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QUALITY OF LIFE AND COMPLIANCE TO THERAPY IN PATIENTS FOLLOWING SUCCESSFUL TRANSLUMINAL CORONARY ANGIOPLASTY, WHO WERE PRESCRIBED LESCOL XL (FLUVASTATIN) ADDED TO STANDARD THERAPY. RESULTS OF THE LESQOL OPEN-LABEL OBSERVATIONAL STUDY

https://doi.org/10.20996/1819-6446-2010-6-4-447-454

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Abstract

Aim. The main aim of the present study was to evaluate quality of life changes and compliance to therapy in patients following successful transluminal angioplasty, who were prescribed fluvastatin extended release in addition to standard treatment.

Material and methods. This was a national prospective multicenter observational study. Patients with coronary heart disease following successful transluminal coronary angioplasty, who were prescribed fluvastatin extended release (Lescol Forte, Novartis) 80 mg QD were included in the present observation. The following efficacy and safety parameters were evaluated: quality of life evaluated with SF-36 scale before and during treatment; hypolipidemic efficacy, compliance to therapy; adverse events and serious adverse events. Observation period was 6 months in all patients and 12 months in some patients at the discretion of the investigator.

Results. 524 patients (79% men and 21% women) completed the 6 months observation period and 116 patients were followed up for 12 months. Significant increase of all measures of SF-36 scales, physical and mental health was observed in 6 and 12 months of fluvastatin extended release treatment. Total and low density lipoprotein cholesterol reduction was 30.5% and 54.9% respectively, p<0.01, in 6 months and 34.2% and 34.3% respectively in 12 months of treatment, p<0.01. High density lipoprotein cholesterol was significantly increased by 22.5% in 12 months of treatment, p<0.01. There were very few adverse events and laboratory changes during the course of treatment.

Conclusion. LESQOL study showed significant increase in quality of life and good hypolipidemic efficacy as well as good tolerability of fluvastatin extended release in patients after coronary angioplasty.

About the Authors

A. V. Susekov
Russian Cardiology Research and Production Complex
Russian Federation
Tretya Cherepkovskaya ul. 15a, Moscow, 121552


V. A. Bulatov
Novartis Pharmaceuticals
Switzerland
WSJ-27.4.37, CHBS-4002, Basel


A. V. Vigdorchik
Novartis Pharma
Russian Federation
Sadovnicheskaya ul. 82, stroen. 2, Moscow, 115035


References

1. Алекян Б.Г. Эндоваскулярная хирургия заболеваний сердца и сосудов: со- временное состояние и перспективы развития. Российские медицинские вести 2004; 4: 65-68.

2. Ruygrok P.N., de Jaegere P.T., van Domburg R.T. et al. Clinical outcome 10 years after attempted percutaneous transluminal coronary angioplasty in 856 patients. J Am Coll Cardiol 1996; 27(7): 1669–77.

3. Smith S.C.Jr., Blair S.N., Bonow R.O. et al.AHA/ACC Scientific Statement:AHA/ACC guidelines for preventing heart attack and death in patients with atherosclerotic cardiovascular disease: 2001 update: Astatementfor healthcare professionals from the American Heart Association and the American College of Cardiology. Circulation 2001; 104(13): 1577-9.

4. Herd J.A., Ballantyne C.M., Farmer J.A. et al. Effects of fluvastatin on coronary atherosclerosis in patients with mild to moderate cholesterol elevations (Lipoprotein and Coronary Atherosclerosis Study [LCAS]). Am J Cardiol 1997; 80(3): 278-286.

5. Serruys P.W., Foley D.P., Jackson G. et al. A randomized placebo-controlled trial offluvastatin for prevention ofrestenosis after successful coronary balloon angioplasty; finalresults ofthe fluvastatin angiographic restenosis (FLARE) trial. EurHeartJ 1999; 20(1): 58-69.

