The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study)

Öz:

Background: This study aimed to assess the safety and tolerability of nebivolol in hypertensive patients with coronary artery disease and left ventricular ejection fraction ≥ 40% in a Turkish cohort. Methods: A total of 1015 hypertensive patients and coronary artery disease with left ventricular ejection fraction ≥ 40% were analyzed from 29 different centers in Turkey. Primary outcomes were the mean change in blood pressure and heart rate. Secondary outcomes were to assess the rate of reaching targeted blood pressure (<130/80 mmHg) and heart rate (<60 bpm) and the changes in the clinical symptoms (angina and dyspnea). Adverse clinical events and clinical outcomes including cardiovascular mortality, cardiovascular hospital admissions, or acute cardiac event were recorded. Results: The mean age of the study population was 60.3 ± 11.5 years (male: 54.2%). During a mean follow-up of 6 months, the mean change in blood pressure was −11.2 ± 23.5/−5.1 ± 13.5 mmHg, and the resting heart rate was −12.1 ± 3.5 bpm. Target blood pressure and heart rate were achieved in 76.5% and 37.7% of patients. Angina and functional classifications were improved by at least 1 or more categories in 31% and 23.2% of patients. No serious adverse events related to nebivolol were reported. The most common cardiovascular side effect was symptomatic hypotension (4.2%). The discontinuation rate was 1.7%. Cardiovascular hospital admission rate was 5% and hospitalization due to heart failure was 1.9% during 6 months’ follow-up. Cardiovascular mortality rate was 0.1%. Conclusion: Nebivolol was well tolerated and safe for achieving blood pressure and heart rate control in hypertensive patients with coronary artery disease and heart failure with preserved or mildly reduced ejection fraction.

Anahtar Kelime:

Nebivololün Hipertansiyon ve Koroner Arter Hastalığı Olup Sol Ventrikül Ejeksiyon Fraksiyonu ≥ %40 Olan Hastalarda Güvenilirlik ve Tolere Edilebilirliği: Popülasyon Bazlı Bir Kohort Çalışması (Nebivolol-TR Çalışması)

Öz:

Amaç: Hipertansiyon ve koroner arter hastalığı olup sol ventrikül ejeksiyon fraksiyonu ≥ %40 olan hastalarda nebivolol’ün güvenirlik ve tolere edilebilirliğini bir Türk kohortu üzerinde araştırmak. Yöntemler: Türkiye’deki 29 farklı markezden toplamda 1015 hipertansiyon ve koroner arter hastalığı olup sol ventrikül ejeksiyon fraksiyonu ≥ %40 olan hasta çalışmaya dahil edildi. Çalışmanın birincil sonlanım noktaları kan basıncı ve kalp hızındaki ortalama değişim miktarıydı. İkincil sonlanım noktaları ise hedef kan basınvı (<130/80 mmHg) ve kalp hızına (<60 atım/dk) ulaşma oranını, klinik bulgulardaki (angina, dispne) değişimi değerlendirmekti. Klinik yan etkiler ve kardiyovasküler mortalite, hastaneye yatış, akut kardiyak olayları içeren klinik sonuçlar kaydedildi. Bulgular: Çalışma popülasyonunun ortalama yaşı 60,3 ± 11,5’di (Erkek: %54,2). Ortalama 6 aylık takip sonunda kan basıncı ve kalp hızında ortalama değişiklik −11,2 ± 23,5/−5,1 ± 13,5 mmHg ve −12,1 ± 3,5 atım/dk’ydi. Hedef kan basıncı ve kalp hızına hastaların %76,5 ve %37,7’sinde ulaşıldı. Angina ve fonksiyonel sınıflamada açısından en az 1 sınıf iyileşen hasta sırasıyla %31 ve %23,2’ydi. Nebivolol ile ilişkili ciddi bir yan etki bildirilmedi. En sık görülen kardiyovasküler yan etki semptomatik hipotansiyondu (%4,2). İlacı bırakma oranı %1,7’ydi. 6 aylık takip içinde kardiyovasküler nedenli hastaneye başvuru oranı %5 iken kalp yetersizliği nedenli hastaneye yatış oranı %1,9’du. Kardiyovasküler mortalite oranı %0,1’di. Sonuç: Nebivolol hipertansiyon ve koroner arter hastalığı olup sol ventrikül ejeksiyon fraksiyonu korunmuş veya hafif azalmış olan hastalarda kan basıncı ve nabız kontrolü sağlamak için iyi tolere edilmiştir ve güvenlidir.

Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık

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APA	ALTIN C, okyay k, Kış M, Eren H, bekar l, DOĞAN Y, Aydın G, GÜZEL T, harbalıoğlu h, TANIK V, cerşit s, çakmak karaaslan ö, Çekici Y, Boyuk F, Çoner A, Kocabas U, YENERÇAĞ M, caliskan s, Er F, Sinan U, Ulus T, Oz A, candemir a, Çetinarslan Ö, Yüce E, TANRIVERDİ Z, Tascanov M, Yeni M, TURK U, Ozturk O, BEDİR Ö, YILMAZ M, TEKİNDAL M, Zoghi M (2022). The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). , 568 - 575. 10.5543/tkda.2022.21237
Chicago	ALTIN Cihan,okyay kaan,Kış Mehmet,Eren Hayati,bekar lütfü,DOĞAN YASEMİN,Aydın Gökhan,GÜZEL TUNCAY,harbalıoğlu hazar,TANIK VEYSEL OZAN,cerşit sinan,çakmak karaaslan özge,Çekici Yusuf,Boyuk Ferit,Çoner Ali,Kocabas Umut,YENERÇAĞ Mustafa,caliskan serhat,Er Fahri,Sinan Umit Yasar,Ulus Taner,Oz Ahmet,candemir alper,Çetinarslan Özge,Yüce Elif ilkay,TANRIVERDİ Zülkif,Tascanov Mustafa Begenc,Yeni Mehtap,TURK UGUR ONSEL,Ozturk Onder,BEDİR Ömer,YILMAZ Mehmet Mustafa,TEKİNDAL Mustafa Agah,Zoghi Mehdi The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). (2022): 568 - 575. 10.5543/tkda.2022.21237
MLA	ALTIN Cihan,okyay kaan,Kış Mehmet,Eren Hayati,bekar lütfü,DOĞAN YASEMİN,Aydın Gökhan,GÜZEL TUNCAY,harbalıoğlu hazar,TANIK VEYSEL OZAN,cerşit sinan,çakmak karaaslan özge,Çekici Yusuf,Boyuk Ferit,Çoner Ali,Kocabas Umut,YENERÇAĞ Mustafa,caliskan serhat,Er Fahri,Sinan Umit Yasar,Ulus Taner,Oz Ahmet,candemir alper,Çetinarslan Özge,Yüce Elif ilkay,TANRIVERDİ Zülkif,Tascanov Mustafa Begenc,Yeni Mehtap,TURK UGUR ONSEL,Ozturk Onder,BEDİR Ömer,YILMAZ Mehmet Mustafa,TEKİNDAL Mustafa Agah,Zoghi Mehdi The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). , 2022, ss.568 - 575. 10.5543/tkda.2022.21237
AMA	ALTIN C,okyay k,Kış M,Eren H,bekar l,DOĞAN Y,Aydın G,GÜZEL T,harbalıoğlu h,TANIK V,cerşit s,çakmak karaaslan ö,Çekici Y,Boyuk F,Çoner A,Kocabas U,YENERÇAĞ M,caliskan s,Er F,Sinan U,Ulus T,Oz A,candemir a,Çetinarslan Ö,Yüce E,TANRIVERDİ Z,Tascanov M,Yeni M,TURK U,Ozturk O,BEDİR Ö,YILMAZ M,TEKİNDAL M,Zoghi M The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). . 2022; 568 - 575. 10.5543/tkda.2022.21237
Vancouver	ALTIN C,okyay k,Kış M,Eren H,bekar l,DOĞAN Y,Aydın G,GÜZEL T,harbalıoğlu h,TANIK V,cerşit s,çakmak karaaslan ö,Çekici Y,Boyuk F,Çoner A,Kocabas U,YENERÇAĞ M,caliskan s,Er F,Sinan U,Ulus T,Oz A,candemir a,Çetinarslan Ö,Yüce E,TANRIVERDİ Z,Tascanov M,Yeni M,TURK U,Ozturk O,BEDİR Ö,YILMAZ M,TEKİNDAL M,Zoghi M The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). . 2022; 568 - 575. 10.5543/tkda.2022.21237
IEEE	ALTIN C,okyay k,Kış M,Eren H,bekar l,DOĞAN Y,Aydın G,GÜZEL T,harbalıoğlu h,TANIK V,cerşit s,çakmak karaaslan ö,Çekici Y,Boyuk F,Çoner A,Kocabas U,YENERÇAĞ M,caliskan s,Er F,Sinan U,Ulus T,Oz A,candemir a,Çetinarslan Ö,Yüce E,TANRIVERDİ Z,Tascanov M,Yeni M,TURK U,Ozturk O,BEDİR Ö,YILMAZ M,TEKİNDAL M,Zoghi M "The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study)." , ss.568 - 575, 2022. 10.5543/tkda.2022.21237
ISNAD	ALTIN, Cihan vd. "The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study)". (2022), 568-575. https://doi.org/10.5543/tkda.2022.21237

