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Probucol with colestipol in the treatment of hypercholesterolemia

[Insertion in Stroke, Feb-Mar., 2002]
Double-blind comparative clinical trial of Abana and Simvastatin
in Hyperlipidaemia
Venkataramaiah, H., M.D., D.M. (Cardiology),
Professor of Cardiology, Jayadeva Institute of Cardiology, Jayanagar East End, Bangalore, India. [Corresponding author: Kala Suhas Kulkarni, M.D.,
Medical Advisor, R&D Center, The Himalaya Drug Company, Makali, Bangalore, India]
INTRODUCTION
Nikolai Anichkov first proposed a link between cholesterol and atherosclerosis in 19121. Decades
later observational studies have established hyperlipidaemia as an independent risk factor for
coronary artery disease. It is now proved that hyperlipidaemia is an independent risk factor for
ischemic stroke. Additional evidences from the prospective studies have shown the relationship
between plasma cholesterol levels and risk of stroke. Reduction in the plasma cholesterol is
accompanied by significant decrease in the incidence of coronary artery disease and stroke.

Data from individual randomised trials and meta-analyses of randomised trials consistently show a
reduction in risk for both fatal and nonfatal coronary heart disease following primary and secondary
prevention2-6. A recent comprehensive overview by Law and colleagues incorporated data from 28
trials of cholesterol reduction, including 6 multiple intervention trials that each had a cholesterol-
reducing arm. This overview indicated that a 10% reduction in serum cholesterol level resulted in
highly significant reductions mortality from coronary heart disease. These data from randomised
trials are consistent with observational data when treatment lasts 5 years or more. A 10% reduction
in cholesterol levels was associated with a 25% reduction in coronary events among persons treated
for more than 5 years. These findings from meta-analyses are also supported by recent reports from
the Scandinavian study7 and the West of Scotland Coronary Prevention Study8.
Herbs have been used since ancient times for reducing body lipids. Reports on all garlic studies
performed, found cholesterol was lowered by an average of 9-12% over a one-to-four month
period9. Guggul, a mixture of substances taken from the plant Commiphora mukul, is an approved
treatment for elevated cholesterol in India and has been a mainstay of the Ayurvedic approach in
preventing atherosclerosis. One trial studying the effects of guggul reported that serum cholesterol
dropped by 17.5%10. In another report comparing guggul to the drug clofibrate, average fall in
serum cholesterol was slightly greater in the guggul group while HDL cholesterol rose in 60% of
people responding to guggul, while clofibrate treatment did not elevate HDL11. Wild yam another
herb commonly used has also been reported to raise HDL cholesterol in preliminary research12.
With the above leads we planned a double-blind comparative clinical study using Abana and
Simvastatin.

MATERIALS AND METHODS
Seventy patients were evaluated for general health and lipid profile through a medical history and a
thorough physical examination. Patients with secondary hyperlipidaemia, alcoholism, or body
weight more than 15% above the ideal for their height were excluded from the study. Baseline
cholesterol and triglycerides of estimation were carried out. The patients showing serum total
cholesterol levels more than 200 mg/dL or serum triglyceride levels more than 200 mg/dL were
included in the study.
After screening fifty patients qualified for the study, their ages ranged from 29 to 64 years, with a
median of 46. There were 37 male and 13 female patients. Each patient underwent routine
hematological and biochemical laboratory investigations. Patients were asked not to eat any food,
except for water, for 12 to 14 hours before taking blood samples. Routine urine analysis and
electrocardiography was also carried out. The study planned was double blind, randomized
comparative study for 8 weeks. The written and informed consent was obtained from all the
patients. Patients took 2 capsules of the drug before breakfast and at bedtime. The patients had to
visit every 2 weeks for 8 weeks. A registered dietician interviewed the patients and instructed them
to have diet with low cholesterol and saturated fats.
The clinical side effects if any were recorded at each visit and discussed with the patient to know
the nature, severity and frequency. Patients were seen by the same dietician at every clinic visit
throughout the study and were instructed to follow the same diets and to maintain weight, physical
activity levels and smoking frequency for the duration of the study. To evaluate diet compliance,
patients made written records of the quantity and type of food consumed in 4 consecutive days,
including a weekend, between visits. These food diaries were kept on special forms that were then
translated into computer language and analyzed by a program designed for that purpose. Patients
reported their usual physical activity and smoking habits on a special card at every visit. All but
three patients did not smoke cigarettes. Repeat laboratory investigations and electrocardiography
were done after completion of the study.
Concomitant medications were monitored throughout the study. Twenty-three patients took no other
drugs, 11 took asprin, acetaminophen, or both, 8 took antihistamines / antiallergic preparations,
vitamins, or mineral supplements, 7 took minor tranquilizers, sedatives, or laxatives, 4 took
nonsteroidal anti-inflammatory drugs, 4 took antacids or anticholinergic drugs, and 2 took
antibiotics. The results were analyzed using paired ‘t’ test.

