Response to Statins and Blood Pressure Lowering: A Claim for Ad-Hoc Trials
Cereda and Pietrobelli wrote that the occurrence of overweight or obesity in at least a portion of the patients included in our metaanalysis may have affected our end point or at least contributed to the heterogeneity of our study results.1 Although this is a reasonable contention, a careful evaluation of the trials included in the metaanalysis showed that, in the majority of cases, either no significant body weight change was observed during the study or the changes reported were comparable in the groups receiving statin and control treatment, respectively.2 In fact, both in the study by De Rosa et al,3 which involved obese patients, and in the one by Bak and coworkers,4 which included overweight individuals with prescription of weight reducing diets, the changes actually observed in body weight as an effect of intervention were similar in patients receiving statin therapy and in those who did not. In a few other studies, no mention was made of changes in body weight or other anthropometric parameter.
Cereda and Pietrobelli also raised the point that obesity per se, even in the absence of glucose intolerance or diabetes, may be associated with endothelial dysfunction5 and that this may be favorably affected by a healthier diet or reduction of overweight. We do agree with this view, but again it seems unlikely that this occurrence may explain our results as these alterations affected actively treated and control patients to a similar extent.
In any case, we share the concept that a carefully controlled randomized trial in an appropriately selected patients’ population of adequate sample size would be warranted. We believe that this trial should address the condition of the still large number of individuals, particularly diabetics, who are not prescribed a statin although they would benefit from this treatment to attain LDL-cholesterol targets appropriate to their level of cardiovascular risk. The majority of these patients also have high BP and thus need antihypertensive treatment. If, as it seems possible, statins affect BP through pathways different from those of conventional antihypertensive drugs, these patients could benefit from statin treatment on 2 different grounds, and this therapy could prove very cost-effective.
Cereda E, Pietrobelli A. Statins and blood pressure lowering: a claim for ad-hoc trials. Hypertension. 2007; 50: e12.
Strazzullo P, Kerry SM, Barbato A, Versiero M, D’Elia L, Cappuccio FP. Do statins reduce blood pressure? A meta-analysis of randomized, controlled trials. Hypertension. 2007; 49: 792–798.
Derosa G, Mugellini A, Ciccarelli L, Fogari R. Randomized, double-blind, placebo-controlled comparison of the action of orlistat, fluvastatin or both, on anthropometric measurements, blood pressure and lipid profile in obese patients with hypercholesterolemia prescribed a standardized diet. Clin Ther. 2003; 25: 1107–1122.
Perticone F, Ceravolo R, Candigliota M, Ventura G, Iacopino S, Sinopoli F, Mattioli PL. Obesity and body fat distribution induce endothelial dysfunction by oxidative stress: protective effect of vitamin C. Diabetes. 2001; 50: 159–165.