|
The statin family of medications have been proven in numerous studies to reduce coronary heart disease and lower death rates. However, the benefits are usually modest and require patients to take expensive medications for years even though most will not benefit from them. This is changing with generic lovastatin and pravastatin being available very cheaply, i.e. only $4 per month in the new Walmart generic drug program. Pravastatin is the better of the two and probably as good as any statin on the market. Patented statins are cost-effective for people who already have heart disease, but they have not been found cost effective for people who simply have bad lipid cholesterol profiles. The newer Vytoin (simvastin with emetimibe) is appears an improvement of a statin alone based both on research and it being significantly less expensive than Lipitor or Zocor with better results. Beware of statin or aspirin withdrawal rebound. In a Swiss study, 600 high-risk adults on aspirin therapy found that the risk of stroke within a month tripled when individuals stopped taking their aspirin because of forgetfulness, impending surgery, or minor bleeding. An earlier study found a sharply increased risk of a second heart attack. A 2002 German study found a higher risk of heart attack or death in patients stopping a statin while hospitalized compared to those kept on the drug or never on the drug. In a 10-year, 40,000 women Harvard study, low-dose aspirin helped women over 65 (24%), but not women under 65, to avoid a first heart attack. Men over 45 received some benefit. Do not take ibuprofen or other NSAIDs if on low dose aspirin if at all possible (Consumer Reports 8/05). I don't like aspirin due to its side-effects, which are fatal more often than you think. I prefer many non-pharmacologic interventions listed by following the "Up" button. Statins: Atorvastatin (Lipitor) $56-210, simvastatin (Zocor) $110, simvastatin plus emetimebe (Vytorin) $86, fluvastatin (Lescol) $75, lovastatin (Mevacor) $4 (Wal-Mart), pravastatin (Provachol) $4 (Wal-Mart), rosuvastatin (Crestor) $88. Inhibitors of HMG-CoA reductase rate-limiting step in cholesterol synthesis. Lower LDL and total and triglycerides and may increase HDL. In DB with CHD after 5-6 year decreased death by 3-4% with drug costs per life saved of $175,000-233,000 (NEJM LIPID Study 11/5/98; Scandinavian Simvastatin Study Lancet 344:1383 ‘94). Benefit for primary prevention much less with 0.9% more living after 4 yr with drug cost of $700,000 per life saved (NEJM 333:1301, 1995, TexCAPS JAMA 279:1615 ’98 JR Downs). Higher doses cause fatigue, myalgia, headache, pruritus and lab abnormalities. Other drugs, except policosanol, are less successful. (Cerivastatin (Baycol) was removed from the market in 2001 due to 31 deaths from muscle tissue breakdown. Crestor, a Japanese owned drug, is controversial due to kidney problems in addition to the usual liver and muscle problems caused by the statins. It also probably causes a higher rate of muscle tissue problems at high doses.) Psyllium Allows Reducing Statin Dose: In a 12-week DB PC study, 68 patients were randomized to receive 20 mg of simvastatin plus placebo, 10 mg of simvastatin plus placebo, or 10 mg of simvastatin plus 15 g of psyllium (Metamucil) daily. After 8 weeks the mean LDL-C levels in the group receiving 10 mg of simvastatin plus placebo fell by 55 mg/dL, compared with 63 mg/dL in the group receiving 10 mg of simvastatin plus psyllium (P = .03). The mean lowering of LDL-C in the group receiving 20 mg of simvastatin plus placebo was the same as that in the group receiving 10 mg of simvastatin plus psyllium. Similar results were seen for apolipoprotein B and total cholesterol. No significant changes from baseline triglyceride or high-density lipoprotein cholesterol levels occurred. Effect of combining psyllium fiber with simvastatin in lowering cholesterol. Moreyra AE, Wilson AC, Koraym A. University of Medicine of New Jersey. Arch Intern Med. 2005 May 23;165(10):1161-6. Ed: This strategy cost reduce the risk of side-effects and expense. Primary Prevention: Not Worth It Primary prevention is treating a patient based on an abnormal blood test, e.g. high LDL cholesterol, who has not yet suffered any major harmful effect, like angina or a heart attack. Statins have only a minor benefit even for diabetics in primary prevention