Primary Care-Based Investigation of the Effect of Sitagliptin on Blood Pressure in Hypertensive Patients With Type 2 Diabetes.

BACKGROUND: The influence of long-term sitagliptin therapy on office blood pressure (BP) and home BP has been unclear. METHODS: In a retrospective cohort study of 454 patients with type 2 diabetes, the following variables were analyzed before and at 3, 6, 9, and 12 months after initiation of sitagliptin therapy: office systolic blood pressure (SBP), office diastolic blood pressure (DBP), office pulse rate, morning home SBP, morning home DBP, morning home pulse rate, evening home SBP, evening home DBP, evening home pulse rate, hemoglobin A1c (HbA1c), plasma glucose, lipid profile, and renal function parameters. RESULTS: The office SBP showed a significant decrease after 6 and 12 months of sitagliptin therapy (P < 0.01 and P < 0.01, respectively), while office DBP was decreased significantly at all time points of evaluation (3, 6, 9, and 12 months: P < 0.05, P < 0.001, P < 0.001, and P < 0.05, respectively). Analysis of covariance revealed a significant decrease in office SBP after 6 and 12 months, as well as significant reduction of office DBP after 6 and 9 months. Morning home SBP and DBP were significantly reduced after 6 months, as was evening home DBP after 6 and 12 months, but there was no significant decrease in evening home SBP. HbA1c and plasma glucose levels were significantly reduced at all time points of evaluation. Examination of the lipid profile revealed that total cholesterol, low-density lipoprotein cholesterol, and triglycerides were also decreased at all time points of evaluation, while high-density lipoprotein cholesterol was significantly reduced after 3, 9, and 12 months. Significant reduction of the estimated glomerular filtration rate was observed after 6, 9, and 12 months, and the urinary albumin/creatinine ratio was significantly lower at 9 and 12 months. Serum creatinine was increased significantly at all time points of evaluation. CONCLUSIONS: BP was slightly but significantly reduced from 6 months after initiation of sitagliptin therapy, indicating that this antidiabetic drug has pleiotropic effects, including an antihypertensive effect.

Blood pressure differences between office and home settings among Japanese normotensive subjects and hypertensive patients.

This study attempted to clarify the differences in blood pressure (BP) between the office (clinic) and home settings in patients with controlled, sustained, masked or white-coat hypertension. The following formula was used: office mean systolic BP (omSBP)-mean morning home SBP (mmhSBP)/office mean diastolic BP (omDBP)-mean morning home DBP (mmhDBP). The paired t-test was used for statistical analysis. The omSBP-mmhSBP/omDBP-mmhDBP calculation yielded the following results: among normotensive subjects, -1.1±11.2/-1.7±8.5 mm Hg (mean SBP and mean DBP were higher at home than in the office; n=451, P=0.038 in SBP, P=0.000 in DBP); in controlled hypertensive patients, -0.42±10.9/-2.2±8.2 mm Hg (n=1362, P=0.160 in SBP, P=0.000 in DBP); among sustained hypertensive patients, 5.6±14.7/0.048±9.9 mm Hg (n=1370, P=0.000 in SBP, P=0.857 in DBP); in masked hypertensive patients, -15.3±12.9/-9.3±9.5 mm Hg (n=1308, both P=0.000); and among white-coat hypertensive patients, 23.7±13.2/8.2±9.1 mm Hg (n=580, both P=0.000). Our results showed a difference of 5 mm Hg in SBP among sustained hypertensive patients, as recommended by the Japanese Society of Hypertension Guidelines for the Management of Hypertension; however, in other hypertensive patient types, the differences in SBP and DBP between office and home measurements differed by >5 mm Hg. Office and home BP measurements should be interpreted cautiously, keeping in mind the clinical setting.

A Survey of Actual Clinical Practice Concerning Blood Pressure Control among Patients with Hypertension in Kanagawa 2014.

