amlodipine and atorvastatin in patients with hypertension and

dyslipidemia: results of the AVALON trial. J Clin Hypertens

(Greenwich) 2006;88:571–81; quiz 582–3.

Preston RA, Sun F, Tarasenko L. Safety and tolerability of coadministered amlodipine and atorvastatin in patients with

concomitant hypertension and dyslipidemia in the Respond

study. Am J Hypertens 2005;18:A92–3.

Devabhaktuni M, Bangalore S. Fixed combination of amlodipine

and atorvastatin in cardiovascular risk management: patient

perspectives. Vasc Health Risk Manag 2009;5:377–87.

Preston RA, Harvey P, Herfert O, Dykstra G, Jukema JW, Sun F,

et al. A randomized, placebo-controlled trial to evaluate the

J Ayub Med Coll Abbottabad 2011;23(3)

http://www.ayubmed.edu.pk/JAMC/23-3/Saira.pdf

efficacy, safety, and pharmacodynamic interaction of

coadministered amlodipine and atorvastatin in 1660 patients with

concomitant hypertension and dyslipidemia: the respond trial. J

Clin Pharmacol 2007;47:1555–69.

Hobbs FD, Gensini G, Mancini GB, Manolis AJ, Bauer B,

Böhler S, et al. Can combining different risk interventions into a

single formulation contribute to improved cardiovascular disease

risk reduction? Rationale and design for an international, openlabel program to assess the effectiveness of a single pill

(amlodipine/atorvastatin) to attain recommended target levels for

blood pressure and lipids (The JEWEL Program). Int J Cardiol

;110:242–50.

Blank R, LaSalle J, Reeves R, Maroni J, Tarasenko L, Sun F.

Single-pill therapy in the treatment of concomitant hypertension

and dyslipidemia (the amlodipine/atorvastatin gemini study). J

Clin Hypertens (Greenwich) 2005;7:264–73.

Published

2011-09-01