The National Cholesterol Education Program recommends that LDL-C be lowered to less than 100 mg/dL (2.6 mmol/L) and considers a value <70 mg/dL (1.8 mmol/L) a reasonable goal for patients at very high risk.

The FDA has approved the marketing of pitavastatin (Livalo – Kowa), an HMG-CoA reductase inhibitor (“statin”), for treatment of primary hyperlipidemia or mixed dyslipidemia. It has been available in Japan since 2003. All of the statins now available in the US are listed in the table on page 58.

The text that follows reviews some common bacterial infections and their empiric treatment pending the results of culture and susceptibility testing. The recommendations made here are based on the results of susceptibility studies, clinical trials, and the opinions of Medical Letter reviewers. Tables 1 and 2 list the usual dosages of antibacterial drugs.

A recent report in the New England Journal of Medicine suggested that in children with bacterial meningitis, adding the corticosteroid dexamethasone (Decadron; and others) to antibiotic treatment could decrease the incidence of moderate or severe hearing loss.

Flutamide (Eulexin - Schering), an oral antiandrogen, is now available in the USA for treatment of metastatic prostate cancer. Flutamide is recommended by the manufacturer only for use concurrently with an analog of luteinizing hormone-releasing hormone (LHRH) such as leuprolide (Lupron - Medical Letter, 27:71, 1985).

The US Food and Drug Administration (FDA) has approved 'early access' use of riluzole (Rilutek - Rh ne-Poulenc Rorer) for treatment of amyotrophic lateral sclerosis (ALS). is the first drug to become available for treatment of this condition. The premarketing supply is limited; the manufacturer (1-800-798-7425) has enough on hand to treat 3,000 of the 25,000 patients with the disease in the USA, and those 3,000 have already been selected through a lottery. Similar arrangements have been made in several European countries. Riluzole is not available commercially in any country.

Topotecan hydrochloride (Hycamtin - SmithKline Beecham) was recently approved by the U.S. Food and Drug Administration for parenteral use as a single agent in patients with metastatic ovarian cancer refractory to other drugs. Initial treatment for metastatic ovarian cancer usually consists of cisplatin (Platinol) or carboplatin (Paraplatin) plus paclitaxel (Taxol) or cyclophosphamide (Cytoxan, and others).

Ceritinib (Zykadia – Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). It is the second tyrosine kinase inhibitor to be approved for ALK-positive metastatic NSCLC; crizotinib was the first. Translocations of the ALK gene are found in about 5% of lung cancers; they occur predominantly in nonsmokers with adenocarcinoma.

The FDA has approved Durlaza (New Haven Pharmaceuticals), a 24-hour extended-release (ER) aspirin formulation available only by prescription, for secondary prevention of myocardial infarction (MI) and stroke.

Monitoring adherence of psychiatric patients to oral medication may be especially difficult. The FDA has approved Abilify MyCite (Otsuka/Proteus), an aripiprazole tablet with an embedded sensor that tracks when patients take the medication. It is indicated for treatment of adults with schizophrenia, bipolar disorder, or major depressive disorder. Abilify MyCite is the first drug with a digital ingestion tracking system to be approved in the US.