We performed a cross-sectional survey to investigate actual clinical practice concerning blood-pressure control among patients with hypertension in Kanagawa. The guidelines of the Japanese Society of Hypertension (JSH) for the management of patients with hypertension were revised in 2014. From October 1 to November 30, 2014, questionnaires on the care of patients with hypertension were sent via post to members of the Kanagawa Physicians Association in Kanagawa Prefecture, Japan. -Data on 1,105 patients (mean age: 68.4±12.3 years, 537 men and 568 women) were obtained. The overall mean systolic blood pressure (BP) of these patients was 128.7±12.1 mmHg for home monitoring and 132.9±12.6 mmHg for office monitoring; diastolic BP was 75.7±9.7 for home monitoring and 77.0±9.7 mmHg for office monitoring. According to the JSH 2014 guidelines, the target BP was achieved by 68.1% of all subjects; 89.2% of late-phase elderly patients (75 years or older); 69.1% of young, middle-aged, and early-phase elderly patients (younger than 75 years except in patients with diabetes mellitus [DM] or chronic kidney disease [CKD] with proteinuria); 9.3% of patients with DM except late-phase elderly patients; and 11.9% of CKD patients with proteinuria except DM. Cross-sectional analysis showed that the factors significantly associated with an increased likelihood of achieving the target BP were as follows: 1) good medication compliance even for a small number of antihypertensive agents at small amount of doses in patients 75 years and older; 2) good medication compliance in patients in younger than 75 years; 3) an older age, a larger proportion in the female-to-male ratio and a lower body mass index in patients with DM except late-phase elderly patients; and 4) usage of a large number of antihypertensive agents in CKD patients with proteinuria. Further follow-up surveys are necessary to investigate changes in clinical practice following the introduction of the revised guidelines.

Factor Analysis of Changes in Hemoglobin A1c After 12 Months of Sitagliptin Therapy in Patients With Type 2 Diabetes.

BACKGROUND: Sitagliptin, a dipeptidyl peptidase-4 inhibitor, is an effective oral antidiabetic agent as both monotherapy and when combined with insulin. Data from three observational studies performed in patients with type 2 diabetes receiving sitagliptin therapy in the routine clinical setting were integrated to conduct factor analysis of the changes in hemoglobin A1c (HbA1c), body weight, and estimated glomerular filtration rate (eGFR) over 12 months. METHODS: Among patients with type 2 diabetes attending medical institutions affiliated with Kanagawa Physicians Association, those using sitagliptin were followed for 1 year. In the ASSET-K and ASSIST-K studies, patients were managed by diabetologists, while they were managed by non-diabetologists in the ATTEST-K study. Patients were not administered insulin in ASSET-K, whereas insulin was administered in ASSIST-K. HbA1c (National Glycohemoglobin Standardization Program), blood glucose (fasting/postprandial), body weight, and renal function (serum creatinine and eGFR) were the efficacy endpoints. Factor analysis was performed by analysis of variance using the magnitude of the change in HbA1c, body weight, and eGFR after 12 months of sitagliptin therapy as response variables, and the study, sex, and age as explanatory variables. RESULTS: Of 1,327 patients registered in ASSET-K (diabetologists/without insulin), 1,167 patients in ASSIST-K (diabetologists/with insulin), and 530 patients in ATTEST-K (non-diabetologists), statistical analysis was carried out on 1,074, 854, and 411 patients, respectively. There were significant inter-study differences in patient characteristics (complications, duration of diabetes, and baseline HbA1c), the sitagliptin dose, and the use of other antidiabetic agents. HbA1c decreased significantly in all three studies. According to factor analysis, the magnitude of the change in HbA1c over 12 months showed significant inter-study differences and was also significantly influenced by the age, duration of diabetes, and baseline HbA1c. CONCLUSIONS: Comparison of three observational studies identified differences in patient characteristics, treatment of diabetes (use/non-use of insulin), and the level of specialist care (diabetologist/non-diabetologist). Despite such differences, consistent reduction of HbA1c by sitagliptin was demonstrated in all three studies. The patients showing most improvement in HbA1c with sitagliptin therapy were older patients with a short duration of diabetes and high baseline HbA1c level.

Changes in blood-pressure control among patients with hypertension from 2008 through 2011: surveys of actual clinical practice.

