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Fulltext Comparing survival in patients with chronic kidney disease across three countries - Results from the study of heart and renal protection-extended review

Talbot B, Cass A, Walker R, Hooi L, Jardine M, Jun M, et al.

Nephrology (Carlton), 2023 Jan;28(1):36-43.
PMID: 36309984 DOI: 10.1111/nep.14127

AIM: This study examined whether survival and causes of death differed between participants enrolled from Australia (AUS), Malaysia (MYL), and New Zealand (NZ) in extended follow-up of the Study of Heart and Renal Protection (SHARP), a randomized controlled trial (RCT) of participants with moderate to severe chronic kidney disease comparing placebo to combination therapy with Simvastatin and Ezetimibe.
METHODS: All participants alive at final SHARP study visit in participating centres were eligible for inclusion. Consenting participants were re-enrolled following final SHARP Study visit and followed for 5 years. Data collection included: significant medical events, hospital admissions and requirement for kidney replacement therapy. Data linkage was performed to national kidney and mortality registries. The primary outcome was all-cause mortality compared across the three countries.
RESULTS: The SHARP trial randomized 2029 participants from AUS (1043/2029, 51%), MYL (701/2029, 35%), and NZ (285/2029, 14%), with 1136 participants alive and eligible for extended follow-up at the end of SHARP. In multivariable analysis, risk of death was increased for participants in MYL (HR 1.37, 95% CI 1.17-1.61, p

Matched MeSH terms: Simvastatin/therapeutic use
Role of Simvastatin on fracture healing and osteoporosis: a systematic review on in vivo investigations

Moshiri A, Sharifi AM, Oryan A

Clin Exp Pharmacol Physiol, 2016 Jul;43(7):659-84.
PMID: 27061579 DOI: 10.1111/1440-1681.12577

Simvastatin is a lipid lowering drug whose beneficial role on bone metabolism was discovered in 1999. Several in vivo studies evaluated its role on osteoporosis and fracture healing, however, controversial results are seen in the literature. For this reason, Simvastatin has not been the focus of any clinical trials as yet. This systematic review clears the mechanisms of action of Simvastatin on bone metabolism and focuses on in vivo investigations that have evaluated its role on osteoporosis and fracture repair to find out (i) whether Simvastatin is effective on treatment of osteoporosis and fracture repair, and (ii) which of the many available protocols may have the ability to be translated in the clinical setting. Simvastatin induces osteoinduction by increasing osteoblast activity and differentiation and inhibiting their apoptosis. It also reduces osteoclastogenesis by decreasing both the number and activity of osteoclasts and their differentiation. Controversial results between the in vivo studies are mostly due to the differences in the route of administration, dose, dosage and carrier type. Local delivery of Simvastatin through controlled drug delivery systems with much lower doses and dosages than the systemic route seems to be the most valuable option in fracture healing. However, systemic delivery of Simvastatin with much higher doses and dosages than the clinical ones seems to be effective in managing osteoporosis. Simvastatin, in a particular range of doses and dosages, may be beneficial in managing osteoporosis and fracture injuries. This review showed that Simvastatin is effective in the treatment of osteoporosis and fracture healing.

Matched MeSH terms: Simvastatin/therapeutic use*
Fulltext Using primary care prescribing databases to determine drug switching and continuation of care

Mohamed IN, Helms PJ, McLay JS

Basic Clin Pharmacol Toxicol, 2012 Dec;111(6):396-401.
PMID: 22734606 DOI: 10.1111/j.1742-7843.2012.00917.x

Drug switching is a common medical practice. It indicates continuation of treatment regardless of the reason why the original therapy was stopped and switched. Therefore, the aims of this study were to develop a novel method for determining drug switching from routinely acquired NHS health data and to explore the aspect of continuation of care for patients. Patients who were first prescribed ramipril, simvastatin and an angiotensin receptor blocker (ARB) between 1 March 2004 and 28 February 2007 and discontinued their medication within 6 months of the index prescription were identified from the PTI database. The identified patients were then categorized into three groups: i) patients who were switched to a different drug for the same medical condition, ii) patients who were being prescribed with other types of antihypertensive/lipid-regulating drug prior to the initiation of study; and iii) patients who were without any continuation of care or therapy. Twenty percent (808), 29%(1429) and 14%(455) of the identified patients discontinued ramipril, simvastatin and ARB, respectively, within 6 months of an index prescription. Among the ramipril discontinuation group, 36.4% of the patients were switched to another antihypertensive, while another 31.6% of them were without continuation of care. In patients discontinuing ARB, 30.6% were switched, while another 30.1% were without continuation of treatment. In patients discontinuing simvastatin, 28.8% were switched to another lipid-regulating medicine, while another 63.1% of them were without continuation of care. The results of this study confirm that primary care prescribing databases can be used to determine drug-switching information and continuation of care/therapy.

