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040			_aEG-GICUC _beng _cEG-GICUC _dEG-GICUC _erda
041	0		_aeng _beng _bara
049			_aDeposit
082	0	4	_a615.1
092			_a615.1 _221
097			_aM.Sc
099			_aCai01.08.08.Ph.D.2025.Ra.E
100	0		_aRabab Ahmed Mohamed, _epreparation.
245	1	0	_aEfficacy and safety of early initiation of canagliflozin in patients with acute decompensated heart failure / _cby Rabab Ahmed Mohamed ; Supervision Prof. Dr. Nirmeen Ahmed Sabry, Prof. Dr. Maggie Magdy Abbassi, Prof. Dr. Bassem Zarif Fouad.
246	1	5	_aفعالية وسلامة العلاج المبكر بدواء الكاناجليفلوزين في المرضي الذين يعانون من قصور القلب الحاد اللاتعويضي
264		0	_c2025.
300			_a131 pages : _billustrations ; _c25 cm. + _eCD.
336			_atext _2rda content
337			_aUnmediated _2rdamedia
338			_avolume _2rdacarrier
502			_aThesis (Ph.D)-Cairo University, 2025.
504			_aBibliography: pages 69-94.
520		3	_aBackground and Objectives: Initiating sodium-glucose cotransporter 2 inhibitor empagliflozin early in hospitalized acute decompensated heart failure (ADHF) patients was found to increase urine output and resulted in shorter hospital stays, a decrease in heart failure events (HFEs), and an improvement in health- related quality of life following hospital discharge. However, limited data is available related to the early initiation of canagliflozin in ADHF patients. This trial aims to investigate the effectiveness and safety of early initiation of canagliflozin within 24 hours of hospital admission, in comparison to empagliflozin, in patients with ADHF presenting with volume overload. Methods: This was a multicenter, prospective, randomized equivalence trial. ADHF diabetic and non-diabetic patients were randomized within 24 hours from hospital admission to either receive 100 mg canagliflozin or 10 mg empagliflozin in addition to the standardized protocol for intravenous loop diuretics. The primary outcome was the median daily diuresis during the hospitalization period. Secondary outcomes during the hospitalization period include diuretic response (weight change per 40 mg of furosemide), clinical congestion score, dyspnea assessment, change in level of NT-pro BNP, and hospital stay length. Patients were followed-up for 90 days post-discharge to assess the level of NT-pro B-NP at day 30 post-hospital discharge, the change in patients 'quality of life as assessed by the Kansas City cardiomyopathy questionnaire (KCCQ-23) and the development of heart failure events (HFEs). In addition, safety outcomes, including volume depletion, renal adverse effects, hypoglycemia, and ketoacidosis, were assessed throughout the entire study period. Results: A total of 142 patients were randomized, with 71 patients assigned to each group. The median daily diuresis during the hospitalization period was 4200 ml in the canagliflozin group, which was statistically equivalent to Abstract VII empagliflozin (4117 ml) with a difference of 83 ml, which falls within the predefined equivalence margin (±10% of the median daily diuresis of empagliflozin; Δ = ±411.7 mL), confirming equivalence via bootstrap TSOT p < 0.001. During hospitalization no difference was observed in diuretic response, dyspnea score, orthodema congestion score or length of hospital stay. After 30 days of hospital discharge, the NT-proBNP levels were lower in the canagliflozin (median, 1098 pg/mL) compared to the empagliflozin groups (median, 1768 pg/mL). However, this did not reach statistical significance (p = 0.025). Statistical significance was defined as P-values < 0.0125 to correct for multiple comparisons. For the analysis of KCCQ-23 domains (KCCQ-Total Symptom Score, KCCQ- Clinical Summary Score, and KCCQ-Overall Summary Score), no statistically significant differences in mean changes from baseline to day 90 post hospital discharge were observed between groups. The incidence of HFEs until the end of the trial was 16 (23.9%) in the canagliflozin group and 17(27%) in the empagliflozin group (p = 0.684). There were no significant differences in the incidence of safety events. Conclusion: Early initiation of canagliflozin within 24 hours of hospital admission for patients with ADHF, independent of their diabetes condition, was equivalent to empagliflozin in diuresis effect. Canagliflozin also resulted in comparable decreases in congestion and NT-proBNP levels, lowering HF events and enhancing patients' quality of life but the study was not powered for the secondary outcomes. These findings suggest that the initiation of canagliflozin could be a part of usual care for hospitalized ADHF patients and an alternative to empagliflozin without safety concerns.
520		3	_aكانت هذه دراسة معادلة، عشوائية، متعددة المراكز، استشرافية ، هدفت إلى تقييم البدء المبكر بعقار كاناجليفلوزين مقارنة بإمباغليفلوزين في 142 مريضًا أدخلوا إلى المستشفى بسبب قصور القلب الحاد اللاتعويضي (ADHF) مع وجود احتباس سوائل. خلال أول 24 ساعة من دخول المستشفى، تم توزيع المرضى عشوائيًا بغض النظر عن إصابتهم بالسكري لتلقّي إما 100 ملغ من كاناجليفلوزين أو 10 ملغ من إمباغليفلوزين، مع العلاج القياسي بمدرات البول الحلقية الوريدية. كان المعيار الأساسي للدراسة هو متوسط الإدرار البول اليومي خلال فترة الاستشفاء، وقد أظهرت النتائج تكافؤًا إحصائيًا بين المجموعتين (كاناجليفلوزين: 4200 مل؛ إمباغليفلوزين: 4117 مل؛ p < 0.001 ). لم تُسجل فروق ذات دلالة إحصائية في النتائج الثانوية داخل المستشفى، بما في ذلك الاستجابة لمدرات البول، درجة الاحتقان الوذمي، أو مدة الإقامة في المستشفي. بعد مرور 30 يومًا من الخروج من المستشفى، كانت مستويات NT-proBNP أقل في مجموعة الكاناجليفلوزين مقارنةً بمجموعة الإمباغليفلوزين، إلا أن هذا الفرق لم يصل إلى مستوى الدلالة الإحصائية (p = 0.025). كذلك، كانت نتائج جودة الحياة ومعدل الأحداث المرتبطة بقصورعضلة القلب خلال 90 يومًا متقاربة بين المجموعتين . كما لم تُلاحظ فروق تُذكر في معدلات أحداث السلامة بين المجموعتين.
530			_aIssues also as CD.
546			_aText in English and abstract in Arabic & English.
650		0	_aClinical pharmacology
650		0	_aالصيدلة الإكلينيكية
653		1	_aAcute decompensated heart failure _aCanagliflozin _aEmpagliflozin _aSodium-glucose cotransporter 2 inhibitor _aقصور القلب الحاد اللا تعويضي _aكاناجليفلوزين
700	0		_aNirmeen Ahmed Sabry _ethesis advisor.
700	0		_aMaggie Magdy Abbassi _ethesis advisor.
700	0		_aBassem Zarif Fouad _ethesis advisor.
900			_b01-01-2025 _cNirmeen Ahmed Sabry _cMaggie Magdy Abbassi _cBassem Zarif Fouad _UCairo University _FFaculty of Pharmacy _DDepartment of Clinical Pharmacy
905			_aShimaa
942			_2ddc _cTH _e21 _n0
999			_c177219