The FDA has approved the marketing of Resperate (InterCure), a device that helps patients breathe slowly, as an adjunct for treatment of hypertension. The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.

The thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) are peripheral insulin sensitizing agents used to treat hyperglycemia in patients with type 2 diabetes; one or the other is often used as a second or third agent with metformin (Glucophage, and others) and/or a sulfonylurea such as glimepiride (Amaryl, and others). A recent report suggested that rosiglitazone may increase the incidence of myocardial infarction (MI) and cardiovascular mortality.

Sitagliptin phosphate (Januvia - Merck) is the first dipeptidyl-peptidase-4 (DPP-4) inhibitor to be marketed for treatment of type 2 diabetes. It has been approved by the FDA for oral use as monotherapy or in combination with metformin (Glucophage, and others), pioglitazone (Actos) or rosiglitazone (Avandia).

The FDA has approved Descovy (Gilead), a fixed-dose combination of the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine (FTC) and tenofovir alafenamide (TAF) for use with other antiretroviral agents for treatment of HIV-1 infection. A combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF; Truvada) has been available since 2004 for the same indication. Emtricitabine and TAF are also available in combination with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine as Odefsey and with the integrase strand transfer...

The FDA has approved nivolumab (Opdivo – BMS), an IV programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (and a BRAF inhibitor in patients who are BRAF V600 mutation positive) and for treatment of metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. It is the second PD-1 inhibitor to be marketed in the US after pembrolizumab (Keytruda), and the first to be approved for treatment of NSCLC.

The recent "PROVE IT" trial in patients with coronary heart disease showed clinical benefits associated with reducing LDL cholesterol concentrations lower than the 100 mg/dL (2.59 mmol/L) or less that had been considered optimal.

A variety of glucose monitoring devices have been used in an effort to reduce the hypoglycemia and wide glucose excursions that complicate insulin treatment of diabetes. Since the last Medical Letter issue reviewing such devices, more continuous glucose monitoring (CGM) systems have become available. Five devices available now, and two expected to be marketed soon, are listed in the table on page 14. The FDA has approved continuous glucose devices only for the observation of glucose trends.

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...

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy), which was approved by the FDA in 2021 for chronic weight management in adults, has now been approved for chronic weight management in children ≥12 years old with an initial BMI in the ≥95th percentile for age and sex.Semaglutide is also available as Ozempic and Rybelsus for treatment of type 2 diabetes in adults.

The FDA has approved Cabenuva (ViiV Healthcare), an extended-release formulation of the new integrase strand transfer inhibitor (INSTI) cabotegravir copackaged with an extended-release formulation of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine, as a once-monthly complete regimen for intramuscular (IM) treatment of adults with HIV-1 infection who are virologically suppressed (HIV-1 RNA...