Single-pill combinations: a therapeutic option or necessity for vascular risk treatment?

Accepted: 30 April 2013; published online: 28 May 2013 Citation: J Drug Assess 2013; 2:67–71 In a recently published paper in the Journal of Drug Assessment, Axthelm et al. reported on the effectiveness of single-pill combination (SPC) aliskiren 300 mg/ amlodipine 10 mg in high-risk subgroups of hypertensive patients with uncontrolled blood pressure (BP). Briefly, 4-week’s treatment with SPC aliskiren 300 mg/amlodipine 10 mg resulted in further lowering of both systolic and diastolic BP in elderly ( 65 years), overweight/obese (body mass index 25 kg/m) and diabetic patients as well as individuals with at least one metabolic risk factor (i.e., serum glucose 5.56 mmol/l, low density lipoprotein cholesterol 4.16 mmol/l or triglycerides 2.28 mmol/l) that were inadequately controlled by prior use of SPC olmesartan 40 mg/amlodipine 10 mg. The efficacy and safety of aliskiren/amlodipine SPCs in patients previously on either drug monotherapy were also reported in earlier studies. Of note, adverse effects such as peripheral edema as well as discontinuation rates were fewer in the SPC groups. Cardiovascular disease (CVD) represents the main cause of death worldwide and thus research still focuses on potential genetic and physiological biomarkers, imaging techniques, healthcare technologies and indices for both CVD prevention and treatment as well as personalized prediction models. There are several CVD risk factors, including hypertension, dyslipidemia, diabetes mellitus (DM), smoking and obesity, as well as platelet dysfunction. Certain drugs are currently available for treating these risk factors, whereas drug combinations are frequently needed to achieve therapeutic goals especially in hypertension, DM and coronary heart disease (CHD). W th regard to hypertension, the 2009 reappraisal of the European guidelines (European Society of Cardiology/European Society of Hypertension) recommends the use of a renin–angiotensin–aldosterone system (RAAS) blocker plus calcium channel blocker (CCB) or RAAS blocker plus diuretic or CCB plus diuretic as possible two-drug combination therapies. Such combinations are available as SPCs. For example, the first SPC of an angiotensin receptor blocker (ARB) and a CCB was valsartan plus amlodipine which, apart from achieving better efficacy than each component, was also shown to significantly decrease the risk of edema, a frequent side-effect of dihydropyridine CCBs. Similarly, olmesartan has been combined with either amlodipine or hydrochlorothiazide in SPCs, as is the case with telmisartan, losartan, irbesartan, candesartan and aliskiren (a direct renin antagonist). Perindopril, an angiotensin converting enzyme (ACE) inhibitor, and amlodipine SPC can be also used to adequately treat hypertensives, whereas perindopril/indapamide fixed-dose combination is effective in reducing both macroand micro-vascular diabetic complications. Another therapeutic option is SPCs of benazepril (ACE inhibitor) plus amlodipine or hydrochlorothiazide; the former combination decreased the progression of chronic kidney disease to a