We performed cross-sectional surveys to investigate changes in clinical practices regarding blood-pressure control in patients with hypertension from 2008 through 2011. Questionnaires regarding the care of patients with hypertension were mailed to members of the Kanagawa Physicians Association in Kanagawa Prefecture, Japan. Data were obtained on 675 patients in 2008, 332 in 2009, and 1,076 in 2011. The mean systolic blood pressure (BP) was significantly lower in 2011 than in 2008 (132.2±11.9 mm Hg versus 134.6±10.6 mm Hg). The office-measured target BP, according to the 2009 guidelines of the Japanese Society of Hypertension for the management of patients with hypertension, was achieved in 53.9% of patients in 2008, 55.1% in 2009, and 57.1% in 2011. In nonelderly patients (younger than 65 years), the achievement rate was significantly greater in 2011 (41.2%) than in 2008 (23.6%). This analysis showed that the factor most significantly associated with a decrease in office-measured BP was treatment with a larger number and higher doses of antihypertensive agents. To investigate changes in clinical practices according to the guidelines, further follow-up surveys are necessary.

Comparison of effects of angiotensin II receptor blocker on morning home blood pressure and cardiorenal protection between morning administration and evening administration in hypertensive patients: the COMPATIBLE study.

Whether the time of administering the angiotensin receptor antagonist olmesartan influences antihypertensive and renoprotective effectiveness remains unclear. This study compared the effects of olmesartan on morning home blood pressure (MHBP), office BP (OBP) and renoprotective parameters between morning and evening administration. A total of 218 patients with primary hypertension were randomly assigned to receive olmesartan once daily in the morning (morning-dose group) or evening (evening-dose group), and 188 completed the study protocol (morning-dose group, n=95; evening-dose group, n=93). In both groups, morning home systolic BP, morning home diastolic BP, office systolic BP and office diastolic BP decreased significantly. There was no significant difference between the groups in MHBP or OBP after 6 months of treatment. The urinary albumin-to-creatinine ratio (UACR) decreased from 13.9 to 6.9 mg g(-1) (geometric means, P<0.001) in the morning-dose group and from 14.4 to 9.1 mg g(-1) (P<0.001) in the evening-dose group. The changes in UACR after treatment did not differ significantly between the groups. SV1+RV5 decreased significantly from baseline to 6 months in the morning-dose group (P<0.001) and the evening-dose group (P<0.01), and did not differ significantly between the groups. In conclusion, olmesartan effectively decreased MHBP, OBP, SV1+RV5 and UACR regardless of whether the drug was administered in the morning or in the evening. Our results suggest that olmesartan can be prescribed once daily, either in the morning or in the evening.

The current status of blood pressure control among patients with hypertension: a survey of actual clinical practice.

We performed a cross-sectional survey to investigate actual clinical practices regarding blood-pressure control in patients with hypertension. From October 16 to 31, 2008, postal questionnaires regarding the care of patients with hypertension were sent to members of the Kanagawa Physicians Association in Kanagawa, Japan. Data of 675 patients (mean age: 70.1 ± 10.6 years, 301 men and 374 women) were returned. The overall mean systolic blood pressure (BP) in these patients was 134.6 ± 10.6 mm Hg, and diastolic BP was 76.2 ± 8.3 mm Hg. According to the 2009 guidelines of the Japanese Society of Hypertension for the management of patients with hypertension, the target office BP was achieved by 53.9% of all subjects; 29.7% of patients with diabetes mellitus, chronic kidney disease, or a history of myocardial infarction; 72.0% of elderly patients; 23.6% of nonelderly patients (younger than 65 years); and 75.4% of patients with cerebrovascular disease. Cross-sectional analysis showed that factors significantly associated with an increased likelihood of achieving the target office BP were: 1) usage of a larger number of antihypertensive agents in nonelderly patienys and in patients with diabetes mellitus, chronic kidney disease, or a history of myocardial infarction and: 2) usage of a smaller number of antihypertensive agents in elderly patients and patients with cerebrovascular disease. Further follow-up surveys are necessary to provide a full assessment.