Can you take metformin if you are not diabetic?

Metformin—a safe and inexpensive glucose-lowering drug—is sometimes used to treat non-diabetic people with polycystic ovarian syndrome, for aiding weight loss, and for some people with impaired glucose tolerance, partly on the basis of its purported cardiovascular benefits.

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All participants provided written informed consent and were followed up for 18 months. This study was approved by the Medicines and Healthcare Products Regulatory Agency and West Glasgow Research Ethics Committee, and done in accordance with the principles of the Declaration of Helsinki and good clinical practice guidelines. CAMERA was a randomised, placebo-controlled, double-blind trial done at the Glasgow Clinical Research Centre (Glasgow, UK). Inclusion criteria were: age 35–75 years, proven coronary heart disease (previous acute coronary syndrome, coronary artery bypass surgery, or angiographically proven coronary heart disease), large waist circumference as per International Diabetes Foundation criteria (≥94 cm in men, ≥80 cm in women),and prescribed a statin (dose and type were not adjusted). Exclusion criteria were: pregnancy or lactation at screening; premenopausal woman not taking adequate contraception (daily oral hormonal contraception or regular injectable hormonal contraception); type 2 diabetes or people with either HbAof 7·0% (53 mmol/mol) or more, or fasting plasma glucose of 7·0 mmol/L or more at screening; acute coronary syndrome within the previous 3 months; New York Heart Association functional class 3 or 4 heart failure; uncontrolled angina; hepatic impairment (based on assessment of available liver function tests and liver imaging by the study physician but not on biochemical thresholds); renal impairment (estimated glomerular filtration rate <45 mL/min per 1·73 mat screening); hypersensitivity to metformin; acute illness (dehydration, severe infection, shock, acute cardiac failure); and suspected tissue hypoxia. People with HbA6·0–6·9% (42–52 mmol/mol) and fasting plasma glucose less than 7·0 mmol/L at screening had an oral glucose tolerance test; those with post-challenge glucose of 11·1 mmol/L or more were excluded. The trial was designed before the adoption of HbAas a diagnostic test for type 2 diabetes. Participants were randomly assigned to metformin or placebo (1:1) on the CAMERA website. The randomisation sequence was generated independently by computer (by the Robertson Centre for Biostatistics) with permuted blocks of four without stratification. Patients, investigators, trial staff, and statisticians were masked to treatment allocation.

Procedures

Participants were advised to take one study tablet (850 mg metformin or matching placebo) daily for 1 week before titrating up to 2 tablets daily (one with the morning meal, one with the evening meal). Participants unable or unwilling to take the medication twice daily could take one tablet daily from any point. Masked study medication was supplied in numbered bottles and compliance (defined as taking >80% of study medication during the trial) was assessed by tablet count. Study medication was reduced to one tablet daily if estimated glomerular filtration rate fell below 45 mL/min per 1·73 m2, and stopped below 30 mL/min per 1·73 m2.

17 Touboul PJ

Hennerici MG

Meairs S

et al. Mannheim intima-media thickness consensus. 18 Liang Q

Wendelhag I

Wikstrand J

Gustavsson T A multiscale dynamic programming procedure for boundary detection in ultrasonic artery images. For assessment of mean cIMT, carotid artery scans were done at baseline, 12 months, and 18 months. The imaging protocol consisted of B-mode ultrasound image acquisition of the right and left far walls of the distal 10 mm of the common carotid arteries, using an Acuson Sequoia C512 (Siemens Medical Solutions; Erlangen, Germany) with an L8 5–12 MHz linear array broadband transducer, and electrocardiogram gating.All images were obtained from a single ultrasound machine by one doctor (DP). Participants were positioned recumbent with the head tilted 10° to the contralateral side. On each side of the neck, three digital clips were recorded from lateral, posterolateral, and anterolateral angles, each clip including roughly three QRS complexes. Depending on image quality, up to 18 cIMT images (in end-diastolic frame) were available from each visit for analysis of mean cIMT. Mean left-side and right-side cIMT were calculated separately and averaged to give the overall mean cIMT. Participants in whom only one side could be assessed at baseline had the same side analysed throughout. Images were analysed when all study visits had been completed by a single researcher using semiautomated artery measurement softwareor a combination of semiautomated and manual approaches depending on image quality. Pretrial intra-individual cIMT reproducibility was 7%. 19 Spence JD Measurement of intima-media thickness vs. carotid plaque: uses in patient care, genetic research and evaluation of new therapies. Carotid plaque score—a value of 0–6 depending on plaque presence in six regions—was assessed by transverse and longitudinal transducer positioning. Presence of plaque was assessed in three regions for both left and right carotid arteries (ie, six regions): distal 10 mm of the common carotid artery, carotid bulb (from the widening of the common carotid artery to the flow divider), and proximal 10 mm of the internal carotid artery (distal from the flow divider). Plaque was defined as cIMT of 1·5 mm or more, or 0·5 mm or more focal encroachment into the arterial lumen. Plaques in the entire common carotid artery and internal carotid artery were also recorded for a sensitivity analysis to avoid any effect of variations in the selection of the 10 mm boundaries. Other plaque surrogate markers (carotid plaque area and carotid plaque volume) have been proposed;however, we did not use them because of concern about potential subjectivity of carotid plaque area and the requirement for experience in operating specialised equipment to assess carotid plaque volume.