RESULTS
Of the 50 patients who entered the active-treatment phase of the study, 3 were excluded because of
non-compliance. The patients followed fairly uniform dietary patterns during the trial and their
compliance was assured by routine interviews with the dietician and review of the computer’s
analysis of dietary records at every clinic visit. Routine follow-up by the dietician resulted in good
overall dietary compliance and accounted for the attainment, in many patients of normal cholesterol
levels in both the drug treatment. Results of those patients taking Abana showed a reduction of
cholesterol from 215.3 ± 7.42 mg/dl to 192.3 ± 9.08 mg/dl. Reduction in cholesterol from 204.2 ±
8.43 to 157.0 ± 7.54 mg/dl occurred with Simvastatin. Triglycerides levels were also reduced from
216.0 ± 26.37 mg/dl to 187.7 ± 21.28 mg/dl and 214.7 ± 34.09 to 173.5 ± 23.23 mg/dl with Abana
and Simvastatin respectively. In HDL, levels were increased in a similar fashion with Abana and
Simvastatin treatment. Although, the rise in HDL cholesterol was similar in both the drugs,
Simvastatin produced increase of HDL-cholesterol marginally higher than the Abana.
Level of lipids before and after treatment
133.0 ± 7.07 mg/dl to 115.4 ± 8.45 mg/dl and 115.1 ± 7.90 mg/dl to 81.55 ± 6.00 respectively. The VLDL levels were Total reduced from 41.57 ± 4.33 mg/dl to 39.53 cholesterol (mg/dl) ± 7.42 ± 9.08* ± 8.43 ± 4.16 mg/dl and 45.93 ± 6.77 mg/dl to Triglycerides Simvastatin respectively (Table). Thus, HDL (mg/dl) cholesterol, triglycerides, LDL and VLDL LDL (mg/dl) levels. The analysis of both drugs shows the reduction of cholesterol, triglycerides, *p<0.001 as compared to the before treatment value
LDL and VLDL in comparative manner. However, it is noticed that Simvastatin group presented
with more number of side-effects, especially the liver function tests.

DISCUSSION
High serum cholesterol is regarded by many as the main cause of coronary arherosclerosis13.
Several cholesterol lowering interventions have reduced coronary heart disease (CHD) events in
primary and secondary prevention clinical trials14,15. Even expert panels in Europe and the USA
have therefore recommended dietary changes and, if necessary, addition of drugs to reduce high
cholesterol concentrations especially low-density-lipoprotein (LDL) cholesterol16,17 especially in
patients with CHD. No statistically or clinically significant changes were seen in weight, blood
pressure, serum blood glucose levels, uric acid levels, or findings of other routine biochemical tests.
Until the mid-1990s, the importance of dyslipidaemia as a risk factor for coronary heart disease was
controversial, as was the use of lipid lowering treatment. However, after publication of the 4S trial
in 1994, four other trials confirmed significant reductions in fatal and non-fatal cardiovascular
events when statins were used in both primary and secondary prevention.
Many guidelines have been recommended for reducing levels of total cholesterol, triglycerides and
low-density lipoproteins to decrease risk for coronary heart disease. Most cardiologists agree that
adherence to these guidelines would reduce rates of morbidity and mortality from heart disease.
There is little doubt that elevated cholesterol levels increases the risk for coronary heart disease.
Observational research indicates that a linear relation exists: A 20% increase in risk for coronary
heart disease is associated with a 10% increase in serum cholesterol levels. This dose-response
effect occurs at any cholesterol level and is apparent in both men and women and in both black and
white persons.
Since many guidelines for the use of statins recommend in primary prevention in those with the
highest absolute risk of coronary heart disease, we decided to compare statins with the herbal
preparation Abana. Statins even though have proven to be highly effective in treating
hypercholesteremia; it has also shown to have adverse effects such as impotence. Abana however,
have shown that it is safe and effective in treatment of hypercholesteremia. In a study Abana
reduced total cholesterol, triglycerides and LDLc levels in patients with essential hypertension and
angina18,19. In other study conducted on lean and obese postmenopausal women showed reduction
in all the lipid levels after 12 weeks of therapy with increase in HDL levels20. In another study,
Abana increased the TC/HDLc ratio and increased HDLc levels thereby indicating that Abana
prevents atherosclerosis and reduces the risk of CHD.
Our findings show Abana to have the unique ability to lower serum low density cholesterol levels
with lowering of serum triglyceride levels without causing any side effects and the biochemical
tests showed that all the parameters were within normal limits before and after treatment. The
reduction of all the lipids was more aggressive in patients who were taking Simvastatin. However
there was marginal increase in the liver function tests.
CONCLUSION
According to our results, Abana and Simvastatin both produce significant reduction of cholesterol
and triglycerides. The fact that Simvastatin group had marginally increased incidence of side-
effects, Abana would be a safer alternative.

