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Open Label, Single Center Study. The results of the study are an average of the individual and all subjects who took 10 mg of PolicosanolPlus composition twice a day and lipid lowering agent. The PolicosanolPlus extract (active material) was produced by Innovation Laboratories, Inc (Miami, Florida), (Innovation lot PolicosanolPlusŪ-01255-A) and was formulated in 0 gelatin capsules containing 10 mg of PolicosanolPlus. Our study was conducted from open label, single center study, in a random population of men and women between the ages of 20 70 years of age. All enrollees were educated on the purpose and safety of the study and then subjected to an informed consent. Reduction changes in LDL-C and total cholesterol levels were considered as primary efficacy variables. Furthermore, changes in HDL-C, triglycerides and ratios of total cholesterol to HDL-C and LDL-C to HDL-C, were also analyzed. All data is reported in mg/dL.
REDUCED STATIN DOSE PolicosanolPlusŪ (20 mg) CHOL/HDL LDL/HDL PRODUCT/DOSE/DURATION TRIG CHOL HDL LDL RATIO RATIO #1 Zocor 40mg (8wks) 218 203 41 118 5.0 2.8 Zocor20mg+ PolicosanolPlusŪ 201 179 50 89 3.6 1.78 % change -8 -12 +22 -25 -28 -36 #2 Zocor40mg (11 wks) 129 156 37 93 4.2 2.5 Zocor 20mg + PolicosanolPlusŪ 136 147 36 84 4.1 2.3 %change +5 -6 -3 -10 -2.3 -8 #3 Pravachol 40mg (11 wks) 259 230 53 135 4.3 2.5 Lipitor 20 mg + PolicosanolPlusŪ 238 200 55 107 3.6 2.3 %change -8 -13 +4 -21 -16 -8 #4 Lipitor 20mg (10 wks) 103 147 53 73 2.8 1.3 Lipitor 10mg + PolicosanolPlusŪ 104 165 60 84 2.8 1.4 %change +1 +12 +13 +15 0 +7 #5 Zocor 40 mg (10 wks) 163 213 49 131 4.3 2.7 Zocor 20mg+ PolicosanolPlusŪ 142 174 51 95 3.4 1.8 %change -12 -18 -4 -27 -20 -33 #6 Lipitor 20mg (9 wks) 287 156 40 59 3.9 1.5 Lipitor l0mg+ PolicosanolPlusŪ 287 179 41 81 4.4 1.9 %change 0 +14 +2 +54 +12 +26
#7 Zocor 20mg (12 wks) 71 158 61 83 2.6 1.4 Zocor 10mg + PolicosanolPlusŪ 71 176 62 100 2.8 1.6 %change 0 +11 +1 +20 +7 +14 #8 Lipitor40mg (3 wks) 165 157 33 91 4.8 2.7 Lipitor20mg+ PolicosanolPlusŪ 151 161 38 93 4.2 2.4 %change -8 +2 +15 +2 -12 -11 #9 Lipitor 20mg (12 wks) 196 231 64 128 3.6 2 Lipitor l0mg+ PolicosanolPlusŪ 98 167 53 94 3.2 1.8 %change -50 -27 -17 -26 -11 -10 #10 Zocor 40 mg (11 wks) 129 156 37 93 4.2 2.5 Zocor20mg+ PolicosanolPlusŪ 136 147 36 84 4.1 2.3 %change +5 -5 -2 -9 -2 -8 #11 Lipitor 20mg (11 wks) 154 195 42 122 4.6 2.9 Lipitor 10mg + PolicosanolPlusŪ 135 179 41 111 4.4 2.7 % change -12 -8 -2 -9 -4 -7 #12 Lipitor 20mg (10 wks) 120 153 55 74 2.8 1.3 Lipitor l0mg + PolicosanolPlusŪ 133 179 51 101 3.5 1.9 %change +10 +16 -7 +36 +25 +46 #13 Lipitor 20mg (4 wks) 204 187 38 108 4.9 2.8 Lipitor l0mg + PolicosanolPlusŪ 181 194 43 115 4.5 2.6 %change -11 +3 +13 +6 +8 -7 #14 Lipitor 20mg (12 wks) 190 185 53 94 3.5 1.8 Lipitor 10 mg + PolicosanolPlusŪ 153 162 55 76 2.9 1.4 %change -19 -12 +3 -19 -17 -22
PolicosanolPlusŪ (20 mg) RESULTS NO MEDICATIONS CHOL/HDL LDL/HDL DURATION TRIG CHOL HDL LDL RATIO RATIO #15 201 265 64 159 4.1 2.5 6 weeks 90 199 60 121 3.3 2 % change -57 -25 -6 -24 -20 -20
#16 86 249 78 154 3.2 1.9 6 weeks 50 212 82 120 2.6 1.5 %change -42 -15 +5 -22 -19 -21
#17 271 269 42 173 6.4 4.1 6 weeks 205 210 44 125 4.8 2.8 % change -24 -22 +4 -28 -25 -31
#18 247 220 39 132 5.6 3.4 8 weeks 266 203 36 114 5.6 3.1 %change +7 -7 -7 -13 0 -8.8
#19 95 178 58 111 3.1 1.9 11 weeks 74 145 41 89 3.5 2.1 %change -22 -18 -29 -22 +12 +10
#20 208 202 48 112 4.2 2.3 10 weeks 154 189 58 110 3.2 1.9 %change -25 -6 +20 -1 -23 -17.3
#21 117 225 67 135 3.4 2 10 weeks 150 196 72 94 2.7 1.3 % change -28 -12 +7 -30 -20 -35
