טיפול בBNP, סיפור הצלחה? (ללא צבע וללא תמונות, כדי להקטין את הקובץ)

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טיפול בBNP, סיפור הצלחה? (ללא צבע וללא תמונות, כדי להקטין את הקובץ)

רקע תרופה אשר מחקה פעולה פיזיולוגית של ה-BNP האנדוגני, המופרש מתאי אנדותל באופן פיזיולוגי ( מנגנון הפעולה מ-RX LIST: Human BNP binds to the particulate guanylate cyclase receptor of vascular smooth muscle and endothelial cells, leading to increased intracellular concentrations of guanosine 3'5'-cyclic monophosphate (cGMP) and smooth muscle cell relaxation. Cyclic GMP serves as a second messenger to dilate veins and arteries. Nesiritide has been shown to relax isolated human arterial and venous tissue preparations that were precontracted with either endothelin-1 or the alpha-adrenergic agonist, phenylephrine. In human studies, nesiritide produced dose-dependent reductions in pulmonary capillary wedge pressure (PCWP) and systemic arterial pressure in patients with heart failure.

עוד מ-RX Natrecor® (nesiritide) is a sterile, purified preparation of a new drug class, human B-type natriuretic peptide (hBNP), and is manufactured from E. coli using recombinant DNA technology. Nesiritide has a molecular weight of 3464 g/mol and an empirical formula of C143H244N50O42S4. Nesiritide has the same 32 amino acid sequence as the endogenous peptide, which is produced by the ventricular myocardium.

BNP- מדד מעבדתי חשוב בהערכת החולה ב-CHF בעת אס"ק לב והחמרתה, ה-BNP משוחרר ברמות גבוהות מחדר שמאל... כאן תבחרי אם תרצי להגיד משהו על מדידת ה- BNP בתהליך האבחנה והערכת החולה. אפשר להכניס את המאמר החדש מה-NEJM

טיפול ב-NESIRITIDE אפשר להתחיל מהסוף של הסיפור. זו דוגמא של קמפיין של חברת תרופות, שנגמר באזהרה של ה- FDA: האזהרה די מסכמת את הכול...

המחקר שהביא לאישור התרופה- VMAC: Intravenous Nesiritide vs. Nitroglycerin for Treatment of Decompensated Congestive Heart Failure, a Randomized Controlled Trial (JAMA 2002). מחקר RCT, double-blinded ב-489 חולים. המחקר הראה יתרון לתרופה, לעומת NTG ו/או פלצבו, בטיפול בחולי CHF, המאושפזים עם הידרדרות אקוטית. היתרון הוא במצב ההמודינמי (מדידת PCWP) ובתלונות החולים (קוצר נשימה) לאחר 3 שעות. הטיפול ניתן במקביל לתרופות נוספות! אבל (מתוך האזהרה-) In VMAC, the serum creatinine rose by more than 0.5 mg/dL above baseline in at least one blood draw in 7% of patients in the control groups and 8% in the nesiritide groups by 5 days, and by 21% and 28% respectively, by 30 days. Most of these increases occurred days after discontinuation of the drug.

עוד בעד: עוד בשנת 2000, ה-NEJM פרסם את INTRAVENOUS NESIRITIDE, A NATRIURETIC PEPTIDE, IN THE TREATMENT OF DECOMPENSATED CONGESTIVE HEART FAILURE כאן מדובר במחקר רנדומאלי של 432 חולים בדקומפנסציה של CHF. חולקו ל-2 קבוצות: 1. הקבוצה של ה- Efficacy(127 חולים), בהם היה צורך בניטור Swan-Ganz, וטיפול למשך 6 שעות 2. קבוצת ה-Comparative (305), כאן ניתן טיפול ללא ניטור חודרני למשך של עד 7 ימים. בשתי הקבוצות התרופה הפחיתה תחושת קוצר נשימה וחולשה כללית, באופן תלוי מינון ומשמעותי לעומת פלצבו. בקבוצה הראשונה נמדדה גם ירידה ב- PCWP.

טיפול מקובל בסקירה של ה-NEJM מ-2003: “Medical Progress- Heart Failure”, הוכנסה ההמלצה לטיפול ב-NESIRITIDE כטיפול ב- Stage C של אס"ק לב, כאשר תפקידו בהורדת Preload וגם Afterload.

אבל... אפשר להכניס כאן את האזהרות של ה-FDA אולי...או להתחיל במאמרים שמדברים על סיכון השימוש בתרופה. אני אקצר לך אותם בשקופיות הבאות

JAMA 2005 Short-term Risk of Death After Treatment With Nesiritide for Decompensated Heart Failure