The FDA has approved Soaanz (Sarfez), a new formulation of the loop diuretic torsemide, for treatment of edema associated with heart failure or renal disease in adults. Torsemide has been available generically for years for treatment of hypertension and treatment of edema due to heart failure, renal disease, or hepatic disease. According to the manufacturer, Soaanz tablets are formulated to provide a gradual and sustained diuresis, lowering the risk of excessive urination and hypokalemia.

The FDA has approved the dual endothelin receptor antagonist aprocitentan (Tryvio – Idorsia) for use in combination with other antihypertensive drugs to treat hypertension in adults whose blood pressure is not adequately controlled on other drugs. Three other dual endothelin receptor antagonists, ambrisentan (Volibris, and generics), bosentan (Tracleer, and generics), and macitentan (Opsumit), are available in the US for treatment of pulmonary arterial hypertension.

American College of Cardiology/American Heart Association (ACC/AHA) guidelines for treatment of hypertension were last published in 2018. Treatment of hypertensive urgencies and emergencies is not discussed here.

The FDA has required the addition of information about an increased risk of nonmelanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) to the labels of products containing the diuretic hydrochlorothiazide.

Drugs available for treatment of chronic hypertension and their dosages, adverse effects, and costs are listed in the tables. Treatment of hypertensive urgencies and emergencies is not discussed here.

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.

The FDA has approved Byvalson (Allergan), a fixed-dose combination of the beta blocker nebivolol (Bystolic) and the angiotensin receptor blocker (ARB) valsartan (Diovan, and generics), for treatment of hypertension. It is the only combination product that contains nebivolol, and the first to combine a beta blocker with an ARB.

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.

Breaking drug tablets in half is a common practice. Since our last article on this subject, some new data have become available.

Drugs available in the US for treatment of chronic hypertension, with their dosages and adverse effects, are listed in the tables that begin on page 2. Combination products are listed on page 8. Drugs for treatment of hypertensive emergencies are not discussed here. They were reviewed previously.

The FDA has approved aliskiren/amlodipine/hydrochlorothiazide (Amturnide) for treatment of hypertension, with no restrictions except that it should not be used for initial therapy. A combination of the direct renin inhibitor aliskiren and the calcium channel blocker amlodipine (Tekamlo) was approved earlier for initial treatment.1

Use of combination tablets is, of course, more convenient than taking the components separately, and as long as all the same doses are available and the cost is no greater, there is no reason not to use them.

Aliskiren alone or in combination has not been shown to improve clinical outcomes.2 Whether it offers any advantage over the angiotensin receptor blockers (ARBs), which are also available in various antihypertensive combinations, remains to be determined.

1. Aliskiren/amlodipine (Tekamlo): another combination tablet for hypertension. Med Lett Drugs Ther 2010; 52:94.

2. Drugs for hypertension. Treat Guidel Med Lett 2009; 7:1.

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Many patients with hypertension require more than one drug to control their blood pressure. Tribenzor (Daiichi Sankyo), recently approved by the FDA for treatment of hypertension, combines the calcium channel blocker amlodipine (Norvasc, and others), the angiotensin receptor blocker (ARB) olmesartan (Benicar)and the most commonly prescribed diuretic, hydrochlorothiazide (HCTZ). Tribenzor is not approved for initial therapy, but is recommended for patients not adequately controlled on any 2-drug combination of a calcium channel blocker, an ARB or a diuretic.

Readers have asked us to update our 2004 article on tablet splitting. Breaking drug tablets in half is a common practice, but the FDA recently advised consumers against it (FDA Consumer Health Information, July 2009).

Most patients with hypertension require more than one drug to control their blood pressure. Exforge HCT (Novartis) is a new 3-drug fixed-dose combination tablet approved by the FDA for treatment of hypertension. It combines the calcium-channel blocker amlodipine (Norvasc, and others) and the angiotensin receptor blocker (ARB) valsartan (Diovan), which are already available in a combination tablet (Exforge), with the most commonly prescribed diuretic hydrochlorothiazide (HCTZ). Exforge HCT is not approved for initial treatment of hypertension, but rather for patients not adequately controlled on a 2-drug combination of a calcium-channel blocker, an ARB or a diuretic. It can also be substituted for amlodipine, valsartan and HCTZ in patients already taking all 3 of these drugs.

Effective treatment of hypertension can prevent organ damage and death. The choice of drugs for initial treatment continues to be controversial.

Drugs available in the US for treatment of chronic hypertension, with their dosages, adverse effects and costs, are listed in the tables that begin on page 2. Combination products are listed on page 9. Drugs for treatment of hypertensive emergencies are not discussed here. They were reviewed in Treatment Guidelines (volume 1, page 19, December 2002) and in The Medical Letter (volume 50, page 73, September 22, 2008).

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).

Drugs available in the US for treatment of chronic hypertension, with their dosages, adverse effects and costs, are listed in the tables that begin on page 40. Combination products are listed on page 47. Drugs for treatment of hypertensive emergencies are not discussed here.