and are simply not cost-effective, especially if the human cost of taking so many pills in included. There is considerable evidence that statins do not help people who have never had a heart attack live any longer. Statins Don't Increase Longevity in Primary Prevention: In a review of the seven trials of at least one year covering a total of 42,848 patients of whom 90% had no history of CV disease, the mean follow-up was 4.3 years. Statin therapy reduced the RR of major coronary events, major cerebrovascular events, and revascularizations by 29.2% (P<.001), 14.4% (P = .02), and 33.8% (P<.001). Statins produced a nonsignificant 22.6% RR reduction in coronary heart disease mortality (P = .13). No significant reduction in overall mortality (RR, 0.92) (P = .09) or increases in cancer or levels of liver enzymes or creatine kinase were observed. Primary prevention of cardiovascular diseases with statin therapy: a meta-analysis of randomized controlled trials. Thavendiranathan P, et al. University of Toronto. Arch Intern Med 2006 Nov 27;166(21):2307-13. Statins Weak Benefit for Diabetics in CARDS Study: In a post hoc (i.e. after the fact and therefore less scientific) analysis to compare the efficacy and safety of atorvastatin among 1,129 patients aged 65-75 years at randomization with 1,709 younger patients in the Collaborative Atorvastatin Diabetes Study (CARDS) randomized placebo-controlled trial of 10 mg/day atorvastatin for primary prevention of cardiovascular disease in diabetic patients with LDL cholesterol concentrations </=4.14 mmol/l followed for a median of 3.9 years, atorvastatin resulted in a 38% reduction in relative risk (P = 0.017) of first major cardiovascular events in older patients and a 37% reduction (P = 0.019) in younger patients. Corresponding absolute risk reductions were 3.9 and 2.7%; numbers needed to treat for 4 years to avoid one event were 21 and 33. All-cause mortality was reduced nonsignificantly by 22% (P = 0.245) and 37% (P = 0.98), respectively. Analysis of efficacy and safety in patients aged 65-75 years at randomization: Collaborative Atorvastatin Diabetes Study (CARDS). Neil HA, et al. University of Oxford, UK. . Diabetes Care 2006 Nov;29(11):2378-84. Ed: At $1300 per year for Lipitor, it costs over $125,000 for the medication cost alone to prevent one heart attack with no significant effect on overall mortality. Most people would not knowingly count out and take a pill 36,500 times over a period of 100 years with numerous trips to the pharmacy and pay $125,000 for that benefit. This study is widely used to claim that diabetes should all be given statins. Perhaps those with high cholesterol and other risk factors should, but this study shows the senselessness of treating those with low cholesterol. Japanese MEGA Study Found Very Small Benefit from Pravastatin in Primary Prevention: In a randomised, open-labelled, blinded 5.3 year study, 7832 patients with hypercholesterolaemia (total cholesterol 5.69-6.98 mmol/L) and no history of coronary heart disease or stroke were randomly assigned diet or diet plus 10-20 mg pravastatin daily. Mean total cholesterol was reduced by 2.1% vs. 11.5% and mean LDL cholesterol by 3.2% vs. 18.0% in the diet vs. the diet plus pravastatin groups. Coronary heart disease was significantly lower in the diet plus pravastatin group than in the diet alone group (66 events vs 101 events; HR 0.67; p=0.01). There was no difference in the incidence of malignant neoplasms or other serious adverse events between the two groups. Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective randomised controlled trial. Nakamura H, et al. Tokyo, Japan. . Lancet 2006 Sep 30;368(9542):1155-63. Ed: 100 patients had to take pravastatin for 5.3 years or take pills on 193,000 occasions to prevent one heart attack. What a waste of time and money. Aspirin and Treating High Blood Pressure Cost-Effective; Simvastatin (Zocor) Unreasonably Expensive: An analysis of the cost of treating a non-obese, non-smoking patient with high blood pressure and high cholesterol (10% risk of coronary event in five years) found that cost over the five years per coronary event prevented was $5,500 for aspirin, $20,000 for initial blood pressure treatment (diuretic plus beta-blocker), $30,000 for intensive blood pressure treatment (added enalapril), $100,000 for clopidogrel, and $102,000 for