Use of the Cardiovascular Polypill in Secondary Prevention of Cerebrovascular Disease: A Real-Life Tertiary Hospital Cohort Study of 104 Patients

Abstract

<b><i>Background:</i></b> The use of the cardiovascular polypill, a fixed-dose combination treatment, is conceived to improve adherence. However, randomized controlled trials (RCTs) may overestimate it. Studies focusing on cerebrovascular disease and real-life efficacy compared with conventional treatment are lacking. <b><i>Methods:</i></b> This is a retrospective, hospital-based cohort study of acute ischaemic stroke patients who were prescribed a polypill (aspirin 100 mg, atorvastatin 20/40 mg, ramipril 2.5/5/10 mg) versus conventional treatment (aspirin 100 mg and other blood pressure/lipid-lowering agents) in secondary prevention (2017–2018). Clinical records were reviewed 90 days after discharge for stroke recurrence, vascular risk factor control, and safety. Adherence was assessed using the adapted Morisky-Green scale. <b><i>Results:</i></b> A total of 104 patients were included (61% male; mean age 69.7 ± 13.9 years); 54 were treated with the polypill and 50 with conventional treatment. No baseline differences in clinical or demographic variables were detected. No recurrences were registered in the polypill group, compared to 1 recurrence in the conventional treatment group. A significant reduction of systolic blood pressure (SBP) was achieved in the polypill group (12.1 mm Hg) compared to the conventional treatment group (6.8 mm Hg) (<i>p</i> = 0.002). No significant differences were detected regarding the goal of LDL cholesterol ≤70 mg/dL (41 vs. 44%). The adverse events were mild and their frequency was similar in the two groups (9 vs. 2%, ns). Adherence was similarly good in the two groups (93 vs. 88%, ns). Polypill group adherence was similar to that reported in a previous meta-analysis of RCTs (93 vs. 84%, ns). <b><i>Conclusion:</i></b> In our experience, the cardiovascular polypill achieved a higher reduction in SBP levels and was well tolerated. Adherence was similar to that found in the previous literature, which is remarkable given the real-life setting of our study.

The CNIC-Polypill reduces recurrent major cardiovascular events in real-life secondary prevention patients in Spain: The NEPTUNO study

“…The CNIC-Polypill is approved for use in secondary prevention of cardiovascular events as substitution therapy in adult patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic doses [15]. Clinical data to date with the CNIC-Polypill include a prospective randomized clinical trial which showed a significant improvement in adherence, as well as various real world studies which demonstrated significant risk factor control [10,12,[16][17][18][19][20]. In addition, a pharmacodynamic study has shown that there might be a synergistic effect between ramipril and atorvastatin in the CNIC-Polypill as there is an additional 7% decrease in low-density lipoprotein cholesterol (LDLc) levels compared to atorvastatin alone [18].…”

Benefits of the Polypill on Medication Adherence in the Primary and Secondary Prevention of Cardiovascular Disease: A Systematic Review

“… 19 In a real-world retrospective study conducted with 104 patients with a history of stroke, an adherence (measured by the Morisky scale) of 93% in the polypill group (same components of the CNIC-Polypill) and 88% in usual management was reported. 25 In contrast, the TIPS-3 study, an RCT with a factorial design that included 5713 adults with intermediate or high INTERHEART score recibing the Polycap (Cadila Pharmaceuticals, Polycap™, Ahmedabad, India) containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril compared with placebo showed that both arms had a similar proportion of adherence (81%) at 24-month follow-up. 16 Also, the multicap study involved 100 patients with a history of acute myocardial infarction within the last 7 days and were randomized and assigned to either the Multi-cap (Hospital El Cruce, Buenos aires, Argentina, composed of aspirin 100 mg, atenolol 50 or 100 mg, ramipril 5 or 10 mg, and simvastatin 40 mg) or the control group.…”

“… 24 In contrast, the study of Ros-Castello et al showed that stroke recurrence only occurred in one patient in the usual treatment group vs none in the polypill group. 25 …”

“…Additionally, regarding safety, most studies described that the number of patients with serious adverse events was not statistically different but minimal and comparable between groups. [16][17][18][19][20][21][22]24,25,28…”

Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial

“…Moreover, a post-hoc analysis in the cohort of subjects with established CVD showed an improvement in the overall lipid profile, including markers indicative of atherogenic dyslipidaemia [ 14 ]. These improved outcomes have been partially attributed to the reported enhanced adherence and persistence in patients who were treated with the CNIC-polypill compared with those on the identical loose combination or conventional treatment [ 17 , 18 , 25 ]. In our study, we must take account of the possible greater reduction in LDL-c levels among subjects who were treated with less potent statins (e.g., atorvastatin 10 mg, simvastatin 10 or 20 mg, fluvastatin 40 or 80 mg) before study entry.…”