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A Polypill for Global Cardiovascular Prevention: Current Data and Future Perspectives
Published in Giuseppe Mancia, Guido Grassi, Konstantinos P. Tsioufis, Anna F. Dominiczak, Enrico Agabiti Rosei, Manual of Hypertension of the European Society of Hypertension, 2019
José Maria Castellano, Mónica Doménech, Antonio Coca
In the last 10 years, several studies have shown that the polypill strategy can favourably affect CV prevention in patients with established CV disease. The second Indian Polycap Study (TIPS-2) (6) made use of ramipril, atenolol, hydrochlorothiazide, simvastatin and aspirin (supplemented by potassium) in a single capsule (half-dose of the drugs) and compared its effects to the administration of two capsules (full doses of the drugs) for 8 weeks in more than 500 patients with CV disease or type 2 diabetes. Compared to one capsule, two Polycap capsules significantly reduced BP by a further 2.8/1.7 mmHg, total serum cholesterol by 7.2 mg/dL and LDL-cholesterol by 6.6 mg/dL, with a calculated reduction in the relative risk of coronary disease of 69% and stroke of 57%. Discontinuation of treatment was low and similar in the two groups (6.9% and 7.8%, respectively) showing that the Polycap had a good tolerability.
Customized 3D printed multi-drug systems: an effective and efficient approach to polypharmacy
Published in Expert Opinion on Drug Delivery, 2022
Kundai R. Mazarura, Pradeep Kumar, Yahya E. Choonara
As the name suggests, these formulations contain multiple active ingredients, each with a different pharmacological effect. A commercially available example is PolycapTM constituting enteric-coated Aspirin, Ramipril, Simvastatin, Atenolol, and Hydrochlorothiazide, other examples include RamitorvaTM (Aspirin, Ramipril, and Atorvastatin), StarpillTM (Aspirin, Losartan, Atenolol, and Atorvastatin) [12,13]. The development of the majority of polypills was motivated by the serious burden and incidence of cardiovascular disorders; however, the concerns around polypharmacy are not limited to cardiovascular diseases. Furthermore, the rationale behind multi-drug systems hinges on the effectiveness of combined therapy, simplified treatment regimens, reduced production and storage costs, and efficient supply chain and logistics, in addition to the highlighted grounds of enhanced adherence and compliance [13]. However, polypills like any other intervention have their drawbacks, notably the production process, which has proven to be quite complex. Different procedures are utilized in the classic compression process, such as granulation of all active components, individual granulation of actives, and drug separation by layering in circumstances where there are incompatibles and interactions between the actives [13].
Embracing the polypill as a cardiovascular therapeutic: is this the best strategy?
Published in Expert Opinion on Pharmacotherapy, 2018
Beata Franczyk, Anna Gluba-Brzózka, Łukasz Jurkiewicz, Peter Penson, Maciej Banach, Jacek Rysz
Several clinical trials have assessed the utility of the polypill in primary prevention. A phase II, double blind, randomized clinical noninferiority trial (The Indian Polycap Study [TIPS]) evaluated the efficacy, tolerability, and safety of Polycap in over 2000 individuals in 50 centers in India. This study demonstrated that the Polycap was noninferior to its individual components in lowering blood pressure and heart rate (a surrogate for β-blockade), but it did not reduce LDL concentrations to the same extent as simvastatin monotherapy (27 vs. 32 mg/dL; p = 0.04) [24]. Another double-blind, randomized, placebo-controlled, cross over trial analyzed the efficacy of a polypill containing amlodipine 2.5 mg, losartan 25 mg, HCTZ 12.5 mg, and simvastatin 40 mg in 86 individuals over the age of 50 years, treated for 12 weeks followed by 12 weeks crossover to placebo [25]. Polypill therapy was associated with reductions in DBP by 9.8 mm Hg, systolic blood pressure (SBP) by 17.9 mm Hg, and LDL by 1.4 mmol/L. This would be expected to result in relative risk reductions of 72% in CVD and 64% in stroke [26]. The fact that the participants in this trial were recruited from patients already taking simvastatin and blood pressure lowering medications may have contributed to the remarkable adherence rate (98% of participants took more than 85% of their pills).
3D printing for enhanced drug delivery: current state-of-the-art and challenges
Published in Drug Development and Industrial Pharmacy, 2020
Melissa Wallis, Zaisam Al-Dulimi, Deck Khong Tan, Mohammed Maniruzzaman, Ali Nokhodchi
Generally, wherever multiple drug therapies can improve the treatment outcomes for complex diseases, it is beneficial to the patient to use a polypill. These include HIV-1 infection, hypertension or cardiovascular diseases, tuberculosis and type II diabetes mellitus. In addition, the use of polypill is growing as the number of drugs that a patient needs to administer enhances. This, in turn, can enhance patient confusion and less adherence and compliance to the therapy. Therefore, polypill could be a good solution to this. For example, PolycapTM which contains five medications has been shown to be effective in reducing cardiovascular risk factors, thereby reducing the incidence of cardiovascular diseases [61,62].