simvastatin (Zocor). BMJ 2004 Statins Pravastatin (Pravachol), Lovastatin (Mevacor) for Primary Prevention: The West of Scotland Coronary Prevention Study found pravastatin (Pravachol) treatment of men with hypercholesterolemia without an heart attack helped. For the AFCAPS and TexCAPS Studies the cost-effectiveness would be lower in regards to decreased coronary heart disease death. James Mason, U York, JAMA 2/3/99 281:415-6. The AFCAPS study did find lovastatin (Mevacor) reduced coronary heart disease (CHD) and CHD death but there were actually more deaths in the treatment group than the placebo group, 80 vs. 77! This finding is the same as in two earlier primary prevention studies: the Lipid Reseach Clinics Coronary Primary Prevention Trial and the Helsinki Heart Study. Thus, lovastatin seems inferior and to be avoided. Of all the statins studies, only one, the Pravastatin Primary Prevention Trial showed even a borderline total mortality benefit and this was only in men with very high cholesterol (272 mg/dL) WOSCOPS West of Scotland Pravastatin (Pravachol) Study Flimsy: Pravastatin 40 mg/day was used in a DB PC study of 6,595 men with LDLs of 155-232 for 4.9 years. Death rate with placebo was 4.1% vs. 3.2% for pravastatin, not a significant difference. AFCAPS Lovastatin (Mevacor) Helps with Average Cholesterol But No Decrease in Mortality: 5,608 men and 997 women with average cholesterols of 221 and low HDL cholesterols were treated with lovastatin 20-40 mg./day for 5.2 years with a heart attack risk with lovastatin of RR .60. Lovastatin reduced LDL bad cholesterol by 25% and increased HDL good cholesterol by 6%. 3.5% of lovastatin patients had a major coronary event vs. 5.5% on placebo. Downs, JAMA 98;279:1615-22 Cholesterol Lowering Statin Therapy Appears Safe for Children; Questionable Wisdom and Ethics: Children with familial hypercholesterolemia have endothelial dysfunction and increased carotid intima-media thickness (IMT), which precede the premature atherosclerotic disease they develop much later in life. In a 2-year DB PC study of 214 children with familial hypercholesterolemia, all were encouraged to follow a fat-restricted diet and to get regular physical activity. Those given pravastatin, 20 to 40 mg/d (n = 106), had a mild carotid IMT regression of -0.010 mm vs. an increase of +0.005 mm with placebo. Pravastatin significantly reduced LDL cholesterol by 24.1% vs. an increase of +0.3% for placebo ( P<.001). No differences were observed for growth, muscle or liver enzymes, endocrine function parameters, Tanner staging scores, onset of menses, or testicular volume between the 2 groups. Efficacy and safety of statin therapy in children with familial hypercholesterolemia: a randomized controlled trial. Wiegman A, Hutten BA, et al. University of Amsterdam, The Netherlands. JAMA. 2004 Jul 21;292(3):331-7. Ed: The wisdom and cost of expensive cholesterol lowering therapy to prevent heart attacks an average of 50-60 years later is highly questionable. Diets in Amsterdam are almost as miserable as in the U.S. I doubt that the actual diets consumed were very healthy. Policosanol is vastly less expensive and very few side-effects compared to statins. It would have been a better choice to research. Even if it didn't work, primary prevention with statins is extremely wasteful even for hypercholesterolemic middle-aged adults and of very minimal value. PROSPER Study of Elderly with Pravastatin Finds Some Value: In a 3-year DB PC of 5,804 elderly averaging 75 years old target for primary or secondary prevention, pravastatin 40 mg/day improved lipid levels: low-density lipoprotein cholesterol (-34%), high-density lipoprotein cholesterol (+5%), and triglycerides (-13%) and produced no adverse effects on liver function tests or myopathy. There was a 24% reduction in CHD death (p=0.043) and 19% reduction in combined CHD death and nonfatal myocardial infarction (p=0.006). Although transient ischemic attacks fell by 25% (p=0.05) with pravastatin, there were no significant reductions in stroke or improvements in cognitive function. A prospective study of pravastatin in the elderly at risk: new hope for older persons. Shepherd J. University of Glasgow. Am J Geriatr Cardiol. 