NHS green light for £1.40-a-day heart pill that could save lives of thousands of suffering from common heart condition, trumpets the Daily Mail.
The dug, Ivabradine, is claimed to improve heart function and reduce tachycardia, while not reducing blood pressure – I’ll come back to that last claim – and is recommended for people who, like me, can’t tolerate beta-blockers. Obviously, then I’m interested in this drug, and I set out to find out more about it. It didn’t go well.
This drug was authorised for the treatment of angina in 2005 (source: European Medicines Agency ), and yet, internationally, it’s quite remarkable for the fact that, in 7 years, the amount of information about it that has been amassed is effectively zero (other than that it was authorised for heart failure in March of this year – EMA again). My preferred resource for drugs information, http://www.drugs.com/ has absolutely nothing beyond the fact that it exists. The only information I’ve found came from the EMA.
In the Mail article, a GP is quoted as saying “We have proof that it works, it’s safe and the drug is beneficial.” Well, I’ve looked at a summary of the research (see this PDF document ), and I’m unconvinced.
What concerns me most is the size of the test populations, most of which were below the statistically-critical 1,000. 1,000 is the figure at which results are returned that are considered statistically reliable, the further below that figure you go, the more unreliable the results become – one test population was a mere 360 people, and it’s not as if there’s any shortage of people with heart failure, around 100,000 of us die every year.
A study in which Ivabradine was compared with a placebo had a population of 6,558 so people were obviously available. I’d have been more impressed, though, if that study had compared it with Digoxin, which is similar in effect, in that it improves heart function and reduces tachycardia (though its effect on tachycardia is much slower than with beta-blockers).
One of the few facts I have been able to establish, from the above PDF, is that it must not be prescribed for patients with very low blood pressure. Can this be because it does have a lowering effect on blood pressure?
Another PDF from the EMA site is the Summary of Product Characteristics which demonstrates, on pages 7 and 8, that while it’s not as beset by side effects as some other drugs, it most certainly is NOT as safe as claimed, and the reason for its ban in patients with very low blood pressure is that a Common adverse reaction(≥1/100 to <1/10), is “Uncontrolled blood pressure,” which I seriously doubt will improve the health of any heart failure patients. Hypotension (low blood pressure), is listed as Uncommon (≥1/1,000 to <1/100), and Bradycardia (slow heartbeat), is also listed as Common.
Obviously, then, there is considerable scope for this causing severe, perhaps life-threatening, side-effects in patients unfortunate enough to fall victim to a particular combination of side effects, so claiming it as “safe” is, in my view, overly optimistic, if not a blatant lie. It does have the capacity to be safe, for some patients, but equally it can be hazardous for others. Like most drugs, in fact. And, as always it’s a trade-off between benefits and risks – but to tag it, unqualified, as “safe” is, in my view, wrong, as it would be for any drug. I don’t have a single drug in my personal pharmacopoeia that I’d consider safe. All are capable of causing severe problems. And even the humble aspirin can kill.
All things considered, I’d be willing to give this a try, though I really want more information on exactly what is meant by “Uncontrolled blood pressure”. That’s dangerously vague. I mean, does the b-p soar stroke-inducingly upwards, or crash catastrophically, causing death? Or does it just fluctuate a bit? I want to know exactly what might happen.
There are remarkably few adverse drug interactions, but that could be because there are few patients on this drug ( according to the Mail about 20,000 presumably in the UK, though it doesn’t say). And I’m still worried by the fact that information is so scarce
But if you’re thinking of rushing out to your GP for a prescription, you’ll probably be unlucky – the Mail’s article ends with this, from the bean-counters at NICE:-
‘In clinical trials Ivabradine has been shown to have a beneficial effect in reducing mortality and improving quality of life in people with some types of chronic heart failure.
‘The Committee was mindful that there is robust evidence for the effectiveness of ACE inhibitors, beta-blockers and Aldosterone antagonists that are used routinely in managing heart failure.
‘They concluded that Ivabradine should be initiated only after optimal treatment with these drugs has been achieved when patients are still symptomatic after receiving optimised initial therapies, or when beta-blockers are contraindicated as specified in the marketing authorisation or not tolerated by the patients.’
So don’t be surprised if your GP says no.
Finally, a search of the FDA** drugs list came up blank, suggesting that Ivabradine has not yet been approved.
**FDA = the US Food and Drugs Administration not, as is often wrongly believed in the UK, Federal Drugs Administration.