Testosterone replacement
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<span><p><head><title></title><style type="text/css">ol{margin:0;padding:0}p{margin:0}.c1{line-height:1.15;text-indent:0pt;direction:ltr}.c0{color:#000000;font-size:11pt;font-family:Arial}.c13{color:#000000;font-size:10pt;font-family:Arial}.c8{font-weight:bold}</style></head><td><p><p class="c1"><span class="c0">Lindsay Wilson</span></p><p class="c1"><span class="c0">August 20, 2010</span></p><p class="c1"><span class="c0">Journal Club</span></p><p class="c1"><span class="c0">Thanks to Mike Lamantia for the format used:</span></p><p class="c1"><span class="c0 c8">Basaria S, et al. Adverse events associated with testosterone administration.</span></p><p class="c1"><span class="c0 c8">N Engl J Med. 2010 Jul 8;363(2):109-22. Epub 2010 Jun 30.</span></p><p class="c1"><span class="c8 c13">Background: </span><span class="c13"> Testosterone levels decrease gradually as men age. It has previously been theorized that many features of aging, such as decreased muscle mass, impaired sexual functioning, reduced bone strength, could be attributed to lower testosterone. </span></p><p class="c1"><span class="c13 c8">Source population: </span><span class="c13"> Men >65 at three New England medical sites</span></p><p class="c1"><span class="c13 c8">Study population: </span><span class="c13"> 209 men age 65 or older who had a total serum testosterone level 100 - 350 ng per dL or a free serum testosterone level of < 50 pg (173 pmol per liter) as measured in a blood sample obtained in the morning. Also had to evidence of limitations in mobility= having difficulty walking two blocks on a level surface or climbing 10 steps and having a score 4-9 on the Short Physical Performance Battery.</span></p><p class="c1"><span class="c13 c8">Exclusion criteria</span><span class="c13">: Uncontrolled hypertension, unstable angina, MI within 3 months before enrollment, NYHA class III or IV CHF, prostate or other active cancer, severe LUTS, untreated severe OSA, glucocorticoid or anabolic steroid therapy, a Hgb A1C > 8.5%, a Hct > 48, a PSA > 4 ng per milliliter, and a BMI >40.</span></p><p class="c1"><span class="c13 c8">Initial comparability of groups: Tables 1 and 2. </span><span class="c13">Simila but a greater number of those in the testosterone group were on a statin or carried a diagnosis of hyperlipidemia. </span></p><p class="c1"><span class="c13 c8">Methods: </span><span class="c13"> Parallel-group, randomized, placebo-controlled, double-blind trial involving community-dwelling men, 3 recruitment sites-->Men were stratified according to age and randomly assigned to receive 10 g of gel with either placebo or 100 mg of testosterone to be applied daily for 6 months--> Two weeks after randomization performed, the dose was adjusted if the average of two testosterone levels was <500 ng/dL or >1000 ng/dL </span></p><p class="c1"><span class="c13 c8">Primary Outcome</span><span class="c13">= Change from baseline in maximal voluntary muscle strength in a leg press</span></p><p class="c1"><span class="c13 c8">Secondary Outcomes</span><span class="c13">= Changes from baseline in chest-press strength, 50-m walking speed, stair-climbing speed and power, and a lift-and-lower test</span></p><p class="c1"><span class="c13 c8">Safety monitoring: </span><span class="c13">Hgb, Hct, PSA, Prostate exam, UT sxs, assessment of adverse events</span></p><p class="c1"><span class="c13 c8">Statistical analyses: </span><span class="c13">Kaplan-Meier and Fisher’s exact tests, time to event </span></p><p class="c1"><span class="c13 c8">Adherance: </span><span class="c13"> Assessed by count of unused gel tubes, greater than 90%</span></p><p class="c1"><span class="c13 c8">Potential for selection bias</span><span class="c13"> (+ to +++): ++, no information on how these men were selected, were they volunteers or referrals?</span></p><p class="c1"><span class="c13 c8">Potential for measurement bias</span><span class="c13">: ++, outcome not planned, no systematic evaluation</span></p><p class="c1"><span class="c13 c8">Potential for confounding:</span><span class="c13"> ++ While there was increase in statin use and hyperlipidemia in testosterone group, adjustment for this did not change the outcome.</span></p><p class="c1"><span class="c13 c8">Results:</span></p><p class="c1"><span class="c13">Experimental group: Mean testosterone levels were 574 in exp grp and 292 in control grp, there was a significant increase in Hgb/Hct and decrease in HDL</span></p><p class="c1"><span class="c13">Adverse Events: Twice as many in the testosterone group were referred for med eval of an adverse event</span></p><p class="c1"><span class="c13">Table 3. Not all reported adverse events are really significant. Placebo had 1 significant event (syncope). Testosterone group had 10-12</span></p><p class="c1"><span class="c13">Comments and overall conclusions:</span></p><p class="c1"><span class="c13">Trial stopped early, so effect may have been magnified</span></p><p class="c1"><span class="c13">No information on statistical analyses used to determine the requirements for stopping the trial--run the chance that it is due to chance alone</span></p><p class="c1"><span class="c13">Nonetheless, numbers are impressive!</span></p><p class="c1"><span class="c0"> </span></p></td></span>