REFERENCES
1.
Gotto AM, Jr. Some reflections on arteriosclerosis: Past, present, and future. Circulation 1985; 72: 8-17. Muldoon MF, Manuck SB, Matthews KA. Lowering cholesterol concentrations and mortality: a quantitative review of primary prevention trials. BMJ 1990; 301: 309-14. Rossouw JE, Lewis B, Rifkind BM. The value of lowering cholesterol after myocardial infarction. N Engl J Med 1990; 323: 1112-9. Holme I. An analysis of randomised trials evaluating the effect of cholesterol reduction on total mortality and coronary heart disease incidence. Circulation 1990; 82: 1916-24. Ravnskov U. Cholesterol lowering trials in coronary heart disease: frequency of citation and outcome. BMJ 1992; 305: 15-9. Collins R, Keech A, Peto R, Sleight P, Kjekshus J, Wilhelmsen L, et al. Cholesterol and total mortality: need for larger trials? BMJ 1992; 304: 1689. Scandinvanian Simvastatin Survival Study Group. Randomized trail of cholesterol lowering in 4444 patients with coronary heart disease: Scandinvanian Simvastatin survival study (45). Lancet 1994; 344: 1383- 89. Shepard J, Cobbe S, Ford L, Isles C, Lorimer AR, MacFarlane PW et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med 1995; 333: 1301-09. Holzgartner J, Schmidt U, Kuhn U. Comparison of the efficacy of garlic preparation vs bezafibrate. Arzneim-Forsch Drug Res 1992; 42: 1473-77. 10. Agarwal RC, Singh SP, Saran RK et al. Clinical trial of guggul lipid new hypolipidemic agent of plant origin in primary hyperlipidaemia. Indian J Med Res 1986; 84: 626-34. 11. Nityanand S, Srivastava JS, Asthana OP. Clinical trials with gugulipid – A new hypolipidemic agent. J Assoc Phys India 1989; 37: 323-28. 12. Araghiniknam M, Chung S, Nelson-White T, et al. Antioxidant activity of dioscorea and dehydroepiandrosterone (DHEA) in older humans. Life Science 1996; 11: 147-57. 13. Gotto AM Jr, LaRosa JC, Hunninghake D, et al. The cholesterol facts. A summary of the evidence relating dietary facts, serum cholesterol and coronary heart disease. Circulation 1990; 81: 1721-33. 14. Leren P. The Oslo Diet Heart Study: eleven-year report. Circulation 1970; 42: 935-42. 15. Buchwald H, Varco RL, Matts JP, et al. Effect of partial ileal bypass on mortality and morbidity from coronary heart disease in patients with hypercholesterolemia-report of the program on the Surgical Control of Hyperlipidaemias (POSCH). N Engl J Med 1990; 323: 946-55. 16. Expert panel on detection, evaluation and treatment of high blood cholesterol in adults. Summary of the second report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, evaluation and treatment of high blood cholesterol in adults (adult treatment panel II). JAMA 1993; 269: 3015-23. 17. Pyorala K, De Becker G, Graham I, on behalf of the Task Force. Prevention of coronary heart disease in clinical practice. Recommendations of the task force of the European Society of Cardiology, European Atherosclerosis Society and European Society of Hypertension. Eur Heart J 1994; 15: 1300-31. 18. Tiwari, A.K., Shukla, S.S., Agarwal, A and Dubey,G.P. “Hypolipidaemic Action of Abana”. Alternative Medicine 1990; 3: 139. 19. Tiwari, A.K., Agrawal, A., Gode, J.D. and Dubey, G.P. “A prospective randomised crossover study of propranolol and Abana in hypertensive patients: Effect of lipids and lipoproteins. The Antiseptic 1991; 88: 41. 20. Pratima Shukla, Aruna Agrawal, Tiwari, A.K. and Dubey, G.P. “Effect of Abana on the lipid profiles on lean and obese postmenopausal women-A double-blind placebo controlled trial. The Med. & Surg 1993; 32(5/6/7): 25.

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