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High-Molecular-Weight HydroxypropylmethylcelluloseA Cholesterol-Lowering Agent
Jennifer B. Dressman, PhD;
Constance H. Adair, MS, RD;
Jeffrey L. Barnett, MD;
Rosemary R. Berardi, PharmD;
Valerie A. Dunn-Kucharski, PharmD;
Kathleen M. Jarvenpaa, RN;
Douglas D. Parr, PharmD;
Cynthia A. Sowle;
Sahar Z. Swidan, PharmD;
Stephen W. Tobey, PhD;
Christos Reppas, PhD
Arch Intern Med. 1993;153(11):1345-[NP].
Abstract
Background
We assessed the efficacy of a high-molecular-weight hydroxypropylmethylcellulose (K8515) as a cholesterol-lowering agent, the dose-response profile of its action, and the ability of adult subjects to tolerate its ingestion at effective doses.
Methods
These studies were conducted at the Clinical Research Center of The University of Michigan Hospitals, Ann Arbor. Efficacy was assessed in 10 normal and 12 mildly hyperlipidemic subjects in double-blind, randomized crossover trials of 1 and 2 weeks' duration, respectively. The dose-response profile was studied in 12 mildly hypercholesterolemic subjects in a nonrandomized control trial with doses given in escalating order. Tolerance was assessed by a questionnaire of adverse effects and bowel movement habits in all subjects.
Results
We found that 10 g of K8515 ingested in a prehydrated form three times a day with meals lowered total cholesterol levels by an average of 1.45 mmol/L (56 mg/ dL) (32%) in normal subjects within 1 week. In two studies in subjects with mildly elevated cholesterol levels (with entry levels ranging from 5.35 mmol/L [207 mg/dL] to 6.70 mmol/L [260 mg/dL]), average reductions of 1.00 mmol/L (39 mg/dL) (18%) and 1.15 mmol/L (45 mg/dL) (20%) were observed within the same period. The effect was primarily due to a reduction in low-density lipoprotein cholesterol levels. Low-density lipoprotein levels in normal subjects were an average of 1.10 mmol/L (42 mg/dL) (38%) lower after a week of 10 g of K8515 three times a day with meals, and in the two studies in subjects with mild hyperlipidemia, the reductions in low-density lipoprotein levels after 1 week were 0.95 mmol/L (37 mg/dL) (23%) and 1.05 mmol/L (40 mg/dL) (25%). Although there was a tendency for high-density lipoprotein cholesterol levels to decrease, this was significant only in normal subjects. Decreases in cholesterol levels were not accompanied by any rise in triglyceride levels. Dose-response studies in those with mildly elevated cholesterol levels indicated that it is possible to achieve a 15% decrease in low-density lipoprotein cholesterol levels within 1 week at a dose of 6.7 g three times a day, with minimal adverse effects.
Conclusion
These results suggest a role for high-molecular-weight hydroxypropylmethylcellulose in the clinical treatment of mild hypercholesterolemia.
(Arch Intern Med. 1993;153:1345-1353)
Author Affiliations
From the College of Pharmacy (Drs Dressman, Berardi, Dunn-Kucharski, Parr, and Swidan), Clinical Research Center (Mss Adair and Jarvenpaa), and Department of Internal Medicine (Dr Barnett), The University of Michigan, Ann Arbor; Dow Chemical Co, Midland, Mich (Ms Sowle and Dr Tobey); and Department of Pharmacy, University of Athens (Greece) (Dr Reppas).
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