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High-molecular-weight hydroxypropylmethylcellulose. A cholesterol-lowering agent.
Arch Intern Med. 1993 Jun 14; 153(11):1345-53.AI

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.

Authors+Show Affiliations

College of Pharmacy, University of Michigan, Ann Arbor.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

8507125

Citation

Dressman, J B., et al. "High-molecular-weight Hydroxypropylmethylcellulose. a Cholesterol-lowering Agent." Archives of Internal Medicine, vol. 153, no. 11, 1993, pp. 1345-53.
Dressman JB, Adair CH, Barnett JL, et al. High-molecular-weight hydroxypropylmethylcellulose. A cholesterol-lowering agent. Arch Intern Med. 1993;153(11):1345-53.
Dressman, J. B., Adair, C. H., Barnett, J. L., Berardi, R. R., Dunn-Kucharski, V. A., Jarvenpaa, K. M., Parr, D. D., Sowle, C. A., Swidan, S. Z., & Tobey, S. W. (1993). High-molecular-weight hydroxypropylmethylcellulose. A cholesterol-lowering agent. Archives of Internal Medicine, 153(11), 1345-53.
Dressman JB, et al. High-molecular-weight Hydroxypropylmethylcellulose. a Cholesterol-lowering Agent. Arch Intern Med. 1993 Jun 14;153(11):1345-53. PubMed PMID: 8507125.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-molecular-weight hydroxypropylmethylcellulose. A cholesterol-lowering agent. A1 - Dressman,J B, AU - Adair,C H, AU - Barnett,J L, AU - Berardi,R R, AU - Dunn-Kucharski,V A, AU - Jarvenpaa,K M, AU - Parr,D D, AU - Sowle,C A, AU - Swidan,S Z, AU - Tobey,S W, PY - 1993/6/14/pubmed PY - 1993/6/14/medline PY - 1993/6/14/entrez SP - 1345 EP - 53 JF - Archives of internal medicine JO - Arch. Intern. Med. VL - 153 IS - 11 N2 - 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. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/8507125/High_molecular_weight_hydroxypropylmethylcellulose__A_cholesterol_lowering_agent_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/vol/153/pg/1345 DB - PRIME DP - Unbound Medicine ER -