2004 May-Jun;13(3 Suppl):17-24 Pravastatin Recommended Over the Others: Twenty-one clinical studies, each with a duration of statin therapy of 6 months or longer, were reviewed. Statistical event reduction was achieved in seven of nine pravastatin studies, one of three simvastatin studies, one of six lovastatin studies, zero of two fluvastatin studies, and zero of one atorvastatin study. Pravastatin was the only statin proven statistically to reduce events in both primary and secondary prevention. Pravastatin 40 mg daily at bedtime appears to be a unique molecule, with the strongest evidence for event reduction in the majority of patients with moderate hypercholesterolemia with, or who are at risk for, coronary heart disease. If LDL-C is the answer...what was the question? What do the data really show? Katholi RE, et al. Southern Illinois University, Springfield, USA. . Heart Disease 2001 Jan-Feb;3(1):2-13. Note: St John's Wort decreases plasma concentrations of simvastatin but not of pravastatin.Clin Pharmacol Ther 2001 Dec;70(6):518-24. Statin Lipitor Helps Diabetics as Primary Prevention: In the 4-year DB PC CARDS study of 2,838 UK type 2 diabetics with no history of CVD, low-density lipoprotein (LDL) levels of 160 mg/dL or lower, triglyceride levels of 600 mg/dL or lower, and at least one of the following risk factors: hypertension, retinopathy, microalbuminuria, macroalbuminuria, or smoking, 25% of patients had LDL cholesterol levels less than 100 mg/dL. Those who received 10 mg daily of atorvastatin had a 37% reduction in major cardiovascular events such as acute myocardial infarction (33 vs. 61; 8 vs. 20 fatal), stroke, angina, and revascularization compared with control patients. In all, 48% fewer patients in the atorvastatin group than in the placebo group suffered strokes, and all-cause mortality was 27% lower. During the course of the study, about 9% of patients who were in the placebo group originally started taking a statin. In the atorvastatin group overall about 15% of patients stopped taking atorvastatin and weren't taking any other statin either. This means the results are probably an underestimate of the real effect. ADA 64th Annual Scientific Sessions: Abstract 15-LB. June 6, 2004 High Dose Atorvastatin (Lipitor) Made Absolutely No Difference on Rate of Death; May Increase Death: In a massive 4.9-year DB PC study of 10,001 patients with clinically evident coronary heart disease and LDL cholesterol levels of less than 130 mg, there was no difference in the rate of death between those on 10 mg or 80 mg of atorvastatin per day. The primary end point was the occurrence of a first major cardiovascular event, defined as death from CHD, nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest, or fatal or nonfatal stroke. LDL cholesterol levels were 77 mg/dl with 80 mg of atorvastatin and 101 mg/dl with 10 mg of atorvastatin. Persistent elevations in liver aminotransferase levels was 0.2% with 10 mg and 1.2% with 80 mg of atorvastatin (P<0.001). Nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest, or nonfatal stroke occurred in 8.7% receiving 80 mg vs. 10.9% with 10 mg of atorvastatin, representing an absolute reduction in the rate of major cardiovascular events of 2.2% (P<0.001). Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease. Larosa JC, Grundy SM, et al. N Engl J Med. 2005 April 7. Ed: The number of patients needing to take the high dose for 5 years to prevent one non-fatal event was 45. That means that $95,000 extra Lipitor had to be taken to prevent one non-fatal event! The news coverage of this study made it sound like the treatment was great and saved lives. The corrupt people behind this study slyly lumped together the fatal and non-fatal events, headlined the word "died" ("died or suffered a stroke, heart attack or other major problem") to the news media as part of the events that were decreased by 22% without ever saying that fatal events weren't decreased at all! In fact, deaths, especially cancer deaths, were actually non-significantly higher with the high dose treatment! Also, a 22% decrease sounds like a lot. In fact, only 2% of the people taking the high dose for 5 years were helped. Only such a huge study was able to tease out such a small difference. The Associated Press said, "The risk of strokes and heart attacks was cut more impressively than expected." Since the impact was so small, I wonder what had been expected. The PRNewswire-FirstCall also makes no mention of the fact the deaths were not decreased and