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A multi-center, open-label, two-arm parallel group non-inferiority randomized controlled trial evaluating the effect of pitavastatin, compared to atorvastatin, on glucose metabolism in prediabetics with hypertension and dyslipidemia: Rationale and design for the China hemoglobin A1c Metabolism Protection Union Study (CAMPUS)

Cardiovascular Drugs and Therapy Sep 10, 2018

Zhang J, et al. - Researchers provide the rationale and design for the China hemoglobin A1c Metabolism Protection Union Study (CAMPUS), which will be a first ever multi-center, prospective, open-label, 12-month, two-arm parallel group, non-inferiority, randomized, controlled trial to assess the impact of pitavastatin vs atorvastatin on glucose metabolism as measured by hemoglobin A1c in Chinese prediabetics patients with hypertension and dyslipidemias (n=396). Participants will be randomized 1:1 to either pitavastatin 2 mg/day or atorvastatin 20 mg/day and followed for 12 months (follow-up visits at 1, 3, 6, and 12 months). Participants will receive doubled drug doses if the results of low-density lipoprotein cholesterol levels do not meet individual targets in month 3 following treatment initiation. Findings might facilitate the improvement of primary prevention in patients at risk for diabetes and cardiovascular disease.

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