Statin therapy has disappointing results in Chinese patients

by Michael Woodhead
Only about one in four Chinese patients taking a statin have their cholesterol levels under control, according to a new study.

A review of the effects of statin therapy in 8965 outpatients with cardiovascular disease from 200 clinical departments of 122 hospitals across China found that about 75% of patients still had poorly controlled lipid levels.

The findings, published in the International Journal of Cardiology showed that despite taking long term statin therapy in medium to high doses, about 75% of patients had an above-target LDL-cholesterol level. In a similar manner elevated levels of total cholesterol and triglycerides as well as low HDL-cholesterol persisted in 34–43% of patients despite statin therapy, according to Professor Wei Yidong and colleagues at the Department of Cardiology, Shanghai Tenth People’s Hospital and Tongji University School of Medicine.

Only about 10% of patients overall had optimal levels of all lipid measures (LDL, HDL and triglycerides) despite taking statins. Patients with diabetes had slightly better control of lipid levels (43%) compared to those without diabetes (39%).

The study authors said it was not clear why patients taking statins did not have good control of their lipid levels. Oddly, there appeared to be no relationship between the potency of the statin doses and the degree of lipid level control.

About 77% of patients taking low doses of statins had LDL-C not at goal, compared to 72% of patients taking medium potency regimens and 74% of patients taking high potency courses of statins.
Chinese patients may need more intensive lipid-lowering therapy with additional agents other than statins, to improve their lipid levels. Patients may also need more attention on lifestyle factors such as diet and exercise before starting statin therapy, they added.

However, they could not rule out poor adherence to treatment a a possible cause of the poor lipid control.

6 clinical stories from China

1. Abuse of prescription and over-the-counter drugs is  common among Chinese high school students, a study from Guangzhou has shown. The survey of more than 20,000 students found that more than one in twenty had abused medical drugs at some time. The most common drugs of abuse were analgesics (4%), followed by cough syrups with codeine (2%) and valium or tramadol (1%). Peer pressure was one of the major influences in illicit use of prescription and OTC drugs, and it was also more common in children who already smoked, according to researcher Dr Wang Hui of the Guangzhou Centre for Disease Control and Prevention, writing in the journal Drug and Alcohol Dependance.


2. The agricultural practice of burning straw is a major overlooked contributor to smog and air pollution in Chinese cities, say respiratory physicians from the Shanghai Jiao Tong University Affiliated Sixth People’s Hospital. Burning straw caused PM2.5 levels to reach 194 μg/m3 in Nanjing, which far exceeded the daily average maximum allowable concentration of 75 μg/m3, they note in the American Journal of Infection Control. The pollution is linked to respiratory illness and infections such as pneumonia, they say, and thus needs to be regulated.

3. China has a north-south divide when it comes to hypertension in children, a new review has found. shows. Children and adolescents in the north China have hypertension rates of  18% (Beijing) or 23% (Shandong) whereas those in South of China including Shanghai and Changsha have hypertension rates ranging from 3% to 11%, according to researchers from School of Public Health, Shandong University, Jinan. The higher prevalence of hypertension in the north might be due to higher dietary salt intake they say in the International Journal of Cardiology. 

4. The inherited condition of highly-elevated cholesterol levels, familial hypercholesterolaemia, occurs in about one in 200 Chinese people but is rarely detected, a study from Jiangsu suggests. In a study of more than 9000 people they found that about 0.5% had the condition, which confers a very high risk of cardiovascular disease and early death. They suggest that screening to aid detection and family tracing is carried out by hospital cardiology departments.

5. Gastric cancers account for a fifth of all cancer deaths in China and are especially common in younger women, a study from Guangzhou has found. The review of more than 2000 cases of gastric cancer found that the malignancy was common in older men but was also frequently seen in women under the age of 40.  Most patients had advanced stage disease at diagnosis, suggesting that better detection and treatment of early gastric cancer  is needed.

6. Chinese children are at risk from inappropriate prescribing of medicines, say paediatricians in a letter to The Lancet this week. Dr Tang Wenchu and colleagues from the First People's Hospital of Huzhou University Medical College, Zhejiang, say about a third of medicines taken by children are indiscriminately prescribed, and children are also at risk because there are few paediatric formulations of medication in China. The lack of a national adverse drug reaction surveillance system also means that children may have side effects that are not acted on, they say.

No benefit from high dose atorvastatin: Hunan study

For people who have had a heart attack, taking a high dose of atorvastatin (up to 40mg/day) has no added benefit over a moderate dose (10mg/day) a study has shown.
In a two year clinical trial involving more than 1300 patients with acute coronary syndromes (ACS), cardiologists from the Second Xiangya Hospital of Central South University, Changsha, found that the dose of statin had no impact on the primary end points of cardiac death, non-fatal acute myocardial infarction, revascularization, ischaemic stroke and unstable angina or severe heart failure requiring emergency hospitalization. The patients' lipid levels were low initially (mean LDL cholesterol level of 2.7mmol/L) and declined by 20% in the moderate dose statin group and 27% in the intensive statin group, respectively.
"For ACS patients with a relatively low baseline LDL cholesterol level who received optimized current medication and interventional therapy, the incremental LDL cholesterol reduction of 6.4% achieved by double-dose statin did not bring significant clinical effectiveness," the researchers concluded.
The findings are published in Atherosclerosis.

Chinese women with PCOS have high rates of hypertension and metabolic abnormalities

by Michael Woodhead

One in five Chinese women with Polycystic Ovarian Syndrome (PCOS) have hypertension, almost twice the rate of other women, a study from Shandong has found.

