in the US and their dosages, adverse effects, and costs are listed in the tables. Treatment of hypertensive urgencies and emergencies is not discussed here.

Heart failure is usually associated with left ventricular dysfunction. According to recent guidelines, patients with a left ventricular ejection fraction (LVEF) ≤40% are considered to have heart failure with reduced ejection fraction (HFrEF) or systolic heart failure. Patients with a LVEF ≥50% and symptoms of heart failure are considered to have heart failure with preserved ejection fraction (HFpEF) or diastolic heart failure; there is little evidence that drug treatment improves clinical outcomes in these patients. The treatment of acute heart failure is not included here.

A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in 8606 patients with type 2 diabetes and renal impairment (ALTITUDE) was terminated prematurely by the manufacturer because the combined incidence of cardiovascular and renal events was higher in patients who received aliskiren than in those who received placebo.1

Combining two different types of drugs that block the renin angiotensin system in patients at high-risk for cardiovascular and renal events has been studied previously. Use of both the ACE inhibitor ramipril (Altace, and others) and the ARB telmisartan (Micardis) in hypertensive patients with diabetes or vascular disease (ONTARGET) did not improve cardiovascular or renal outcomes compared to use of either drug alone, and patients treated with both drugs had more hypotensive symptoms, syncope and renal dysfunction.2

Aliskiren is available alone (Tekturna) and in fixed-dose combinations with hydrochlorothiazide (Tekturna HCT), the calcium channel blocker amlodipine (Tekamlo), both hydrochorothiazide and amlodipine (Amturnide) and the ARB valsartan (Valturna) for treatment of hypertension.3 None of these products has been shown to improve clinical outcomes. Novartis is advising prescribers not to use aliskiren-containing products with an ACE inhibitor or an ARB in patients with diabetes.

1. Novartis.Novartis announces termination of ALTITUDE study with Rasilez/Tekturna in high-risk patients with diabetes and renal impairment. Available at www.novartis.com/newsroom/rasileztekturna-information-center/index.shtml. Accessed January 17, 2012.

2. S Yusuf et al. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med 2008; 358:1547.

3. Aliskiren/valsartan (Valturna) for hypertension. Med Lett Drugs Ther 2009; 51:94.

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The FDA has approved Tekamlo (Novartis), an oral fixed-dose combination of the direct renin inhibitor aliskiren (Tekturna) and the calcium channel blocker amlodipine (Norvasc, and others), for treatment of hypertension in patients not adequately controlled on monotherapy or already taking both drugs, and as initial therapy in those likely to need multiple drugs to control their blood pressure (BP). Both aliskiren and amlodipine are available in combinations with other antihypertensive agents.

The FDA has approved the use of aliskiren (Tekturna), a direct renin inhibitor, with valsartan (Diovan), an angiotensin-receptor blocker (ARB), in a fixed-dose combination as Valturna (Novartis) for treatment of hypertension in patients already taking both drugs or not adequately controlled on monotherapy, and as initial therapy in those likely to need multiple drugs to control their blood pressure.

Aliskiren (Tekturna - Novartis), the first direct renin inhibitor for treatment of hypertension, has been approved for use in a fixed-dose combination with the diuretic hydrochlorothiazide (Tekturna HCT - Novartis). Many angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are also available in fixed-dose combinations with hydrochlorothiazide (HCTZ).