High olive oil consumption has a protective role

A protective role for high olive oil consumption on the risk of stroke in older subjects has been suggested by a study published online on 15^th June, 2011 in Neurology 2011;77:1–1

Sameiri C from From the Research Center INSERM, U897, Department of Nutritional Epidemiology, France determined whether high olive oil consumption, and high plasma oleic acid (as an indirect biological marker of olive oil intake), are associated with lower incidence of stroke in older subjects. They enrolled participants from the Three-City Study with no history of stroke at baseline.

They found that in the main sample, 148 incident strokes occurred. After adjustment for sociodemographic and dietary variables, physical activity, body mass index, and risk factors for stroke, a lower incidence for stroke with higher olive oil use was observed (p for trend = 0.02). Compared to those who never used olive oil, those with intensive use had a 41% lower risk of stroke. It was also seen that higher plasma oleic acid was associated with lower stroke incidence. Compared to those in the first tertile, participants in the third tertile of plasma oleic acid had a 73% reduction of stroke risk.

The authors concluded that in the present population-based study, intensive olive oil use was prospectively associated with a lower stroke risk after controlling for numerous confounding factors, including lifestyle and nutritional factors, main stroke risk factors, and blood lipids.

Statin therapy associated with excess risk of developing diabetes mellitus

Priess D and colleagues from BHF Glasgow Cardiovascular Research Centre, University of Glasgow, United Kingdom conducted a meta-analysis to investigate whether intensive-dose statin therapy is associated with increased risk of new-onset diabetes compared with moderate-dose statin therapy. They included all randomized controlled end-point trials (January 1, 1996, through March 31, 2011) that compared intensive-dose statin therapy with moderate-dose statin therapy and had more than 1000 participants with > 1 year follow-up.

They found that in 5 statin trials with 32 752 participants without diabetes at baseline, 2749 developed diabetes (2.0 additional cases in the intensive-dose group per 1000 patient-years) and 6684 experienced cardiovascular events (6.5 fewer cases in the intensive-dose group per 1000 patient-years) over a weighted mean (SD) follow-up of 4.9 (1.9) years. Odds ratios were 1.12 for new-onset diabetes and 0.84 for cardiovascular events for participants receiving intensive therapy compared with moderate-dose therapy.

The authors concluded that in a pooled analysis of data from 5 statin trials, intensive-dose statin therapy was associated with an increased risk of new-onset diabetes compared with moderate-dose statin therapy.

http://www.ncbi.nlm.nih.gov/pubmed/21693744

PPI use associated with antifracture activity of Alendronate

The use of PPIs to control upper GIT complaints in patients treated with oral bisphosphonates should be discouraged according to a study published on 13^th June, 2011 online in Archives of Internal Medicine.

Bo Abrahamsen, MD, PhD from Institute of Clinical Research, Denmark and colleagues conducted a population-based, national register–based, open cohort observational study of 38 088 new alendronate sodium users with a mean duration of follow-up of 3.5 years.  They related risk of hip fracture to recent pharmacy records of refill of prescriptions for alendronate.

They found that for hip fractures, there was a statistically significant interaction with alendronate for PPI use (P < .05). The treatment response associated with complete refill compliance to alendronate was a 39% risk reduction (P < .001) in patients who were not PPI users, while the risk reduction in concurrent PPI users was not significant (P = .06). It was found that decrease of the risk reduction was dependent on dose and age. In contrast, there was no significant impact of concurrent use of histamine H₂ receptor blockers.

The authors concluded that the concomitant use of PPI and alendronate was associated with a dose-dependent loss of protection against hip fracture with alendronate in elderly patients.

http://archinte.ama-assn.org/cgi/content/abstract/171/11/998?etoc.

Consumption of coffee independent predictor of improved virologic response to therapy in hepatitis C patients

High-level consumption of coffee (more than 3 cups per day) is an independent predictor of improved virologic response to peginterferon plus ribavirin in patients with hepatitis C, according to a study published online on 10^th June, 2011  in the Gastroenterology journal.

Neel D Freedman PhD MPH, from National Cancer Institute, Maryland, USA and colleagues  assessed patients for early virologic response (2 log₁₀ reduction in level of hepatitis C virus RNA at week 12; n = 466), and undetectable hepatitis C virus RNA at weeks 20, 48 , and 72. They enrolled 885 patients from the lead-in phase of the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial recorded coffee intake before retreatment with peginterferon α-2a (180 μg/wk) and ribavirin (1000–1200 mg/day).  

