Online First articles
Long-Term Effects of Nutraceuticals (Berberine, Red Yeast Rice, Policosanol) in Elderly Hypercholesterolemic Patients
Giuseppe Marazzi, Luca Cacciotti, Francesco Pelliccia, Luigi Iaia, Maurizio Volterrani, Giuseppe Caminiti, Barbara Sposato, Rosalba Massaro, Fabrizia Grieco, Giuseppe Rosano
DOI: 10.1007/s12325-011-0082-5
Adv Ther. 2011;28(12):1105-1113.
Abstract | Full text
Introduction: Statins are at the forefront of strategies to manage dyslipidemia, although they are not always well tolerated. At 6-7 months after the drug was supplied, discontinuation rates averaged 30%. Alternate agents to statins have been studied. Some nutraceuticals demonstrated an efficacy in reducing cholesterol concentrations. However, there are no data regarding the use of nutraceuticals in elderly dyslipidemic patients. The purpose of this study was to examine the efficacy, safety, and tolerability of a nutraceutical-based protocol in elderly hypercholesterolemic patients previously intolerant to statins. Methods: This study was performed as a randomized, prospective, parallel group, single-blind study. Patients were included in the study if they had high total cholesterolemia, high low-density lipoprotein cholesterol (LDL-C), >75 years of age, statin-intolerant, and were refusing other pharmaceutical treatments for hypercholesterolemia. At the baseline visit, eligible patients were randomized to either nutraceutical-combined pill (containing berberine 500 mg, policosanol 10 mg, red yeast rice 200 mg, folic acid 0.2 mg, coenzyme Q10 2.0 mg, and astaxanthin 0.5 mg) or placebo, and the first dose was dispensed. The efficacy, safety, and tolerability of the proposed treatment were fully assessed after 3, 6, and 12 months of treatment. Results: Out of 106 consecutive patients screened, 80 eligible patients were randomized to receive either nutraceutical-combined pill (40 patients) or placebo (40 patients). No patients were lost and no deaths occurred during the follow-up. There was a statistically significant reduction in total cholesterolemia (–20%), LDL-C (–31%), and insulin resistance (–10%) with nutraceutical treatment. No significant changes were detected for plasma high-density lipoprotein cholesterol (HDL-C). Furthermore, no statistical differences were found between baseline and end-study safety parameters. Medication compliance and tolerability were high. Conclusion: In this study the authors have demonstrated that combined nutraceuticals significantly reduce cholesterolemia and achieved acceptable plasma LDL-C levels in elderly hypercholesterolemic patients who were previously statin-intolerant. Combined nutraceuticals is also safe and well tolerated in these patients.
Prostaglandin E2 Inhibition of Ketorolac 0.45%, Bromfenac 0.09%, and Nepafenac 0.1% in Patients Undergoing Phacoemulsification
Frank A. Bucci Jr., L. David Waterbury
DOI: 10.1007/s12325-011-0080-7
Adv Ther. 2011;28(12):1089-1095.
Abstract | Full text
Introduction : We compared the prostaglandin E2 (PGE2) inhibition of three topical nonsteroidal antiinflammatory drugs (NSAIDs): ketorolac 0.45%, bromfenac 0.09%, and nepafenac 0.1% at peak dosing levels in patients previously scheduled to undergo phacoemulsification. Methods: This was a single-center, double-masked observational study of 121 patients randomized to one of three NSAID treatment arms. Patients were instructed to take the NSAID per on-label dosing (twice daily [b.i.d.] for ketorolac 0.45% and bromfenac 0.09%, three times a day [t.i.d.] for nepafenac 0.1%) for 1 day before surgery, and were to instill one drop the morning of surgery. Each patient received an additional four doses 1 hour prior to undergoing phacoemulsification. After completion of the paracentesis site with a super blade, aqueous humor (0.15 mL) was collected through the peripheral clear cornea with a 30 G needle attached to a tuberculin (TB) syringe. Aqueous humor samples were stored at –40°C prior to analysis, and diluted 1:10 with diluent. Assays were conducted on multiple plates in duplicate (seven standards per plate). Results: The mean (±SD) PGE2 concentrations were 224.8±164.87 pg/mL for ketorolac 0.45% (n=42), 288.7±226.05 pg/ml for bromfenac 0.09% (n=41), and 320.4±205.6 pg/mL for nepafenac 0.1% (n=38). The difference between ketorolac 0.45% and nepafenac 0.1% was statistically significant (P=0.025). The difference between bromfenac 0.09% and nepafenac 0.1% was not significantly different (P=0.516). Conclusions: Ketorolac 0.45% achieved the greatest inhibition of PGE2 compared to nepafenac 0.1% and bromfenac 0.09%. Ketorolac 0.45% may be more efficacious at controlling inflammation at the time of cataract surgery versus nepafenac 0.1% and bromfenac 0.09%.
Dosimetric Comparison of Three Different External Beam Whole Breast Irradiation Techniques
Bilge Gursel, Deniz Meydan, Nilgun Ozbek, Tenzile Ofluoglu
DOI: 10.1007/s12325-011-0078-1
Adv Ther. 2011;28(12):1114-1125.
Abstract | Full text
Introduction: The purpose of this study was to compare the dosimetries of three different external beam whole breast radiotherapy techniques: two-dimensional RT (2D-RT), three-dimensional conformal RT (3D-CRT), and field-in-field intensity-modulated RT (FiF-IMRT). In addition, we aimed to evaluate the patients who needed more or less complex treatment modalities. Methods: Thirty patients were included in the study. All the patients had early-stage breast cancer and conserving surgery had been performed. Plans that employed the three techniques were generated for each patient. Dosimetric comparisons were conducted, and correlations with patient characteristics and dosimetric outcomes were analyzed. Results: The 2D-RT technique was found to be suboptimal for treating the intact breast. Its dose homogeneity index (DHI) was 20.68. The authors were unable to define a patient characteristic in which 2D-RT dosimetry would perform better. FiF-IMRT was found to be the superior technique with a better homogeneity in the breast (DHI=9.35 and P=0.000002 when compared to 3D-CRT). When compared according to patient characteristics, again the FiF-IMRT planning is the best for all subgroups, but the DHI gets worse by increased breast volume and separation. While FiF-IMRT achieves better DHI in the breast, it has little effect on heart and lung doses. But the normal tissues’ volume (cc) that gets the 100% of the prescribed dose (V100) was lowered because of the treatment without wedges and scatter and with less monitor unit. Conclusions: 2D-RT could not be performed safely on the intact breast in any of the subgroups. FiF-IMRT is a superior technique for breast dosimetry, and normal tissue. For patients with large breast size or separation, further intensive techniques must be investigated.