Matched MeSH terms: Simvastatin/therapeutic use
Fulltext Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study

Hing Ling PK, Civeira F, Dan AG, Hanson ME, Massaad R, De Tilleghem Cle B, et al.

Lipids Health Dis, 2012;11:18.
PMID: 22293030 DOI: 10.1186/1476-511X-11-18

A considerable number of patients with severely elevated LDL-C do not achieve recommended treatment targets, despite treatment with statins. Adults at high cardiovascular risk with hypercholesterolemia and LDL-C ≥ 2.59 and ≤ 4.14 mmol/L (N = 250), pretreated with atorvastatin 20 mg were randomized to ezetimibe/simvastatin 10/40 mg or atorvastatin 40 mg for 6 weeks. The percent change in LDL-C and other lipids was assessed using a constrained longitudinal data analysis method with terms for treatment, time, time-by-treatment interaction, stratum, and time-by-stratum interaction. Percentage of subjects achieving LDL-C < 1.81 mmol/L, < 2.00 mmol/L, or < 2.59 mmol/L was assessed using a logistic regression model with terms for treatment and stratum. Tolerability was assessed.

Matched MeSH terms: Simvastatin/therapeutic use*
A randomised comparison of simvastatin versus simvastatin and low cholesterol diet in the treatment of hypercholesterolaemia

Thuraisingham S, Tan KH, Chong KS, Yap SF, Pasamanikam K

Int J Clin Pract, 2000 Mar;54(2):78-84.
PMID: 10824361

There is little evidence to show that strict dietary modification alone confers any significant impact on cardiac events in primary and secondary prevention of coronary heart disease. Given the efficacy of the statins, the need for strict dietary modification in patients on statin therapy has been questioned. This study was performed to assess 1) the added benefit on serum lipid levels of a strict low-fat dietary regimen in patients with hypercholesterolaemia already treated with simvastatin; 2) the efficacy of simvastatin on the lipid profile of our sample Asian population; and 3) the tolerability and side-effect profile of simvastatin. This study was a prospective evaluation of 60 patients with hypercholesterolaemia treated with simvastatin who were subjected to either a normal diet or a dietitian guided low-fat diet. Assessment of the effects on serum lipid levels, side-effects, biochemical and haematological markers were performed. After 24 weeks of treatment, a strict dietitian guided low-fat diet conferred no additional benefit over and above what was achieved by simvastatin alone. Furthermore, a higher dose of simvastatin was needed in the dietitian guided diet group to achieve the target LDL-cholesterol level. Simvastatin resulted in a significant positive alteration of lipid profiles in all patients. The drug was well tolerated, with no significant change in either haematological or biochemical indices. Simvastatin is a highly effective cholesterol-lowering drug with a beneficial effect on the entire lipid spectrum in a cross-section of Asian patients, and is well tolerated. A dietitian guided dietary approach confers no additional advantage once statin therapy has been initiated.

Matched MeSH terms: Simvastatin/therapeutic use*
Fulltext Low-density lipoprotein cholesterol goal attainment among Malaysian dyslipidemic patients

