Medicare Prescription Drug Benefit Realities

David K. Cundiff

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In This Article

Chronic Treatment Realities

Medications for chronic medical conditions (coronary artery disease [CAD], hypertension, hyperlipidemia, type 2 diabetes, osteoporosis, depression, etc.) lead to most of the drug expenditures for seniors. For many of these conditions, lifestyle changes (eg, diet, exercise, etc.) may improve the prognosis and alleviate symptoms as well as or better than drugs. Some specific examples will illustrate what I mean.

The latest National Cholesterol Education Program (NCEP) guidelines raise the number of Americans in whom cholesterol-lowering drugs are indicated to about 36 million.[16] Only about 28% of Americans with indications for cholesterol-lowering drugs (10 million/36 million) now take them, spending about $15 billion per year for statins[17] and $1 to $2 billion for other drugs.

A randomized trial of atorvastatin (Lipitor) in hypertensive patients with average cholesterol levels[18] led to the call for the NCEP guidelines to be broadened to include lipid-lowering drug treatment for the approximately 20 million hypertensives without high cholesterol levels or other indications for cholesterol-lowering drugs. If the NCEP drug recommendations were further expanded to include hypertensives without hyperlipidemia and all these 56 million people (mostly Medicare recipients) with indications took statins, the cost of the statins alone would be about $84 billion per year. Since about 60% of people taking statins do not reach their recommended low-density lipoprotein (LDL) cholesterol target levels,[19] additional costs of other lipid-lowering medication would be considerable.

Jenkins and colleagues[20] recently demonstrated that the "portfolio diet" produces reductions in LDL cholesterol essentially equivalent to that of lovastatin plus a low-fat diet (lovastatin plus low-fat diet = 30.9% vs portfolio diet = 28.6%). A safe, effective, and less expensive alternative to lipid-lowering medication exists -- adopting the portfolio diet or similar plant-based diet and engaging in regular aerobic exercise.

For a senior with CAD risks, the choice of lifestyle change vs drugs depends largely on what Medicare covers and what the personal doctor recommends. Those who choose drugs instead of an effective cholesterol-lowering diet and exercise program should pay the cost of the drugs. Instituting Medicare insurance coverage for comprehensive lifestyle change programs instead of lipid-lowering medications would help control costs and improve the overall health of our seniors.

Seniors constitute the majority of the 55 million Americans with hypertension. In 2003, direct medical costs of hypertension will be $37 billion, including $9 billion for physicians and $18 billion for drugs.[21] We could spend much more for drugs since 70% of hypertensives are aware of their diagnosis, 59% are on drug treatment, and 34% are controlled (blood pressure less than 140/90 mm Hg).

About 60% of people with hypertension have a mild increase in blood pressure (systolic blood pressure [SBP] = 140-149 mm Hg and/or diastolic blood pressure [DBP] = 90-99 mm Hg).[22] Reductions in cardiovascular events and mortality are documented in randomized trials of patients with moderate to severe hypertension (DBP > 99 and/or SBP > 159), but what is the scientific evidence supporting drug treatment for mild hypertension? In a randomized trial of 785 men aged 40-49 years old with mild hypertension, hydrochlorothiazide or combinations of hydrochlorothiazide with beta blocking drugs or methyldopa were compared with placebos. Coronary events occurred more frequently in the hydrochlorothiazide-treated group (CAD mortality, 14 vs 3, P < 0.01).[23] The investigators from the Hypertension Detection and Follow-up trial found that antihypertension medication caused a 20% reduction in overall mortality in the "mild hypertension" subgroup of patients with DBPs from 90 to 104 and any SBP.[24] However, this does not meet today's definition of mild hypertension (SBP/DBP = 140-159/90-99).

The US Veterans Administration randomized more than 1000 patients with mild to moderate hypertension (DPB from 85 to 105 mm Hg) to receive either chlorthalidone or placebo. In 2 years, a total of 8 chlorthalidone-treated and 5 placebo patients developed myocardial infarction or died suddenly; heart arrhythmias developed in 17 chlorthalidone-treated patients vs 8 in the placebo group; and significant chemical abnormalities developed in 20 times as many chlorthalidone-treated patients as those on placebo.[25]

The "Treatment of Mild Hypertension" study compared: (1) placebo, (2) chlorthalidone, (3) acebutolol (Sectral), (4) doxazosin (Cardura), (5) amlodipine (Norvasc), and (6) enalapril (Vasotec). A nonsignificantly smaller percentage of participants assigned to the drug-treatment groups died or experienced a major nonfatal cardiovascular event than those assigned to the placebo group (5.1% vs 7.3%; P = .21).[26]

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) compared chlorthalidone, doxazosin, lisinopril (Previnil), and amlodipine. Although none of these antihypertensive drugs have been shown to be clinically beneficial for people with mild hypertension in randomized trials, ALLHAT included no placebo arm. Chlorthalidone had significantly better outcomes than the other antihypertensive medications.[27] Since chlorthalidone itself is unproven to benefit patients with mild hypertension, this study suggests that the other drugs do more harm than good for people with mild hypertension.

For those with moderate to severe hypertension, the newer, more expensive drugs (angiotensin-converting enzyme inhibitors, calcium channel blockers, alpha blockers, and angiotensin receptor blockers) are not evidence-based to be more effective than thiazide diuretics and beta-blockers. Consequently, the Medicare prescription drug benefit should provide 100% coverage for diuretics and beta-blockers for moderate to severe hypertension.

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