#22 133 188 51 110 3.7 2.1 12 weeks 92 177 49 110 3.6 2.2 % change -30 -5 -3 0 -2 +4.7
SAME STATIN DOSE PolicosanolPlusŪ (20 mg)
CHOL/HDL LDL/HDL PRODUCT/DOSE/DURATION TRIG CHOL HDL LDL RATIO RATIO #23 Lipitor l0mg (10 wks) 189 175 35 102 5.0 2.9 Lipitor l0mg + PolicosanolPlusŪ 113 161 38 100 4.2 2.6 % change -40 -8 +9 -2 -24 -10.3 #24 Lipitor 10mg (12 wks) 103 198 58 129 3.4 2.2 Lipitor 10mg + PolicosanolPlusŪ 146 189 58 112 3.5 1.9 % change +40 -5 0 -13 +3 -13.6 #25 Lipitor 10mg (4 wks) 101 213 59 124 3.6 2.1 Lipitor l0mg + PolicosanolPlusŪ 68 182 62 97 2.9 1.5 %change -33 -15 +5 -26 -19 -28 #10 Lipitor 10 mg (8 wks) 126 228 40 163 5.7 4 Lipitor 10mg + PolicosanolPlusŪ 63 143 38 92 3.8 2.4 % change -50 -37 +5 -44 -33 -40 #26 Lipitor 10mg (6 wks) 104 161 51 89 3.2 1.7 Lipitor l0mg + PolicosanolPlusŪ 120 153 55 74 2.8 1.3 %change +15 -5 +8 -17 -13 -23 #27 Lipitor 10mg (6 wks) 129 172 49 97 3.5 1.9 Lipitor l0mg + PolicosanolPlusŪ 132 134 40 68 3.4 1.7 %change +2 -22 -18 -30 -3 -10.5 #28 Lipitor l0mg (6 wks) 132 167 39 102 4.3 2.6 Lipitor 10mg + PolicosanolPlusŪ 138 162 36 98 4.5 2.7 % change +4 -2 -7 -3 -4 +3.8
#29 Pravachol 40mg (10 wks) 283 222 38 127 5.8 3.3 Pravachol 40mg + PolicosanolPlusŪ 260 168 33 83 5.1 2.5 %change -8 -24 -13 -34 -12 -24 #30 Lipitor 10mg (11 weeks) 68 169 52 103 3.3 1.9 Lipitor l0mg + PolicosanolPlusŪ 61 151 58 81 2.6 1.4 %change -10 -10 +11 -21 -21 -26 #31 Lipitor 10mg (12 weeks) 101 151 43 88 3.5 2 Lipitor 10mg + PolicosanolPlusŪ 115 121 37 61 3.3 1.6 %change + 13 -19 -13 -30 -5 -20 #32 Lipitor 40mg (11 weeks) 199 214 50 124 4.3 2.5 Lipitor40mg + PolicosanolPlusŪ 171 183 48 101 3.8 2.1 %change -14 -14 -8 -18 -11 -16 #33 Zocor 20 mg (11 weeks) 110 171 52 98 3.3 1.9 Zocor 20mg + PolicosanolPlusŪ 104 151 60 80 2.5 1.3 %change -5 -I +15 -18 -24 -31 #34 Lipitor 10mg (11 weeks) 170 178 49 95 3.6 1.9 Lipitor 10mg + PolicosanolPlusŪ 115 163 47 93 3.5 1.9 % change -32 -8 +4 -2 -5 0 #35 Lipitor 10mg (12 weeks) 81 191 69 106 2.8 1.5 Lipitor l0mg + PolicosanolPlusŪ 54 210 64 135 3.3 2.1 %change -20 +9 -7 +27 +17 +40
PolicosanolPlusŪ WITH DISCONTINUED. NON TAPERED STATIN DOSE
CHOL/HDL LDL/HDL PRODUCT/DOSE/DURATION TRIG CHOL HDL LDL RATIO RATIO
#36 Altacor 60mg+Lopid 343 184 34 81 5.4 2.4 (11 wks) PolicosanolPlusŪ 382 203 34 93 6.0 2.7
#37 Pravachol 20mg 49 171 51 110 3.4 2.1 (11 wks) PolicosanolPlusŪ 5 205 60 135 3.4 2.2
#38 Lipitor 40 mg 69 143 48 81 3.0 1.7 ( 12 wks) PolicosanolPlusŪ 130 232 74 132 3.1 1.8
#39 Pravachol 20mg 91 146 49 79 3.0 1.6 (11 wks) PolicosanolPlusŪ 146 199 42 128 4.7 3
#40 Lipitor 20 mg 251 187 53 84 3.5 1.6 (11 wks) PolicosanolPlusŪ 117 201 55 123 3.7 2.2
#41 Zocor 80mg 88 136 66 73 2.1 1.1 (11 wks ) PolicosanolPlusŪ 203 260 54 146 4.8 2.7
OBSERVATIONS AND RECCOMENDATIONS The following statements are based from an open label, single center study with PolicosanolPlusŪ; for a period of four months with excellent results. PolicosanolPlusŪ can enhance current treatment for hyperlipidemia and hypercholesterolemia and may be as indicated new strategies for safe combination therapy with statins, this combination may have some synergistic triglyceride-lowering and HDL-C raising effects; actions that may improve outcomes independent of their effect on LDL-C. That allows patients to reduce their dosage of statins, and also reduce risk of side effects associated with statins, and may also serve as a bridge toward new dimensions in cholesterol control. There is persuasive evidence that statins and/or PolicosanolPlusŪ have beneficial effects extending beyond reduction of major coronary event rate and all-cause mortality. Statins