Sibeprenlimab (Voyxact – Otsuka), a subcutaneously injected cytokine A proliferation-inducing ligand (APRIL) blocker, has been granted accelerated approval by the FDA to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk for disease progression. Sibeprenlimab is the first APRIL blocker to be approved in the US. Atacicept (Trutakna), a B-lymphocyte stimulator and APRIL blocker, was recently granted accelerated FDA approval for the same indication; it will be reviewed in a future issue.

Polycystic ovary syndrome (PCOS), an endocrine abnormality characterized by hyperandrogenism and anovulation, affects 5-10% of women of reproductive age in the US. It is often accompanied by obesity and insulin resistance. In recent years, antidiabetic drugs, although not approved for such use by the FDA, have been tried for treatment of this disorder. This review describes the effectiveness of metformin and the thiazolidinediones in women with PCOS. Also included is a dosage and cost table for some insulin-sensitizing drugs.

BiDil (NitroMed), a fixed-dose combination of isosorbide dinitrate and hydralazine, was approved by the FDA for adjunctive use in the treatment of heart failure in black patients.Both drugs are oral vasodilators that have been used together off-label for many years to treat heart failure in patients not responding to other drugs.

View the Comparison Chart: Some Drugs for HFrEF

The FDA has approved a progestin-only oral contraceptive ("minipill") containing drospirenone (Slynd – Exeltis). All other progestin-only oral contraceptives available in the US contain norethindrone (Camila, and others). Progestin-only oral contraceptives are similar in efficacy to combination oral contraceptives. They are used predominantly by breastfeeding women and by those in whom estrogen is poorly tolerated or contraindicated. Combination oral contraceptives containing drospirenone and ethinyl estradiol have been available for years.

Finerenone (Kerendia – Bayer), an oral nonsteroidal mineralocorticoid receptor antagonist (MRA), has been approved by the FDA to reduce the risk of sustained eGFR decline, end-stage renal disease, nonfatal MI, hospitalization for heart failure (HF), and cardiovascular death in adults with chronic kidney disease (CKD) associated with type 2 diabetes. It is the first nonsteroidal MRA to be approved in the US.

Many commonly used drugs can interfere with sexual function in both men and women, causing loss of libido, interfering with erection or ejaculation in men, and delaying or preventing orgasm in women. Drug-related effects on sexual function may be difficult to distinguish from the effects of depression or disease, but most are reversible when drug use is stopped and sometimes when dosage is decreased. Since many patients are reluctant to talk about sexual difficulties, physicians may wish to ask about the possibility of drug-induced sexual dysfunction, particularly when they have...

A combination tablet containing estradiol and drospirenone (Angeliq - Berlex) recently became available for treatment of moderate to severe menopausal symptoms in women with an intact uterus. Since the last Medical Letter issue reviewing such devices,1 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 osilodrostat (Isturisa – Recordati), a cortisol synthesis inhibitor, for oral treatment of adults with Cushing's disease when surgical resection of the pituitary adenoma is not an option or has not been curative. Osilodrostat is the first cortisol synthesis inhibitor to be approved in the US for this indication. Other oral steroidogenesis inhibitors such as ketoconazole and metyrapone have been used off-label for this indication for many years.

The FDA has approved a combination oral contraceptive containing the estrogen estetrol and the progestin drospirenone (Nextstellis – Mithra/Mayne). Estetrol is the first new estrogen to become available in the US in 50 years. Drospirenone is available alone (Slynd) and in combinations with the estrogen ethinyl estradiol for prevention of pregnancy.