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INTRODUCTION to the Eighth Joint National Committee (JNC 8)

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INTRODUCTION to the Eighth Joint National Committee (JNC 8) CMYK CMYK Front Cover Page Insights from Clinical Practice Insights from Clinical Practice Insights from Clinical Practice References The Indian ‘Polycap’ Study (TIPS)12 1. Prabhakaran D, Jeemon P, et al. Cardiovascular Diseases in India: Current Epidemiology and Future 1) Significantly higher reduction in systolic and diastolic BP with ‘Polycap’ Directions. Circulation. 2016 Apr 19;133(16):1605-20. ISSUE 1 as compared to groups not receiving BP lowering drugs and those with 2. Lafeber M, Spiering W, et al. Multifactorial Prevention of Cardiovascular Disease in Patients three individual BP-lowering drugs, with or without aspirin. with Hypertension: the Cardiovascular Polypill. Curr 2) Higher LDL cholesterol-lowering in the ‘Polycap’ group than the groups Hypertens Rep. 2016 Apr;18(5):40. without Simvastatin. 3. James PA, Oparil S, et al. 2014 evidence-based guideline for the management of high blood pressure 3) Similar reductions in 11-dehydrothromboxane B2 with ‘Polycap’ as in adults: report from the panel members appointed INTRODUCTION to the Eighth Joint National Committee (JNC 8). compared to the three blood-pressure-lowering drugs plus aspirin and JAMA. 2014 Feb 5;311(5):507-20. Dr. Jagdish S. Hiremath aspirin alone. 4. Filipovský J, Widimský Jr J, et al. Summary of 2013 DM, DNB (Cardiology) ESH/ESC Guidelines for the management of arterial n India today, cardiovascular diseases are emerging Interventional Cardiologist Meta analysis of three studies2: hypertension. Prepared by the Czech Society of Hypertension/Czech Society of Cardiology. Cor et as a major health concern both among rural and urban Director: Cath. Lab., 1) ‘Use of a Multidrug Pill In Reducing cardiovascular Events’ (UMPIRE) trial I vasa. 2014;56(e506):e494-e518. population. There has been a phenomenal increase of 59% in Ruby Hall Clinic, Pune 2) ‘IMProving Adherence using Combination Therapy’ (IMPACT) trial 5. Bansilal S, Castellano JM, et al. Global burden of the mortality rates due to coronary vascular disease (CVD) in CVD: focus on secondary prevention of cardiovascular 1 3) ‘Kanyini-Guidelines Adherence with the Polypill’ (GAP) trial disease. Int J Cardiol. 2015 Dec;201 Suppl 1:S1-7. India over the past decade. 6. Barreto M da S, Reiners AAO, et al. Knowledge about Result hypertension and factors associated with the non- There are various risk factors for cardiovascular disease such As compared to conventional regimen, Polypill recipients showed: adherence to drug therapy. Rev Lat Am Enfermagem. as hypertension, dyslipidemia, obesity and insulin resistance. 2014 May-Jun; 22(3): 491-498. 1) Higher adherence (relative risk 1.58; 95% CI 1.32 to 1.90) These risk factors tend to co-exist making an individual prone to the development of cardiovascular disease. Among these risk 7. Kolandaivelu K, Leiden BB, et al. Non-adherence to factors, hypertension is a major, if not the most important, contributor to the disease burden and premature death which is due to 2) 2.5 mmHg (95% CI 0.4 to 4.5) lower systolic BP cardiovascular medications. Eur Heart J. 2014 Dec 7;35(46):3267-76. cardiovascular diseases. Thus, early aggressive lowering of blood pressure is one of the key strategies that is undertaken in order 3) 0.1 mmol/L (95% CI 0.0 to 0.2) lower LDL cholesterol 8. Desgraz B, Collet T-H, et al. Comparison of self- to prevent cardiovascular events like myocardial infarction and stroke.2 perceived cardiovascular disease risk among smokers with Framingham and PROCAM scores: a cross- Among the guideline based strategies, combination of more than one anti-hypertensive agents in patients who fail to achieve target sectional analysis of baseline data from a randomised controlled trial. BMJ Open. 2017; 7(1): e012063. blood pressure (BP) within one month of treatment forms one of the key recommendation. Combination therapies lead to physiological Cost reduction: As one pill can uncontrolled hypertension, received 9. Yusuf S. Two decades of progress in preventing and pharmacological synergies between different classes of agents thus imparting greater efficacy and reducing side-effects that may replace multiple pills overall cost of ‘Polycap’ which provided effective vascular disease. Lancet. 2002 Jul 6;360(9326):2-3. occur due to increased dose of a single class of drug.3,4 therapy also decreases. hypertension management and primary 10. Wald NJ, Law MR. A strategy to reduce cardiovascular prevention. This was largely due the fact disease by more than 80%. BMJ. 2003 Jun Apart from BP lowering drugs, anti-platelet drugs like aspirin and cholesterol-lowering therapies like statins also find a place in Polypill administration along with 28;326(7404):1419. strategies to prevent cardiovascular events.2 Overwhelming data from clinical trials show that pharmacologic interventions with that ‘Polycap’ improved his compliance 11. Lonn E, Bosch J, et al. The polypill in the prevention of lifestyle advice can play a potential role 5 to medication as his regimen was now cardiovascular diseases: key concepts, current status, aspirin, statins and BP-lowering agents considerably reduce the risk of vascular events and total mortality. in CVD prevention in a larger number of challenges, and future directions. Circulation. 