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1c , fasting lipid profile, high sensitivity C-reactive protein, fasting insulin, vitamin B12, tissue plasminogen activator, and high sensitivity troponin T. With the exception of insulin, vitamin B12, tissue plasminogen activator, and high sensitivity troponin T, all biochemical and haematology analyses were done at Gartnavel General Hospital, Glasgow, UK, with strict quality control procedures and where all assays (Abbott Diagnostics, North Chicago, IL) performed acceptably according to UK National External Quality Assessment Service, our external quality assurance scheme. Vitamin B12 and high sensitivity troponin T were analysed from stored plasma samples with an automated clinically validated analyser (Roche Diagnostics; Burgess Hill, UK) and manufacturer standards and quality control material; the low control coefficient of variation was 8·1% for vitamin B12 and 8·3% for high sensitivity troponin T and high control coefficient of variation was 10·4% for vitamin B12 and 5·7% for high sensitivity troponin T. Concentrations for insulin and tissue plasminogen activator were also measured from stored samples with commercial ELISAs (Mercodia, Diagenics Bletchley, UK; and Stago, Theale, UK). Intra-assay coefficient of variation was 5·5% for insulin and 8·4% for tissue plasminogen activator, and interassay coefficient of variation was 9·7% for insulin and 6·2% for tissue plasminogen activator. We calculated homoeostasis model assessment of insulin resistance (HOMA-IR; fasting plasma glucose [mmol/L]×fasting insulin [mU/L])/22·5) and estimated glomerular filtration rate (with abbreviated Modification of Diet in Renal Disease equation 20 Levey AS

Bosch JP

Lewis JB

Greene T

Rogers N

Roth D A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Laboratory assessments measured at every visit included renal and liver function tests and—at every 6 month visit—fasting plasma glucose, HbA, fasting lipid profile, high sensitivity C-reactive protein, fasting insulin, vitamin B12, tissue plasminogen activator, and high sensitivity troponin T. With the exception of insulin, vitamin B12, tissue plasminogen activator, and high sensitivity troponin T, all biochemical and haematology analyses were done at Gartnavel General Hospital, Glasgow, UK, with strict quality control procedures and where all assays (Abbott Diagnostics, North Chicago, IL) performed acceptably according to UK National External Quality Assessment Service, our external quality assurance scheme. Vitamin B12 and high sensitivity troponin T were analysed from stored plasma samples with an automated clinically validated analyser (Roche Diagnostics; Burgess Hill, UK) and manufacturer standards and quality control material; the low control coefficient of variation was 8·1% for vitamin B12 and 8·3% for high sensitivity troponin T and high control coefficient of variation was 10·4% for vitamin B12 and 5·7% for high sensitivity troponin T. Concentrations for insulin and tissue plasminogen activator were also measured from stored samples with commercial ELISAs (Mercodia, Diagenics Bletchley, UK; and Stago, Theale, UK). Intra-assay coefficient of variation was 5·5% for insulin and 8·4% for tissue plasminogen activator, and interassay coefficient of variation was 9·7% for insulin and 6·2% for tissue plasminogen activator. We calculated homoeostasis model assessment of insulin resistance (HOMA-IR; fasting plasma glucose [mmol/L]×fasting insulin [mU/L])/22·5) and estimated glomerular filtration rate (with abbreviated Modification of Diet in Renal Disease equation). Vital signs (blood pressure, pulse, bodyweight, body fat by bio-impedance with a Tanita BIA body fat analyser [Tanita Corporation, Tokyo, Japan]), waist circumference (measured midway between lowest rib and iliac crest), and hip circumference (measured around widest part of the buttocks) were measured at each visit. Participants were asked about adverse events and serious adverse events at each visit. Serious adverse events were recorded from paper and electronic hospital records but were not independently reviewed.

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