Impact of subclinical hypothyroidism treatment in systolic and diastolic cardiac function

OBJECTIVE: To evaluate the effects of levothyroxine (L-T4) replacement in echocardiographic parameters of middle-aged women with subclinical hypothyroidism (SH). SUBJECTS AND METHODS: This was a randomized, double-blind, placebo-controlled study. Echocardiographic evaluation was carried out at baseline and one year after restoration of euthyroidism. Thirty-three women with SH were assigned to one of two groups (L-T4 or placebo). RESULTS: The two groups had similar basal characteristics. There was a significant deterioration of left ventricular Tei index after one year of placebo use, which differed from the effect of L-T4 replacement (+0.086 ± 0.092 vs. -0.014 ± 0.012; p = 0.047). There was also a slight reduction in cardiac output and cardiac index with placebo use, which was not different from L-T4 effect. CONCLUSION: Results suggest a positive impact of L-T4 replacement in cardiac function of middle-aged women with SH.

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Effect of Levothyroxine on Cardiac Function and Structure in Subclinical Hypothyroidism: A Double Blind, Placebo-Controlled Study

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jcem.86.3.7291 ◽

2001 ◽

Vol 86 (3) ◽

pp. 1110-1115 ◽

Cited By ~ 123

Author(s):

Fabio Monzani ◽

Vitantonio Di Bello ◽

Nadia Caraccio ◽

Alessio Bertini ◽

Davide Giorgi ◽

...

Keyword(s):

Cardiac Function ◽

Subclinical Hypothyroidism ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo

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No evidence that frailty modifies the positive impact of antihypertensive treatment in very elderly people: an investigation of the impact of frailty upon treatment effect in the HYpertension in the Very Elderly Trial (HYVET) study, a double-blind, placebo-controlled study of antihypertensives in people with hypertension aged 80 and over

BMC Medicine ◽

10.1186/s12916-015-0328-1 ◽

2015 ◽

Vol 13 (1) ◽

Cited By ~ 133

Author(s):

Jane Warwick ◽

Emanuela Falaschetti ◽

Kenneth Rockwood ◽

Arnold Mitnitski ◽

Lutgarde Thijs ◽

...

Keyword(s):

Treatment Effect ◽

Antihypertensive Treatment ◽

Positive Impact ◽

Controlled Study ◽

80 And Over ◽

Very Elderly ◽

Aged 80 And Over ◽

Double Blind ◽

Double Blind Placebo ◽

The Impact

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Amlodipine reduces myocardial ischaemia during exercise without compromising left ventricular function in patients with silent ischaemia: a randomised, double-blind, placebo-controlled study

European Journal of Heart Failure ◽

10.1016/s1388-9842(99)00052-5 ◽

1999 ◽

Vol 1 (4) ◽

pp. 395-400 ◽

Cited By ~ 2

Author(s):

Jan Bech ◽

Jan Kyst Madsen ◽

Henning Kelbaek

Keyword(s):

Left Ventricular Function ◽

Ventricular Function ◽

Myocardial Ischaemia ◽

Left Ventricular ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Silent Ischaemia

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EFFECT OF THYROID HORMONE REPLACEMENT ON METHIONINE-STIMULATED HOMOCYSTEINE LEVELS IN PATIENTS WITH SUBCLINICAL HYPOTHYROIDISM: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Endocrine Practice ◽

10.4158/ep.12.5.529 ◽

2006 ◽

Vol 12 (5) ◽

pp. 529-534 ◽

Cited By ~ 6

Author(s):

Shon Meek ◽

Robert C. Smallridge

Keyword(s):

Thyroid Hormone ◽

Subclinical Hypothyroidism ◽

Hormone Replacement ◽

Controlled Study ◽

Double Blind ◽

Thyroid Hormone Replacement ◽

Double Blind Placebo

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Left ventricular end-diastolic dimensions measured at the P wave and Q wave during a randomized, double-blind one-year follow-up study comparing the effect of atenolol vs. hydrochlorothiazide + amiloride on blood pressure in men with mild to moderate hypertension

Scandinavian Journal of Clinical and Laboratory Investigation ◽

10.3109/00365519309088402 ◽

1993 ◽

Vol 53 (2) ◽

pp. 155-162

Author(s):

J. E. Otterstad ◽

G. Froeland ◽

J. Erikssen

Keyword(s):

Blood Pressure ◽

Moderate Hypertension ◽

Left Ventricular ◽

P Wave ◽

Double Blind ◽

Follow Up Study ◽

One Year ◽

Q Wave

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A double-blind randomized placebo-controlled study of relapse prevention in remitted first-episode psychosis patients following one year of maintenance therapy

Schizophrenia Research ◽

10.1016/j.schres.2007.12.020 ◽

2008 ◽

Vol 98 ◽

pp. 11-12 ◽

Cited By ~ 1

Author(s):

E.Y.H. Chen ◽

C.L.M. Hui ◽

M. Lam ◽

C.W. Law ◽

C.P.Y. Chiu ◽

...

Keyword(s):

Maintenance Therapy ◽

Relapse Prevention ◽

First Episode Psychosis ◽

Controlled Study ◽

First Episode ◽

Double Blind ◽

Episode Psychosis ◽

One Year

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A phase III, randomized, double-blind, placebo (Pla)-controlled study of pertuzumab (P) + trastuzumab (H) + docetaxel (D) versus Pla + H+ D in previously untreated HER2-positive locally recurrent/metastatic breast cancer (LR/MBC) (PUFFIN).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.1026 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 1026-1026 ◽

Cited By ~ 3

Author(s):

Binghe Xu ◽

Wei Li ◽

Qingyuan Zhang ◽

Shao Zhimin ◽

Wang Xiao Jia ◽

...

Keyword(s):

Primary Endpoint ◽

Objective Response ◽

Metastatic Breast ◽

Left Ventricular ◽

Phase Iii ◽

Left Ventricular Ejection ◽

Controlled Study ◽

Her2 Positive ◽

Double Blind ◽

Ventricular Ejection Fraction

1026 Background: In CLEOPATRA (NCT00567190), adding P to H + D significantly improved progression-free and overall survival (PFS/OS) v Pla + H + D in patients (pts) with previously untreated HER2-positive LR/MBC. PUFFIN (NCT02896855) is a China bridging study; the objective being to assess consistency of efficacy with CLEOPATRA. Methods: Pts with previously untreated HER2-positive LR/MBC were randomized 1:1 to P + H + D or Pla + H + D, stratified by visceral v non-visceral disease and hormone receptor status. The primary endpoint was investigator-assessed PFS. Secondary endpoints included objective response rate (ORR in pts with measurable baseline disease), OS, and safety. The target sample size (240) was determined based on the consistency threshold for PFS, defined as hazard ratio (HR) < 0.81, which maintains ≥ 50% of the risk reduction determined in CLEOPATRA (HR 0.62). Results: Two hundred forty-three pts were randomized. Baseline/disease characteristics and prior therapies were generally balanced between arms. For PFS, the HR was 0.69 (95% CI 0.49, 0.99) in the ITT population. No cases of heart failure or symptomatic left ventricular ejection fraction decline were reported. Efficacy/safety are shown in the table. Conclusions: PUFFIN met its primary endpoint. Overall, efficacy data were consistent with CLEOPATRA (ITT population and Asian subgroup). Safety was also consistent and in line with the known P safety profile, with no new or unexpected signals reported. PUFFIN adds to the totality of data with P in previously untreated HER2-positive LR/MBC, and supports the favorable benefit–risk profile of P in Chinese pts. Clinical trial information: NCT02896855. [Table: see text]

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