Women with PCOS also had abnormal lipid, insulin and glucose levels compared to women without PCOS according to a study conducted by Dr Shi Yuhau and co-researchers at the Reproductive Medicine Hospital Affiliated to Shandong University, Jinan.

The researchers studies 3396 women with PCOS and 1891 controls They found the prevalence of hypertension to be 19.2% in the women with PCOS, which was much higher than that in the controls (11.9%). After matching for BMI, the hypertensive PCOS group had significantly higher glucose, insulin, and lipid levels than the normotensive PCOS group; these differences were significant.

The researchers said the likelihood of long-term metabolic complications was high in hypertensive PCOS patients.

 “These findings underscore the importance of preventive strategies in women with PCOS in order to prevent hypertension,” they said.

“Cardiac risk factors associated with PCOS have public health implications and should drive early screening and intervention measures. Fasting lipid profiles and glucose examinations should be performed regularly. Treatment of the associated cardiovascular risk factors, including insulin resistance, hypertension and dyslipidaemia, should be incorporated into routine PCOS patient wellness care programmes. These results suggest that it is importance to control weight and blood pressure in women with PCOS in order to reduce their excess risk of future complications. “

Read the full study in: European Journal of Obstetrics & Gynecology and Reproductive Biology

Chinese trial results sink hopes for niacin as lipid therapy

Niacin (Tredaptive) caused higher rates of myopathy in Chinese patients

Results from a Chinese trial have forced Merck to drop plans to seek U.S. regulatory approval for the lipid modifying drug niacin after it failed to reduce the risk of heart attacks and strokes, while increasing the risk of adverse health events.
The company also recommended doctors not start new patients on the combination of niacin and an anti-flushing drug (Tredaptive) in the approximately 40 countries where it is sold outside the U.S.
The negative outcome deals a blow to Merck, which has been trying to bring new drugs to market to help offset patent expirations for top drugs that have triggered sales-eroding generic competition.
The drug's failure also reinforces questions about the effectiveness of niacin - the key component of Tredaptive, as well as the broader strategy of seeking to raise levels of good cholesterol as a way to combat cardiovascular disease.
Tredaptive is a single-pill combination of niacin, a B vitamin that has been available for more than half a century, with a Merck-developed compound called laropiprant. Niacin is known primarily for increasing levels of good cholesterol, which theoretically should help ward off heart attacks and other cardiovascular events. Niacin also has been shown to lower bad cholesterol and triglycerides, a fatty substance in the bloodstream.
Laropiprant is designed to inhibit a common side effect of niacin, a reddening of the skin known as flushing.
Merck believed the flushing side effect has hampered the use of niacin and that combining it with laropiprant would make the drug more palatable to patients.
Merck initially applied in 2007 for U.S. Food and Drug Administration approval of Tredaptive, based on studies showing it improved cholesterol levels and inhibited flushing. But the FDA declined to approve it, asking Merck to wait for the outcome of a study called "HSP2-Thrive."
HPS2-Thrive tested whether adding Tredaptive to a regimen including simvastatin—which belongs to an older class of cholesterol-lowering drugs known as statins—reduces cardiovascular risk compared with the statin therapy alone.
The University of Oxford's clinical trial service unit conducted the HPS2-Thrive study, which enrolled about 25,670 patients at high risk of heart attack and related cardiovascular events. Of those enrolled, 14,741 were from Europe—the U.K. and Scandinavia—and 10,932 were from China, Merck said. Patients in the study were followed for a median of 3.9 years.
Merck said Thursday that Tredaptive plus statin therapy didn't significantly reduce the risk of the combination of coronary deaths, nonfatal heart attacks, strokes or procedures known as revascularizations, compared with statin therapy.
There was a statistically significant increase in the incidence of some types of nonfatal serious adverse events in the group that received Tredaptive.
The Oxford Clinical Trial Service Unit said in a separate statement posted online that it would present full results in the first quarter of 2013. One of the study investigators, Richard Haynes, said: "It has long been known that niacin causes a number of side effects, and the HPS2-Thrive study allows these to be explored in more detail."
The Oxford researchers earlier said that the Chinese patients seemed to be more prone to myopathy with niacin
Source: WSJ

Is turtle jelly the Chinese answer to Lipitor?

The traditional Chinese food of turtle jelly (also known as 龟苓膏 or Guilinggao) in southern China has anti-cholesterol effects, a study shows.
The hypocholesterolemic effects of turtle jelly were investigated in rats and it was found that turtle jelly markedly reversed the increased serum total cholesterol, increased LDL lipoprotein, and decreased HDL lipoprotein induced by hypercholesterolemic diet with a dose-dependent improvement on the atherogenic index. It also demonstrated good hepatoprotective function by reducing fat depositions and overall lipid contents in the liver and increasing the activities of hepatic antioxidative enzymes. The blunted nitric oxide/endothelium-mediated aortic relaxation in rats fed with hypercholesterolemic diet was partially restored after turtle jelly consumption. It is postulated that the hypocholesterolemic effect is the primary beneficial effect given by turtle jelly; it then leads to secondary beneficial effects such as vasoprotective and hepatoprotective functions. The results suggest that turtle jelly may block the downregulation of LDLR and PEPCK and upregulation of PPARα mRNA and protein expressions in the livers of rats fed with hypercholesterolemic diet.
Source: Evidence based Alternative and Complementary Medicine.