used the same wording to leave the read with the misimpression that lives were saved. Dr. Joseph Feczko, Pfizer's chief medical officer crowed, “TNT is the very first study to demonstrate even greater cardiovascular benefits of lowering LDL beyond recommended guidelines with Lipitor 80 mg." He claims "outstanding benefits" and that this study was "critical new information." in Medical News Today which also made no mention that there was no difference in the actual rate of death. Only Healthday News told the truth and even there it was buried in the fluff. No one calculated the money spent. WebMD made no mention that deaths were not reduced by Lipitor and gave readers the same misimpression. Statins: Secondary prevention Lowering LDL-Cholesterol Still Further Helpful in REVERSE: In an 18-month, 654-patient DB PC study of 40 mg pravastatin (moderate) or 80 mg atorvastatin (intensive) each day to lower LDL-Cholesterol in patients with coronary atherosclerosis, baseline low-density lipoprotein cholesterol level (mean, 150.2 mg/dL [3.89 mmol/L]) was reduced to 110 mg/dL with pravastatin group and 79 mg/dL with atorvastatin group (P<.001). C-reactive protein decreased 5.2% with pravastatin and 36.4% with atorvastatin (P<.001). Progression of coronary atherosclerosis occurred in the pravastatin group (2.7%; P =.001) compared with baseline, but not with atorvastatin (-0.4%). Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. Nissen SE, Tuzcu EM, Schoenhagen P, Brown BG, Ganz P, Vogel RA, Crowe T, Howard G, Cooper CJ, Brodie B, Grines CL, DeMaria AN; REVERSAL Investigators. JAMA. 2004 Mar 3;291(9):1071-80. Ed: This is secondary prevention, i.e., helping someone with established, symptomatic severe coronary disease. One can't conclude that the same goals are appropriate for people with high LDL-Cholesterol, but no symptoms of heart disease. Also, policosanol 10mg/day and flush-free niacin 2000 mg/day would probably achieve the same results for $25/month vs. $225/month for atorvastatin. PROVE-IT Study Suggests Aggressive LDL-C Lowering is Best: The PROVE-IT study of 4,162 patients who were hospitalized for acute coronary syndromes and who had LDL cholesterols averaging 106 mg/dL were randomized to 40 mg pravastatin (standard therapy) or 80 mg atorvastatin (intensive therapy). After treatment, median the LDL cholesterol level in the pravastatin group was 95 mg/dL while the use of intensive lipid-lowering therapy using atorvastatin lowered LDL cholesterol to a median of 62 mg/dL (P < .001). All-cause mortality was reduced by 28% in the aggressive-treatment arm, while death from MI was reduced by 18%. New England Journal of Medicine 3/7/04 Pravastatin and Simvastatin Helped in SSSS, CARE, and LIPID: A mini-review (Griffiths, 2002) of double-blind randomized controlled trials (RCTs) was undertaken to assess the long-term effect of lipid lowering treatments (statins versus placebo) in secondary prevention of myocardial infarction (MI). The trials all compared statins against a placebo; one trial was of simvastatin--the Scandinavian Simvastatin Survival Study (SSSS) (1994)--and the other two were of pravastatin--the Cholesterol and Recurrent Events Trial (CARE) (Sacks et al, 1996) and Long Term Intervention with Pravastatin Ischaemic Disease (LIPID) (Anon, 1998). The trials demonstrated that statins had a clear and consistent effect in significantly reducing the risk of MI. Overall an approximate decline of 30% in MI was produced from the three trials. Statins and secondary prevention of coronary heart disease. Ahmed M, et al. . Br J Community Nursing 2004 Apr;9(4):160-5. Statin Plus Niacin Better than Vitamins A, C, E, and Selenium for Heart: Statins lower LDL "bad" cholesterol. Niacin is the best at raising HDL good cholesterol. 160 heart patients in a DB PC study had low levels of HDL (<36). 