and/or PolicosanolPlusŪ appear to have a number of potentially beneficial effects, some of which are independent of their cholesterol-lowering effect, and this could increase the number of circulatory disorders in which they could help. Further large, prospective, randomized trials are needed to confirm them and establish their clinical importance. Future studies will further clarify possible expanded indications for statins and/or PolicosanolPlusŪ therapy. PolicosanolPlusŪ is well tolerated. None of the patients have asked to stop the supplement for any reason. PolicosanolPlusŪ is safe to use as a first line treatment in patients with mild dislipidemias; patients that refuse statins, and patients where statins are contraindicated. PolicosanolPlusŪ is very effective with a reduced dose of statins, when either the patient or the physician wishes to reduce the dose. PolicosanolPlusŪ is very effective as an additive to a statin dose when either the patient or the doctor does not wish to increase the dose. This appears to be the most beneficial scenario for the use of PolicosanolPlusŪ. PolicosanolPlusŪ offers a significant savings to most patients when a higher dose of statin would be indicated instead. PolicosanolPlusŪ SHOULD NOT be used to replace an effective statin dose unless side effects indicate the discontinuation of the statin. When statins are discontinued abruptly, there is an unacceptable change in the lipid profile parameters. If an unacceptable change in the lipid profile appears after statins are discontinued while the patient is on PolicosanolPlusŪ, a lower dose of statin can be re introduced, with beneficial effects. The PolicosanolPlusŪ therapy, with 10 mg twice a day, demonstrated excellent short-term safety and efficacy in reducing total and low-density lipoprotein cholesterol levels in patients with primary hypercholesterolemia and without diet restrictions. Cardiovascular disease is a leading cause of morbidity and mortality in the United States. Systematic reviews have found that lowering cholesterol in people at high risk of ischemic coronary events substantially reduces the risk of cardiovascular mortality and morbidity. Hypercholesterolemia is a major independent risk factor for coronary heart disease. Reduction of LDL-C levels in clinical trials for secondary prevention has been demonstrated to produce favorable effects on atherosclerotic coronary artery disease, resulting in the retardation of the progression of stenotic lesions, regression of lesions, and prevention of formation of new lesions, and prevention of thrombotic events associated with non-stenotic lesions. Reduction of the LDL-C level has also been associated with a reduced incidence of fatal and nonfatal myocardial infarction, angina pectoris, angioplasty, and coronary artery bypass surgery. Having multiple therapeutic effects the PolicosanolPlus can enhance current treatment for hyperlipidemia and hypercholesterolemia and may be as indicated new strategies for safe combination therapy with lipid lowering agents, this combination may have some synergistic triglyceride-lowering and HDL-C-raising effects; actions that may improve outcomes independent of their effect on LDL-C and also on the CHD risk. That allows patients to reduce their dosage of lipid lowering agents and also reduces risk of side effects associated with lipid lowering agent such as Statins, Niacins, Resins and Fibrates, or their pharmaceutically acceptable salts or their derivatives, and may also serve as a bridge toward new dimensions in cholesterol control.
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