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No Miracle Pills Just Yet

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No Miracle Pills Just Yet Editor’s Memo No miracle pills just yet What do you get when ■ One pill fits all less-than-perfect result. There are no you combine three The TIPS study stirred discussion quick fixes, in life or in medicine.”3 BP-lowering drugs, a among attendees at the American Col- Pharmaceutical companies con- cholesterol-lowering lege of Cardiology’s 58th scientific ses- tinually seek to improve pharmaco- statin, and aspirin into sion held in Orlando this past March. logic treatment options, and the TIPS a single pill? The polypill! The Indian Even though many questioned the study did receive industry support. Polycap Study (TIPS) recently pub- practicality and safety of a treatment Until large, multicenter Phase III clin- lished a report on a double-blind, option that would be difficult to tailor ical trials are conducted, APNs must clinical trial conducted in 50 medical to a large number of patients, the continue to assess risk and counsel all centers in India; 2,053 individuals age polypill could potentially reduce the patients accordingly about healthy 45 to 80 without cardiovascular dis- burden of adherence for patients with lifestyle behaviors to reduce their risk ease (CVD) and with one risk factor complicated medication regimens. of CVD. The Seventh Report of the for CVD consented to participate.1 The risk factors identified for in- clusion criteria should be familiar to Until large Phase III trials are conducted, APNs must advanced practice nurses (APNs): continue to assess risk and counsel all patients about type 2 diabetes mellitus; BP over 140 healthy behaviors to reduce their CVD risk. mm Hg systolic or 90 mm Hg dias- tolic, but under 160/100 mm Hg; smoker within the past 5 years; in- In the TIPS Phase II trial, study Joint National Committee on Preven- creased waist-to-hip ratio; or abnor- participants were relatively healthy and tion, Detection, Evaluation, and Treat- mal lipids (high low-density without known CVD, so “the thought ment of High Blood Pressure and lipoprotein [LDL] or low HDL). that people might be able to take a sin- Adult Treatment Panel III stresses the Participants were randomly as- gle pill to reduce multiple cardiovascu- importance of therapeutic lifestyle signed to one of nine treatment groups lar risk factors has generated a lot of changes. We cannot rely on a miracle using various combinations of the five excitement.”2 polypill just yet! medications; only one group received the Polycap pill over the 12-week study ■ Back to reality REFERENCES period. The Polycap pill contained The idea of a polypill was first intro- 1. The Indian Polycap Study (TIPS). Effects of a polypill (Polycap) on risk factors in middle-aged very low doses of hydrochlorthiazide, duced in 2003 as a strategy to reduce individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomized atenolol, ramipril, simvastatin, and as- CVD. After the article appeared in the trial. Lancet. 2009;373:1341-1351. pirin. Adverse reactions and tolerability British Medical Journal, letters to the 2. Childs D. ‘Polypill’ no heart risk magic bullet for were similar to those experienced by editor voiced multiple concerns. How now. ABC News. 2009. http://abcnews.go.com/ Health/HeartDiseaseNews/story?id=7208946& patients taking one agent or a combi- would a healthcare provider know page=1. nation of individual agents. Study re- which component was the culprit in 3. Trewby P, Trewby C. “Polypill” to fight cardiovas- cular disease: patients before populations. BMJ sults were mixed, with the Polycap pill the case of an adverse reaction? How 2003;327:807-810. demonstrating lower or higher efficacy would dosage titration be handled? in reducing systolic and diastolic BP One writer stated, “How nice it would and LDL cholesterol when compared be to live in a polypill world. In reality, with each of the other eight treatment however, we must deal with each Jamesetta Newland, RN, PhD, FNP-BC, FAANP, FNAP Editor-in-Chief groups. problem in turn, often accepting a [email protected] www.tnpj.com The Nurse Practitioner • June 2009 5.
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