Al-Khateeb A, Mohamed MS, Imran K, Ibrahim S, Zilfalill BA, Yusof Z

Southeast Asian J Trop Med Public Health, 2011 Mar;42(2):388-94.
PMID: 21710862

The aim of the present study was to evaluate Malaysian dyslipidemic patient treatment practices and outcomes. Factors contributing to success in reaching treatment goal were determined. A retrospective review of the records of dyslipidemic patients who attended the Universiti Sains Malaysia Hospital in 2007 was conducted. All the patients were receiving standard recommended doses of statins. Records were analysed for 890 patients. Patients were divided into three categories: 384 patients (43.1%) had coronary heart disease or coronary heart disease risk equivalents, 216 patients (24.3%) had moderate risk for coronary heart disease and 290 patients (32.6%) had low risk. Statins were the most commonly prescribed drug group (92%), of which atorvastatin was the most commonly prescribed drug (50.6%). The overall success rate for reaching goal was 64.2%. The percentages of patients achieving low-density lipoprotein cholesterol targets in the coronary heart disease and coronary heart disease risk equivalents, moderate, and low-risk groups were 50.5, 66.7, and 80.3%, respectively (p < 0.001). Multiple logistic regression showed achievement of therapeutic goal declined with increasing risk group. The baseline low-density lipoprotein cholesterol value was inversely related to therapeutic goal attainment. An inadequate proportion of dyslipidemic patients achieved the National Cholesterol Education Program therapeutic goals for low-density lipoprotein cholesterol, especially those in the coronary heart disease and coronary heart disease risk equivalent group. The achievement of this goal was dependent on baseline low-density lipoprotein cholesterol levels.

Matched MeSH terms: Simvastatin/therapeutic use
In-vivo evaluation of Alginate-Pectin hydrogel film loaded with Simvastatin for diabetic wound healing in Streptozotocin-induced diabetic rats

Rezvanian M, Ng SF, Alavi T, Ahmad W

Int J Biol Macromol, 2021 Feb 28;171:308-319.
PMID: 33421467 DOI: 10.1016/j.ijbiomac.2020.12.221

Previously we developed and characterized a novel hydrogel film wound dressing containing Sodium Alginate and Pectin loaded with Simvastatin with multi-functional properties. This study investigated the in-vivo efficacy of the developed wound dressing on type I diabetic wound model. Experiments were performed on male Wistar rats for the period of 21-days. Animals developed diabetes after intraperitoneal injection (50 mg/kg) of Streptozotocin then randomly divided into different groups. On days 7, 14, and 21 of post-wounding, animals were euthanized and the wounds tissue were harvested for analysis. The wound healing rate, hematology and histological analysis, hydroxyproline assay, and Vascular Endothelial Growth Factor A measurements were noted. The results revealed that the wound dressing healed the wounded area significantly (p Simvastatin. Thus, the present study demonstrated that developed film holds great potential for the acceleration of diabetic wound healing by its pro-angiogenic effect, faster re-epithelialization and increased collagen deposition.

Matched MeSH terms: Simvastatin/therapeutic use
Fulltext Statin Treatment and Clinical Outcomes of Heart Failure Among Africans: An Inverse Probability Treatment Weighted Analysis

Bonsu KO, Owusu IK, Buabeng KO, Reidpath DD, Kadirvelu A

J Am Heart Assoc, 2017 Apr 01;6(4).
PMID: 28365564 DOI: 10.1161/JAHA.116.004706

BACKGROUND: Randomized control trials of statins have not demonstrated significant benefits in outcomes of heart failure (HF). However, randomized control trials may not always be generalizable. The aim was to determine whether statin and statin type-lipophilic or -hydrophilic improve long-term outcomes in Africans with HF.
METHODS AND RESULTS: This was a retrospective longitudinal study of HF patients aged ≥18 years hospitalized at a tertiary healthcare center between January 1, 2009 and December 31, 2013 in Ghana. Patients were eligible if they were discharged from first admission for HF (index admission) and followed up to time of all-cause, cardiovascular, and HF mortality or end of study. Multivariable time-dependent Cox model and inverse-probability-of-treatment weighting of marginal structural model were used to estimate associations between statin treatment and outcomes. Adjusted hazard ratios were also estimated for lipophilic and hydrophilic statin compared with no statin use. The study included 1488 patients (mean age 60.3±14.2 years) with 9306 person-years of observation. Using the time-dependent Cox model, the 5-year adjusted hazard ratios with 95% CI for statin treatment on all-cause, cardiovascular, and HF mortality were 0.68 (0.55-0.83), 0.67 (0.54-0.82), and 0.63 (0.51-0.79), respectively. Use of inverse-probability-of-treatment weighting resulted in estimates of 0.79 (0.65-0.96), 0.77 (0.63-0.96), and 0.77 (0.61-0.95) for statin treatment on all-cause, cardiovascular, and HF mortality, respectively, compared with no statin use.
CONCLUSIONS: Among Africans with HF, statin treatment was associated with significant reduction in mortality.

Matched MeSH terms: Simvastatin/therapeutic use