6. Serruys P.W., de Feyter P., Macaya C. et al. Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention: a randomized controlled trial. JAMA 2002; 287(24): 3215-3222.

7. Ballantyne C.M., Riegger G., Moore N. et al. Fluvastatin reduces cardiac mortality in patients with coronary heart disease. Cardiovasc Drugs Ther 2004; 18(1):67-75.

8. Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide. Boston, MA: New England Medical Center, The Health Institute; 1993.

9. Ware J.E., Kosinski M., Keller S.D. SF-36 Physical and MentalHealth Summary Scales: A User`s Manual. Boston, MA: The Health Institute; 1994.

10. Инструкция по обработке данных, полученных с помощью опросника SF- 36. Компания Эвиденс — Клинико-фармакологические исследования. Доступна на http://webmed.irkutsk.ru/doc/pdf/sf36.pdf.

11. Сусеков А.В., Булатов В.А., Вигдорчик А.В. Качество жизни и приверженность проводимой терапии у пациентов, перенесших успешную транслюминальную коронарную ангиопластику и получающих флувастатин замедленного высвобождения как добавление к стандартному лечению.Протокол открытого наблюдательного исследования. Рациональная Фармакотерапия в Кардиологии 2010; 6(3): 347-350.

12. Ballantyne C.M., Pazzucconi F., Pinto X. et al. Efficacy and tolerability of fluvastatin extended-release delivery system: a pooled analysis. Clin Ther 2001; 23(2): 177-192.

13. Перова НВ. Исследование нормализующей атерогенные дислипопротеидемии активности и безопасности препарата флувастатина медленного высвобождения (Лескола ЭЛ) в условиях практического здравоохранения России. Атмосфера. Кардиология 2005; 3: 26-30.

14. Мацкеплишвили С.Т., Чахая Г.О., Арипов М.А. с соавт. Качество жизни в отдаленные сроки после стентирования коронарных артерий у больных острым коронарным синдромом. Бюлл НЦССХ им А.Н.Бакулева РАМН (приложение) 2009;10(1):253-258.

15. PoldermansD., Schouten O., Bax J. et al. Reducing cardiac risk in non-cardiac surgery: evidence from the DECREASE studies. EuropeanHeartJournal Supplements 2009; 11 (Supplement A): A9–A14.

16. Schouten O., Boersma E., Hoeks S.E. et al. Fluvastatin and Perioperative Events in Patients Undergoing Vascular Surgery. N Engl J Med 2009; 361(10): 980-9.

17. Poldermans D., Bax J.J., Boersma E. et al. The Task Force for Preoperative Cardiac Risk Assessment and Perioperative Cardiac Management in Non-cardiac Surgery of the European Society of Cardiology (ESC) and endorsed by the European Society ofAnaesthesiology (ESA). Guidelines for pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery. EurHeartJ 2009; 30(22):2769-812.

18. Poldermans D., Bax J.J., Boersma E. с соавт. Рабочая группа Европейского общества кардиологов (ESC) при поддержке Европейского общества анестезиологов (ESA). Рекомендации по оценке сердечно-сосудистого риска перед операциями и тактике ведения пациентов при некардиальных операциях. Рациональная Фармакотерапия в Кардиологии 2010; 6(3): 391- 412.


For citation:


Susekov A.V., Bulatov V.A., Vigdorchik A.V. QUALITY OF LIFE AND COMPLIANCE TO THERAPY IN PATIENTS FOLLOWING SUCCESSFUL TRANSLUMINAL CORONARY ANGIOPLASTY, WHO WERE PRESCRIBED LESCOL XL (FLUVASTATIN) ADDED TO STANDARD THERAPY. RESULTS OF THE LESQOL OPEN-LABEL OBSERVATIONAL STUDY. Rational Pharmacotherapy in Cardiology. 2010;6(4):447-454. (In Russ.) https://doi.org/10.20996/1819-6446-2010-6-4-447-454

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ISSN 1819-6446 (Print)
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