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Fulltext Generic atorvastatin is as effective as the brand-name drug (LIPITOR®) in lowering cholesterol levels: a cross-sectional retrospective cohort study

Loch A, Bewersdorf JP, Kofink D, Ismail D, Abidin IZ, Veriah RS

BMC Res Notes, 2017 Jul 17;10(1):291.
PMID: 28716156 DOI: 10.1186/s13104-017-2617-6

BACKGROUND: In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin.
METHODS: This cross-sectional, retrospective cohort study was conducted at the University of Malaya Medical Centre from 1 May 2013 until 30 May 2013. We analyzed the lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) of 629 patients before and at least 3 months after switching them from proprietary atorvastatin (Lipitor®) to generic atorvastatin (atorvastatin calcium from Ranbaxy Laboratories, Inc.). We also investigated if there was any difference in the effectiveness of both atorvastatin formulations in various ethnic groups.
RESULTS: 266 patients were included in this study. When comparing the median values we found no statistically significant differences (Wilcoxon signed-rank test; p cholesterol (4.60 mmol/l pre-transition vs. 4.50 mmol/l post-transition; p = 0.583), LDL-cholesterol (2.42 mmol/l vs. 2.41 mmol/l; p = 0.923) and triglycerides (1.50 mmol/l vs. 1.50 mmol/l; p = 0.513). While there was a statistically significant (p = 0.009) difference in HDL-cholesterol levels favouring proprietary atorvastatin, the extent of this change (1.26 mmol/l vs. 1.25 mmol/l) was deemed not to be clinically relevant. There was no statistically significant difference when analyzing the effects on various ethnic groups.
CONCLUSIONS: Substituting proprietary atorvastatin for its generic formulation atorvastatin calcium does not result in a less effective management of hyperlipidemia. Our findings lend support to the approach of lowering health care costs by switching patients from branded drugs to their less expensive generic analogues.

Matched MeSH terms: Cholesterol, LDL/drug effects*
Comparison of the efficacy and level of adherence for morning versus evening versus before bedtime administration of simvastatin in hypercholesterolemic patients

Heng WK, Ng YP, Ooi GS, Habshoh J, Nurazlin J, Nor Azah MN, et al.

Med J Malaysia, 2019 12;74(6):477-482.
PMID: 31929472

BACKGROUND: Simvastatin is usually taken in the evening due to the circadian rhythm of hepatic cholesterol biosynthesis. The degree of reduction of low-density lipoprotein cholesterol (LDL-C) and the level of adherence to different administration time remained unknown in the Malaysian population. This study aims to investigate the effect of simvastatin on the percentage changes of lipid profile and the level of adherence to when simvastatin was instructed to be taken at different timing.
METHODS: Nine primary care health clinics across Malaysia participated in this study. 147 statin-naive subjects were selected through convenient sampling and randomised into one of the three arms (after breakfast, after dinner or before bedtime). Differences on percentage reduction of LDL-C from baseline and level of adherence among the three groups at week-16 were compared. The main outcomes measured in this study were the percentage change of lipid parameters and the percentage of high-adherence (MMAS=8) at week-16.
RESULTS: 59.2% of the patients were male. The mean age of the study population was 53.93± 10.85 years. Most of the patients were Malays (69.4%); followed by Indians (22.4%) and Chinese (8.2%). LDL-C decreased from 4.26 (Standard Deviation, SD1.01) to 2.36 (SD0.69)mmol/L at week-16 for patients taking simvastatin before bedtime; an absolute reduction of 44.95%.The differences of LDL-C percentage reduction between three arms were significantly different (p<0.001). The greatest LDL-C reduction was observed when simvastatin was taken before bedtime and revealed 56.2% patients with high-adherence at week-16.
CONCLUSION: Simvastatin showed superior LDL-reduction and higher level of adherence when being instructed to be taken before bedtime.

Matched MeSH terms: Cholesterol, LDL/drug effects
Fulltext Do Singapore patients require lower doses of statins? The SGH Lipid Clinic experience

Tan CE, Loh LM, Tai ES

Singapore Med J, 2003 Dec;44(12):635-8.
PMID: 14770258

A substantial number of physicians in Asian countries believe that Asian patients need lower doses of statins to achieve therapeutic lipid target because of the smaller size of patients. This belief is deep rooted and we looked at the SGH Lipid Clinic to determine if our experience bears out this belief. Between 1996 and August 2000, the Lipid Unit treated a total of 841 patients, of which 548 patients (77.5% Chinese, 12.1% Malays, 7.6% Asian Indians; 49.6% males, 50.4% females; 54.7% diabetics, 45.3% non-diabetic) were on statins alone. These patients had > or =2 coronary risk factors, diabetes mellitus or documented coronary heart disease. The pre-treatment lipid levels or the worst lipid levels available were entered as the baseline lipid values (mean LDL-C: 5.38+1.5 mmol/l). Duration of therapy ranged from six months to five years. The choice and titration of statins were determined by attending physicians. The median statin dose (Simvastatin equivalent) was 20.0 mg with 52.5% requiring 20 mg or more. Statin dose did not differ between diabetic and non-diabetic subjects. The median statin dose was 15 mg for the lower two tertiles and 20 mg for the upper tertile; this difference did not achieve statistical significance. The reduction in LDL cholesterol was 41.5% (40.1-42.8) and total cholesterol was 33.0% (32.9-34.1). Only 25% of our patients achieved LDL cholesterol of less than 2.6 mmol/l whilst 77.5% had LDL cholesterol less than 3.4 mmol/l. Our experience at the Lipid Clinic suggests that the Asian patients require similar statin doses to achieve target cholesterol levels.

