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Rationale and design of a multicenter randomized controlled study to evaluate the preventive effect of ipragliflozin on carotid atherosclerosis: the PROTECT study

Overview of attention for article published in Cardiovascular Diabetology, September 2016
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Title
Rationale and design of a multicenter randomized controlled study to evaluate the preventive effect of ipragliflozin on carotid atherosclerosis: the PROTECT study
Published in
Cardiovascular Diabetology, September 2016
DOI 10.1186/s12933-016-0449-7
Pubmed ID
Authors

Atsushi Tanaka, Toyoaki Murohara, Isao Taguchi, Kazuo Eguchi, Makoto Suzuki, Masafumi Kitakaze, Yasunori Sato, Tomoko Ishizu, Yukihito Higashi, Hirotsugu Yamada, Mamoru Nanasato, Michio Shimabukuro, Hiroki Teragawa, Shinichiro Ueda, Satoshi Kodera, Munehide Matsuhisa, Toshiaki Kadokami, Kazuomi Kario, Yoshihiko Nishio, Teruo Inoue, Koji Maemura, Jun-ichi Oyama, Mitsuru Ohishi, Masataka Sata, Hirofumi Tomiyama, Koichi Node

Abstract

Type 2 diabetes mellitus is associated strongly with an increased risk of micro- and macro-vascular complications, leading to impaired quality of life and shortened life expectancy. In addition to appropriate glycemic control, multi-factorial intervention for a wide range of risk factors, such as hypertension and dyslipidemia, is crucial for management of diabetes. A recent cardiovascular outcome trial in diabetes patients with higher cardiovascular risk demonstrated that a SGLT2 inhibitor markedly reduced mortality, but not macro-vascular events. However, to date there is no clinical evidence regarding the therapeutic effects of SGLT2 inhibitors on arteriosclerosis. The ongoing PROTECT trial was designed to assess whether the SGLT2 inhibitors, ipragliflozin, prevented progression of carotid intima-media thickness in Japanese patients with type 2 diabetes mellitus. A total of 480 participants with type 2 diabetes mellitus with a HbA1c between 6 and 10 % despite receiving diet/exercise therapy and/or standard anti-diabetic agents for at least 3 months, will be randomized systematically (1:1) into either ipragliflozin or control (continuation of conventional therapy) groups. After randomization, ipragliflozin (50-100 mg once daily) will be added on to the background therapy in participants assigned to the ipragliflozin group. The primary endpoint of the study is the change in mean intima-media thickness of the common carotid artery from baseline to 24 months. Images of carotid intima-media thickness will be analyzed at a central core laboratory in a blinded manner. The key secondary endpoints include the change from baseline in other parameters of carotid intima-media thickness, various metabolic parameters, and renal function. Other cardiovascular functional tests are also planned for several sub-studies. The PROTECT study is the first to assess the preventive effect of ipragliflozin on progression of carotid atherosclerosis using carotid intima-media thickness as a surrogate marker. The study has potential to clarify the protective effects of ipragliflozin on atherosclerosis. Trial registration Unique Trial Number, UMIN000018440 ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021348 ).

Twitter Demographics

The data shown below were collected from the profiles of 2 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 93 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Japan 1 1%
Unknown 92 99%

Demographic breakdown

Readers by professional status Count As %
Student > Master 17 18%
Student > Bachelor 13 14%
Other 11 12%
Researcher 9 10%
Student > Ph. D. Student 9 10%
Other 19 20%
Unknown 15 16%
Readers by discipline Count As %
Medicine and Dentistry 40 43%
Nursing and Health Professions 16 17%
Pharmacology, Toxicology and Pharmaceutical Science 5 5%
Sports and Recreations 3 3%
Economics, Econometrics and Finance 2 2%
Other 8 9%
Unknown 19 20%

Attention Score in Context

This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 24 April 2020.
All research outputs
#9,242,961
of 15,099,310 outputs
Outputs from Cardiovascular Diabetology
#443
of 861 outputs
Outputs of similar age
#139,911
of 265,579 outputs
Outputs of similar age from Cardiovascular Diabetology
#1
of 1 outputs
Altmetric has tracked 15,099,310 research outputs across all sources so far. This one is in the 36th percentile – i.e., 36% of other outputs scored the same or lower than it.
So far Altmetric has tracked 861 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.3. This one is in the 44th percentile – i.e., 44% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 265,579 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 43rd percentile – i.e., 43% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 1 others from the same source and published within six weeks on either side of this one. This one has scored higher than all of them