Zusammenfassung
Hintergrund
Die multifaktorielle Genese kardiovaskulärer Erkrankungen hat in der Primär- und Sekundärprophylaxe zur Polypharmazie mit evidenzbasierten Therapeutika wie Statinen, Antihypertensiva und Thrombozytenhemmern geführt. Die Anzahl verschriebener Phamaka korreliert umgekehrt mit der Adhärenz, was die Effektivität der Therapie beeinträchtigen kann. Fixe Kombinationspräparate („Polypill“) könnten die Adhärenz der Patienten steigern und damit kardiovaskulären Ereignissen vorbeugen.
Methoden
Literaturrecherche in Medline (via PubMed) und The Cochrane Library sowie der Studiendatenbank ClinicalTrials.gov.
Ergebnisse
In den bisher durchgeführten Studien zur kardiovaskulären Primärprävention zeigt die Polypill eine überlegene Kontrolle der Risikofaktoren (Hypertonie, „Low-density-lipoprotein“-Cholesterin [LDL-C]) gegenüber Placebo und gegenüber einer Standardtherapie aus Einzelpräparaten mindestens eine Nichtunterlegenheit. In der Sekundärprävention zeigen Kombinationspräparate vorwiegend Vorteile bei nichtadhärenten Patienten bezüglich Blutdruckkontrolle und Reduktion der LDL-C-Konzentration. Der Nachweis, dass die Polypill die kardiovaskuläre Morbidität und Mortalität gegenüber einer Standardtherapie absenkt, steht aus.
Schlussfolgerung
Kombinationspräparate sind nach Risiko-Nutzen-Einschätzung als Alternative zur Polypharmazie, insbesondere bei nichtadhärenten Patienten in Erwägung zu ziehen. Inwieweit durch die erwiesene Senkung der Risikofaktoren kardiovaskuläre Ereignisse verhindert werden können, ist Gegenstand laufender Untersuchungen. Limitiert sind die gegenwärtigen Polypills durch eine zu geringe Auswahl an Dosierungen der Einzelwirkstoffe, um eine Über- und Untertherapie in der individuellen Behandlung zu vermeiden.
Abstract
Background
The multifactorial origin of cardiovascular diseases has led to polypharmacy in primary and secondary prophylaxis with evidence-based medications, such as statins, antihypertensive drugs and platelet aggregation inhibitors. The number of prescribed drugs correlates inversely to adherence and can lead to treatment failure. Fixed-dose combination drugs (polypills) could increase the medication adherence of patients, reduce risks and prevent cardiovascular events.
Methods
This review is based on publications that were retrieved from Medline (via PubMed) and The Cochrane Library. The clinical database ClinicalTrials.gov. was also considered.
Results
In the studies on primary prevention conducted to date, fixed-dose combinations showed a superior control of risk factors, e.g. hypertension and low-density lipoprotein (LDL) cholesterol compared to placebo and at least non-inferiority compared to usual care. In secondary prevention, the effect of the polypill is mostly on the reduction of blood pressure and LDL cholesterol in non-adherent patients; however, evidence that fixed-drug combinations reduce cardiovascular morbidity and mortality compared to standard therapy is lacking.
Conclusion
The polypill can be considered as an alternative to polypharmacy after a risk-benefit assessment, especially in non-adherent patients. Ongoing studies are investigating the effect of the polypill on cardiovascular events. Current polypills are limited by the lack of sufficient dosages of the individual components to avoid overtreatment and undertreatment at the individual treatment level.
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W. März ist Angestellter von Synlab Holding Deutschland GmbH. Er bekam Vortrags- und Beraterhonorare von den Firmen Aegerion Pharmaceuticals, Amgen, AstraZeneca, Danone Research, Sanofi, MSD, Synageva und Unilever. P. Bramlage bekam Beraterhonorare von den Firmen Aspen, AstraZeneca, Bayer Schering, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Hexal, Merck, Novartis, Pfizer, Sanofi und Takeda. D. Westermann erklärt, dass er von einer Reihe von Firmen, die Antihypertensiva und Statine produzieren, Beratungs- und Vortragshonorare erhalten hat. B. Weisser erklärt, dass er von einer Reihe von Firmen, die Antihypertensiva und Statine produzieren, Beratungs- und Vortragshonorare erhalten hat. J.H. Wirtz erklärt, dass er von einer Reihe von Firmen, die Antihypertensiva und Statine produzieren, Beratungs- und Vortragshonorare erhalten hat. U. Zeymer erhielt Vortrags- und Beraterhonorare von den Firmen Aspen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Hexal, MSD, Novartis, Pfizer und Sanofi. P. Baumgart erklärt, dass er von einer Reihe von Firmen, die Antihypertensiva und Statine produzieren, Beratungs- und Vortragshonorare erhalten hat. B.K. Krämer bekam Vortrags- und/oder Beraterhonorare von den Firmen Amgen, Astellas, Bayer, BMS, Chiesi und Pfizer. T. Unger erhielt Vortrags- und Beraterhonorare von den Firmen Actelion, AstraZeneca, Bayer, Berlin-Chemie, Boehringer-Ingelheim, BMS, Daiichi Sankyo, Hexal, MSD, Novartis, Pfizer, Roche, Sanofi, Servier, Takeda und Vicore. G. van Mark und U. Laufs geben an, dass kein Interessenkonflikt besteht.
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Bramlage, P., März, W., Westermann, D. et al. Management verschiedener kardiovaskulärer Risikofaktoren mit einem Kombinationspräparat („Polypill“). Herz 43, 246–257 (2018). https://doi.org/10.1007/s00059-017-4554-5
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DOI: https://doi.org/10.1007/s00059-017-4554-5