Median log₁₀ drop from baseline to week 20 was 2.0 among nondrinkers and 4.0 among patients that drank 3 or more cups/day of coffee (P trend <.0001). After adjustment for age, race/ethnicity, sex, alcohol, cirrhosis, ratio of aspartate aminotransferase to alanine aminotransferase, the IL28B polymorphism rs12979860, dose reduction of peginterferon, and other covariates, odds ratios for drinking 3 or more cups/day vs nondrinking were 2.0 (P trend = .004) for early virologic response, 2.1 (P trend = .005) for week 20 virologic response, 2.4 (P trend = .001) for end of treatment, and 1.8 (P trend = .034) for sustained virologic response.

The authors highlighted that in patients with advanced HCV-related chronic liver disease in the HALT-C trial receiving peginterferon plus ribavirin treatment, 3 or more cups per day coffee drinkers were 3 times more likely to have a virologic response than nondrinkers. In contrast to results for coffee, no effect was observed for tea drinking.

http://www.gastrojournal.org/article/S0016-5085(11)00273-3/fulltext

Finasteride and Dutasteride- Recommendations for label change

FDA has recommended that prior to initiating therapy with 5-alpha reductase inhibitors (ARIs) like finasteride or Dutasteride, the healthcare professionals should  perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH).
The Warnings and Precautions section of the labels for the 5-ARI class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
The decision has been taken in view of the results of two large randomised controlled trials (RCTs) conducted in 2010-the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial.
Finasteride and Dutasteride are available as Proscar, Avodart, and Jalyn.
These are approved to improve symptoms of benign prostatic hyperplasia (BPH).
Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate.
Propecia is approved to treat male pattern hair loss.
Ironically, 5-ARIs were used for chemoprevention of prostate cancer without the FDA approval.
Also, the guidelines released jointly in 2009 by the American Society of Clinical Oncologists and the American Urological Association recommended that, "Asymptomatic men with a prostate-specific antigen (PSA) ≤3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer)." ⁽¹⁾
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258529.htm
(1) http://caonline.amcancersoc.org/cgi/content/full/61/1/1

Simvastatin (ZOCOR)- New recommendations by FDA

US FDA has recommended that Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug. 
Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).
Simvastatin is a lipid lowering drug used by patients who have had a Coronary Artery Disease (CAD) or they are at a high risk of having  CAD.
Simvastatin belongs to the group of HMG-CoA reductase inhibitors (or statins). The known adverse effects of statins are the hepatic damage and myopathy.
FDA has mentionedd that patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.
The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258384.htm

Systolic BP treatment goal of 130 to 135 mm Hg acceptable in Type 2 diabetes

In patients with type 2 diabetes mellitus/impaired fasting glucose/impaired glucose tolerance, a systolic BP treatment goal of 130 to 135 mm Hg is acceptable, according to the results of a meta-analysis published online in June 1, 2011 issue of Circulation.

Sripal Bangalore, MD, MHA, Assistant Professor of Medicine,  from, New York University School of Medicine, USA and colleagues performed a meta-analysis of randomized clinical trials from 1965 to October 2010 of antihypertensive therapy in patients with type 2 diabetes mellitus or impaired fasting glucose/impaired glucose tolerance that enrolled at least 100 patients with achieved systolic BP of 135 mm Hg in the intensive BP control group and 140 mm Hg in the standard BP control group, had a follow-up of at least 1 year, and evaluated macrovascular or microvascular events.

They found that intensive BP control was associated with a 10% reduction in all-cause mortality, a 17% reduction in stroke, and a 20% increase in serious adverse effects, but with similar outcomes for other macrovascular and microvascular (cardiac, renal, and retinal) events compared with standard BP control. More intensive BP control ( 130 mm Hg) was associated with a greater reduction in stroke, but did not reduce other events. Meta–regression analysis showed continued risk reduction for stroke to a systolic BP of <120 mm Hg.

The authors also reported that with more aggressive goals (<130 mm Hg), they observed target organ heterogeneity in that the risk of stroke continued to fall, but there was no benefit regarding the risk of other macrovascular or microvascular (cardiac, renal and retinal) events, and the risk of serious adverse events even increased.