40% people with coronary artery disease fit this profile. Even people with higher HDLs may benefit. Some in the study received simvastatin and niacin (aver. 13 mg and 2.4 g), vs. antioxidant vitamins A, C, E, and selenium vs. all three treatments vs. placebos. All received exercise training and dietary counseling. The results were startlingly different with simvastatin and niacin increasing HDL from 31 to 38, while LDL dropped from 125 to 76 -- an extremely good level, and coronary artery disease was lowered by 60% over 3 years. Simvastatin plus niacin (mean daily dose 13 mg and 2.4 g) side effects were gastrointestinal upset, nausea, anorexia, vision, skin, and energy problems, or muscle aches minor. Flushing (30% vs. 23%, p = NS), fatigue, nausea, and/or muscle aches (9% vs. 5%, p = NS), SGOT >3 times upper limit of normal (3% vs. 1%, p = NS), CPK >2 times upper limit of normal (3% vs. 4%, p = NS), CPK >5 times upper limit of normal, new onset of uric acid >7.5 mg/dl (18% vs. 15%, p = NS), and homocysteine >15 micromol/L (9% vs. 4%, p = NS). Glycemic control among diabetics declined mildly but returned to pretreatment levels at 8 months. Univ. Washington, Safety and tolerability of simvastatin plus niacin in patients with coronary artery disease and low high-density lipoprotein cholesterol (The HDL Atherosclerosis Treatment Study). Zhao XQ, Morse JS, Dowdy AA, Heise N, DeAngelis D, Frohlich J, Chait A, Albers JJ, Brown BG. Am J Cardiol. 2004 Feb 1;93(3):307-12. Ed: This level of niacin costs $0.42 per day for the least expensive which I found. Policosanol would be much better than simvastatin ($6 vs. $110) with many fewer side-effects and would allow a somewhat lower dose of niacin. LIPID Study 3% Benefit: 9,014 patients with coronary heart disease, angina, or a heart attack who had cholesterols of 218 or higher were treated with pravastatin 40 mg/day for 6.1 years with 11% died vs. 14% on placebo. NEJM 339:1349, 11/5/98. That's $260,000 in wholesale pharmacist medication cost spent per death avoided. CARE Study Pravastin: Using 40 mg/day at a cost of $107/month for medication, a 5-year study of 4159 patients with heart attacks and cholesterol under 240 found 3% fewer heart attacks and 1.2% fewer strokes. Sacks, NEJM 335:1001, ’96. This is a small benefit for the time and expense involved. Scandinavian Simvastin Study: Using 20-40 mg/day in 4444 patients with moderate hypercholesterolemia of 213-310 mg/dl and angina or a heart attack history and treating them for 4.9-6.3 years, 12% of the placebo patients died vs. 8% on medications. Lancet 344:1383, 1994. The $110,000 wholesale medication cost per life saved is a high cost but within the range of many other treatments. Statin Better Than Angioplasty: 341 patients with stable CAD were referred for angioplasty randomized to high dose atorvastatin 80 mg/day or angioplasty with usual care in which 70% got a statin. After 18 months, 13% of atorvastin and 21% with angioplasty had a cardiac event.. B. Pitt, AHA Meeting, Dallas, 11/98 Pravastatin Cuts Mortality 3.8% in 8 Years: 9,014 patients with MI or unstable angina and elevated cholesterol (over 4.9 mmol/L) DB 40 mg/day vs. placebo. Reduced CHD, MI, and stroke with overall mortality 15.9% vs. 19.7%. No significant side-effects. Lancet 2002; 359:1379 Heart Protection Study: Statins for At Risk: Cut MI and stroke by 1/3 in pts with CVD or DM, or narrow leg arteries or previous stroke. 20,000 patients 40-80 followed. No benefit Vit E 600, Vit C 250, and Beta-carotene 20. BMJ 11/17/01 Statin Help, HRT Doesn’t: Statins had a 21% lower risk of heart attack and death related to heart disease and a 33% lower risk of dying from any cause during four years of treatment, compared to women who did not take statins. Statin therapy was also associated with a 55% lower risk of venous thromboembolism. HERS study of 2763 women. Circ 6/02. First year on HRT 75% more heart attacks, but if on statin, there was no increase. Statins: Treat all High Risk MI, Stroke: University of Oxford studied 20,000 patients for 5 years and found that all high risk patients benefit, not just those with high cholesterol. Lancet 7/2/02. Study with atorvastatin was stopped after 5 years because of one-third reduction in heart attacks in high blood pressure patients with normal or slightly elevated cholesterol. Statin Helps Decrease Heart Deaths But No Benefit for Alzheimer's in Huge 3-Year Study: In a 3-year DB PC PROSPER study of 5,804 elderly average age 75 and at high risk for coronary heart disease, pravastatin was found to lower deaths from heart disease by 19% but had no effect on strokes or cognition. The NNT (number needed to treat to prevent one death of any cause) was not reported in the abstract. A prospective study of pravastatin in the elderly at risk: new hope for older persons. Shepherd J., University of Glasgow. Am J Geriatr Cardiol. 