Breaking drug tablets in half is a common practice. In some cases, a lower drug dose may be as effective as a higher one, with fewer adverse effects. Sometimes tablets are split to achieve an intermediate dose between marketed strengths. When 2 tablet sizes cost the same, as they often do, splitting the larger size saves money. Is this a reasonable practice?

The importance of adequate control of hypertension in preventing organ damage and death is well established, but the choice of drugs is still controversial. Three recent drug trials, one supporting initial therapy with a diuretic, the second favoring an angiotensin converting enzyme (ACE) inhibitor, and the third showing equivalence between a calcium-channel blocker and an angiotensin-receptor blocker (ARB) have intensified the debate.

Drugs available in the US for treatment of chronic hypertension, with their dosages, adverse effects and costs, are listed in the table that begins on page 35. Combination products are listed on page 39. Drugs for treatment of hypertensive emergencies were discussed in Treatment Guidelines volume 1, issue 4, page 19, December 2002.

Olmesartan medoxomil (Benicar - Sankyo), a substituted imidazole, is the seventh oral angiotensin II receptor blocker (ARB) approved by the FDA for treatment of hypertension.

Drugs available in the USA for treatment of chronic hypertension, their dosages and adverse affects are listed in the table and discussed in the text.

Perindopril, the tenth angiotensin converting enzyme (ACE) inhibitor to be marketed in the USA, and telmisartan and eprosartan, the fifth and sixth angiotensin receptor blockers, have recently become available for treatment of hypertension.

Drugs available in the USA for treatment of chronic hypertension, their dosages and adverse affects are listed in the table and discussed in the text.

Candesartan cilexetil (Atacand - Astra) is the fourth angiotensin II receptor antagonist to become available in the USA for oral treatment of hypertension.

Nisoldipine (Sular -Zeneca), a dihydropyridine calcium-channel blocker structurally similar to nifedipine, has been approved for marketing by the US Food and Drug Administration. It is available in an oral extended-release formulation for treatment of hypertension.

Moexipril hydrochloride (Univasc - Schwarz Pharma), an angiotensin-converting enzyme (ACE) inhibitor, was recently approved by the US Food and Drug Administration (FDA) for treatment of. It is the eighth ACE inhibitor to be marketed in the USA.

Torsemide, a new loop diuretic similar in action to bumetanide (Bumex) and furosemide, was recently approved by the US Food and Drug Administration for treatment of edema due to congestive heart failure, renal disease, or hepatic disease and also for treatment of hypertension. It is available for both oral and intravenous use.

Doxazosin (mesylate - Roerig), an alpha1-adrenergic receptor blocker similar to prazosin (Minipress, and others) and terazosin (Hytrin), was recently approved by the US Food and Drug Administration for treatment of hypertension.

Some commonly used systemic drugs that may cause pulmonary toxicity are listed in the table below. These adverse effects may sometimes be difficult to distinguish from the underlying disease (JAD Cooper, Jr et al, Am Rev Respir Dis, 133:321, 488, 1986). Pulmonary effects that are part of a generalized reaction or are indirect effects of drugs - on respiratory muscles, for example, or on the immune system - are not included here.

Fluconazole (Diflucan - Roerig), an antifungal azole, was recently approved by the US Food and Drug Administration for oral and intravenous (IV) treatment of cryptococcal meningitis and various forms of candidiasis. Both cryptococcal meningitis and candidiasis occur frequently in patients with AIDS, organ transplants, or cancer.

Recent advertisements for indapamide (Lozol - Rorer), an oral antihypertensive/diuretic (Medical Letter, 26:17, 1984), claim that the drug, unlike thiazide diuretics, does not significantly increase serum cholesterol and has a minimal impact on potassium. Indapamide has no thiazide ring but, like chlorthalidone (Hygroton; and others) and hydrochlorothiazide (HydroDiuril; and others), it does have a sulfamoyl benzamide moiety, which is probably responsible for its natriuretic and diuretic effects. Unlike the thiazides, it also has a methylindoline moiety, which apparently decreases peripheral resistance.

Nicardipine (Cardene - Syntex), a dihydropyridine calcium-entry blocker structurally related to nifedipine (Procardia; Adalat), was recently approved by the US Food and Drug Administration for oral treatment of angina and hypertension. Advertisements for the drug claim that nicardipine is more vasoselective; than other calcium-channel blockers and does not depress myocardial contractility.

Microx (Pennwalt), a new low-dosage formulation of the thiazide-type diuretic metolazone (Zaroxolyn; Diulo), was recently marketed in the USA. The manufacturer claims that the low dose of controls hypertension with less potassium loss, making it safer than other diuretics and as effective as combination drugs, such as Dyazide, that include both a thiazide and a potassium-sparing diuretic. Medical Letter consultants generally do not recommend Dyazide or other fixed-dose combinations for treatment of hypertension.

- Merck; Zestril - Stuart), a new angiotensin-converting enzyme (ACE) inhibitor, was recently approved by the US Food and Drug Administration (FDA) for once-daily treatment of . Two other ACE inhibitors, captopril (Capoten - Squibb) and e