J Clin Pharmacol
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The Journal of Clinical Pharmacology and the Journal of New Drugs, 1968; 8:360-369
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Comparison of Phentermine-Amphetamine Resin Complex With Sustained-Release Dextroamphetamine and Placebo in the Treatment of Exogenous Obesity

Eugene A. de Felice M.D.1, Albert Cohen M.D.2, Paul L. Schmitz M.D.2, Kenneth G. Rothwell M.D.3, and Aldo P. Truant Ph.D.3

1 Clinical Pharmacology, Sandoz Pharmaceuticals, Hanover, N.J.
2 Southern Testing, Inc., North Miami Beach. Fla.
3 Research and Development, Strasenburgh Laboratories, Rochester, N.Y.

PA resin complex, a combination of phentermine and amphetamine bases in a sustained-release formulation, was found to be safe, reasonably well tolerated, and superior to sustained-release dextroamphetamine and placebo when used in recommended doses as an adjunct to diet in the treatment of exogenous obesity.

Given once a day, PA resin complex significantly enhanced the ability of patients to adhere to the prescribed diet most of the time, suppressed appetite for about 8 hours, and effected weight loss of approximately 1.7 pounds per week over the course of six weeks of therapy. There were no adverse reactions, and side effects were reported to be similar to those of other anorexigenic agents of the amphetamine class. Tolerance to side effects, but not to appetite suppression or weight loss, occurred.

Note:

The authors wish to acknowledge the assistance of La Huis Clinical Laboratories, 211 Huntington Medical Building, Miami, Fla., in performance of the laboratory tests of organ function; and Dean J. Clyde, Ph.D., Director, Biometrics Laboratory, University of Miami, Miami, Fla., for the statistical analyses used to interpret the data. We also wish to thank Mrs. Beate Walterman, R.N., Mrs. Ruth Bruce, and Mr. Larry Olon for their technical assistance in compiling the data, and Southern Testing, Inc., 1140 N.E. 163rd Street, North Miami Beach, Fla. 33162, for the use of its facilities and personnel in the conduct of the study. PA resin complex used in this study was supplied by Strasenburgh Laboratories, Rochester, N.Y.


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