Chelation therapy involves oral administration, intravenous infusion or intramuscular injection of drugs that increase excretion of heavy metals. The Medical Letter’s last article on this subject found no evidence that it was effective for treatment of cardiovascular disease. Since then, off-label use of chelation therapy has expanded to include treating children with autism and adults with Alzheimer’s disease, cancer and other chronic diseases.

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Clevidipine (Cleviprex - The Medicines Company), a dihydropyridine calcium channel blocker (CCB), has been approved by the FDA for intravenous (IV) use in lowering high blood pressure. It is the second IV CCB to be marketed in the US; nicardipine has been available in an IV formulation (Cardene IV) for more than 10 years. Like IV nicardipine, clevidipine will probably be used mainly for urgent treatment of hypertension in intensive care units, operating rooms and emergency departments.

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.

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.

Many patients ask their healthcare providers whether they should take vitamins. Since the last Medical Letter article on this subject, more data have become available on the benefits and risks of taking vitamins.

Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid, will soon be marketed in the USA as (Ciba-Geigy), an oral drug for dissolution of gallbladder stones. The labeling for the drug, which has been available in other countries for the past ten years, will restrict its use to dissolution of radiolucent, noncalcified gallbladder stones less than 20 mm in diameter in patients who have refused or are at increased risk from surgery.

Sevelamer carbonate (Renvela – Genzyme), a buffered form of the anion-exchange resin sevelamer hydrochloride (Renagel – Genzyme),1 has been approved by the FDA for use in patients with chronic kidney disease on dialysis. According to the manufacturer, Renvela will replace Renagel, which has been shown to induce or exacerbate metabolic acidosis in patients on dialysis. Two randomized, crossover studies found the two sevelamer salts equivalent in their ability to lower serum phosphate.2,3 Patients taking the carbonate had higher serum bicarbonate concentrations and fewer gastrointestinal...

Several recent case reports suggest that oral sildenafil may be effective for treatment of pulmonary arterial hypertension (PAH). Sildenafil is currently marketed as Viagra for treatment of erectile dysfunction (Medical Letter 1998; 40:51).

The FDA has approved the sodium/hydrogen exchanger 3 (NHE3) inhibitor tenapanor (Xphozah – Ardelyx) to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy when phosphate binders are ineffective or as monotherapy when phosphate binders cannot be tolerated. Tenapanor is the first NHE3 inhibitor to be approved in the US for hyperphosphatemia. It was previously approved as Ibsrela to treat irritable bowel syndrome with constipation (IBS-C).

Isosorbide mononitrate (ISMN; Ismo - Wyeth-Ayerst), an oral nitrate long available in Europe, was recently approved by the US Food and Drug Administration for prophylactic use in patients with chronic stable angina. ISMN is the major active metabolite of isosorbide dinitrate (ISDN; Isordil, and others).