Matched MeSH terms: Cholesterol, LDL/drug effects*
Prevalence of lipid abnormalities and attainment of normal lipid levels among patients with dyslipidaemia: a pooled analysis of observational studies from five Asian countries

Unniachan S, Bash LD, Khovidhunkit W, Sri RZ, Vicaldo E, Recto C, et al.

Int J Clin Pract, 2014 Aug;68(8):1010-9.
PMID: 24666791 DOI: 10.1111/ijcp.12407

Guidelines emphasise the importance of low-density lipoprotein cholesterol (LDL-C) goals for cardiovascular risk reduction. Given the importance of association between high-density lipoprotein (HDL-C) and triglycerides (TG) normal levels and cardiovascular risk, there is an additional need to further evaluate diverse dyslipidaemic populations.

Matched MeSH terms: Cholesterol, LDL/drug effects*
Colesevelam for Type 2 diabetes mellitus: an abridged Cochrane review

Ooi CP, Loke SC

Diabet Med, 2014 Jan;31(1):2-14.
PMID: 24024701 DOI: 10.1111/dme.12295

Colesevelam, a second-generation bile acid sequestrant, may be beneficial in controlling both glycaemia and lipids simultaneously. Our goal was to evaluate the systemic effects of colesevelam on Type 2 diabetes mellitus.

Matched MeSH terms: Cholesterol, LDL/drug effects
Fulltext Glycaemic control of diabetic patients in an urban primary health care setting in Sarawak: the Tanah Puteh Health Centre experience

Wong JS, Rahimah N

Med J Malaysia, 2004 Aug;59(3):411-7.
PMID: 15727390 MyJurnal

Achieving glycaemic goals in diabetics has always been a problem, especially in a developing country with inadequate facilities such as in Sarawak in Malaysia. There are no reported studies on the control of diabetes mellitus in a diabetic clinic in the primary health care setting in Sarawak. This paper describes the profile of 1031 patients treated in Klinik Kesihatan Tanah Puteh Health Centre. The mean age was 59 years, the mean BMI 27 kg/m2. There was a female preponderance and mainly type-2 diabetes. Mean HbA1c was 7.4%. Glycaemic control was optimal in 28% (HbA1c <6.5%), fair in 34% (HbA1c 6.5-7.5%) and poor in 38% (HbA1c >7.5%). Reasonable glycaemic control can be achieved in the primary health care setting in Sarawak.
Study site: Klinik Kesihatan Tanah Puteh, Sarawak, Malaysia

Matched MeSH terms: Cholesterol, LDL/drug effects
The effect of Malaysian cocoa extract on glucose levels and lipid profiles in diabetic rats

Ruzaidi A, Amin I, Nawalyah AG, Hamid M, Faizul HA

J Ethnopharmacol, 2005 Apr 8;98(1-2):55-60.
PMID: 15763363

The present study aims to investigate the effect of cocoa extract on serum glucose levels and lipid profiles in streptozotocin-diabetic rats. Cocoa extract (contained 285.6 mg total polyphenol per gram extract) was prepared from fermented and roasted (140 degrees C, 20 min) beans by extracting using 80% ethanol in the ratio of 1-10. The extract of three dosages (1, 2, and 3%) was fed to normal and diabetic rats for a period of 4 weeks. In hyperglycaemic group, cocoa extract (1 and 3%) diets were found to significantly lower (p<0.05) the serum glucose levels compared to the control. Furthermore, supplementation of 1 and 3% cocoa extract had significantly reduced (p<0.05) the level of total cholesterol in diabetic rats. In addition, 1, 2, and 3% cocoa extract diets had significantly lowered (p<0.05) the total triglycerides. Interestingly, this study found that serum HDL-cholesterol had increased significantly (p<0.05) in diabetic rats fed with 2% cocoa extract, while the LDL-cholesterol had decreased significantly (p<0.05) in the 1% treated group. These results indicate that cocoa extract may possess potential hypoglycaemic and hypocholestrolemic effects on serum glucose levels and lipid profiles, respectively. The results also found that the effect of cocoa extract was dose-dependent.

Matched MeSH terms: Cholesterol, LDL/drug effects