2010 simple. Apart from this, the patient However, in actual clinical practices, there exists large treatment gaps in appropriate prevention of CVD as a result of which a large at-risk individuals. Nov 16;122(20):2078-88. received appropriate education about his 12. Indian Polycap Study (TIPS), Yusuf S, et al. Effects of number of patients are undetected or under controlled. Some of the reasons may be a lack of a systematic approach to screening condition and therapy along with advice a polypill (Polycap) on risk factors in middle-aged of the adult population, the use of simple, low-cost and effective BP-lowering therapies and lack of patient education. Apart from individuals without cardiovascular disease (TIPS): a Conclusion on lifestyle modification which led to an 5,6 phase II, double-blind, randomised trial. Lancet. 2009 this, non-adherence to cardiovascular medications is another major reason for the apparent discrepancy in CVD control. In the current case, patient who had overall improved response to therapy. Apr 18;373(9672):1341-51. Non adherence to cardiovascular medications can lead to major consequences like increase in cardiovascular events and mortality. In the Reduction of Atherothrombosis for Continued Health (REACH) registry spanning 44 countries, risk of cardiovascular death, myocardial infarction or stroke increased from 13.4 to 17.4% for patients non-adherent at baseline, being even worse in patients For the use of a Registered Medical Practitioner or Hospital LaboratoryFor only. who went from taking to not taking medications at 1 year.7 Non-adherence to cardiovascular strategies could be due to the fact Eligible patients for polypill: that there are multiple drugs required for appropriate control which Hypertensive patients with high CV risk. makes the regimen complex.6 Published in Patients requiring multiple drugs but likely It is thus important to simplify the therapeutic regimen in order to to be non-adherent/non compliant due to increase adherence to drug therapy. One of the strategies to simplify many pills. the regimen would be use of a single pill which is a combination of the essential drugs classes. Such a pill can impart potential synergistic Patients reporting inconvenience due to actions and improve patients’ adherence to medication by reducing complex multiple drug dosing schedules. pill burden and dosing frequency.2 PIF No. : 026/MS/02/17 : PIF No. 4 1 CMYK CMYK CMYK CMYK Insights from Clinical Practice Insights from Clinical Practice Treatment and follow up Results of other assessments BP and imparting primary prevention. Apart from this, ‘Polycap’ also improved CASE: MANAGEMENT OF HIGH RISK PATIENT Patient had a 10-year risk for coronary at 12 weeks (Table 6) the lipid profile of the patient. The patient heart disease as per Framingham Point The patient lost around 2 kg of weight benefited from the lifestyle modification WITH CORONARY VASCULAR DISEASE (CVD) Scores of 18 equivalent to ≥ 30% risk. which could be attributed to lifestyle advice which led to apparent weight The aim of the consulting physician was modifications which he incorporated. loss in 12 weeks time. In the long term, to ensure primary prevention of an event ‘Polycap’ administration and lifestyle He was also on atorvastatin 10 mg Laboratory examination (Table 4) as the patient was found to be at a higher Case Table 6 Results of assessments modifications will definitively change the for lipid management. However, with The patient’s blood pressure was not risk as per Framingham Risk Score. This is a case of a 59-year-old man with patient’s hypertension status and is also number of tablets increasing, he often under control. Laboratory examinations Name of the Result uncontrolled hypertension. The consulting physician also aimed to likely to improve his body mass index avoided taking additional statin tablet revealed dyslipidemia. assessment simplify the treatment regimen of the (BMI) and high-density lipoprotein (HDL) daily. The patient also complained of patient in order to improve the patient’s Lipid profile LDL: 135 mg/dL status. Patient profile chest discomfort while climbing stairs Results of laboratory Triglycerides: 145 mg/dL Table 4 compliance to the medication. A busy executive with a stressful job or physical exertion occasionally. examination HDL: 35 mg/dL profile Name of the Result In India, various combinations of Heart rate 60 beats/minute ‘Polycap’: Polypill concept The Framingham Risk Score of the patient Job involves extensive travel examination antihypertensives are available. However, A hypothesis by Yusuf et al,9 suggested as assessed by the physician during one LDL: Low-density lipoprotein; HDL: High-density Lipid Profile LDL: 160 mg/dL ‘Polycap’ is the only combination with 5 lipoprotein.
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