APA	ALTIN C, okyay k, Kış M, Eren H, bekar l, DOĞAN Y, Aydın G, GÜZEL T, harbalıoğlu h, TANIK V, cerşit s, çakmak karaaslan ö, Çekici Y, Boyuk F, Çoner A, Kocabas U, YENERÇAĞ M, caliskan s, Er F, Sinan U, Ulus T, Oz A, candemir a, Çetinarslan Ö, Yüce E, TANRIVERDİ Z, Tascanov M, Yeni M, TURK U, Ozturk O, BEDİR Ö, YILMAZ M, TEKİNDAL M, Zoghi M (2022). The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). Türk Kardiyoloji Derneği Arşivi, 50(8), 568 - 575. 10.5543/tkda.2022.21237
Chicago	ALTIN Cihan,okyay kaan,Kış Mehmet,Eren Hayati,bekar lütfü,DOĞAN YASEMİN,Aydın Gökhan,GÜZEL TUNCAY,harbalıoğlu hazar,TANIK VEYSEL OZAN,cerşit sinan,çakmak karaaslan özge,Çekici Yusuf,Boyuk Ferit,Çoner Ali,Kocabas Umut,YENERÇAĞ Mustafa,caliskan serhat,Er Fahri,Sinan Umit Yasar,Ulus Taner,Oz Ahmet,candemir alper,Çetinarslan Özge,Yüce Elif ilkay,TANRIVERDİ Zülkif,Tascanov Mustafa Begenc,Yeni Mehtap,TURK UGUR ONSEL,Ozturk Onder,BEDİR Ömer,YILMAZ Mehmet Mustafa,TEKİNDAL Mustafa Agah,Zoghi Mehdi The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). Türk Kardiyoloji Derneği Arşivi 50, no.8 (2022): 568 - 575. 10.5543/tkda.2022.21237
MLA	ALTIN Cihan,okyay kaan,Kış Mehmet,Eren Hayati,bekar lütfü,DOĞAN YASEMİN,Aydın Gökhan,GÜZEL TUNCAY,harbalıoğlu hazar,TANIK VEYSEL OZAN,cerşit sinan,çakmak karaaslan özge,Çekici Yusuf,Boyuk Ferit,Çoner Ali,Kocabas Umut,YENERÇAĞ Mustafa,caliskan serhat,Er Fahri,Sinan Umit Yasar,Ulus Taner,Oz Ahmet,candemir alper,Çetinarslan Özge,Yüce Elif ilkay,TANRIVERDİ Zülkif,Tascanov Mustafa Begenc,Yeni Mehtap,TURK UGUR ONSEL,Ozturk Onder,BEDİR Ömer,YILMAZ Mehmet Mustafa,TEKİNDAL Mustafa Agah,Zoghi Mehdi The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). Türk Kardiyoloji Derneği Arşivi, vol.50, no.8, 2022, ss.568 - 575. 10.5543/tkda.2022.21237
AMA	ALTIN C,okyay k,Kış M,Eren H,bekar l,DOĞAN Y,Aydın G,GÜZEL T,harbalıoğlu h,TANIK V,cerşit s,çakmak karaaslan ö,Çekici Y,Boyuk F,Çoner A,Kocabas U,YENERÇAĞ M,caliskan s,Er F,Sinan U,Ulus T,Oz A,candemir a,Çetinarslan Ö,Yüce E,TANRIVERDİ Z,Tascanov M,Yeni M,TURK U,Ozturk O,BEDİR Ö,YILMAZ M,TEKİNDAL M,Zoghi M The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). Türk Kardiyoloji Derneği Arşivi. 2022; 50(8): 568 - 575. 10.5543/tkda.2022.21237
Vancouver	ALTIN C,okyay k,Kış M,Eren H,bekar l,DOĞAN Y,Aydın G,GÜZEL T,harbalıoğlu h,TANIK V,cerşit s,çakmak karaaslan ö,Çekici Y,Boyuk F,Çoner A,Kocabas U,YENERÇAĞ M,caliskan s,Er F,Sinan U,Ulus T,Oz A,candemir a,Çetinarslan Ö,Yüce E,TANRIVERDİ Z,Tascanov M,Yeni M,TURK U,Ozturk O,BEDİR Ö,YILMAZ M,TEKİNDAL M,Zoghi M The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study). Türk Kardiyoloji Derneği Arşivi. 2022; 50(8): 568 - 575. 10.5543/tkda.2022.21237
IEEE	ALTIN C,okyay k,Kış M,Eren H,bekar l,DOĞAN Y,Aydın G,GÜZEL T,harbalıoğlu h,TANIK V,cerşit s,çakmak karaaslan ö,Çekici Y,Boyuk F,Çoner A,Kocabas U,YENERÇAĞ M,caliskan s,Er F,Sinan U,Ulus T,Oz A,candemir a,Çetinarslan Ö,Yüce E,TANRIVERDİ Z,Tascanov M,Yeni M,TURK U,Ozturk O,BEDİR Ö,YILMAZ M,TEKİNDAL M,Zoghi M "The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study)." Türk Kardiyoloji Derneği Arşivi, 50, ss.568 - 575, 2022. 10.5543/tkda.2022.21237
ISNAD	ALTIN, Cihan vd. "The Safety and Tolerability of Nebivolol in Hypertensive Patients with Coronary Artery Disease and Left Ventricular Ejection Fraction ≥ 40%: A Population-Based Cohort Study (Nebivolol-TR Study)". Türk Kardiyoloji Derneği Arşivi 50/8 (2022), 568-575. https://doi.org/10.5543/tkda.2022.21237