2004 May-Jun;13(3 Suppl):17-24. Ed: In view of the extreme expensive of these medications, I suspect that the cost per year of life saved was fairly high and more than most of us would be willing to pay if we could leave it to our children. The lack of a benefit for dementia is what caught my eye since statins have been promoted in the popular press for preventing dementia. Policosanol probably works just as well and is much less expensive, but no one cares. General Atorvastatin(Lipitor) & Simvastatin(Zocor) Did Well: UK study 2468 patient. Statins achieved the target value for serum cholesterol (5 mmol/l) than those taking fibrates (1307 (57%) vs. 46 (26%); P<0.0001). Atorvastatin and simvastatin were the most effective drugs in achieving the target. Significant differences were found between lipid lowering drugs for the pretreatment serum cholesterol concentration, the most recent cholesterol concentration, and the associated percentage reduction. Atorvastatin and simvastatin achieved the greatest percentage reduction in serum cholesterol concentrations (30.1%, 95% confidence interval 28.8% to 31.4%, and 28.0%. BMJ 4/4/03 Vytorin (Ezetimibe/Simvastin) Better than Increasing Atorvastatin (Lipitor): In a 6-week DB study of 435 hypercholesterolemic adults with coronary heart disease with high LDL cholesterol despite atorvastatin 10 mg/day, ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg did better than doubling the atorvastatin (ATV) dose. EZE/SIMVA 10/20 mg 32.8% decrease in bad cholesterol vs. 20.3% for atorvastatin; p </= 0.001). Apolipoprotein B (-23.4 vs. -14.7%) and HDL-C (1.8 vs. -0.4%) also favored switching to EZE/SIMVA 10/20 mg (p < 0.05). Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease. Barrios V, et al. Hospital Ramon y Cajal, Madrid, Spain. . Int J Clin Pract 2005 Dec;59(12):1377-86. Simvastatin: Take at Night: Cholesterol is highest at night. 60 patient DB PC. Taking simvastatin in the morning compared with in the evening: randomized controlled trial. Alan Wallace, David Chinn, Greg Rubin. BMJ 2003;327:788 Statins Don't Lower Cancer Risk: In a review of 26 double-blind studies of 73,000 patients, atorvastatin and simvastatin had no effect on the risk of developing or dying from any form of cancer. JAMA 1/11/06. In another study in the J Natl Cancer Institute, statins were of no benefit for preventing colorectal cancer. Earlier, lower quality studies had suggested a benefit. Statins May Decrease Melanoma: The AFCAPS study found a barely significant decrease in melanoma cases (14 vs. 27) in the lovastatin group (P=.04). J Papadakis, JAMA 2/3/99 281:416. Statins Inhibition of CoQ10 May Cause the Statin Myalgia: In 34 patients placed on atorvastatin, ehe mean blood concentration of CoQ(10) was 1.26 micro g/mL at baseline, and decreased to 0.62 micro g/mL after 30 days of atorvastatin therapy (P<.001). A significant decrease was already detectable after 14 days of treatment (P<.001). Widespread inhibition of CoQ(10) synthesis could explain the most commonly reported adverse effects of statins, especially exercise intolerance, myalgia, and myoglobinuria. Atorvastatin decreases the coenzyme Q10 level in the blood of patients at risk for cardiovascular disease and stroke. Rundek T, Naini A, Sacco R, Coates K, DiMauro S. Columbia University. Arch Neurol. 2004 Jun;61(6):889-92. Ed: I greatly prefer policosanol as a first treatment before statins on the basis of cost and the absence of side-effects. I do have a couple patients on policosanol whose primary care doctor gave up on statins and the lowering of LDL cholesterol because of myalgia problems. Statin Slightly Increases HDL Good Cholesterol: In a 6-week DB PC crossover study of 151 adults with stable type 2 diabetes, both simvastatin 80 and 40 mg significantly increased total HDL-C from baseline ( 8% and 5%; p < 0.001) compared with placebo, and significantly reduced plasma concentrations of LDL-C (p < 0.001), triglycerides (p < 0.001), apolipoprotein B (p < 0.001), and hs-CRP (p < or = 0.012). Compared with simvastatin 40 mg, the 80 mg dose provided additional efficacy. Simvastatin 80 mg also significantly (p < 0.001) increased HDL(2) from baseline (14%) and placebo phases (10%). Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C. Miller M, Dobs A, Yuan Z, Battisti WP, Borisute H, Palmisano J. University of Maryland. Curr Med Res Opin. 2004 Jul;20(7):1087-94
|