Planep在国内上市了吗？

The FDA (U.S. Food and Drug Administration) has approved it for use in stable patients with poor left ventricular systolic dysfunction (ejection fraction <40%) and congestive heart failure after acute myocardial infarction (MI) to improve survival rates. Planep is the first aldosterone receptor blocker approved for this indication. The FDA's approval was based on the results of the EPHESUS (Planep Efficacy and Survival Study in Heart Failure After Acute Myocardial Infarction) trial. For heart failure patients after myocardial infarction, Planep plus standard treatment can reduce mortality by 15% compared with placebo and standard treatment (ACE inhibitors and β-blockers). Planep was developed by Pfizer of the United States and was first launched in the United States in 2002. It is mainly used clinically to treat hypertension. In 2003, the FDA approved it for the treatment of heart failure after acute myocardial infarction.

Planep Precautions 1. Liver damage: Use with caution in patients with moderate to severe liver damage; 2. Kidney damage: As kidney function declines, the risk of hyperkalemia increases. Use with caution in patients with mild renal impairment; may be disabled based on indications and degree of impairment; 3. Drug-drug interactions: Significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapies; 4. Potassium supplements: Avoid potassium supplements, potassium-containing salt substitutes, potassium-rich diets, or other drugs that may cause hyperkalemia (such as other potassium-sparing diuretics, nonsteroidal anti-inflammatory drugs). Concomitant use of potassium supplements or potassium-sparing diuretics is contraindicated in the treatment of hypertension. 5. Pregnancy: Untreated hypertension and heart failure are both associated with adverse pregnancy outcomes. It is not recommended to use mineralocorticoid receptor antagonists to treat chronic simple hypertension in pregnant women, and should generally be avoided in women of reproductive potential; 6. Diabetes: Use with caution in patients with diabetes and heart failure after myocardial infarction (especially those with proteinuria); the risk of hyperkalemia is increased.