The FDA has approved Synjardy (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) and metformin (Glucophage, and others), for treatment of patients with type 2 diabetes not adequately controlled on either of these drugs alone or already being treated with both empagliflozin and metformin. It is the third SGLT2 inhibitor/metformin combination to be approved in the US.

The FDA has approved Juluca (ViiV Healthcare/Janssen), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (Edurant), as a once-daily complete regimen for treatment of adults with HIV-1 infection who do not have a history of treatment failure or known substitutions associated with resistance to either drug and have been taking a stable suppressive antiretroviral regimen for ≥6 months. Dolutegravir/rilpivirine is the first complete regimen to be approved for...

Insulin detemir (Levemir - Novo Nordisk) is the second long-acting basal insulin analog to be marketed in the US for treatment of both type 1 and type 2 diabetes. Detemir differs from human insulin by the elimination of the amino acid threonine in position B30 and the addition of a 14-carbon fatty acid chain at position B29. Insulin glargine (Lantus), the first long-acting insulin analog, has been available since 2001 and is usually given once daily.1 NPH insulin is an intermediate-acting basal insulin given twice daily. Basal insulins are usually combined with prandial doses of a rapid-acting...

Saxagliptin (Onglyza - Bristol-Myers Squibb), the second oral dipeptidyl peptidase-4 (DPP-4) inhibitor to be marketed in the US, has been approved by the FDA for treatment of adults with type 2 diabetes.

Most experts agree that lifestyle modifications and metformin (Glucophage, and others) should be used first to treat patients with type 2 diabetes. If metformin alone fails to control hyperglycemia, there is no general agreement on which drug should be added next. A recent article in The Medical Letter offered some support for a sulfonylurea. Three recent trials published in The Lancet favored the long-acting basal insulin glargine, the glucagon-like peptide (GLP-1) analog exenatide, and the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, respectively. Some of the advantages...

An oral formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk) has been approved by the FDA for once-daily treatment of type 2 diabetes in adults. Semaglutide, which has been available in a subcutaneously-injected formulation (Ozempic) since 2017, is the first GLP-1 receptor agonist to become available for oral administration; the 4 other GLP-1 receptor agonists currently available in the US are administered by subcutaneous (SC) injection.

Glimepiride (Amaryl - Hoechst Marion Roussel), a new sulfonylurea similar to glyburide and glipizide (Medical Letter, 26:79, 1984), was recently marketed for treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not controlled by diet and exercise. The new drug is the first sulfonylurea approved by the US Food and Drug Administration (FDA) for use concurrently with insulin.

Exenatide injection (Byetta - Amylin/Lilly), a synthetic peptide that stimulates release of insulin from pancreatic beta cells, has been approved by the FDA as adjunctive therapy for patients with type 2 diabetes who have not achieved optimal glycemic control on metformin (Glucophage, and others), a sulfonylurea, such as glyburide (DiaBeta, and others), or both. Exenatide is not indicated for use with insulin.

Oxymorphone hydrochloride, a semi-synthetic opioid agonist, has been available for many years in the US as Numorphan (Endo) for parenteral use and as a rectal suppository. Now it has been approved by the FDA for oral administration as an immediate-release (IR) tablet (Opana) for treatment of moderate to severe acute pain, and as an extended-release tablet (Opana ER) for treatment of moderate to severe pain in patients requiring continuous opioid treatment for an extended period of time.

Proton pump inhibitors (PPIs), which are used for treatment of gastroesophageal reflux disease (GERD) and for prevention of upper gastrointestinal adverse effects caused by NSAIDs and aspirin, are one of the most commonly prescribed classes of drugs in the US. All PPIs are similarly effective and generally well tolerated, but their long-term use has been associated with a number of safety concerns. Recommendations addressing these concerns have recently been published.